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.
6 ADVERSE REACTIONS 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 widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of SUPPRELIN LA in children with CPP was evaluated in two single-arm clinical trials conducted in a total of 47 patients (44 females and 3 males) over a period of time ranging from 9 to 18 months.
The most commonly reported adverse reaction was implant site reaction, which was reported by 24 of 47 (51.1%) patients.
5 WARNINGS AND PRECAUTIONS Initial Agnostic Action: Initial transient increases of estradiol and/or testosterone may cause a temporary worsening of symptoms ( 5.1 ).
Implant Breakage: Have been observed during implant removal.
Monitor luteinizing hormone, follicle stimulating hormone or testosterone for suppression of CPP ( 5.2 , 5.6 ) Psychiatric Events: Have been reported in patients taking GnRH agonists.
Events include emotional lability, such as crying, irritability, impatience, anger, and aggression.
Monitor for development or worsening of psychiatric symptoms.
Like all medications, Supprelin La 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: