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Oxervate

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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  • Product Details

    Description

    Oxervate (cenegermin-bkbj) ophthalmic solution 0.002% is a recombinant human nerve growth factor (rhNGF) indicated for the treatment of neurotrophic keratitis, a rare degenerative disease of the cornea characterized by reduced or absent corneal sensitivity. Oxervate promotes corneal healing by supporting nerve regeneration and epithelial repair. This sterile, preservative-free eye drop is the first FDA-approved treatment targeting the underlying nerve damage in neurotrophic keratitis.

    Fact Table

    Formula

    C7650H11990N2030O2400S50

    License

    US FDA, EMA

    Bioavailability

    Topical (ocular); systemic absorption is minimal

    Legal status

    Rx-only

    Chemical Name

    Cenegermin

    Elimination half-life

    Not systemically measurable; rapidly degraded locally

    Dosage (Strength)

    0.002% (20 mcg/mL) ophthalmic solution

    Pregnancy

    Consult a doctor; no adequate human data

    Brands

    Oxervate

    Protein binding

    Not applicable (topical application)

    PubChem CID

    16129693

    MedlinePlus

    a619064

    ChEBI

    N/A (not assigned)

    ATC code

    S01XA21

    DrugBank

    DB13931

    KEGG

    D11124

    Routes of administration

    Ophthalmic (topical eye drops)

    Directions

    Oxervate should be administered as one drop in the affected eye(s), six times daily at intervals of approximately two hours for eight consecutive weeks. Contact lenses should be removed before application and may be reinserted 15 minutes after administration. The treatment should be initiated and supervised by an ophthalmologist experienced in managing neurotrophic keratitis.

    Ingredients

    Active Ingredient: Cenegermin-bkbj (recombinant human nerve growth factor) 0.002% (20 mcg/mL) Inactive Ingredients: L-methionine, mannitol, polysorbate 20, sodium phosphate monobasic monohydrate, trehalose dihydrate, water for injection. The solution is pH-adjusted to 7.0.

    Contraindications

    Oxervate is contraindicated in patients with known hypersensitivity to cenegermin or any of the formulation components.

    Cautions

    Use with caution in patients with active ocular infections. Proper hygiene and aseptic technique must be followed during administration to avoid contamination. The dropper vial should not come into contact with the eye or surrounding surfaces. As the product is preservative-free, any unused portion must be discarded immediately after use. Avoid use in conjunction with other ophthalmic medications unless advised by a healthcare provider.

    Side Effects

    Common side effects may include:

    • Eye pain
    • Ocular hyperemia (eye redness)
    • Increased lacrimation (tearing)
    • Eye inflammation
    • Foreign body sensation
    • Corneal deposits Less commonly, patients may experience eyelid pain or visual disturbances. If severe reactions occur, treatment should be discontinued and a healthcare professional consulted.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 14197

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