Oxervate

What is Oxervate used for?

Oxervate is a prescription medicine that is used to treat a certain eye problem called neurotrophic keratitis.

Description

OXERVATE ophthalmic solution contains cenegermin-bkbj, a recombinant form of human nerve growth factor produced in Escherichia coli.

Cenegermin-bkbj contains 118 amino acids. Cenegermin-bkbj has a relative molecular mass of 13,266 Daltons and the following molecular formula: C583H908N166O173S8. OXERVATE (cenegermin-bkbj) is a clear, colorless sterile solution with a pH of 7.0-7.4 and osmolarity 280-320 mOsm/kg for topical ophthalmic use.

Each mL contains Active: 20 mcg of cenegermin (0.002% w/v); Inactives: disodium hydrogen phosphate anhydrous (2.87 mg), hydroxypropylmethyl cellulose (1.0 mg), L-methionine (0.01 mg), mannitol (12.22 mg), polyethylene glycol 6000 (10.0 mg), sodium dihydrogen phosphate dihydrate (1.22 mg), trehalose dihydrate (47.03 mg), Water for Injection, USP, and hydrochloric acid and/or sodium hydroxide to adjust pH.

Mechanism of Action

Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.

Before taking Oxervate, tell your doctor:

• If you are allergic to Oxervate; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

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 Oxervate 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 Oxervate?

• Tell all of your health care providers that you take Oxervate. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Oxervate while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Oxervate best taken?

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

• For the eye only.
• Wash your hands before use.
• Do not shake.
• Be sure you know how to take Oxervate. Talk with your doctor if you have questions.
• Take out contact lenses before using Oxervate. Lenses may be put back in 15 minutes after Oxervate is given. Do not put contacts back in if your eyes are irritated or infected.
• If you are using any other eye drops in the same eye, wait at least 15 minutes between using each drug.
• If you are using an eye ointment, gel, or thick eye drop in the same eye, use Oxervate at least 15 minutes before using the other drug.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of Oxervate 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.
• Very bad eye pain.
• Eye or eyelid swelling.
• Very bad eye irritation.

What are some other side effects of Oxervate?

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:

• Eye pain.
• Feeling that something is in the eye.
• Eye redness.
• More tears.

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 Oxervate?

• Within 5 hours after getting Oxervate from the pharmacy, store the weekly carton in the refrigerator. The weekly carton is good for up to 14 days when stored in the refrigerator. Do not put back in the freezer.
• This medicine is stored in a freezer at the pharmacy. If you use Oxervate right after getting it from the pharmacy, you will need to let the first vial thaw at room temperature before use.
• Only remove 1 vial from the weekly carton at a time. If you are using Oxervate in both eyes, remove 2 vials from the weekly carton. Store opened vials in the weekly carton in the refrigerator or at room temperature. Throw away any part of the opened vial not used after 12 hours.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL- DELIVERY SYSTEM KIT