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Cenegermin: Pediatric drug information

Cenegermin: Pediatric drug information
(For additional information see "Cenegermin: Drug information" and see "Cenegermin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Oxervate
Brand Names: Canada
  • Oxervate
Therapeutic Category
  • Recombinant Human Nerve Growth Factor
Dosing: Pediatric
Neurotrophic keratitis

Neurotrophic keratitis: Children ≥2 years and Adolescents: Instill 1 drop into the affected eye(s) every 2 hours for 6 doses daily for 8 weeks

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Cenegermin: Drug information")

Neurotrophic keratitis

Neurotrophic keratitis: Instill 1 drop into affected eye(s) 6 times daily at 2-hour intervals for 8 weeks.

Missed dose: If a dose is missed, continue treatment at the next scheduled administration.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Ophthalmic: Eye pain (16%)

1% to 10%:

Nervous system: Headache

Ophthalmic: Corneal deposits, foreign body sensation of eye, lacrimation, ocular hyperemia, ophthalmic inflammation, photophobia

Postmarketing: Ophthalmic: Blepharitis (including crusting of eyelid [margin], eyelid edema), corneal disease (corneal neovascularization), eye irritation

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Ocular effects: May cause mild to moderate eye discomfort (eg, eye pain); notify health care professional if more serious eye reactions occur.

Special populations:

• Contact lens wearers: Remove contact lenses prior to administration and wait 15 minutes before reinserting.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic [preservative free]:

Oxervate: Cenegermin-bkbj 0.002% (1 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution (Oxervate Ophthalmic)

0.002% (per mL): $2,273.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Oxervate: Cenegermin-bkbj 0.002% (1 mL)

Administration: Pediatric

Ophthalmic: Prior to dispensing, weekly carton is kept frozen. If treatment is initiated immediately after receiving the weekly carton, vials may still be frozen and first vial must be thawed (may take up to 30 minutes at room temperature). Attach vial adapter to vial. Clean surface of valve on the connector part of the vial adapter; wait ~1 minute and screw pipette (clockwise) into the connector part of the vial adapter; make sure plunger is pushed all the way down. Invert vial and gently pull pipette plunger until it stops (to draw the eye drop solution into the pipette). After the pipette has been correctly filled, unscrew pipette (counter-clockwise) from the connector part of the vial adapter.

Wash hands before use; pull down lower eyelid and administer into the conjunctival fornix (space between inner eyelid and eyeball). Blink a few times so the surface of the eye is covered. Discard pipette immediately after use. If using drops in both eyes, use new pipette for each eye. See manufacturer's labeling for detailed administration. Remove contact lenses prior to instillation and wait at least 15 minutes before reinserting. If more than one topical ophthalmic medication is being used, separate administration of other ophthalmic products by at least 15 minutes to avoid dilution of products; administer cenegermin at least 15 minutes prior to eye ointment, gel, or other viscous eye drops. If a dose is missed, continue treatment at the next scheduled administration.

Administration: Adult

Ophthalmic: If more than one topical ophthalmic drug is being used, administer the drugs at least 15 minutes apart; administer cenegermin 15 minutes prior to any eye ointment, gel, or other viscous eye drops. Remove contact lenses prior to administration and wait 15 minutes before reinserting. Pull down lower eyelid and administer into the conjunctival fornix (space between inner eyelid and eyeball). Keep head tilted back and blink a few times so the surface of the eye is covered. Discard pipette immediately after use and use a new pipette for each eye and administration. See manufacturer's labeling for detailed administration.

Storage/Stability

Store at -20°C (-4°F). Dispense weekly carton in the insulated pack in the Delivery System Kit. Within 5 hours of leaving the pharmacy, store the weekly carton at 2°C to 8°C (36°F to 46°F) for up to 14 days. Opened vials, including those with the vial adapter connected, may be stored in the original weekly carton in the refrigerator between 2°C to 8°C (36°F to 46°F) or at room temperature up to 25°C (77°F) for up to 12 hours. Do not refreeze; do not shake vial. Discard any unused portion.

Use

Treatment of neurotrophic keratitis (FDA approved in ages ≥2 years and adults)

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Mechanism of Action

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (DE) Germany: Oxervate;
  • (FR) France: Oxervate;
  • (IT) Italy: Oxervate;
  • (PR) Puerto Rico: Oxervate;
  • (SK) Slovakia: Oxervate
  1. Oxervate (cenegermin-bkbj) [prescribing information]. Boston, MA: Dompé US Inc; October 2019.
  2. Oxervate (cenegermin-bkbj) [prescribing information]. Boston, MA: Dompé US Inc; October 2023.
Topic 119701 Version 42.0

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