Safety information¹

Clinical use:

Safety and efficacy have not been established in pediatrics (< 18 years of age).

Most serious warnings and precautions:

• QT prolongation

Relevant warnings and precautions:

• Co-administration with an oral P-glycoprotein (P-gp) inhibitor or a combined P-gp and strong cytochrome P450 (CYP) 3A inducer
• Androgen deprivation therapy can prolong the QT interval
• Therapy results in suppression of the pituitary gonadal system
• Tests of pituitary gonadotropic and gonadal functions conducted during and after therapy may be affected
• Monitor prostate-specific antigen (PSA) levels; if PSA increases, measure serum testosterone concentrations
• Consider periodic monitoring of electrocardiogram and serum electrolyte levels for those at risk for QTc prolongation and electrolyte abnormality
• Risk of decreased bone density with use of gonadotropin-releasing hormone receptor agonist or antagonist
• Men and women of reproductive potential should use contraception during treatment and for 2 weeks after the last dose
• May impair fertility in males of reproductive potential

For more information:

Consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing that has not been discussed in this piece. The Product Monograph is also available by calling 1-866-260-6291.