Sermorelin Acetate is a prescription medicine used for diagnostic evaluation of pituitary function as well as for anti-aging purposes in adults.
Sermorelin Acetate may be used alone or with other medications. It belongs to a class of drugs called Somatropin; Somatropin Agonists.
Sermorelin therapy is provided to people with growth hormone deficiency. One should expect an increase in HGH levels within 3 – 6 months from the initiation of therapy.
Description
Sermorelin acetate (sermorelin) is the acetate salt of an amidated synthetic 29- amino acid peptide (GRF 1-29 NH 2 ) that corresponds to the amino-terminal segment of the naturally occurring human growth hormone-releasing hormone (GHRH or GRF) consisting of 44 amino acid residues. The structural formula for sermorelin acetate is:
The free base of sermorelin has the empirical formula C 149 H 246 N 44 O 42 S and a molecular weight of 3,358 daltons.
Sermorelin is a sterile, non-pyrogenic, lyophilized powder intended for subcutaneous injection after reconstitution with Sodium Chloride Injection, USP. The reconstituted solution has a pH of 5.0 to 5.5.
Sermorelin is available in vials. The quantitative composition per vial is:
- 0.5 mg vial: Each vial contains 0.5 mg sermorelin (as the acetate) and 5 mg mannitol. The pH is adjusted with dibasic sodium phosphate and monobasic sodium phosphate buffer.
- 3.0 mg vial: Each vial contains 3.0 mg sermorelin (as the acetate) and 5 mg mannitol. The pH is adjusted with dibasic sodium phosphate and monobasic sodium phosphate buffer.
Indications & Dosage
Sermorelin is approved for diagnostic evaluation of pituitary function and also for increasing growth in children. Another usage may include acute or age-related growth hormone insufficiency.
A dosage of 0.2 – 0.3 mcg once daily at bedtime by subcutaneous injection is recommended. It is also recommended that subcutaneous injection sites be periodically rotated.
To prevent possible contamination, wipe the rubber vial stopper with an antiseptic solution before puncturing it with the needle. It is recommended that Sermorelin 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.
To reconstitute Sermorelin, inject the diluent into the vial of the Sermorelin aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. Do not administer Sermorelin if particles are visible in the reconstituted solution or if the reconstituted solution is cloudy.
How is it supplied?
Vials of Sermorelin (sermorelin acetate for injection) should be stored refrigerated (2°-8°C/36°-46°F). Expiration dates are stated on the labels.
Sermorelin acetate (sermorelin) is a sterile, nonpyrogenic, lyophilized powder supplied in packages containing:
- 1 vial 0.5 mg Sermorelin and 1 vial 2 mL Sodium Chloride Injection
- 1 vial 3.0 mg Sermorelin and 1 vial 2 mL Sodium Chloride Injection.
Side Effects
A large proportion of patients develop anti- GRF antibodies at least once during treatment with Sermorelin. The significance of these antibodies is not clear and often a positive test at one growth assessment will become negative by the next assessment.
The presence of antibodies does not appear to affect growth or appear to be related to a specific adverse reaction profile. No generalized allergic reactions to Sermorelin have been reported.
The most common treatment-related adverse event (occurring in about 1 patient in 6) is local injection reaction characterized by pain, swelling, or redness. Of 350 patients exposed to Sermorelin in clinical trials, three discontinued therapy due to injection reactions.
Other treatment-related adverse events had individual occurrence rates of less than 1% and include headache, flushing, dysphagia, dizziness, hyperactivity, somnolence, and urticaria.
When administered intravenously for diagnostic use, the following adverse reactions have been noted: flushing of the face, injection site pain, redness and/or swelling, nausea, headache, vomiting, dysgeusia, pallor, and tightness in the chest.
Drug Interactions
Concomitant glucocorticoid therapy may inhibit the response to Sermorelin.
Precautions
General: Sermorelin acetate therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of growth hormone deficiencies.
In clinical studies, the incidence of hypothyroidism during Sermorelin therapy was 6.5%. In the largest clinical study, 8 of 110 enrolled patients were on thyroid replacement therapy prior to Sermorelin therapy and an additional 5 after initiating therapy.
Untreated hypothyroidism can jeopardize the response to Sermorelin. Therefore, thyroid hormone determinations should be performed before the initiation and throughout the duration of Sermorelin therapy. Thyroid hormone replacement therapy should be initiated when indicated.
As with the administration of any peptide, local or systemic allergic reactions may occur. 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 Sermorelin therapy.
Overdose
The recommended dosage of Sermorelin (sermorelin acetate for injection) should not be exceeded.
Contraindications
Sermorelin should not be used by patients with a known sensitivity to sermorelin or any of the excipients.
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