Trelstar 3.75 mg - Consumer Medicine Information
|Class:||Gonadotropin releasing hormones, Hormones/antineoplastics|
|Form:||Intramuscular (IM), Powder|
|Ingredients:||Triptorelin Pamoate, Poly-d,l-lactide-co-glycolide, Mannitol, Carboxymethylcellulose Sodium and Polysorbate 80|
About this medication
TRELSTAR belongs to a class of drugs called gonadotropin- releasing hormone (GnRH) agonists.
What the medication is used for:
Your doctor has prescribed TRELSTAR to treat your endometriosis. Endometriosis is a disease in which abnormal tissue grows in the abdomen and other places in the body. It can be treated with pain medication, hormones and surgery.
What it does:
TRELSTAR works like a hormone and reduces the level of estrogen in your body. A reduction in the level of your estrogen may help reduce the pain and other symptoms of endometriosis. The duration of your treatment will be up to 6 months. Once you stop treatment, the level of estrogen will return to normal. Even though you will be stopping treatment after 6 months, you will still benefit from the treatment for many months afterwards.
When it should not be used:
TRELSTAR should not be used if:
- You are allergic or oversensitive to triptorelin, or to drugs called LHRH agonists, or to any ingredients in the formulation or component of the vial.
- You are or may become pregnant, or if you are nursing. In pregnant women, TRELSTAR may cause harm to the baby.
- You have abnormal vaginal bleeding that has not been checked by your doctor.
- You are a woman under 18 years of age. TRELSTAR was not studied in children.
What the medicinal ingredient is:
What the important nonmedicinal ingredients are:
Poly-d,l-lactide-co-glycolide, mannitol, carboxymethylcellulose sodium and polysorbate 80.
What dosage forms it comes in:
TRELSTAR is a sterile powder stored in a vial. The powder will be mixed by your doctor with sterile water to make a suspension before injecting it into your muscle. The active ingredient contained in the microgranules will slowly be released from the injection site.
TRELSTAR contains 3.75 mg of triptorelin (as pamoate).
Warnings and precautions
BEFORE you use TRELSTAR talk to your doctor or pharmacist if:
- You have any allergies to this drug, or its ingredients, or to components of the vial
- You think you may be pregnant
- You are nursing
- You have a history of chronic alcohol and/or tobacco use
- You have a strong family history of osteoporosis
- You have a history of chronic use of drugs such as anticonvulsants or corticosteroids.
- You have kidney and/or liver disease
Since menstruation (your period) should stop while you are on TRELSTAR treatment, you should tell your doctor if regular menstruation continues.
Before beginning treatment with TRELSTAR, your doctor should have you take a test to ensure that you are not pregnant.
You may experience breakthrough bleeding or ovulation if you miss one or more doses of TRELSTAR. Because of the risk to a baby should you become pregnant while on TRELSTAR treatment, it is important to use a nonhormonal method of contraception. If you suspect you might be pregnant, consult your doctor immediately. Your treatment should be discontinued.
You should know how TRELSTAR affects you before driving a vehicle or operating machinery.
Interactions with this medication
Before your treatment with TRELSTAR, check with your doctor or pharmacist before taking any other drugs, including nonprescription drugs (for colds, nausea, etc). During your treatment with TRELSTAR do not start taking a new medicine before checking with your doctor or pharmacist.
Proper use of this medication
How is TRELSTAR given?
Your doctor will administer one injection of TRELSTAR, containing 3.75 mg triptorelin, into your muscle on a specified day, generally once every 28 days, for a period of 6 months.
If you forget to have TRELSTAR administered on the specified day, have it administered as soon as you can.
It is very important that your doctor check your progress at regular medical visits. Don't stop your TRELSTAR treatment if you feel better; consult your doctor before you decide to change your treatment.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Side effects and what to do about them
Like all medicines, TRELSTAR may have, in addition to its beneficial effects, some unwanted effects.
TRELSTAR treatment, given once a month, results in suppression of your sex hormones. Any effects you experience may be related to this hormone-suppressing action of TRELSTAR. These effects may include hot flushes, reduction in sex drive, headaches, emotional changes, acne, reduction in breast size and vaginal dryness*. If these continue to make you feel uncomfortable, consult your doctor. Since estrogen levels return to normal after treatment is discontinued, these effects should disappear.
Occasionally, a local skin reaction may occur at the injection site such as itching, redness, burning and swelling. These reactions generally are mild and disappear after a few days. If they get worse or do not go away, tell your doctor.
Consult your doctor immediately if you develop severe or increased pain, numbness or weakness of the limbs, or persistent difficulty in urinating.
Other side effects not listed above may also occur in some patients. If you notice any other effects, tell your doctor immediately.
|Symptom / effect||Talk with your||Stop taking
drug and call
|Only if severe||In all cases|
|No menstrual periods||√|
|Difficulty falling asleep||√|
|Decreased sex drive*||√|
|Reduction in breast size*||√|
|Lower abdominal pain||√|
|Infection of bladder and/or kidneys||√|
|Acute abdominal pain||√|
|Injection site reaction||√|
|Swelling in the limbs||√|
|Constipation and diarrhea||√|
|Lack of interest or concern||√|
|Yellow/pale discharge from vagina||√|
|Severe bleeding from vagina||√|
*Are considered expected side effects related to the hormone-suppressing action of TRELSTAR.
This is not a complete list of side effects. For any unexpected effects while taking TRELSTAR, contact your doctor or pharmacist.
How to store it
Store TRELSTAR vial supplied with MIXJECT Dose Delivery System (with Sterile Water for Injection) at 20-25oC; excursions permitted: 15 – 30 oC.
Store TRELSTAR vial (without Sterile Water for Injection) at 20- 25oC; excursions permitted: 15 - 30oC.
Do not freeze. Protect from light.
Keep out of reach of children.
|REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at:
www.actavis.ca or by contacting the sponsor, Actavis Specialty Pharmaceuticals Co., at