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Hyrimoz

  • Generic Name: alimumab-adaz injection
  • Brand Name: Hyrimoz
  • Drug Class: DMARDs, TNF Inhibitors
Reviewed by Medsayfa.com Last updated July 17, 2023

Patient Information

HYRIMOZ®
(hye-RI-moze)
(adalimumab-adaz) injection, for subcutaneous use

Read the Medication Guide that comes with HYRIMOZ before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about HYRIMOZ?

HYRIMOZ is a medicine that affects your immune system. HYRIMOZ can lower the ability of your immune system to fight infections.

Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body.

Some people have died from these infections.

  • Your doctor should test you for TB before starting HYRIMOZ.
  • Your doctor should check you closely for signs and symptoms of TB during treatment with HYRIMOZ.

You should not start taking HYRIMOZ if you have any kind of infection unless your doctor says it is okay.

Before starting HYRIMOZ, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweats or chills
    • warm, red, or painful skin or sores on your body
    • muscle aches
    • diarrhea or stomach pain
    • cough
    • burning when you urinate or urinate more often than normal
    • shortness of breath
    • feel very tired
    • blood in phlegm
    • weight loss
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have diabetes.
  • have TB, or have been in close contact with someone with TB.
  • were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
  • live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use HYRIMOZ. Ask your doctor if you do not know if you have lived in an area where these infections are common.
  • have or have had hepatitis B.
  • use the medicine ORENCIA® (abatacept), KINERET® (anakinra), RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (6–mercaptopurine, 6-MP).
  • are scheduled to have major surgery.

After starting HYRIMOZ, call your doctor right away if you have an infection, or any sign of an infection. HYRIMOZ can make you more likely to get infections or make any infection that you may have worse.

Cancer

  • For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including HYRIMOZ, the chances of getting cancer may increase.
  • There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.
  • People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
  • If you use TNF-blockers including HYRIMOZ your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that does not heal.
  • Some people receiving TNF-blockers including HYRIMOZ developed a rare type of cancer called hepatosplenic Tcell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN® (azathioprine) or PURINETHOL® (6-mercaptopurine, 6–MP).

What is HYRIMOZ?

HYRIMOZ is a medicine called a Tumor Necrosis Factor (TNF)-blocker. HYRIMOZ is used:

  • To reduce the signs and symptoms of:
    • moderate to severe rheumatoid arthritis (RA) in adults. HYRIMOZ can be used alone, with methotrexate, or with certain other medicines.
    • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. HYRIMOZ can be used alone or with methotrexate.
    • psoriatic arthritis (PsA) in adults. HYRIMOZ can be used alone or with certain other medicines.
    • ankylosing spondylitis (AS) in adults.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
  • To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).

What should I tell my doctor before taking HYRIMOZ?

HYRIMOZ may not be right for you. Before starting HYRIMOZ, tell your doctor about all of your medical conditions, including if you:

  • have an infection. See “What is the most important information I should know about HYRIMOZ?”
  • have or have had cancer.
  • have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
  • have or had heart failure.
  • have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using HYRIMOZ. Children should be brought up to date with all vaccines before starting HYRIMOZ.
  • are allergic to HYRIMOZ or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in HYRIMOZ.
  • are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your doctor should decide if you should take HYRIMOZ while you are pregnant or breastfeeding.
  • have a baby and you were using HYRIMOZ during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you use:

  • ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol) or SIMPONI® (golimumab), because you should not use HYRIMOZ while you are also using one of these medicines.
  • RITUXAN® (rituximab). Your doctor may not want to give you HYRIMOZ if you have received RITUXAN® (rituximab) recently.
  • IMURAN® (azathioprine) or PURINETHOL® (6–mercaptopurine, 6-MP).

Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take HYRIMOZ?

  • HYRIMOZ is given by an injection under the skin. Your doctor will tell you how often to take an injection of HYRIMOZ. This is based on your condition to be treated. Do not inject HYRIMOZ more often than you were prescribed.
  • See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject HYRIMOZ.
  • Make sure you have been shown how to inject HYRIMOZ before you do it yourself. You can call your doctor or 1- 800-525-8747 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject HYRIMOZ.
  • Do not try to inject HYRIMOZ yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of HYRIMOZ at home, you should receive training on the right way to prepare and inject HYRIMOZ.
  • Do not miss any doses of HYRIMOZ unless your doctor says it is okay. If you forget to take HYRIMOZ, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject HYRIMOZ, call your doctor or pharmacist.
  • If you take more HYRIMOZ than you were told to take, call your doctor.

What are the possible side effects of HYRIMOZ?

HYRIMOZ can cause serious side effects, including:

See “What is the most important information I should know about HYRIMOZ?”

  • Serious Infections. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with HYRIMOZ and during treatment with HYRIMOZ. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking HYRIMOZ. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking HYRIMOZ:
    • cough that does not go away
    • weight loss
    • low grade fever
    • loss of body fat and muscle (wasting)
  • Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use HYRIMOZ. Your doctor should do blood tests before you start treatment, while you are using HYRIMOZ, and for several months after you stop treatment with HYRIMOZ. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
    • muscle aches
    • clay-colored bowel movements
    • feel very tired
    • fever
    • dark urine
    • chills
    • skin or eyes look yellow
    • stomach discomfort
    • little or no appetite
    • skin rash
    • vomiting
  • Allergic reactions. Allergic reactions can happen in people who use HYRIMOZ. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:
    • hives
    • swelling of your face, eyes, lips or mouth
    • trouble breathing
  • Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
  • New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking HYRIMOZ, including:
    • shortness of breath
    • swelling of your ankles or feet
    • sudden weight gain
  • Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop HYRIMOZ.
  • Liver Problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
    • feel very tired
    • skin or eyes look yellow
    • poor appetite or vomiting
    • pain on the right side of your stomach(abdomen)
  • Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with HYRIMOZ.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with HYRIMOZ may be stopped.

The most common side effects of HYRIMOZ include:

  • injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your doctor right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
  • upper respiratory infections (including sinus infections).
    • headaches.
    • rash.

These are not all the possible side effects with HYRIMOZ. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store HYRIMOZ?

  • Store HYRIMOZ in the refrigerator at 36°F to 46°F (2°C to 8°C). Store HYRIMOZ in the original carton until use to protect it from light.
  • Do not freeze HYRIMOZ. Do not use HYRIMOZ if frozen, even if it has been thawed.
  • Refrigerated HYRIMOZ may be used until the expiration date printed on the carton of the HYRIMOZ single-dose prefilled Sensoready Pen or the HYRIMOZ single-dose prefilled syringe. Do not use HYRIMOZ after the expiration date.
  • If needed, for example when you are traveling, you may also store the HYRIMOZ 40 mg/0.8 mL single-dose prefilled Sensoready Pen or single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard, the HYRIMOZ 20 mg/0.4 mL single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard or the HYRIMOZ 10 mg/0.2 mL single-dose prefilled syringe at room temperature up to 77°F (25°C) for up to 21 days and HYRIMOZ 80 mg/0.8 mL single-dose prefilled Sensoready Pen or single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard, HYRIMOZ 40 mg/0.4 mL single-dose prefilled Sensoready Pen or single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard, HYRIMOZ 20 mg/0.2 mL single-dose prefilled syringe and HYRIMOZ 10 mg/0.1 mL single-dose prefilled syringe for up to 14 days. Store HYRIMOZ in the original carton until use to protect it from light. Throw away HYRIMOZ 40 mg/0.8 mL, HYRIMOZ 20 mg/0.4 mL and HYRIMOZ 10 mg/0.2 mL if it has been kept at room temperature and not been used within 21 days. Throw away HYRIMOZ 80 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL and 10 mg/0.1 mL if it has been kept at room temperature and not been used within 14 days.
  • Record the date you first remove HYRIMOZ from the refrigerator in the spaces provided on the carton.
  • Do not store HYRIMOZ in extreme heat or cold.
  • The solution should be clear and colorless or slightly yellowish. Do not use HYRIMOZ if the solution is cloudy, discolored, or has flakes or particles in it.
  • Do not drop or crush HYRIMOZ. The prefilled syringe is glass.
  • The prefilled syringes and injection devices are not made with natural rubber latex.

Keep HYRIMOZ, injection supplies, and all other medicines out of the reach of children.

General information about the safe and effective use of HYRIMOZ.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use HYRIMOZ for a condition for which it was not prescribed. Do not give HYRIMOZ to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about HYRIMOZ. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about HYRIMOZ that is written for health professionals.

What are the ingredients in HYRIMOZ?

Active ingredient: adalimumab-adaz

HYRIMOZ single-dose prefilled Sensoready Pen 40 mg/0.8 mL, HYRIMOZ single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard 40 mg/0.8 mL, HYRIMOZ single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard 20 mg/0.4 mL and HYRIMOZ 10 mg/0.2 mL single-dose prefilled syringe:

Inactive ingredients: adipic acid, citric acid monohydrate, mannitol, polysorbate 80, sodium chloride, and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.

HYRIMOZ single-dose prefilled Sensoready Pen 80 mg/0.8 mL and 40 mg/0.4 mL, HYRIMOZ single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard 80 mg/0.8 mL and 40 mg/0.4 mL and HYRIMOZ single-dose prefilled syringe 20 mg/0.2 mL and 10 mg/0.1 mL.

Inactive ingredients: adipic acid, mannitol, polysorbate 80, and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.

INSTRUCTIONS FOR USE

HYRIMOZ®
(hye-RI-moze) (adalimumab-adaz) 40 mg/0.8 mL 20 mg/0.4 mL

Single-dose prefilled Syringe with BD UltraSafe Passive™ Needle Guard and finger flange injection, for subcutaneous use

To help avoid possible infections and to ensure that you use HYRIMOZ correctly, it is important that you follow these instructions.

Be sure that you read, understand, and follow this Instructions for Use before injecting HYRIMOZ. Your doctor should show you how to prepare and inject HYRIMOZ properly using the HYRIMOZ single-dose prefilled syringe before you use it for the first time. Talk to your doctor if you have any questions.

Figure A: HYRIMOZ prefilled syringe with BD UltraSafe Passive™ Needle Guard and finger flange

HYRIMOZ prefilled syringe with BD UltraSafe Passive™ Needle Guard and finger flange - Illustration

 

It is important that you:

  • do not use the prefilled syringe if the seals of the blister are broken, as it may not be safe for you to use.
  • do not open the outer box until you are ready to use the prefilled syringe.
  • never leave the prefilled syringe unattended where others might misuse it.
  • do not remove the needle cap until just before you give the injection.
  • be careful not to touch the needle guard wings before use. Touching them may cause the needle guard to be activated too early.
  • do not remove the finger flange before the injection.
  • inject HYRIMOZ 15 to 30 minutes after taking it out of the refrigerator for a more comfortable injection.
  • throw away (dispose of) the used prefilled syringe right away after use. Do not re-use a prefilled syringe. See “4. Disposing of used prefilled syringes” at the end of this Instructions for Use.

Note: HYRIMOZ prefilled syringe and injection device are not made with natural rubber latex.

How should you store HYRIMOZ single-dose prefilled syringe?

  • Store your outer carton of prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • If needed, for example if you are traveling, you may store the prefilled syringe at room temperature up to 77°F (25°C) for up to 21 days.
  • Throw away the prefilled syringe that has been stored at room temperature after 21 days.
  • Record the date you first remove HYRIMOZ from the refrigerator in the spaces provided on the carton.
  • Keep your prefilled syringes in the original carton until ready to use to protect from light.
  • Do not store your prefilled syringes in extreme heat or cold.
  • Do not freeze your prefilled syringes.
  • Do not drop or crush HYRIMOZ. The prefilled syringe is glass.

Keep HYRIMOZ and all medicines out of the reach of children.

What do you need for your injection?

Included in your prefilled syringe carton are:

  • HYRIMOZ prefilled syringes (see Figure A). Each prefilled syringe contains 40 mg/0.8 mL or 20 mg/0.4 mL of adalimumab-adaz.

Not included in your HYRIMOZ prefilled syringe carton are:

  • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container. See “4. Disposing of used prefilled syringes” at the end of this Instructions for Use.
  • Adhesive bandage

Figure B: Items not included in the carton

Items not included in the carton - Illustration

 

Before your injection

Figure C: Needle guard is not activated – the single-dose prefilled syringe is ready for use

Needle guard is not activated – the single-dose prefilled syringe is ready for use - Illustration

 

  • In Figure C the needle guard is not activated.
  • The prefilled syringe is ready for use (see Figure C).

Figure D: Needle guard is activated – do not use

Needle guard is activated – do not use - Illustration

 

  • In Figure D the needle guard of your prefilled syringe is activated.
  • Do not use the prefilled syringe (see Figure D).

Preparing the prefilled syringe

  • For a more comfortable injection, take the carton containing the prefilled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes to allow it to reach room temperature. Do not try to warm the prefilled syringe by using a heat source such as hot water or a microwave.
  • Take the prefilled syringe out of the blister. The solution should be clear and colorless or slightly yellowish. Do not use a prefilled syringe if the solution is cloudy, discolored, or has flakes or particles in it. If you are not sure what color the solution should be, contact your pharmacist for help.
  • Do not use the prefilled syringe if it is broken or the needle guard is activated. Return the prefilled syringe and the package it came in to the pharmacy.
  • Look at the expiration date (EXP) on your prefilled syringe. Do not use your prefilled syringe if the expiration date has passed.

Contact your pharmacist if:

  • you are unsure about the color of the solution in the prefilled syringe.
  • the prefilled syringe is broken or the needle guard is activated.
  • the expiration date has passed.

1. Choosing your injection site

  • The recommended injection site is the front of your thighs. You may also use the lower abdomen, but not the area 2 inches (5 cm) around your navel (belly button) (see Figure E).
  • Choose a different site each time you give yourself an injection.
  • Do not inject into areas where the skin is tender, bruised red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should not inject directly into areas with psoriasis plaques.

Figure E: Choose Your Injection Site

Choose Your Injection Site - Illustration

 

2. Cleaning your injection site

  • Wash your hands well with soap and water.
  • Using a circular motion, clean the injection site with an alcohol wipe. Allow the skin to dry before injecting (see Figure F). Do not fan or blow on the cleaned area.
  • Do not touch the cleaned area before injecting.

Figure F: Clean Your Injection Site

Clean Your Injection Site - Illustration

 

3. Giving your injection

  • Carefully pull the needle cap straight off to remove it from the prefilled syringe (see Figure G).
  • Throw away (discard) the needle cap.
  • You may see a drop of liquid at the end of the needle. This is normal.

Figure G: Pull The Needle Cap Off

Pull The Needle Cap Off - Illustration

 

  • Gently pinch the skin at the injection site (see Figure H).
  • Insert the needle into your skin as shown.
  • Push the needle all the way in to ensure that the medicine can be fully given.

Figure H: Insert The Needle

Insert The Needle - Illustration

 

  • Hold the single-dose prefilled syringe as shown (see Figure I).
  • Slowly press down on the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.
  • Continue to press fully on the plunger while you hold the syringe in place for 5 seconds.

Figure I: Hold The Syringe

Hold The Syringe - Illustration

 

Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J).

Figure J: Lift The Needle Straight Out

Lift The Needle Straight Out - Illustration

 

  • Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K).
  • There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Figure K: Slowly Release The Plunger

Slowly Release The Plunger - Illustration

 

4. Disposing of used prefilled syringes

  • Put your used prefilled syringe in an FDA-cleared sharps disposal container right away after use (see Figure L). Do not throw away (dispose of) any prefilled syringes in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps container is almost full, you will need to follow your community guidelines, for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes, needles and prefilled syringe. For more information about safe sharps disposal, and for specific Figure L dispose of your used prefilled syringe information about sharps disposal, in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal

Figure L : Dispose of your used prefilled syringe

Dispose of your used prefilled syringe - Illustration

 

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

INSTRUCTIONS FOR USE

HYRIMOZ®
(hye-RI-moze) (adalimumab-adaz) 80 mg/0.8 mL, 40 mg/0.4 mL

Single-dose prefilled Syringe with BD UltraSafe Passive™ Needle Guard and finger flange injection, for subcutaneous use

To help avoid possible infections and to ensure that you use HYRIMOZ correctly, it is important that you follow these instructions.

Be sure that you read, understand, and follow this Instructions for Use before injecting HYRIMOZ. Your doctor should show you how to prepare and inject HYRIMOZ properly using the HYRIMOZ single-dose prefilled syringe before you use it for the first time. Talk to your doctor if you have any questions.

Figure A: HYRIMOZ prefilled syringe with BD UltraSafe Passive™ Needle Guard and finger flange

HYRIMOZ prefilled syringe with BD UltraSafe Passive™ Needle Guard and finger flange - Illustration

 

It is important that you:

  • do not use the prefilled syringe if the seals of the blister are broken, as it may not be safe for you to use.
  • do not open the outer box until you are ready to use the prefilled syringe.
  • never leave the prefilled syringe unattended where others might misuse it.
  • do not remove the needle cap until just before you give the injection.
  • be careful not to touch the needle guard wings before use. Touching them may cause the needle guard to be activated too early.
  • do not remove the finger flange before the injection.
  • inject HYRIMOZ 15 to 30 minutes after taking it out of the refrigerator for a more comfortable injection.
  • throw away (dispose of) the used prefilled syringe right away after use. Do not re-use a prefilled syringe. See “4. Disposing of used prefilled syringes” at the end of this Instructions for Use.

Note: HYRIMOZ prefilled syringe and injection device are not made with natural rubber latex

How should you store HYRIMOZ single-dose prefilled syringe?

  • Store your outer carton of prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • If needed, for example if you are traveling, you may store the prefilled syringe at room temperature up to 77°F (25°C) for up to 14 days.
  • Throw away the prefilled syringe that has been stored at room temperature after 14 days.
  • Record the date you first remove HYRIMOZ from the refrigerator in the spaces provided on the carton.
  • Keep your prefilled syringes in the original carton until ready to use to protect from light.
  • Do not store your prefilled syringes in extreme heat or cold.
  • Do not freeze your prefilled syringes.
  • Do not drop or crush HYRIMOZ. The prefilled syringe is glass.

Keep HYRIMOZ and all medicines out of the reach of children.

What do you need for your injection?

Included in your prefilled syringe carton are:

  • HYRIMOZ prefilled syringes (see Figure A). Each prefilled syringe contains 80 mg/0.8 mL or 40 mg/0.4 mL of adalimumab-adaz.

Not included in your HYRIMOZ prefilled syringe carton are:

  • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container See “4. Disposing of used prefilled syringes” at the end of this Instructions for Use.
  • Adhesive bandage

Figure B: Items Not Included In The Carton

Items Not Included In The Carton - Illustration

 

Before your injection

Figure C: Needle Guard Is Not Activated – The Single-Dose Prefilled Syringe Is Ready For Use

Needle Guard Is Not Activated – The Single-Dose Prefilled Syringe Is Ready For Use - Illustration

 

  • In Figure C the needle guard is not activated.
  • The prefilled syringe is ready for use (see Figure C).

Figure D: Needle Guard Is Activated – Do Not Use

Needle Guard Is Activated – Do Not Use - Illustration

 

  • In Figure D the needle guard of your prefilled syringe is activated.
  • Do not use the prefilled syringe (see Figure D).

Preparing the prefilled syringe

  • For a more comfortable injection, take the carton containing the prefilled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes to allow it to reach room temperature. Do not try to warm the prefilled syringe by using a heat source such as hot water or a microwave.
  • Take the prefilled syringe out of the blister. The solution should be clear and colorless or slightly yellowish.  Do not use a prefilled syringe if the solution is cloudy, discolored, or has flakes or particles in it. If you are not sure what color the solution should be, contact your pharmacist for help.
  • Do not use the prefilled syringe if it is broken or the needle guard is activated. Return the prefilled syringe and the package it came in to the pharmacy.
  • Look at the expiration date (EXP) on your prefilled syringe. Do not use your prefilled syringe if the expiration date has passed.

Contact your pharmacist if:

  • you are unsure about the color of the solution in the prefilled syringe.
  • the prefilled syringe is broken or the needle guard is activated.
  • the expiration date has passed.

1. Choosing your injection site

The recommended injection site is the front of your thighs. You may also use the lower abdomen, but not the area 2 inches (5 cm) around your navel (belly button) (see Figure E).

Choose a different site each time you give yourself an injection.

Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should not inject directly into areas with psoriasis plaques.

Figure E: Choose Your Injection Site

Choose Your Injection Site - Illustration

 

2. Cleaning your injection site

  • Wash your hands well with soap and water.
  • Using a circular motion, clean the injection site with an alcohol wipe. Let it dry before injecting (see Figure F). Do not fan or blow on the cleaned area.
  • Do not touch the cleaned area before injecting.

Figure F: Clean your injection site

Clean your injection site - Illustration

 

3. Giving your injection

  • Carefully pull the needle cap straight off to remove it from the prefilled syringe (see Figure G).
  • Throw away (discard) the needle cap.
  • You may see a drop of liquid at the end of the needle. This is normal.

Figure G: Pull The Needle Cap Off

Pull The Needle Cap Off - Illustration

 

  • Gently pinch the skin at the injection site (see Figure H).
  • Insert the needle into your skin as shown.
  • Push the needle all the way in to ensure that the medicine can be fully given.

Figure H: Insert The Needle

Insert The Needle - Illustration

 

    • Hold the single-dose prefilled syringe as shown (see Figure I).
  • Slowly press down on the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.
  • Continue to press fully on the plunger while you hold the syringe in place for 5 seconds.

Figure I: Hold The Syringe

Hold The Syringe - Illustration

 

  • Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J).

Figure J: Lift The Needle Straight Out

Lift The Needle Straight Out - Illustration

 

  • Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K).
  • There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Figure K: Slowly Release The Plunger

Slowly Release The Plunger - Illustration

 

4. Disposing of used prefilled syringes

  • Put your used prefilled syringe in an FDA-cleared sharps disposal container right away after use (see Figure L). Do not throw away (dispose of) any prefilled syringes in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps container is almost full, you will need to follow your community guidelines, for the right way to dispose of your sharps disposal container. There may be a state or local laws about how you should throw away used syringes, needles and prefilled syringe. For more information about safe sharps disposal, and for specific information about sharps disposal, in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal
  • Do not dispose your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Figure L: Dispose of your used prefilled Syringe

Dispose of your used prefilled Syringe - Illustration

 

INSTRUCTIONS FOR USE

HYRIMOZ®
(hye-RI-moze) (adalimumab-adaz) 40 mg/0.8 mL

Single-dose prefilled Sensoready® Pen injection, for subcutaneous use

To help avoid possible infections and to ensure that you use HYRIMOZ correctly, it is important that you follow these instructions.

Be sure that you read, understand, and follow this Instructions for Use before injecting HYRIMOZ. Your doctor should show you how to prepare and inject HYRIMOZ properly using the HYRIMOZ single-dose prefilled Sensoready Pen before you use it for the first time. Talk to your doctor if you have any questions.

Figure A: HYRIMOZ Sensoready Pen parts

HYRIMOZ Sensoready Pen parts - Illustration

 

In Figure A, the Sensoready Pen is shown with the cap removed. Do not remove the cap until you are ready to inject.

It is important that you:

  • do not use the Sensoready Pen if either the seal on the outer carton or the safety seal on the Pen is broken.
  • keep your Sensoready Pen in the sealed outer carton until you are ready to use it.
  • do not use your Sensoready Pen, if you dropped it, it looks damaged, or if you dropped it with the cap removed.
  • inject HYRIMOZ 15 to 30 minutes after taking it out of the refrigerator for a more comfortable injection.
  • throw away (dispose of) the used Sensoready Pen right away after use. Do not reuse a Sensoready Pen. See “8. Disposing of used Sensoready Pens” at the end of this Instructions for Use.

Note: HYRIMOZ prefilled syringe and injection device are not made with natural rubber latex.

How should you store your Sensoready Pen?

  • Store your Sensoready Pen carton in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • If needed, for example if you are traveling, you may store your Sensoready Pen at room temperature at up to 77°F (25°C) for up to 21 days.
  • Throw away any Sensoready Pen that has been stored at room temperature after 21 days.
  • Record the date you first remove HYRIMOZ from the refrigerator in the spaces provided on the carton.
  • Keep your Sensoready Pen in the original carton until ready to use to protect from light.
  • Do not store your Sensoready Pen in extreme heat or cold.
  • Do not freeze your Sensoready Pen.
  • Do not drop or crush HYRIMOZ. Your Sensoready Pen contains glass.

Keep HYRIMOZ and all medicines out of the reach of children.

What do you need for your injection?

Included in your Sensoready Pen carton are:

  • HYRIMOZ prefilled Sensoready Pens (see Figure A). Each Sensoready Pen contains 40 mg/0.8 mL of adalimumab-adaz.

Not included in your Sensoready Pen carton are:

  • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container. See “8. Disposing of used Sensoready Pens” at the end of this Instructions for Use.
  • Adhesive bandage

Figure B: Items Not Included In The Carton

Items Not Included In The Carton - Illustration

 

Before your injection

Preparing the Sensoready Pen

  • For a more comfortable injection, take your Sensoready pen out of the refrigerator 15 to 30 minutes before injecting HYRIMOZ to allow it to reach room temperature. Do not try to warm the prefilled pen by using a heat source such as hot water or a microwave.
  • Look through the viewing window. The solution should be clear and colorless or slightly yellowish. Do not use your Sensoready Pen if the solution is cloudy, discolored, or has flakes or particles in it. You may see small air bubbles, which is normal. If you are not sure what color the solution should be, then contact your pharmacist for help.
  • Look at the expiration date (EXP) on your Sensoready Pen (see Figure C). Do not use your Sensoready Pen if the expiration date has passed.
  • Do not use if the safety seal has been broken.

Figure C: Safety Checks Before Injection

Safety Checks Before Injection - Illustration

 

Contact your pharmacist if:

  • you are unsure about the color of the solution in the Sensoready Pen.
  • the safety seal of your Sensoready Pen is broken.
  • the expiration date has passed.

1. Choosing your injection site

  • The recommended injection site is the front of your thighs. You may also use the lower abdomen, but not the area 2 inches (5 cm) around your navel (belly button) (see Figure D).
  • Choose a different site each time you give yourself an injection.
  • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.
  • If you have psoriasis, you should not inject directly into areas with psoriasis plaques.

Figure D: Choose Your Injection Site

Choose Your Injection Site - Illustration

 

2. Cleaning your injection site

  • Wash your hands well with soap and water.
  • Using a circular motion, clean the injection site with an alcohol wipe. Allow the skin to dry before injecting (see Figure E). Do not fan or blow on the cleaned area.
  • Do not touch the cleaned area again before injecting.

Figure E: Clean Your Injection Site

Clean Your Injection Site - Illustration

 

3. Removing the cap of your Sensoready Pen

  • Only remove the cap when you are ready to use the Sensoready Pen.
  • Twist off the cap in the direction of the arrows (see Figure F).
  • After removed, throw away the cap. Do not try to reattach the cap.
  • Use your Sensoready Pen within 5 minutes of removing the cap.
  • You may see a few drops of medicine come out of the needle. This is normal.

Figure F: Remove The Cap

Remove The Cap - Illustration

 

4. Holding your Sensoready Pen

  • Hold your Sensoready Pen at 90 degrees to the cleaned injection site (see Figure G).

Correct and Incorrect

Correct and Incorrect - Illustration

 

Figure G: Hold Your Pen

Hold Your Pen - Illustration

 

Your injection

You must read this before injecting

During the injection you will hear 2 loud clicks:

  • The first click indicates that the injection has started.
  • Several seconds later a second click will indicate that the injection is almost finished.

You must keep holding your Sensoready Pen firmly against your skin until you see a green indicator fill the window and stop moving.

5. Starting your injection

  • Press your Sensoready Pen firmly against the skin to start the injection (see Figure H).
  • The first click indicates the injection has started.
  • Keep holding your Sensoready Pen firmly against your skin.
  • The green indicator shows the progress of the injection.

Figure H: Start Your Injection

Start Your Injection - Illustration

 

6. Completing your injection

  • Listen for the second click. This indicates the injection is almost complete.
  • Check that the green indicator fills the window and has stopped moving (see Figure I).
  • The Sensoready Pen can now be removed.

Figure I: Complete Your Injection

Complete Your Injection - Illustration

 

After your injection

7. Check that the green indicator fills the window (see Figure J)

  • This means the medicine has been delivered. Contact your doctor if the green indicator is not visible.
  • There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Figure J: Check the green indicator

Check the green indicator - Illustration

 

8. Disposing of used Sensoready Pens

  • Put your used Sensoready Pen in an FDA-cleared sharps disposal container right away after use (see Figure K). Do not throw away (dispose of) any Sensoready Pens in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.

Figure K: Dispose of your used pen

Dispose of your used pen - Illustration

 

  • When your sharps container is almost full, you will need to follow your community guidelines, for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes, needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal

Do not dispose your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

INSTRUCTIONS FOR USE

HYRIMOZ®
(hye-RI-moze) (adalimumab-adaz) 80 mg/0.8 mL, 40 mg/0.4 mL

Single-dose prefilled Sensoready® Pen injection, for subcutaneous use

To help avoid possible infections and to ensure that you use HYRIMOZ correctly, it is important that you follow these instructions.

Be sure that you read, understand, and follow this Instructions for Use before injecting HYRIMOZ. Your doctor should show you how to prepare and inject HYRIMOZ properly using the HYRIMOZ single-dose prefilled Sensoready Pen before you use it for the first time. Talk to your doctor if you have any questions.

Figure A: HYRIMOZ Sensoready Pen parts

HYRIMOZ Sensoready Pen parts - Illustration

 

In Figure A, the Sensoready Pen is shown with the cap removed. Do not remove the cap until you are ready to inject.

It is important that you:

  • do not use the Sensoready Pen if either the seal on the outer carton or the safety seal on the Pen is broken.
  • keep your Sensoready Pen in the sealed outer carton until you are ready to use it.
  • do not use your Sensoready Pen, if you dropped it, it looks damaged, or if you dropped it with the cap removed.
  • inject HYRIMOZ 15 to 30 minutes after taking it out of the refrigerator for a more comfortable injection.
  • throw away (dispose of) the used Sensoready Pen right away after use. Do not reuse a Sensoready Pen. See “8. Disposing of used Sensoready Pens” at the end of this Instructions for Use.

Note: HYRIMOZ prefilled syringe and injection device are not made with natural rubber latex

How should you store your Sensoready Pen?

  • Store your Sensoready Pen carton in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • If needed, for example if you are traveling, you may store your Sensoready Pen at room temperature at up to 77°F (25°C) for up to 14 days.
  • Throw away any Sensoready Pen that has been stored at room temperature after 14 days.
  • Record the date you first remove HYRIMOZ from the refrigerator in the spaces provided on the carton.
  • Keep your Sensoready Pen in the original carton until ready to use to protect from light.
  • Do not store your Sensoready Pen in extreme heat or cold.
  • Do not freeze your Sensoready Pen.
  • Do not drop or crush HYRIMOZ. Your Sensoready Pen contains glass.

Keep HYRIMOZ and all medicines out of the reach of children.

What do you need for your injection?

What do you need for your injection?

Included in your Sensoready Pen carton are:

  • HYRIMOZ prefilled Sensoready Pens (see Figure A). Each Sensoready Pen contains 80 mg/0.8 mL or 40 mg/0.4 mL of adalimumab-adaz.

Not included in your Sensoready Pen carton are:

  • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container See “8. Disposing of used Sensoready Pens” at the end of this Instructions for Use.
  • Adhesive bandage

Figure B: Items Not Included In The Carton

Items Not Included In The Carton - Illustration

 

Before your injection

Preparing the Sensoready Pen

  • For a more comfortable injection, take your Sensoready pen out of the refrigerator 15 to 30 minutes before injecting HYRIMOZ to allow it to reach room temperature. Do not try to warm the prefilled pen by using a heat source such as hot water or a microwave.
  • Look through the viewing window. The solution should be clear and colorless or slightly yellowish. Do not use your Sensoready Pen if the solution is cloudy, discolored, or has flakes or particles in it. You may see small air bubbles, which is normal. If you are not sure what color the solution should be, then contact your pharmacist for help.
  • Look at the expiration date (EXP) on your Sensoready Pen (see Figure C). Do not use your Sensoready Pen if the expiration date has passed.
  • Do not use if the safety seal has been broken

Figure C: Safety Checks Before Injection

Safety Checks Before Injection - Illustration

 

Contact your pharmacist if:

  • you are unsure about the color of the solution in the Sensoready Pen.
  • the safety seal of your Sensoready Pen is broken.
  • the expiration date has passed.

1. Choosing your injection site

  • The recommended injection site is the front of your thighs. You may also use the lower abdomen, but not the area 2 inches (5 cm) around your navel (belly button) (see Figure D).
  • Choose a different site each time you give yourself an injection.
  • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.
  • If you have psoriasis, you should not inject directly into areas with psoriasis plaques.

Figure D: Choose your injection site

Choose your injection site - Illustration

 

2. Cleaning your injection site

  • Wash your hands well with soap and water.
  • Using a circular motion, clean the injection site with an alcohol wipe. Let it dry before injecting (see Figure E). Do not fan or blow on the cleaned area.
  • Do not touch the cleaned area before injecting.

Figure E: Clean your injection site

Clean your injection site - Illustration

 

3. Removing the cap of your Sensoready Pen

  • Only remove the cap when you are ready to use the Sensoready Pen.
  • Twist off the cap in the direction of the arrows (see Figure F).
  • After removed, throw away the cap. Do not try to re-attach the cap.
  • Use your Sensoready Pen within 5 minutes of removing the cap.
  • You may see a few drops of medicine come out of the needle. This is normal.

Figure F: Remove The Cap

Remove The Cap - Illustration

 

4. Holding your Sensoready Pen

  • Hold your Sensoready Pen at 90 degrees to the cleaned injection site (see Figure G).

Correct and Incorrect

Correct and Incorrect - Illustration

 

Figure G: Hold Your Pen

Hold Your Pen - Illustration

 

Your injection

You must read this before injecting

During the injection you will hear 2 loud clicks:

  • The first click indicates that the injection has started.
  • Several seconds later a second click will indicate that the injection is almost finished.

You must keep holding your Sensoready Pen firmly against your skin until you see a green indicator fill the window and stop moving.

5. Starting your injection

  • Press your Sensoready Pen firmly against the skin to start the injection (see Figure H).
  • The first click indicates the injection has started.
  • Keep holding your Sensoready Pen firmly against your skin.
  • The green indicator shows the progress of the injection.

Figure H: Start Your Injection

Start Your Injection - Illustration

 

6. Completing your injection

  • Listen for the second click. This indicates the injection is almost complete.
  • Check that the green indicator fills the window and has stopped moving (see Figure I).
  • The Sensoready Pen can now be removed.

Figure I: Complete Your Injection

Complete Your Injection - Illustration

 

After your injection

7. Check that the green indicator fills the window (see Figure J)

  • This means the medicine has been delivered. Contact your doctor if the green indicator is not visible.
  • There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Figure J: Check The Green Indicator

Check The Green Indicator - Illustration

 

8. Disposing of used Sensoready Pens

  • Put your used Sensoready Pen in an FDA-cleared sharps disposal container right away after use (see Figure K). Do not throw away (dispose of) any Sensoready Pens in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps container is almost full, you will need to follow your community guidelines, for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes, needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal, in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal
  • Do not dispose your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Figure K: Dispose Of Your Used Pen

Dispose Of Your Used Pen - Illustration

 

INSTRUCTIONS FOR USE

HYRIMOZ®
(hye-RI-moze) (adalimumab-adaz) 10 mg/0.2 mL

Single-dose prefilled Syringe injection, for subcutaneous use

To help avoid possible infections and to ensure that you use HYRIMOZ correctly, it is important that you follow these instructions.

Be sure that you read, understand, and follow this Instructions for Use before injecting HYRIMOZ. Your doctor should show you how to prepare and inject HYRIMOZ properly using the HYRIMOZ single-dose prefilled syringe before you use it for the first time. Talk to your doctor if you have any questions.

Figure A: HYRIMOZ Prefilled Syringe

HYRIMOZ Prefilled Syringe - Illustration

 

It is important that you:

  • do not open the outer carton until you are ready to use the HYRIMOZ prefilled syringe.
  • do not use the prefilled syringe if the seal on the outer carton is broken.
  • never leave the prefilled syringe unattended where others might tamper with it.
  • do not remove the needle cap until just before you give the injection.
  • throw away the used syringe right away after use. Do not re-use a syringe. See “4. Disposing of used
  • prefilled syringes” at the end of this Instructions for Use.
  • inject HYRIMOZ 15 to 30 minutes after taking it out of the refrigerator for a more comfortable injection.
  • consult your doctor or nurse for information on an appropriate injection site and injection technique to use if you are injecting a child.
  • do not remove the finger grip before the injection.

Note: HYRIMOZ prefilled syringe is not made with natural rubber latex.

How should you store HYRIMOZ single-dose prefilled syringe?

  • Store the HYRIMOZ prefilled syringe in the original carton to protect it from light.
  • Store your outer carton of prefilled syringe in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze your prefilled syringe.
  • If needed, for example if you are traveling, you may store the prefilled syringe at room temperature up to 77°F (25°C) for up to 21 days.
  • Throw away the prefilled syringe that has been stored at room temperature after 21 days.
  • Record the date you first remove HYRIMOZ from the refrigerator in the spaces provided on the carton.
  • Do not store your prefilled syringe in extreme heat or cold.
  • Do not drop or crush HYRIMOZ. The prefilled syringe is glass.

Keep HYRIMOZ and all medicines out of the reach of children.

What do you need for your injection?

Included in your prefilled syringe carton is:

  • HYRIMOZ prefilled syringe (see Figure A). Each prefilled syringe contains 10 mg/0.2 mL of adalimumab-adaz.

Not included in your HYRIMOZ prefilled syringe carton are (see Figure B):

    • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container. See “4. Disposing of used prefilled syringes” at the end of this Instructions for Use.
  • Adhesive bandage

Figure B: Items Not Included In The Carton

Items Not Included In The Carton - Illustration

 

Preparing the prefilled syringe

  • For a more comfortable injection, take the outer carton containing the prefilled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes to allow it to reach room temperature. Do not try to warm the prefilled syringe by using a heat source such as hot water or a microwave.
  • Remove the prefilled syringe from the carton box and check it. The solution should be clear and colorless or slightly yellowish. Do not use a prefilled syringe if the solution is cloudy, discolored, or has flakes or particles in it. If you are not sure what color the solution should be, contact your pharmacist for help.
  • Do not use the prefilled syringe if it is broken. Return the prefilled syringe and the package it came in to the pharmacy.
  • Look at the expiration date (EXP) on your prefilled syringe. Do not use your prefilled syringe if the expiration date has passed.

Contact your pharmacist if:

  • you are unsure about the color of the solution in the prefilled syringe.
  • the prefilled syringe is broken.
  • the expiration date has passed.

1. Choosing your injection site

  • The recommended injection site is the front of the thighs. You may also use the lower abdomen, but not the area 2 inches (5 cm) around the navel (belly button) (see Figure C).
  • Choose a different site each time you give an injection.
  • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.
  • If you have psoriasis, you should not inject directly into areas with psoriasis plaques.

Figure C: Choose Your Injection Site

Choose Your Injection Site - Illustration

 

2. Cleaning your injection site

  • When you are ready to use the prefilled syringe, wash your hands well with soap and water.
  • Using a circular motion, clean the injection site with an alcohol wipe (see Figure D). Allow the skin to dry before injecting. Do not fan or blow on the cleaned area.
  • Do not touch the cleaned area again before injecting.

Figure D: Choose your injection site

Choose your injection site - Illustration

 

3. Giving your injection

  • Carefully pull the needle cap straight off to remove it from the prefilled syringe (see Figure E).
  • Throw away (dispose of) the needle cap.
  • You may see a drop of liquid at the end of the needle. This is normal.

Figure E: Pull The Needle Cap Off

Pull The Needle Cap Off - Illustration

 

  • Gently pinch the skin at the injection site (see Figure F).
  • Insert the needle into the skin at a 45-degree angle, as shown (see Figure F).

Figure F: Pinch The Skin And Insert The Needle

Pinch The Skin And Insert The Needle - Illustration

 

  • Hold the single-dose prefilled syringe as shown.
  • Slowly press down on the plunger as far as it will go (see Figure G).
  • Carefully lift the needle straight out from the injection site and let go of the skin.
  • There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Figure G: Press Down The Plunger

Press Down The Plunger - Illustration

 

4. Disposing of used prefilled syringes

  • Put the used prefilled syringe in an FDA-cleared sharps disposal container right away after use (see Figure H). Do not throw away (dispose of) any prefilled syringes in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • Properly labeled to warn of hazardous waste inside the container.
  • When your sharps container is almost full, you will need to follow your community guidelines, for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes, needles and prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal, in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal
  • Do not dispose your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Figure H: dispose of the used prefilled Syringe

Dispose of the used prefilled Syringe - Illustration

 

INSTRUCTIONS FOR USE

HYRIMOZ®
(hye-RI-moze) (adalimumab-adaz) 10 mg/0.1 mL, 20 mg/0.2 mL

Single-dose prefilled Syringe injection, for subcutaneous use

To help avoid possible infections and to ensure that you use HYRIMOZ correctly, it is important that you follow these instructions.

Be sure that you read, understand, and follow this Instructions for Use before injecting HYRIMOZ. Your doctor should show you how to prepare and inject HYRIMOZ properly using the HYRIMOZ single-dose prefilled syringe before you use it for the first time. Talk to your doctor if you have any questions.

Figure A: HYRIMOZ Prefilled Syringe

HYRIMOZ Prefilled Syringe - Illustration

 

It is important that you:

    • do not use the prefilled syringe if the seal on the outer carton is broken, as it may not be safe to use.
    • do not open the inner carton until you are ready to use the HYRIMOZ prefilled syringe.
    • never leave the prefilled syringe unattended where others might misuse it.
  • if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.
  • do not remove the needle cap until just before you give the injection. Inject HYRIMOZ 15 to 30 minutes after taking it out of the refrigerator for a more comfortable injection.
  • throw away the used syringe right away after use. Do not re-use a syringe. See “4. Disposing of used prefilled syringes” at the end of these Instructions for Use.
  • do not remove the finger grip before the injection.
  • consult your doctor or nurse for advice on an appropriate injection site and injection technique if you are underweight or if you are injecting a child.

Note: HYRIMOZ prefilled syringe is not made with natural rubber latex.

How should you store HYRIMOZ single-dose prefilled syringe?

  • Store the HYRIMOZ prefilled syringe in the original carton to protect it from light.
  • Store your outer carton of prefilled syringe in a refrigerator between 36°F and 46°F (2°C and 8°C).
  • If needed, for example if you are traveling, you may store the prefilled syringe at room temperature up to 77°F (25°C) for up to 14 days.
  • Throw away the prefilled syringe that has been stored at room temperature after 14 days.
  • Do not store your prefilled syringe in extreme heat or cold.
  • Do not freeze your prefilled syringe.
  • Record the date you first remove HYRIMOZ from the refrigerator in the spaces provided on the carton.
  • Do not drop or crush HYRIMOZ. The prefilled syringe is glass.

Keep HYRIMOZ and all medicines out of the reach of children.

What do you need for your injection?

Included in your prefilled syringe carton are:

  • HYRIMOZ prefilled syringes (see Figure A). Each prefilled syringe contains 10 mg/0.1 mL or 20 mg/0.2 mL of adalimumab-adaz.

Not included in your HYRIMOZ prefilled syringe carton are (see Figure B):

  • Alcohol wipe
  • Cotton ball or gauze
  • Sharps disposal container See “4. Disposing of used prefilled syringes” at the end of this Instructions for Use.
  • Adhesive bandage

Figure B: Items Not Included In The Carton

HYRIMOZ (adalimumab-adaz) injection, for subcutaneous use Structural Formula - Illustration

 

Preparing the prefilled syringe

  • For a more comfortable injection, take the outer carton containing the prefilled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes to allow it to reach room temperature.
  • Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave.
  • Remove the prefilled syringe out of the carton box and inspect it. The solution should be clear and colorless or slightly yellowish. Do not use a prefilled syringe if the solution is cloudy, discolored, or has flakes or particles in it. If you are not sure what color the solution should be, contact your pharmacist for help.
  • Do not use the prefilled syringe if it is broken. Return the prefilled syringe and the package it came in to the pharmacy.
  • Look at the expiration date (EXP) on your prefilled syringe. Do not use your prefilled syringe if the expiration date has passed.

Contact your pharmacist if:

  • you are unsure about the color of the solution in the prefilled syringe.
  • the prefilled syringe is broken.
  • the expiration date has passed.

1. Choosing your injection site

  • The recommended injection site is the front of the thighs. You may also use the lower abdomen, but not the area 2 inches (5 cm) around the navel (belly button) (see Figure C).
  • Choose a different site each time you give an injection.
  • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.
  • If you have psoriasis, you should not inject directly into areas with psoriasis plaques.

Figure C: Choose Your Injection Site

Choose Your Injection Site - Illustration

 

2. Cleaning your injection site

  • When you are ready to use the prefilled syringe, wash your hands thoroughly with soap and water.
  • Using a circular motion, clean the injection site with an alcohol wipe. Let it dry before injecting (see Figure D).
  • Do not touch the cleaned area again before giving the injection. Allow the skin to dry before injecting. Do not fan or blow on the clean area.

Figure D: Clean Your Injection Site

Clean Your Injection Site - Illustration

 

3. Giving your injection

  • Carefully pull the needle cap straight off to remove it from the prefilled syringe (see Figure E).
  • Throw away (discard) the needle cap.
  • You may see a drop of liquid at the end of the needle. This is normal.

Figure E: Pull The Needle Cap Off

Pull The Needle Cap Off - Illustration

 

  • Gently pinch the skin at the injection site (see Figure F).
  • Insert the needle into the skin at a 45-degree angle, as shown (see Figure F).

Figure F: Pinch The Skin And Insert The Needle

Pinch The Skin And Insert The Needle - Illustration

 

  • Hold the single-dose prefilled syringe as shown (see Figure G).
  • Slowly press down on the plunger as far as it will go.
  • Continue to press fully on the plunger while you hold the syringe in place for 5 seconds.
  • Carefully lift the needle straight out from the injection site and let go of the skin. There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

Figure G: Press Down The Plunger

Press Down The Plunger - Illustration

 

4. Disposing of used prefilled syringes

  • Put the used prefilled syringe in an FDA-cleared sharps disposal container right away after use (see Figure H). Do not throw away (dispose of) any prefilled syringes in your household trash.
  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • Properly labeled to warn of hazardous waste inside the container.
  • When your sharps container is almost full, you will need to follow your community guidelines, for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes, needles and prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal, in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal
  • Do not dispose your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Figure H: DISPOSE OF THE USED PREFILLED SYRINGE

DISPOSE OF THE USED PREFILLED SYRINGE - Illustration

 

This Instructions for Use has been approved by the U.S. Food and Drug Administration

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