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Trelstar Warnings, Precautions, Pregnancy, Nursing, Abuse - Triptorelin pamoate

Trelstar Warnings, Precautions, Pregnancy, Nursing, Abuse - Triptorelin pamoate

WARNINGS

Initially, triptorelin, like other LHRH agonists, causes a transient increase in serum testosterone levels. As a result, isolated cases of worsening of signs and symptoms of prostate cancer during the first weeks of treatment have been reported with LHRH agonists. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction. Cases of spinal cord compression, which may contribute to paralysis with or without fatal complications, have been reported with LHRH agonists.

If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy considered.

TRELSTARTM DEPOT should not be administered to individuals who are hypersensitive to triptorelin, other LHRH agonists, or LHRH. In the event of a hypersensitivity reaction, therapy with TRELSTARTM DEPOT should be discontinued immediately and the appropriate supportive and symptomatic care should be administered.

PRECAUTIONS

General: Patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be closely observed during the first few weeks of therapy (see

WARNINGS

). Hypersensitivity and anaphylactic reactions have been reported with triptorelin as with other LHRH agonists (see CONTRAINDICATIONS and

WARNINGS

).

Laboratory Tests: Response to TRELSTARTM DEPOT should be monitored by measuring serum levels of testosterone and prostate-specific antigen.

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