Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS In clinical trials of 155 pediatric patients, 2.6% reported symptoms suggestive of drug sensitivity, such as shortness of breath, chest pain, urticaria, rash, and pruritus.
In these 155 patients treated for an average of 41 months and as long as 80 months (6.7 years), adverse events most frequently reported (>3% of patients) consisted largely of episodes occurring during the first 6 weeks of treatment as a result of the transient stimulatory action of nafarelin upon the pituitary-gonadal axis: acne (10%) transient breast enlargement (8%) vaginal bleeding (8%) emotional lability (6%) [see Warnings ] transient increase in pubic hair (5%) body odor (4%) seborrhea (3%) Hot flashes, common in adult women treated for endometriosis, occurred in only 3% of treated children and were transient.
Other adverse events thought to be drug-related, and occurring in >3% of patients were rhinitis (5%) and white or brownish vaginal discharge (3%).
Approximately 3% of patients withdrew from clinical trials due to adverse events.
In one male patient with concomitant congenital adrenal hyperplasia, and who had discontinued treatment 8 months previously to resume puberty, adrenal rest tumors were found in the left testis.
Relationship to SYNAREL is unlikely.
Regular examinations of the pituitary gland by magnetic resonance imaging (MRI) or computer assisted tomography (CT) of children during long-term nafarelin therapy as well as during the post-treatment period has occasionally revealed changes in the shape and size of the pituitary gland.
These changes include asymmetry and enlargement of the pituitary gland, and a pituitary microadenoma has been suspected in a few children.
The relationship of these findings to SYNAREL is not known.
Post-Marketing Pituitary apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists.
WARNINGS The diagnosis of central precocious puberty (CPP) must be established before treatment is initiated.
Regular monitoring of CPP patients is needed to assess both patient response as well as compliance.
This is particularly important during the first 6 to 8 weeks of treatment to assure that suppression of pituitary-gonadal function is rapid.
Testing may include LH response to GnRH stimulation and circulating gonadal sex steroid levels.
Assessment of growth velocity and bone age velocity should begin within 3 to 6 months of treatment initiation.
Like all medications, Synarel can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: