Trelstar Side Effects

Generic name: triptorelin

Note: This document contains side effect information about triptorelin. Some of the dosage forms listed on this page may not apply to the brand name Trelstar.

Some side effects of Trelstar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to triptorelin: intramuscular powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking triptorelin (the active ingredient contained in Trelstar) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect. Some of these side effects are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels:

• painful or difficult urination, burning when you urinate, blood in the urine;

• bone pain;

• numbness, tingling, or muscle weakness (especially in your legs and feet);

• loss of movement in any part of your body;

• fever, chills, body aches, flu symptoms;

• sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects of triptorelin may include:

• hot flashes;

• back pain, pain or swelling in your legs;

• headache, dizziness, tired feeling;

• decreased interest in sex, impotence, trouble having an orgasm;

• nausea, vomiting, diarrhea, upset stomach;

• sleep problems (insomnia);

• breast pain or swelling; or

• pain where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to triptorelin: intramuscular powder for injection

General

General effects including hot flushes (58%), pain (2.1%), leg pain (2.1%), and fatigue (2.1%) have been reported.

Musculoskeletal

Musculoskeletal effects including skeletal pain (12.1%) have been reported.

Psychiatric

Psychiatric effects including impotence (7.1%), insomnia (2.1%), and emotional lability (1.4%) have been reported.

Nervous system

Nervous system effects including headache (5.0%) and dizziness (1.4%) have been reported.

Local

Local effects including injection site pain (3.6%) have been reported.

Cardiovascular

Cardiovascular effects including hypertension (3.6%) have been reported. Seven cases of angioedema have also been reported. Myocardial infarction, sudden cardiac death, and stroke have been reported in patients treated with GnRH agonists.

Gastrointestinal

Gastrointestinal effects including vomiting (2.1%) and diarrhea (1.4%) have been reported.

Hematologic

Hematologic effects including anemia (1.4%) have been reported.

Dermatologic

Dermatologic effects including pruritus (1.4%) have been reported.

Genitourinary

Genitourinary effects including urinary retention (1.4%) and urinary tract infection (1.4%) have been reported.

Other

Because administration of triptorelin (the active ingredient contained in Trelstar) in therapeutic dosages results in suppression of the pituitary-gonadal axis, diagnostic tests of pituitary-gonadal function may be misleading.

Endocrine

Endocrine side effects including pituitary apoplexy and diabetes mellitus have been reported.

Metabolic

Metabolic side effects have included hyperglycemia.

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