Trelstar

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• 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, slurred speech, problems with vision or balance;
• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling; or
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Common side effects may include:

• hot flashes;
• back pain, pain or swelling in your legs;
• mild 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. You may report side effects to FDA at 1-800-FDA-1088.

Triptorelin is usually given once every 4, 12, or 24 weeks. Your dose schedule will depend on the strength of triptorelin you are using. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Triptorelin is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Triptorelin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not shake the mixed medicine or it may foam. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin.

While using triptorelin, you may need frequent blood tests.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Store vials and prefilled syringes at room temperature away from moisture, heat, and light. Do not freeze.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Call your doctor for instructions if you miss a dose of triptorelin.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of the three TRELSTAR formulations was evaluated in clinical trials involving patients with advanced prostate cancer. Mean testosterone levels increased above baseline during the first week following the initial injection, declining thereafter to baseline levels or below by the end of the second week of treatment. The transient increase in testosterone levels may be associated with temporary worsening of disease signs and symptoms, including bone pain, neuropathy, hematuria, and urethral or bladder outlet obstruction. Isolated cases of spinal cord compression with weakness or paralysis of the lower extremities have occurred [see WARNINGS AND PRECAUTIONS].

Adverse reactions reported for each of the three TRELSTAR formulations in the clinical trials, are presented in Table 2, Table 3, and Table 4. Often, causality is difficult to assess in patients with metastatic prostate cancer. The majority of adverse reactions related to triptorelin are a result of its pharmacological action, i.e., the induced variation in serum testosterone levels, either an increase in testosterone at the initiation of treatment, or a decrease in testosterone once castration is achieved. Local reactions at the injection site or allergic reactions may occur.

The following adverse reactions were reported to have a possible or probable relationship to therapy as ascribed by the treating physician in at least 1% of patients receiving TRELSTAR 3.75 mg.

Table 2: TRELSTAR 3.75 mg: Treatment-Related Adverse Reactions Reported by 1% or More of Patients During Treatment

The following adverse reactions were reported to have a possible or probable relationship to therapy as ascribed by the treating physician in at least 1% of patients receiving TRELSTAR 11.25 mg.

Table 3: TRELSTAR 11.25 mg: Treatment-Related Adverse Reactions Reported by 1% or More of Patients During Treatment

The following adverse reactions occurred in at least 5% of patients receiving TRELSTAR 22.5 mg. The table includes all reactions whether or not they were ascribed to TRELSTAR by the treating physician. The table also includes the incidence of these adverse reactions that were considered by the treating physician to have a reasonable causal relationship or for which the relationship could not be assessed.

Table 4: TRELSTAR 22.5 mg: Adverse Reactions Reported by 5% or More of Patients During Treatment

The following abnormalities in laboratory values not present at baseline were observed in 10% or more of patients:

TRELSTAR 3.75 mg: There were no clinically meaningful changes in laboratory values detected during therapy.

TRELSTAR 11.25 mg: Decreased hemoglobin and RBC count and increased glucose, BUN, SGOT, SGPT, and alkaline phosphatase at the Day 253 visit.

TRELSTAR 22.5 mg: Decreased hemoglobin and increased glucose and hepatic transaminases were detected during the study. The majority of the changes were mild to moderate.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of gonadotropin releasing hormone agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

During postmarketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

During postmarketing experience, convulsions, and thromboembolic events including, but not limited to, pulmonary emboli, cerebrovascular accident, myocardial infarction, deep venous thrombosis, transient ischemic attack, and thrombophlebitis have been reported.

Trelstar is a prescription medicine approved for the treatment of the symptoms associated with advanced prostate cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category X. This medicine is not approved for any use in women, although, sometimes it is prescribed for "off-label", or unapproved uses. Trelstar should not be used in women who are pregnant. Trelstar decreases production of estrogen in women,  which can cause miscarriage if taken by a pregnant woman.

Before receiving Trelstar, tell your doctor if you are pregnant or plan to become pregnant. Tell your doctor right away if you become pregnant while receiving Trelstar.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Trelstar is excreted in human breastmilk or if it will harm your nursing baby.

Triptorelin is a man-made form of a hormone that regulates many processes in the body. Triptorelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

The Trelstar brand of triptorelin is used in men to treat the symptoms of prostate cancer. Trelstar treats only the symptoms of prostate cancer and does not treat the cancer itself.

The Triptodur brand of triptorelin is used to treat precocious puberty in boys and girls who are at least 2 years old.

Triptorelin may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss a dose, or if you miss an appointment for your triptorelin injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Storage

Parenteral

20–25°C.1 Do not freeze.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

8.1       Pregnancy

Pregnancy Category X [see 'Contraindications' section].

Trelstar is contraindicated in women who are or may become pregnant while receiving the drug.  Expected hormonal changes that occur with Trelstar treatment increase the risk for pregnancy loss. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Studies in pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day (approximately equivalent to 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area) during the period of organogenesis demonstrated maternal toxicity and embryo-fetal toxicities.  Embryo-fetal toxicities consisted of pre-implantation loss, increased resorption, and reduced mean number of viable fetuses at the high dose.  Teratogenic effects were not observed in viable fetuses in rats or mice.  Doses administered to mice were 2, 20, and 200 mcg/kg/day (approximately equivalent to 0.1, 0.7, and 7 times the estimated human daily dose based on body surface area).    

8.3       Nursing Mothers

Trelstar is not indicated for use in women [see Indications and Usage (1)].  It is not known if triptorelin is excreted in human milk.  Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Trelstar, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

8.4       Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5       Geriatric Use

Prostate cancer occurs primarily in an older population.  Clinical studies with Trelstar have been conducted primarily in patients ≥ 65 years [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

8.6       Renal Impairment

Subjects with renal impairment had higher exposure than young healthy males [see Clinical Pharmacology (12.3)].

8.7       Hepatic Impairment

Subjects with hepatic impairment had higher exposure than young healthy males [see Clinical Pharmacology (12.3)].

Pregnancy Category: X

Lactation: not known if excreted in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.