Cenegermin

What is Cenegermin?

• Cenegermin (Oxervate) is a recombinant human nerve growth factor used for the treatment of neurotrophic keratitis.

What are the uses of this medicine?

• This medicine is eye drop solution used to treat a condition called neurotrophic keratitis.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Oxervate.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

• Contact lenses should be removed before applying Oxervate and may be reinserted 15 minutes after administration.

Recommended Dosage

• Instill one drop of Oxervate in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks.

Administration

• Use Oxervate exactly as your doctor tells you.
• Use 1 drop of Oxervate in the affected eye or both eyes if needed, 6 times each day, about 2 hours apart starting in the morning. Continue your treatment for 8 weeks.
• If you use any other eye drops, wait at least 15 minutes before or after using Oxervate. This will help to avoid one eye drop diluting the other eye drop.
• If you also use an eye ointment or gel or an eye drop that is thick, use Oxervate first, and then wait at least 15 minutes before using the other eye ointment, gel, or drops.
• If you wear contact lenses in your affected eye or both eyes remove them before using Oxervate and wait 15 minutes after using Oxervate before reinserting them.
• If you miss a dose of Oxervate, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose.
• Do not use other eye medicines without talking to your doctor.
• Talk to your doctor first before you stop using Oxervate.
• If you have any questions about how to use Oxervate, ask your doctor or pharmacist.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ophthalmic solution: cenegermin-bkbj 0.002% (20 mcg/mL) in a multiple-dose vial.

This medicine is available in fallowing brand namesː

• Oxervate

What side effects can this medication cause?

The most common side effects of this medicine include:

• eye pain
• enlarged blood vessels in the white of the eyes (ocular hyperemia)
• swelling (inflammation) of the eye
• increase of tears (increased lacrimation).

What special precautions should I follow?

• Your vision may be blurred for a short time after using Oxervate. If this happens, wait until your vision clears before you drive or use machines.
• Contact lenses should be removed before applying Oxervate because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.
• Oxervate may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no data from the use of Oxervate in pregnant women to inform any drug associated risks.

Can this medicine be used in children?

• The safety and effectiveness of Oxervate have been established in the pediatric population.

What are the active and inactive ingredients in this medicine?

• Active ingredient: cenegermin-bkbj
• Inactive ingredients: disodium hydrogen phosphate anhydrous, hydroxypropylmethyl cellulose, L‑methionine, mannitol, polyethylene glycol 6000, sodium dihydrogen phosphate dihydrate, trehalose dihydrate, Water for Injection, USP, and hydrochloric acid and/or sodium hydroxide to adjust pH.

Who manufactures and distributes this medicine?

Manufactured by:

• Dompé farmaceutici S.p.A.
• Via Campo di Pile
• L’Aquila, Italy

Manufactured for:

• Dompé U.S. Inc.
• One Marina Park Drive - Ste. 1410, Boston, MA

What should I know about storage and disposal of this medication?

Pharmacy Storage

• Store the weekly cartons in the freezer at or below -4°F (-20°C).
• Supply the weekly cartons in an insulated pack in combination with the Delivery System Kit.

Patient Storage

• Within 5 hours of delivery, store the weekly carton(s) containing Oxervate vials in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days.
• A vial opened for daily use may be stored in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature up to 77°F (25°C), for up to 12 hours .
• Do not refreeze the vials.
• Do not shake the vials.
• Discard the opened vial after 12 hours even if there is still some solution left inside.

• Dailymed label info on Cenegermin
• FDA Cenegermin

Cenegermin Resources
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