Recombinant Human Nerve Growth FactorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Oxervate
CENEGERMIN-BKBJ
1 INDICATIONS AND USAGE OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. ( 1 )
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:OXERVATE
Quick Reference
Medicine ClassRecombinant Human Nerve Growth Factor
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- CENEGERMIN-BKBJ
- Medicine class
- Recombinant Human Nerve Growth Factor
- Brand names
- OXERVATE
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- FDA approved
- Yes
What Is Oxervate?
1 INDICATIONS AND USAGE OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. ( 1 )
Oxervate (CENEGERMIN-BKBJ) belongs to the Recombinant Human Nerve Growth Factor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Oxervate. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Oxervate with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Oxervate is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.
OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION One drop of OXERVATE in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks. ( 2.1 ) 2.1 General Dosing Information Contact lenses should be removed before applying OXERVATE and may be reinserted 15 minutes after administration. If a dose is missed, treatment should be continued as normal, at the next scheduled administration. If more than one topical ophthalmic product is being used, administer the eye drops at least 15 minutes apart to avoid diluting products. Administer OXERVATE 15 minutes prior to using any eye ointment, gel or other viscous eye drops. 2.2 Recommended Dosage and Dose Administration Instill one drop of OXERVATE in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks. 2.3 Preparation for Administration Remove the weekly carton(s) containing OXERVATE vials from the insulated pack and store it for up to 14 days in a refrigerator (no later than 5 hours from when you receive the medicine from your pharma
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dompé U.S.
- at 1-833-366-7387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
- In two clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks.
- The mean age of the population was 61 to 65 years of age (18 to 95).
- The majority of the treated patients were female (61%).
Serious
- 5 WARNINGS AND PRECAUTIONS Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion.
- ( 5.1 ) 5.1 Use with Contact Lens 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.
- 5.2 Eye Discomfort 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion. ( 5.1 ) 5.1 Use with Contact Lens 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 ar
How Oxervate Works
12.1 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.
Pharmacokinetics
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Oxervatewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Oxervate side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Oxervate
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.