Why is this medication prescribed?

Cenegermin-bkbj Ophthalmic, sold under the brand name Oxervate, is prescribed for the treatment of neurotrophic keratitis (NK). Neurotrophic keratitis is a rare degenerative disease of the cornea caused by damage to the trigeminal nerve, which reduces corneal sensitivity and can lead to persistent epithelial defects and ulceration. Cenegermin-bkbj is a recombinant human nerve growth factor (rhNGF) that helps promote healing of the corneal surface in patients with NK.

How should this medicine be used?

Here’s how Cenegermin-bkbj Ophthalmic is typically used:

• Dosage: The recommended dose is one drop of Cenegermin-bkbj into the affected eye(s) every 2 hours while awake (up to 8 times daily), for a total of 8 weeks.
• Administration: Wash hands before use. Tilt your head back, look upward, and pull down the lower eyelid to create a pouch. Hold the single-dose container upside down near your eye and gently squeeze to instill one drop into the eye. Close your eye gently for 1 to 2 minutes, and do not blink or rub the eye.
• Contact Lenses: Contact lenses should be removed prior to application of Cenegermin-bkbj and can be reinserted after 15 minutes.
• Storage: Store the single-dose containers in the refrigerator (2°C to 8°C or 36°F to 46°F). Do not freeze. Once a single-dose container is opened, it should be used immediately and discarded after use.
• Follow-Up: Regular follow-up visits with your healthcare provider are important to monitor your progress and determine if continued treatment with Cenegermin-bkbj is necessary beyond the initial 8 weeks.

It’s crucial to follow your healthcare provider’s instructions and not to exceed the prescribed dosage or frequency of use unless instructed otherwise. If you have any questions about the use of Cenegermin-bkbj Ophthalmic or its effects, consult your healthcare provider or pharmacist for clarification.

Other uses for this medicine

• Persistent Corneal Epithelial Defects: In cases where corneal epithelial defects persist despite standard treatments, Cenegermin-bkbj may be considered to facilitate healing.
• Corneal Ulcers: In certain cases of non-healing corneal ulcers where neurotrophic factors are believed to play a role in the lack of healing, Cenegermin-bkbj might be used to promote epithelialization.
• Corneal Abrasions: In selected cases of traumatic corneal abrasions where neurotrophic changes are suspected or identified, Cenegermin-bkbj could potentially aid in faster healing.

What special precautions should I follow?

When using Cenegermin-bkbj Ophthalmic, it’s important to adhere to several special precautions to ensure safe and effective use:

• Handling: Always wash hands thoroughly before handling the single-dose containers to prevent contamination.
• Administration: Follow the prescribed dosing schedule closely. Do not exceed the recommended frequency of administration unless directed by your healthcare provider.
• Storage: Store Cenegermin-bkbj in the refrigerator at a temperature of 2°C to 8°C (36°F to 46°F). Do not freeze. Once a single-dose container is opened, it should be used immediately and discarded.
• Contact Lenses: Remove contact lenses before applying Cenegermin-bkbj. Contact lenses can be reinserted 15 minutes after instillation of the eye drops.
• Monitoring: Regular follow-up visits with your healthcare provider are essential to monitor the response to treatment and to adjust the treatment plan as necessary.
• Allergic Reactions: Monitor for signs of allergic reactions, such as itching, redness, swelling, or difficulty breathing. Seek medical attention immediately if any of these symptoms occur.
• Pregnancy and Breastfeeding: The safety of Cenegermin-bkbj during pregnancy and breastfeeding has not been established. Consult your healthcare provider before using this medication if you are pregnant, planning to become pregnant, or breastfeeding.
• Children and Elderly: Safety and efficacy in children and elderly patients have not been specifically studied. Use in these populations should be based on clinical judgment and careful monitoring.

By following these precautions and guidelines, you can help ensure the safe and effective use of Cenegermin-bkbj Ophthalmic under the guidance of your healthcare provider.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with the use of Cenegermin-bkbj Ophthalmic. However, it’s generally recommended to maintain a healthy diet to support overall eye health. Ensure you stay well-hydrated, as hydration can affect ocular health.

What should I do if I forget a dose?

If you forget to administer a dose of Cenegermin-bkbj Ophthalmic, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one.

What side effects can this medication cause?

Cenegermin-bkbj Ophthalmic (Oxervate) can cause side effects, although not everyone using the medication will experience them. Common side effects may include:

• Eye Pain: Some patients may experience mild to moderate eye discomfort or pain after using Cenegermin-bkbj.
• Eye Redness: Redness in the eye(s) where the medication is applied can occur.
• Eye Inflammation: Inflammation of the eye(s), such as conjunctival hyperemia (increased blood flow in the conjunctiva), may occur.
• Increased Lacrimation: Increased tear production or tearing may happen as a result of using Cenegermin-bkbj.
• Blurred Vision: Vision may temporarily become blurred after applying the eye drops.
• Foreign Body Sensation: Some patients may feel as if there is a foreign body or something in the eye.
• Eye Discharge: Discharge from the eye(s) can occur as a side effect.
• Eye Pruritus: Itching of the eye(s) may occur in some cases.
• Headache: Headaches have been reported by some individuals using Cenegermin-bkbj.
• Dizziness: Occasionally, users may experience dizziness as a side effect.
• Nausea: Nausea is another potential side effect, although it is less common.
• Cough: Some patients may develop a cough after using Cenegermin-bkbj.

It’s important to note that these side effects are generally mild to moderate and typically resolve on their own without needing medical intervention. However, if you experience any persistent or severe side effects, or if you are concerned about any symptoms, it is advisable to consult your healthcare provider promptly. They can provide guidance and determine if any adjustments to your treatment plan are necessary.

As with any medication, the benefits of using Cenegermin-bkbj Ophthalmic should be weighed against the potential risks of side effects. Your healthcare provider can help you understand these considerations based on your individual health status and medical history.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Store Cenegermin-bkbj Ophthalmic (Oxervate) in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). Keep the single-dose containers in their original packaging to protect them from light. Do not freeze.
• Handling: Wash your hands thoroughly before handling the single-dose containers to prevent contamination. Use each single-dose container immediately after opening and discard any unused portion.
• Disposal: Dispose of used single-dose containers as per local regulations for pharmaceutical waste disposal. Do not reuse containers.

In case of emergency/overdose

In case of accidental ingestion or overdose of Cenegermin-bkbj Ophthalmic, contact your local poison control center (in the US, call 1-800-222-1222) or seek emergency medical assistance immediately. Overdose symptoms are not well-documented for this medication due to its topical ophthalmic administration, but prompt medical evaluation is still recommended if excessive use occurs.

What other information should I know?

• Follow-Up: Attend all scheduled appointments with your healthcare provider to monitor your response to treatment and to assess the need for continued use of Cenegermin-bkbj.
• Missed Dose: If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one.
• Allergic Reactions: Be vigilant for signs of allergic reactions such as itching, redness, swelling, or difficulty breathing. Seek immediate medical attention if any of these symptoms occur after using Cenegermin-bkbj.
• Contact Lenses: Remove contact lenses before applying Cenegermin-bkbj Ophthalmic. Contact lenses can be reinserted 15 minutes after instilling the eye drops.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. The safety of Cenegermin-bkbj during pregnancy and lactation has not been established.
• Children and Elderly: The safety and efficacy of Cenegermin-bkbj in pediatric and elderly patients have not been specifically studied. Use in these populations should be based on clinical judgment and careful monitoring.
• Driving and Operating Machinery: Cenegermin-bkbj Ophthalmic may cause temporary blurred vision after administration. Use caution when driving or operating machinery until you are sure you can perform such activities safely.
• Medical Conditions: Inform your healthcare provider about any other medical conditions you have, especially eye conditions or allergies.

By following these guidelines and staying informed about the use of Cenegermin-bkbj Ophthalmic, you can help ensure safe and effective treatment of neurotrophic keratitis under the supervision of your healthcare provider.