Classes
DEA Class; Rx
Common Brand Names; Supprelin LA, Vantas
- Antineoplastics, GNRH Agonist
Description
A gonadotropin-releasing hormone (GnRH) agonist
Used for the palliative treatment of advanced prostate cancer or the treatment of central precocious puberty in children
Initial increases in hormone levels may cause temporary worsening of symptoms; implant insertion is a surgical procedure
Indications
Indicated for the palliative treatment of advanced prostate cancer.
Contraindications
Hypersensitivity
Women who may become or are currently pregnant, children
Adverse Effects
- Hot flashes (65.5%)
- 1-10%
- Fatigue
- Headache
- Insomnia
- Constipation
- Weight gain
- Decreased libido
- Erectile dysfunction
- Gynecomastia
- Testicular atrophy
- Anemia
- Hepatic disorder
- Implant site reaction
Warnings
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists
Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists
Convulsions reported in patients receiving GnRH agonists; reports with GnRH agonists have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs; convulsions also reported in patients in the absence of any of the conditions listed
Psychiatric events reported in patients taking GnRH agonists; postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression; monitor for development or worsening of psychiatric symptoms during treatment
Reports of MI, sudden cardiac death, and stroke in men treated with GnRH agonists
Pseudotumor cerebri (idiopathic intracranial hypertension) reported in pediatric patients receiving GnRH agonists, including leuprolide acetate; monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea
Pregnancy and Lactation
Contraindicated during pregnancy since expected hormonal changes that occur with treatment increase risk for pregnancy loss; the limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes
There are no data on presence of drug in human or animal milk, effects on breastfed infant, or on milk production; absorption and systemic activity are not expected from potential exposure to drug, in breast milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Maximum Dosage
No more than 1 Vantas subcutaneous implant insertion at any one time.
No more than 1 Vantas subcutaneous implant insertion at any one time.
No more than 1 Supprelin LA subcutaneous implant inserted at any one time, although most children with precocious puberty will discontinue histrelin therapy around adolescence.
Children 2 years and older: No more than 1 Supprelin LA subcutaneous implant inserted at any time.
Children younger than 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Histrelin Acetate
implant
- 50mg (Vantas)
- Vantas delivers ~50mcg/day