Important Safety Information
Indication
VANTAS® (histrelin acetate) subcutaneous implant is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer.
Important Safety Information
- VANTAS causes a transient increase in serum testosterone during the first week of treatment that may result in worsening of tumor symptoms.
- Cases of spinal cord compression, which may result in paralysis, and ureteral obstruction, which may cause renal impairment, have been reported with GnRH agonists. Monitor patients at risk closely during therapy.
- Loss of, or inability to locate or remove, an inserted implant has been reported. Caution is recommended.
- Insertion and removal of the VANTAS implant is a surgical procedure. Sterile gloves and aseptic technique must be used to minimize any chance of infection.
- Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice.
- Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. Monitor for cardiovascular disease and manage according to current clinical practice.
- Response to VANTAS should be monitored by measuring serum concentrations of testosterone and prostate-specific antigen periodically, especially if the anticipated clinical or biochemical response to treatment has not been achieved. Results of testosterone determinations are dependent on assay methodology. It is advisable to be aware of the type and precision of the assay methodology to make appropriate clinical and therapeutic decisions.
- The most common adverse reactions observed in >5% of men were hot flashes, fatigue, implant site reactions and testicular atrophy.
- During post-marketing surveillance, cases of pituitary apoplexy have been reported after the administration of GnRH agonists. Additionally, severe liver injury has been reported in association with VANTAS. The toxicity was reversible with the removal of the VANTAS implant.
- VANTAS is contraindicated in patients with known hypersensitivity to GnRH or GnRH analogs.
- VANTAS can cause fetal harm when administered to a pregnant woman.
Please see the VANTAS full Prescribing Information.
