Geref Indications, Dosage, Storage, Stability - Sermorelin

Geref Indications, Dosage, Storage, Stability - Sermorelin

INDICATIONS

Geref® (sermorelin acetate for injection) is indicated for the treatment of idiopathic growth hormone deficiency in children with growth failure. Most of these short, slowly growing children retain pituitary responsiveness to growth hormone releasing hormone.

Selection of Patients and Evaluation of Growth

All children should be pre-pubescent and treatment should be initiated at a bone age of <= 7.5 year for females, and <= 8 years for males. Prior to initiation of treatment, a growth hormone (GH) stimulation test with Geref® should be performed in all children. Children who do not adequately respond (i.e., peak GH level <= 2 ng/mL) should be excluded from Geref® therapy. The relative growth hormone response to the stimulation test with Geref® is not predictive of the growth response to Geref® therapy. Clinical results are better in children with delayed bone age and in whom treatment is initiated as early as possible in the prepubertal period. Height should be assessed at least every six months during treatment. During Geref® therapy, failure to maintain a pattern of growth consistent with a child's age and stage of development requires investigation. Children should be treated with Geref® for an initial period of 6 months and treatment with growth hormone should be initiated for those children with a poor or waning response to Geref®.

A dosage of 0.03 mg (30 mcg) per kg of body weight once daily at bedtime by subcutaneous injection is recommended. It is also recommended that subcutaneous injection sites be periodically rotated.

Treatment with Geref® should be discontinued when the epiphyses are fused. Patients who fail to respond adequately while on Geref® therapy should be evaluated to determine the cause of unresponsiveness.

Height should be assessed at least every six months during treatment. During Geref® therapy, care shoud be taken to ensure that the child continues to grow at a rate consistent with the child's age and stage of development, and treatment with Geref® should be reevaluated if the response is inadequate. Treatment with growth hormone should be considered for children with a poor or waning response to Geref®.

To prevent possible contamination, wipe the rubber vial stopper with an antiseptic solution before puncturing it with the needle. It is recommended that Geref® be administered using sterile, disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.

After determining the appropriate patient dose, reconstitute each vial of Geref® with 0.5-1.0 mL of Sodium Chloride Injection, USP.

To reconstitute Geref®, inject the diluent into the vial of Geref® aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. Do not administer Geref® if particles are visible in the reconstituted solution or if the reconstituted solution is cloudy.

Before Reconstitution Vials of Geref® (sermorelin acetate for injection) should be stored refrigerated (2°-8°C/36°-46°F). Expiration dates are stated on the labels.

After Reconstitution When reconstituted with Sodium Chloride Injection, USP, the reconstituted solution should be administered immediately. Any unused solution should be discarded.

Geref® (sermorelin acetate for injection) is a sterile, nonpyrogenic, lyophilized powder supplied in packages containing:

1 vial 0.5 mg Geref® and 1 vial 2 mL Sodium Chloride Injection, USP NDC 44087-4005-1

1 vial 1.0 mg Geref® and 1 vial 2 mL Sodium Chloride Injection, USP NDC 44087-4010-1

Rx Only

Manufactured for:
Serono Laboratories, Inc.
Randolph, MA 02368
® Registered trademark of Serono Laboratories, Inc.