Prostate and other male cancers:

Indications for TRELSTAR:

Palliative treatment of advanced prostate cancer.

Adult:

Give by IM inj in buttock. 3.75mg every 4 weeks, or 11.25mg every 12 weeks, or 22.5mg every 24 weeks.

Children:

Not established.

Warnings/Precautions:

Not for use in women. Must administer under physician supervision. Discontinue if hypersensitivity occurs. Initial transient increase in serum testosterone may result in worsening of signs/symptoms including bone pain, neuropathy, hematuria, or urethral/bladder obstruction. Spinal cord compression. Renal or hepatic impairment. Metastatic vertebral lesions. Upper or lower urinary tract obstruction. May prolong QT/QTc interval in patients with congenital long QT syndrome, CHF, frequent electrolyte abnormalities. Correct any electrolyte abnormalities; monitor ECGs and electrolytes periodically. Increased risk of diabetes, MI, sudden cardiac death, stroke; monitor blood glucose and/or HbA1c, and for signs/symptoms of cardiovascular disease. Measure serum testosterone periodically. Embryo-fetal toxicity. Pregnancy. Nursing mothers: not recommended.

Pharmacologic Class:

GnRH analogue.

Interactions:

Concomitant hyperprolactinemic drugs: not recommended. Avoid concomitant drugs that are known to prolong the QT interval. May interfere with pituitary gonadotropic function tests.

Adverse Reactions:

Inj site reactions, hot flushes, skeletal pain, impotence, headache, leg edema/pain, erectile dysfunction, testicular atrophy; hyperglycemia.

How Supplied:

MixJect system—1 (vial + vial adapter + prefilled syringe)