OXERVATE™ Patient Support Program (2023)

OXERVATE™ Patient Support Program (1)

How do I get OXERVATE?

OXERVATE is a prescription medication and you will need to speak with your doctor to determine if it is right for you. If you are prescribed OXERVATE, the Dompé Connect to Care program is here to help you access the medication.

Learn how to dose and administer OXERVATE properly

Please watch this video and read the complete instructions for OXERVATE administration supplied with the kit.

Watch demo video

OXERVATE™ Patient Support Program (4)

Dompé is committed to patient support

Dompé Connect to Care is the single place for you to find support and resources for accessing OXERVATE. The Dompé Connect to Care program will:

OXERVATE™ Patient Support Program (5)

Verify a patient's health insurance coverage for OXERVATE

OXERVATE™ Patient Support Program (7)

Coordinate delivery of OXERVATE to the patient and provide resources about how to administer OXERVATE

Call us at 1-877-422-4412 to speak to Connect to Care representatives and licensed medical professionals who are ready to help answer questions about your prescription and OXERVATE.

How OXERVATE is delivered

You must speak to your Connect to Care representative live in order to receive your first shipment

Shipments can be delivered anywhere in the United States, as long as you are there to receive them

OXERVATE is delivered in an insulated pack with dry ice. Use gloves when opening to protect your hands

OXERVATE is supplied in a weekly carton containing 7 multiple-dose vials in a cooler with an accompanying Delivery System Kit. For weekly use you will receive:

7 vials of OXERVATE 20 mcg/mL

1 vial to be used per day of the week (in an insulated pack)

42 pipettes

42 sterile
disinfectant wipes

1 dose recording card

1 extra adapter, 3 extra pipettes, and 3 extra wipes are included as spares

When taking OXERVATE,
think: 2, 6, 8!

  • Apply 1 drop of OXERVATE, every 2 hours to your affected eye(s) 6 times per day (in a 12-hour period) for 8 weeks
  • One vial of OXERVATE per affected eye is to be used each day
  • Follow the rule of 15: 15 minutes before and after applying OXERVATE
    • Contact lenses should be removed before applying OXERVATE and may be reinserted 15 minutes after administration
    • If more than one topical ophthalmic product is being used, apply the eye drops at least 15 minutes apart to avoid dilution
    • Administer OXERVATE 15 minutes prior to using any eye ointment, gel, or other viscous eye drops

Every 2 hours

6 times daily

For 8 weeks

Learn about OXERVATE storage

  • Refrigerate OXERVATE as soon as possible after receiving it
  • Once refrigerated, it can be stored up to 14 days in the original carton if the vials are unopened
  • If you need to use OXERVATE right away, let the vial sit at room temperature for 30 minutes until the vial is thawed
  • A vial of OXERVATE can remain at room temperature for up to 12 hours once it is opened
  • Once a vial of OXERVATE is opened, it must be discarded within 12 hours (even if solution is left in the vial)

OXERVATE™ Patient Support Program (8)

Talk to your doctor:

  • Before using other eye medicines with OXERVATE
  • Before you decide to stop taking OXERVATE
  • If you have any questions about how to use OXERVATE

OXERVATE™ Patient Support Program (9)

    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

    OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

    The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Adverse reactions included corneal deposits, foreign body sensations in the eye, ocular hyperemia (enlarged blood vessels in the white of the eyes), swelling (inflammation) of the eye, and increase of tears (1-10% of patients).

    WHAT IS OXERVATE™?

    OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

    DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution for topical use in the eye: cenegermin-bkbj 0.002% (20 mcg/mL) is a clear, colorless solution in a multiple-dose vial.

    CONTRAINDICATIONS

    None.

    WARNINGS AND PRECAUTIONS

    Use With Contact Lenses

    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

    Eye Discomfort

    OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

    ADVERSE REACTIONS

    Clinical Studies Experience

    Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be compared directly to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

    In 2 clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95).

    The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase in tears (1%-10% of patients).

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Risk Summary

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

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

    Data

    Animal Data

    In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in postimplantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the maximum recommended human ophthalmic dose [MRHOD]). A no-observed-adverse-effect level (NOAEL) was not established for postimplantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed once each in fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart, and aortic arch dilation, were observed once each in fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

    In a pre- and postnatal development study, daily subcutaneous administration of cenegermin-bkbj to pregnant rats during the period of organogenesis and lactation did not affect parturition and was not associated with adverse toxicity in offspring at doses up to 267 mcg/kg/day.

    In parental rats and rabbits, an immunogenic response to cenegermin-bkbj was observed. Given that cenegermin-bkbj is a heterologous protein in animals, this response may not be relevant to humans.

    Lactation

    Risk Summary

    There are no data on the presence of OXERVATE in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OXERVATE and with any potential adverse effects on the breastfed infant.

    Pediatric Use

    The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in pediatric patients 2 years of age and older is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in children.

    Geriatric Use

    Of the total number of subjects in clinical studies of OXERVATE, 43.5% were 65 years old and older. No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

    The risk information provided here is not comprehensive. To learn more, talk about OXERVATE with your health care provider or pharmacist.

    FAQs

    How long do you use Oxervate? ›

    Administer OXERVATE 15 minutes prior to using any eye ointment, gel or other viscous eye drops. Instill one drop of OXERVATE in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks.

    How do you use Oxervate video? ›

    Oxervate - YouTube

    Is Oxervate available in the US? ›

    The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

    What type of drug is Oxervate? ›

    OXERVATE is a prescription eye drop solution used to treat a condition called neurotrophic keratitis. OXERVATE is safe and effective in children two years of age and older. Before you use OXERVATE, tell your doctor about all of your medical conditions, including if you: have an infection in your eye.

    How is neurotrophic keratitis treated? ›

    Neurotrophic keratitis can be treated with special contact lenses called scleral or corneal contact lenses. The scleral lens is dome-shaped and vaults over the cornea.

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