Triptorelin

Triptorelin is a prescription medication used to treat advanced prostate cancer and central precocious puberty in children. 

• Triptorelin is available under various brand names: Trelstar Depot, Triptodur, Trelstar, Trelstar LA

Common side effects of Triptorelin include:

• pain, swelling, itching, or redness where an injection was given,
• hot flashes,
• decreased interest in sex,
• impotence,
• trouble having an orgasm,
• headache,
• bone pain,
• pain or swelling in the legs,
• nausea,
• vomiting,
• diarrhea,
• upset stomach,
• vaginal bleeding,
• stuffy nose,
• sneezing,
• cough,
• sore throat, and
• ear pain

Serious side effects of Triptorelin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• red skin rash,
• severe itching,
• sweating,
• dizziness,
• fast heartbeats,
• trouble swallowing,
• new or worsening mental problems,
• seizure,
• anger,
• aggression,
• crying,
• restlessness,
• irritableness,
• painful or difficult urination,
• burning while urinating,
• blood in the urine,
• bone pain,
• new or worsening signs of puberty (in children),
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• sudden numbness or weakness,
• slurred speech,
• loss of movement in any part of the body,
• increased thirst,
• increased urination,
• hunger,
• dry mouth,
• fruity breath odor,
• back pain,
• muscle weakness,
• problems with balance or coordination,
• severe numbness or tingling in the legs or feet, and
• loss of bladder or bowel control

Rare side effects of Triptorelin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Lyophilized powder for reconstitution (Trelstar)

Reconstitution results in suspension for IM injection

• 3.75 mg/vial
• 11.25 mg/vial
• 22.5 mg/vial

Advanced Prostate Cancer

Adult dosage

• 22.5 mg IM every 6 Months, OR
• 11.25 mg IM every 3 Months, OR
• 3.75 mg IM 1 Month

Central precocious puberty

Pediatric dosage

• Aged below 2 years: Safety and efficacy not established
• Aged above 2 years: 22.5 mg IM every 6 Months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Triptorelin has severe interactions with the following drugs:
  • amiodarone
  • anagrelide
  • dofetilide
• Triptorelin has serious interactions with at least 47 other drugs.
• Triptorelin has moderate interactions with at least 78 other drugs.
• Triptorelin has minor interactions with the following drugs:
  • maitake
  • taurine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Pregnancy or women who may become pregnant

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Triptorelin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Triptorelin?”

Cautions

• Risk of pituitary apoplexy (rare)
• Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists
• Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists
• Reports of MI, sudden cardiac death, and stroke in men treated with GnRH agonists
• QT prolongation
  • Androgen deprivation therapy may prolong the QT/QTc interval; consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval
  • Electrolyte abnormalities should be corrected
  • Consider periodic monitoring of ECG and electrolytes
• Triptodur
• Gonadotropin and sex steroid levels may initially rise above baseline during initial therapy or subsequent doses owing to the transient stimulatory effect of the drug; puberty signs and symptoms (eg vaginal bleeding) may transiently increase
• Psychiatric events: Monitor development or worsening psychiatric symptoms (eg, crying, irritability, impatience, anger, and aggression)
• Convulsion episodes: Increase risk with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and concomitant use of medications associated with convulsions (eg, SSRIs)
• Pseudotumor cerebri (idiopathic intracranial hypertension) reported in pediatric patients receiving GnRH agonists, including leuprolide acetate; monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea

Pregnancy & Lactation

• Based on findings in animal studies and mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; expected hormonal changes that occur with treatment increase the risk for pregnancy loss; in animal developmental and reproductive toxicology studies, daily administration of the drug to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times estimated human daily dose based on body surface area; advise pregnant patients and females of reproductive potential of the potential risk to the fetus
• Based on the mechanism of action, treatment may impair fertility in males of reproductive potential
• Lactation
  • The safety and efficacy are not established in females; there are no data on the presence of the drug in human milk, the effects of the drug on milk production, or on the breastfed child; because of the potential for serious adverse reactions in a breastfed child from treatment, a decision should be made to either discontinue breastfeeding or discontinue the drug taking into account importance of the drug to mother