RECENT MAJOR CHANGES

• WARNINGS AND PRECAUTIONS (5.4, 5.5)1/2011
• ADVERSE REACTIONS (6.2)2/2010

INDICATIONS AND USAGE

VANTAS is is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer. (1).

DOSAGE AND ADMINISTRATION

The recommended dose of VANTAS is one implant for 12 months. Each implant contains 50 mg histrelin acetate to deliver 41 mg histrelin. The implant is inserted subcutaneously in the inner aspect of the upper arm. (2).

DOSAGE FORMS AND STRENGTHS

Subcutaneous implant: 50 mg histrelin acetate (3).

CONTRAINDICATIONS

• Known hypersensitivity to GnRH or GnRH analogs (4.1).
• Pregnancy: VANTAS can cause fetal harm when used during pregnancy (4.2).

WARNINGS AND PRECAUTIONS

• Transient increase in serum testosterone: detected during the first week of treatment that may result in worsening of tumor symptoms. (5.1)
• Spinal Cord Compression and Urinary Tract Obstruction: may cause paralysis or renal impairment. Monitor patients at risk closely during therapy. (5.2)
• Difficulty Locating or Removing Implant: Loss of or inability to locate or remove an inserted implant has been reported. Caution is recommended. (5.3)
• Hyperglycemia and Diabetes: 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. (5.4)
• Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men. Monitor for cardiovascular disease and manage according to current clinical practice. (5.5)

ADVERSE REACTIONS

• The most common adverse reaction observed in >5% of men: hot flashes, fatigue, implant site reaction, testicular atrophy (6).

To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals Solutions Inc. at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch