OXERVATE 20 ug/mL
cenegermin-bkbj · SOLUTION/ DROPS · Domp farmaceutici S.p.A.
OXERVATE is a solution/ drops containing cenegermin-bkbj at 20 ug/mL, taken ophthalmic. Manufactured by Domp farmaceutici S.p.A..
Key Facts
- Brand Name
- OXERVATE
- Generic Name
- cenegermin-bkbj
- NDC Code (Product)
71981-020- Manufacturer
- Domp farmaceutici S.p.A.
- Strength
- 20 ug/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- BLA761094
- Drug Class
- Recombinant Human Nerve Growth Factor [EPC]
- Marketing Start
- 11/26/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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 pharmacy). OXERVATE is stored in a freezer at the pharmacy. If treatment is started immediately after receiving the weekly carton, wait until the first vial is thawed (this could take up to 30 minutes when …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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. Inc. 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%). The most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients. Eye pain may arise as corneal healing occurs. Other adverse reactions occurring in 1% to 10% of OXERVATE patients included corneal deposits, foreign bo…
Frequently Asked Questions
What is OXERVATE used for?
OXERVATE contains cenegermin-bkbj. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is OXERVATE a controlled substance?
OXERVATE is not classified as a controlled substance by the DEA.
What is the generic name for OXERVATE?
The generic name for OXERVATE is cenegermin-bkbj. There are no other listed brand versions of cenegermin-bkbj.
What is the NDC code for OXERVATE 20 ug/mL?
The NDC (National Drug Code) for OXERVATE 20 ug/mL is 71981-020, listed by Domp farmaceutici S.p.A..
Other OXERVATE Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)