cenegermin (Rx)

Brand and Other Names:Oxervate
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.002% (20 mcg/mL)

Neurotrophic Keratitis

Indicated for the treatment of neurotrophic keratitis

Instill 1 drop in affected eye(s), 6 times a day at 2-hr intervals for 8 weeks

Also see Administration

Dosing Considerations

Remove contact lenses before applying; may be reinserted 15 minutes after administration

Dosage Forms & Strengths

ophthalmic solution

  • 0.002% (20 mcg/mL)

Neurotrophic Keratitis

Indicated for the treatment of neurotrophic keratitis

Note: Safety and effectiveness have been established in the pediatric population; use in children is supported by evidence from adequate and well-controlled trials in adults with additional safety data in children aged ≥2 years

≥ 2 years: Instill 1 drop in affected eye(s), 6 times a day at 2-hr intervals for 8 weeks

Also see Administration

Dosing Considerations

Remove contact lenses before applying; may be reinserted 15 minutes after administration

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Adverse Effects

>10%

Eye pain following installation (~16%)

1-10%

Corneal deposits

Foreign body sensation

Ocular hyperemia

Ocular inflammation and tearing

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Warnings

Contraindications

None

Cautions

Remove contact lenses before application; the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin onto the area of the corneal lesion

Mild-to-moderate eye discomfort (eg, eye pain during treatment); advise patients to contact their doctor if a more serious eye reaction occurs

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Pregnancy & Lactation

Pregnancy

There are no data from the use in pregnant women to inform any drug-associated risks

Animal data

  • Administration of cenegermin to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses
  • In a prenatal and postnatal development study, administration of cenegermin to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Recombinant form of human nerve growth factor produced in Escherichia coli

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

Pharmacokinetics

No pharmacokinetic studies have been conducted in humans

Extent of systemic exposure to cenegermin following topical ophthalmic administration is not known

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Administration

Ophthalmic Preparation

Remove single vial from refrigerator in the morning of administration

If treatment is started immediately after receiving weekly carton, wait until vial is thawed (may take up to 30 minutes at room temperature up to 77°F [25°C]); do not shake vial

Connect vial adapter to vial; attach pipette

Draw eye drop solution into pipette; make sure plunger has reached the stop point

Air bubbles may cause blockage and prevent pipette from filling properly (especially the first time you withdraw the eye drop solution)

Also see Storage

Ophthalmic Administration

Remove contact lenses before applying; may reinsert 15 minutes after administration

If solution missed the eye during administration and there is no solution left in pipette, try again, using a new pipette, wipe, and repeat process

Repeat q2hr 6 times a day, using a new sterile disinfectant wipe and a new pipette each time

If using drops in both eyes, repeat for other eye using a new pipette; 2 vials will be needed each day

Discard used vial at the end of each day, even if there is still some remaining solution left

Record time of administration on the weekly dose-recording card provided with delivery system

If more than 1 topical ophthalmic product is being used, administer the eye drops at least 15 minutes apart

Missed dose

  • If a dose is missed, continue treatment as normal, at next scheduled administration

Storage

Prior to dispensing from the pharmacy

  • Store weekly carton in the freezer at or below -4°F (-20°C); dispense in insulated pack in delivery system kit

Following dispensing from the pharmacy

  • Within 5 hr of leaving the pharmacy, refrigerate carton between 36-46°F (2-8°C) for up to 14 days

Opened vials

  • Refrigerate between 36-46°F (2-8°C) or at room temperature up to 77°F (25°C), for up to 12 hr
  • Do not refreeze; do not shake vial
  • Discard any unused portion after 12 hr
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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.