Poteligeo

What is Poteligeo used for?

Poteligeo is a prescription medicine that is used to treat a type of lymphoma.

Description

Mogamulizumab-kpkc is a recombinant humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4)-expressing cells. Mogamulizumab-kpkc is an IgG1 kappa immunoglobulin that has a calculated molecular mass of approximately 149 kDa. Mogamulizumab-kpkc is produced by recombinant DNA technology in Chinese hamster ovary cells.

POTELIGEO (mogamulizumab-kpkc) injection is a sterile, ready-to-use, preservative-free, clear to slightly opalescent colorless solution in a single-dose vial for dilution prior to intravenous infusion. Each vial contains 20 mg of mogamulizumab-kpkc in 5 mL of solution. Each mL of solution contains 4 mg of mogamulizumab-kpkc and is formulated in: citric acid monohydrate (0.44 mg), glycine (22.5 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. May contain hydrochloric acid/sodium hydroxide to adjust pH to 5.5.

Mechanism of Action

Mogamulizumab-kpkc is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells. CCR4 is expressed on the surface of some T-cell malignancies and is expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells.

Before taking Poteligeo, tell your doctor:

• If you are allergic to Poteligeo; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are able to get pregnant and are not using birth control.
• If you are pregnant or may be pregnant. Do not take Poteligeo if you are pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Poteligeo with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Poteligeo?

• Tell all of your health care providers that you take Poteligeo. This includes your doctors, nurses, pharmacists, and dentists.
• Infusion reactions have happened with Poteligeo. Sometimes, these have been life-threatening or deadly. Tell your doctor if you have chills or shakiness, coughing or wheezing, shortness of breath, dizziness or passing out, fast heartbeat, fever, flushing, headache, tiredness, or upset stomach or throwing up during the infusion.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Tell your doctor if you have signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
• Autoimmune problems have happened with Poteligeo. This includes problems in body organs like the heart, liver, lungs, muscles, nerves, and thyroid. Sometimes, these have been life-threatening or deadly. If you have ever had an autoimmune disease or if you have questions, talk with your doctor.
• If you are having a stem cell transplant, talk with your doctor. Some problems with stem cell transplants using stem cells from someone else (allogeneic) have happened after treatment with Poteligeo. These problems can be very bad and can lead to death.
• If you are 65 or older, use Poteligeo with care. You could have more side effects.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Poteligeo. Talk with your doctor.
• Use birth control to prevent pregnancy while taking Poteligeo and for 3 months after the last dose.
• If you get pregnant while taking Poteligeo or within 3 months after your last dose, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Poteligeo best taken?

Use Poteligeo as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given to help with infusion side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Poteligeo that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Swelling.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Low mood (depression).
• A burning, numbness, or tingling feeling that is not normal.
• Shortness of breath.
• A heartbeat that does not feel normal.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Poteligeo?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Diarrhea.
• Constipation.
• Upset stomach or throwing up.
• Signs of a common cold.
• Muscle pain.
• Bone pain.
• Headache.
• Mouth irritation or mouth sores.
• Not hungry.
• Weight gain or loss.
• Not able to sleep.
• Dry skin.
• Hair loss.
• Dizziness.
• Belly pain.
• Eye redness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Poteligeo?

• If you need to store Poteligeo at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 4 MG/ML VIAL CARTON

• Rx only
• NDC 42747-761-01
• POTELIGEO®
  (mogamulizumab-kpkc)
• Injection
• 20 mg/5 mL
  (4 mg/mL)
• For Intravenous Infusion
• Single-dose vial.
  Discard unused portion.

SRC: NLM .