Geref Warnings, Precautions, Pregnancy, Nursing, Abuse - Sermorelin

Geref Warnings, Precautions, Pregnancy, Nursing, Abuse - Sermorelin

WARNINGS

Following reconstitution of Geref® (sermorelin acetate for injection) with the diluent provided, the solution should be administered immediately. Any unused solution should be discarded.

General:   Geref® (sermorelin acetate for injection) therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of growth disorders.

The growth response of children treated with Geref® should be evaluated on a periodic basis and children with a poor or waning response should be considered for treatment with growth hormone. The effect of Geref® therapy beyond one year and on final adult height remains to be determined.

In clinical studies, the incidence of hypothyroidism during Geref® therapy was 6.5%. In the largest clinical study, 8 of 110 enrolled patients were on thyroid replacement therapy prior to Geref® therapy and an additional 5 after initiating therapy. Untreated hypothyroidism can jeopardize the response to Geref®. Therefore, thyroid hormone determinations should be performed before the initiation and throughout the duration of Geref® therapy. Thyroid hormone replacement therapy should be initiated when indicated.

Bone age should be monitored periodically during Geref® administration, especially in patients who are pubertal and/or receiving concomitant thyroid replacement therapy. Under these circumstances, epiphyseal maturation may progress rapidly.

Patients with growth hormone deficiency secondary to an intracranial lesion were not studied in clinical trials. It is not recommended that such patients be treated with Geref®.

As with the administration of any peptide, local or systemic allergic reactions may occur. Parents/Patients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur.

Laboratory Tests:   Serum levels of inorganic phosphorus, alkaline phosphatase, GH and IGF-1 may increase with Geref® therapy.

Drug Interaction:   Concomitant glucocorticoid therapy may inhibit the response to Geref®. There was no evidence in the controlled studies of Geref®'s interaction with drugs commonly used in the treatment of routine pediatric problems/illnesses. However, formal drug interactions studies have not been conducted.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies for carcinogenicity and impairment of fertility have not been performed with Geref®. There has been no evidence from studies to date of Geref®-induced genetic toxicity.

Pregnancy:   Pregnancy Category C. During teratology studies Geref® produced minor variations in fetuses of rats and rabbits when given at a dose of 0.5 mg/kg/day. This dose is approximately 3 and 6 times the daily human dose calculated on a body surface area (mg/m ² ) basis, for rats and rabbits, respectively. There are no adequate and well controlled studies in pregnant women. Geref® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Women:   It is not known whether Geref® is excreted in human milk. Because many drugs are excreted in human milk, cautions should be exercised when Geref® is administered to a nursing women.

Information For Patients:  Patients being treated with Geref® and/or their parents should be informed of the potential benefits and risks associated with treatment. If home use is determined to be desirable by the physician, instructions on appropriate use should be given, including a review of the contents of the Patient Information Insert. This information is intended to aid in the safe and effective administration of the medication. It is not a disclosure of all possible adverse or intended effects.

If home use is prescribed, a puncture resistant container for the disposal of used syringes and needles should be recommended to the patient. Patients and/or parents should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes (see Patient Information Insert).

Geriatric Use:   The safety and effectiveness of Geref® has not been evaluated in clinical studies in patients 65 years old and over. Elderly patients may be more sensitive to the action of Geref®, and may be more prone to develop adverse reactions.