Sermorelin is approved for diagnostic evaluation of pituitary function and also for increasing growth in children. Off label usage may include acute or age-related growth hormone insufficiency.
Sermorelin should not be used by patients with a known sensitivity to sermorelin or any of the excipients.
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 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.
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.
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 Sermorelin .
As with the administration of any peptide, local or systemic allergic reactions may occur. P atients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur.
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.
If overdose of Sermorelin Acetate is suspected, contact your Doctor immediately.