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Drug overview for OXERVATE (cenegermin-bkbj):
Generic name: cenegermin-bkbj (sen-EH-jer-men)
Drug class: Ophthalmic Human Nerve Growth Factor (hNGF)
Therapeutic class: Ophthalmic Agents
Cenegermin-bkbj is a recombinant form of human nerve growth factor.
No enhanced Uses information available for this drug.
Generic name: cenegermin-bkbj (sen-EH-jer-men)
Drug class: Ophthalmic Human Nerve Growth Factor (hNGF)
Therapeutic class: Ophthalmic Agents
Cenegermin-bkbj is a recombinant form of human nerve growth factor.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for OXERVATE (cenegermin-bkbj) have been approved by the FDA:
Indications:
Neurotrophic keratitis
Professional Synonyms:
Neurotrophic keratopathy
Indications:
Neurotrophic keratitis
Professional Synonyms:
Neurotrophic keratopathy
The following dosing information is available for OXERVATE (cenegermin-bkbj):
For the treatment of neurotrophic keratitis in adults and pediatric patients 2 years of age and older, 1 drop of cenegermin-bkbj 0.002% ophthalmic solution should be instilled into the conjunctival fornix of the affected eye(s) 6 times daily at 2-hour intervals for 8 weeks.
Cenegermin-bkbj is applied topically to the affected eye(s) as a 0.002% ophthalmic solution. Cenegermin-bkbj ophthalmic solution is for topical ophthalmic use only.
Contact lenses should be removed prior to administration of each dose; lenses may be reinserted 15 minutes following administration. If more than one topical ophthalmic drug is used in a patient receiving cenegermin-bkbj, the drugs should be administered at least 15 minutes apart to avoid diluting the preparations. Cenegermin-bkbj ophthalmic solution should be instilled 15 minutes before any ophthalmic ointment, gel, or other viscous drops.
The patient should be instructed to blink several times after administration of each dose so that the drug covers the surface of the eye. If a dose is missed, the usual administration schedule should be resumed with the next scheduled dose. An extra dose should not be administered to make up for a missed dose.
Cenegermin-bkbj 0.002% ophthalmic solution is available in a kit containing a carton of seven 1-mL multiple-dose vials of the drug in an insulated package, 8 vial adapters, 45 pipettes and sterile disinfectant wipes, and a card for recording administration. Prior to dispensing from a pharmacy, the drug should be stored in a freezer at a temperature not exceeding -20degreesC.
Within 5 hours after the patient receives the drug from the pharmacy, the carton containing the 7 vials of drug should be removed from the insulated package and refrigerated at 2-8degreesC for up to 14 days. If the patient initiates treatment immediately after receiving the carton, the first vial should be allowed to thaw at room temperature up to 25degreesC (this may take up to 30 minutes) prior to preparation for use. Only the number of vials required for use during a single day (1 vial for treatment of one eye, 2 vials for treatment of both eyes) should be removed from the refrigerator and prepared for use by piercing the vial stopper with an adapter provided by the manufacturer.
Once the vial adapter has been connected to the vial, it should not be removed. The vial should not be shaken. Prior to removing a dose from the vial, the adapter should be cleaned with a disinfectant wipe, and then a pipette should be screwed into the adapter to withdraw the dose.
Once properly filled, the pipette should be disconnected from the adapter and the dose should be administered directly from the pipette into the conjunctival fornix. Each dose should be withdrawn from the vial just prior to administration with a new pipette for each application in each eye. If the drop misses the eye during administration and no ophthalmic solution remains in the pipette, cenegermin ophthalmic solution should be administered again with a new pipette.
After each use, the vial with connected adapter may be refrigerated or stored at room temperature up to 25degreesC; any unused amount remaining in the vial 12 hours after the adapter was connected should be discarded. The manufacturer's instructions for use should be consulted for detailed information regarding preparation and ocular administration of cenegermin-bkbj ophthalmic solution.
Contact lenses should be removed prior to administration of each dose; lenses may be reinserted 15 minutes following administration. If more than one topical ophthalmic drug is used in a patient receiving cenegermin-bkbj, the drugs should be administered at least 15 minutes apart to avoid diluting the preparations. Cenegermin-bkbj ophthalmic solution should be instilled 15 minutes before any ophthalmic ointment, gel, or other viscous drops.
The patient should be instructed to blink several times after administration of each dose so that the drug covers the surface of the eye. If a dose is missed, the usual administration schedule should be resumed with the next scheduled dose. An extra dose should not be administered to make up for a missed dose.
Cenegermin-bkbj 0.002% ophthalmic solution is available in a kit containing a carton of seven 1-mL multiple-dose vials of the drug in an insulated package, 8 vial adapters, 45 pipettes and sterile disinfectant wipes, and a card for recording administration. Prior to dispensing from a pharmacy, the drug should be stored in a freezer at a temperature not exceeding -20degreesC.
Within 5 hours after the patient receives the drug from the pharmacy, the carton containing the 7 vials of drug should be removed from the insulated package and refrigerated at 2-8degreesC for up to 14 days. If the patient initiates treatment immediately after receiving the carton, the first vial should be allowed to thaw at room temperature up to 25degreesC (this may take up to 30 minutes) prior to preparation for use. Only the number of vials required for use during a single day (1 vial for treatment of one eye, 2 vials for treatment of both eyes) should be removed from the refrigerator and prepared for use by piercing the vial stopper with an adapter provided by the manufacturer.
Once the vial adapter has been connected to the vial, it should not be removed. The vial should not be shaken. Prior to removing a dose from the vial, the adapter should be cleaned with a disinfectant wipe, and then a pipette should be screwed into the adapter to withdraw the dose.
Once properly filled, the pipette should be disconnected from the adapter and the dose should be administered directly from the pipette into the conjunctival fornix. Each dose should be withdrawn from the vial just prior to administration with a new pipette for each application in each eye. If the drop misses the eye during administration and no ophthalmic solution remains in the pipette, cenegermin ophthalmic solution should be administered again with a new pipette.
After each use, the vial with connected adapter may be refrigerated or stored at room temperature up to 25degreesC; any unused amount remaining in the vial 12 hours after the adapter was connected should be discarded. The manufacturer's instructions for use should be consulted for detailed information regarding preparation and ocular administration of cenegermin-bkbj ophthalmic solution.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| OXERVATE 0.002% EYE DROP | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route every 2 hours 6 times per day for 8 weeks |
No generic dosing information available.
The following drug interaction information is available for OXERVATE (cenegermin-bkbj):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for OXERVATE (cenegermin-bkbj):
Drug contraindication overview.
The manufacturer states that there are no known contraindications to the use of cenegermin.
The manufacturer states that there are no known contraindications to the use of cenegermin.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for OXERVATE (cenegermin-bkbj):
Adverse reaction overview.
Adverse effects occurring in 1% or more of patients receiving cenegermin 0.002% ophthalmic solution and reported more frequently with the drug than with the vehicle include eye pain, corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, and increased lacrimation.
Adverse effects occurring in 1% or more of patients receiving cenegermin 0.002% ophthalmic solution and reported more frequently with the drug than with the vehicle include eye pain, corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, and increased lacrimation.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Corneal neovascularization |
There are 9 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Eye tearing Ocular inflammation Ocular pain Ocular redness |
Corneal deposits Foreign body sensation of eye Headache disorder Photophobia |
| Rare/Very Rare |
|---|
|
Blepharitis |
The following precautions are available for OXERVATE (cenegermin-bkbj):
Safety and efficacy of cenegermin-bkbj 0.002% ophthalmic solution in pediatric patients are supported by adequate and well-controlled studies in adults and additional safety data in pediatric patients 2 years of age and older.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data are not available regarding use of cenegermin ophthalmic solution in pregnant women. In animal studies, no adverse effects of the drug on the fetus or offspring were observed.
It is not known whether cenegermin is distributed into milk following topical application to the eye. Data also are not available regarding any effects of the drug on the breast-fed infant or on milk production. The benefits of breast-feeding should be considered along with the importance of the drug to the woman and any potential adverse effects of the drug on the breast-fed infant.
When the total number of patients studied in clinical trials of cenegermin-bkbj is considered, 43.5% were 65 years of age or older. No overall differences in safety and efficacy of cenegermin ophthalmic solution were observed between geriatric patients and younger adults.
The following prioritized warning is available for OXERVATE (cenegermin-bkbj):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for OXERVATE (cenegermin-bkbj)'s list of indications:
| Neurotrophic keratitis | |
| H16.23 | Neurotrophic keratoconjunctivitis |
| H16.231 | Neurotrophic keratoconjunctivitis, right eye |
| H16.232 | Neurotrophic keratoconjunctivitis, left eye |
| H16.233 | Neurotrophic keratoconjunctivitis, bilateral |
| H16.239 | Neurotrophic keratoconjunctivitis, unspecified eye |
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