BRIEF SUMMARY

CENERRMIN-bkbj-(Aug 2018)

Indn-    To   treat neurotrophic keratitis   

Comp-   Ophthalmic solution: cenegermin-bkbj 0.002% (20 mcg/mL) in a multiple-dose vial.  One drop of OXERVATE in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks.

ADR-  The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.

CI-   None.

WARNINGS AND PRECAUTIONS-                                                                                     Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion.

Pat Inform- 

Handling the Vials and the Delivery System-                                                                   Advise patients that OXERVATE should be administered using the vial adapters, pipettes, and sterile disinfectant wipes provided in the Delivery System Kit and according to the instructions. 

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U.S. FDA APPROVED  DRUGS DURING 2018

Sr.No-  32

ADVERSE REACTIONS-

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.

CONTRAINDICATIONS-                                                                                                       None.

WARNINGS AND PRECAUTIONS-                                                                                     Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion.

ADVERSE REACTIONS-

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.

INDICATIONS AND USAGE

OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis.

DOSAGE AND ADMINISTRATION-

 One drop of OXERVATE in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks.

DOSAGE FORMS AND STRENGTHS-                                                                               Ophthalmic solution: cenegermin-bkbj 0.002% (20 mcg/mL) in a multiple-dose vial.

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling

Handling the Vials and the Delivery System-                                                                   Advise patients that OXERVATE should be administered using the vial adapters, pipettes, and sterile disinfectant wipes provided in the Delivery System Kit and according to the instructions.     

One individual pipette should be used per application.

Use with Contact Lenses-                                                                                                  Advise patients that contact lenses should be removed before applying OXERVATE and to wait 15 minutes after instillation of the dose before reinserting the contact lenses into the eyes.

Use with other topical products-                                                                                       Advise the patient to administer the eye drops at least 15 minutes apart, if more than one topical ophthalmic product is being used to avoid diluting products. 

 Administer OXERVATE 15 minutes prior to using any eye ointment, gel or other viscous eye drops.

Delayed or Missed Dose-                                                                                                  If a dose is missed, treatment should be continued as normal, at the next scheduled administration.

Storage Information-                                                                                                           Instruct the patient to remove the weekly carton containing 7 OXERVATE vials from the insulated pack in the Delivery System Kit within 5 hours of leaving the pharmacy and store the weekly carton in the refrigerator [36°F to 46°F (2°C to 8°C)].

Instruct the patient to only remove the number of OXERVATE vials from the weekly carton required for use over the course of a single day. Do not shake the vial.

Once opened, the vial can be kept in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 12 hours or at room temperature up to 77°F (25°C), but must be used within 12 hours. After 12 hours, advise patients to discard the vial with any unused amount.

Manufactured by Dompé farmaceutici S.p.A. Via Campo di Pile 67100 L’Aquila, Italy U.S. License No. 2074

 CLINICAL PHARMACOLOGY-

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

2. Pharmacodynamics-                                                                                                       No pharmacodynamic studies have been conducted in humans.

3.Pharmacokinetics-                                                                                                          No pharmacokinetic studies have been conducted in humans with OXERVATE.  The extent of systemic exposure to cenegermin-bkbj following the topical ophthalmic administration of OXERVATE is not known.

 USE IN SPECIFIC POPULATIONS-

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

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.

2.Lactation-                                                                                                                         Risk Summary- There are no data on the presence of OXERVATE in human milk, the effects on breastfed infant, 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 any potential adverse effects on the breastfed infant from OXERVATE.

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

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