Histrelin is a gonadotropin releasing hormone receptor agonist sold in the U.S. under 2 brand and generic names, for precocious puberty. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Supprelin (application NDA019836). Other histrelin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dose of SUPPRELIN LA is one implant every 12 months. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin for 12 months of hormonal therapy ( 2 ). 2.1 Recommended Dose The recommended dose of SUPPRELIN LA is one implant every 12 months. Each implant contains 50 mg histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin acetate (65 mcg/day) for 12 months of hormonal therapy. SUPPRELIN LA should be removed after 12 months of therapy (the implant has been designed to allow for a few additional weeks of histrelin acetate release, in order to allow flexibility of medical appointments). At the time an implant is removed, another implant may be inserted to continue therapy. Discontinuation of SUPPRELIN LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males). 2.2 Recommended Procedure for Implant Insertion and Removal This procedure section is intended to provide guidance for the insertion and removal of SUPPRELIN LA. The actual procedure used, however, is at the discretion of the qualified healthcare provider performing the procedure. Insertion of a new implant can proceed using the following…
The following serious adverse reactions are described here and elsewhere in the label: Initial Agonist Action [see Warnings and Precautions ( 5.1 )] Implant Breakage [see Warnings and Precautions ( 5.2 )] Psychiatric Events [see Warnings and Precautions ( 5.3 )] Convulsions [see Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is implant site reaction (51.1%), including complications related to the insertion or removal of the implant ( 6 ). Adverse events related to suppression of endogenous sex steroid secretion may occur ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Adverse Reaction Profile The most common adverse reactions with SUPPRELIN LA involved the implant site. Local reactions after implant insertion include bruising, pain, soreness, erythema and swelling. During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms may be observed [see Warnings and Precautions ( 5.1 )] . 6.2 Adverse Reactions in Clinical Trials Because clinical trials are conducted under…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Implant | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
SUPPRELIN LA is contraindicated in: Patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs Pregnancy [see Use in Specific Populations ( 8.1 )] . History of hypersensitivity to gonadotropin releasing hormone (GnRH) or GnRH analogs ( 4 ). Pregnancy ( 4 ).
Overview: No formal drug-drug, drug-food, or drug-herb interaction studies were performed with SUPPRELIN LA. Drug-Laboratory Interactions: Therapy with SUPPRELIN LA results in suppression of the pituitary-gonadal system. Results of diagnostic tests of pituitary gonadotropic and gonadal functions conducted during and after SUPPRELIN LA therapy may be affected. SUPPRELIN LA decreased mean serum insulin like growth factor 1 (IGF 1) levels by approximately 11% in one study (Study 1). SUPPRELIN LA increased the serum concentration of dehydroepiandrosterone (DHEA) in 8 of 36 patients in another study (Study 2).