Trelstar

Trelstar (Triptorelin) is given as an intramuscular (into the muscle) injection by your doctor. When used to treat advanced prostate cancer, it may be given once every 28 days, every 3 months or every 6 months, depending on the dosage form used. Many things can affect the dose and schedule of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose or schedule different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important Trelstar (Triptorelin) be given exactly as prescribed by your doctor. Keeping a consistent schedule of injections is important. If you miss an appointment to receive Trelstar (Triptorelin), contact your doctor as soon as possible to reschedule your appointment.

Trelstar (Triptorelin) vials or dose delivery systems should be stored at room temperature and protected from light and freezing. Keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause hot flashes; it may cause headaches; it may cause pain at the injection site; it may cause pain in your bones and joints; it may cause spots or redness of the skin; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Trelstar (1 month slow release) 3.75 mg Trelstar (Triptorelin) per vial

Each vial of sterile lyophilized microgranules contains Trelstar (Triptorelin) pamoate equivalent to 3.75 mg of Trelstar (Triptorelin) peptide base. Nonmedicinal ingredients: poly-d,l-lactide-co-glycolide (170 mg), mannitol USP (85 mg), carboxymethylcellulose sodium USP (30 mg), and polysorbate 80 USP (2 mg). When 2 mL Sterile Water for Injection is added to the microgranules and mixed, a suspension is formed, which is intended as a single, monthly intramuscular injection.

Trelstar (3 month slow release) 11.25 mg triptorelin/vial

Each vial of sterile lyophilized microgranules contains Trelstar (Triptorelin) pamoate equivalent to 11.25 mg of Trelstar (Triptorelin) peptide base. Nonmedicinal ingredients: poly-d,l-lactide-co-glycolide (145 mg), mannitol USP (85 mg), carboxymethylcellulose sodium USP (30 mg), and polysorbate 80 USP (2 mg). When 2 mL Sterile Water for Injection is added to the microgranules and mixed, a suspension is formed, which is intended as a single, 3 month intramuscular injection.

Trelstar (6 month slow release) 22.5 mg triptorelin/vial

Each vial of sterile lyophilized microgranules contains Trelstar (Triptorelin) pamoate equivalent to 22.5 mg of Trelstar (Triptorelin) peptide base. Nonmedicinal ingredients: poly-d,l-lactide-co-glycolide, mannitol USP, carboxymethylcellulose sodium USP, and polysorbate 80 NF. When 2 mL Sterile Water for Injection is added to the microgranules and mixed, a suspension is formed, which is intended as a single, intramuscular injection administered every 6 months.

Do not use Trelstar (Triptorelin) if you:

• are allergic to Trelstar (Triptorelin) or any ingredients of the medication
• are allergic to medications called GnRH agonists or LHRH agonists (such as Buserelin or Goserelin)
• are breast-feeding
• are pregnant or may become pregnant while taking Trelstar (Triptorelin)

There may be an interaction between Trelstar (Triptorelin) and any of the following:

• Amiodarone
• anti-psychotics (e.g., Aripiprazole, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Asenapine
• beta-2 agonists (salbutamol, salmeterol)
• Buprenorphine
• diabetes medications (e.g., Canagliflozin, Gliclazide, Glyburide, insulin, Metformin, Rosiglitazone, Sitagliptin)
• Disopyramide
• Domperidone
• efavirenz
• lopinavir
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• mifepristone
• procainamide
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• saquinavir
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (e.g., Granisetron, Ondansetron)
• Sotalol
• Tetrabenazine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Trelstar (Triptorelin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Trelstar (Triptorelin).

Anemia: Trelstar (Triptorelin) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Depression: GnRH medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Trelstar (Triptorelin) contact your doctor as soon as possible.

Diabetes: Trelstar (Triptorelin) may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Trelstar (Triptorelin).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed.

Drowsiness/reduced alertness: Trelstar (Triptorelin) may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Trelstar (Triptorelin) affects you.

Heart rhythm: Trelstar (Triptorelin) can cause changes to the normal rhythm of the heart, as a result of reducing the testosterone in the body. An irregular heartbeat called QT prolongation is possible. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels, taking certain medications), discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Trelstar (Triptorelin) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed.

If you have reduced kidney or liver function, discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Trelstar (Triptorelin) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Trelstar (Triptorelin).

Men and the heart: There may be an increased risk of heart-related events (e.g., heart attacks, Stroke, heart-related death) in men being treated for prostate cancer with GnRH medications. Before you start treatment, tell your doctor if you have diabetes, heart disease, had a previous Heart Attack or stroke, or have cardiovascular risk factors (e.g., high blood pressure, smoking, or cholesterol). If you have any of these conditions, discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed.

Osteoporosis: Trelstar (Triptorelin) can cause your bones to lose thickness. If you are at risk for osteoporosis (thin bones) or are taking other medications that tend to thin bones, discuss with your doctor how Trelstar (Triptorelin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelstar (Triptorelin), and whether any special monitoring is needed.

Short-term worsening of symptoms: When Trelstar (Triptorelin) is first used, an increase in testosterone occurs in the body. For some people, their symptoms may temporarily worsen during the first weeks of treatment with Trelstar (Triptorelin). If your medical condition appears to worsen or you experience bone pain, numbness or tingling in the hands or feet, blood in the urine or difficulty urinating, contact your doctor as soon as possible.

Pregnancy: Trelstar (Triptorelin) should not be used during pregnancy. A non-hormonal method of birth control (such as condoms, diaphragms, or IUDs) should be used during treatment. If you become pregnant during treatment, contact your doctor immediately.

Breast-feeding: It is not known if Trelstar (Triptorelin) passes into breast milk. Breast-feeding is not recommended for women taking Trelstar (Triptorelin).

Children: The safety and effectiveness of using Trelstar (Triptorelin) have not been established for children.

This product is usually injected into a muscle (intramuscularly) by a health professional. The injection may be sore for a few days. This medication is typically used only once a month. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects.