What Trelstar 3.75 mg is used for and how to use it
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Trelstar 3.75 mg - Consumer Medicine Information

Manufacture: Actavis
Country: Canada
Condition: Prostate Cancer
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:

Triptorelin pamoate

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?

Usual Dose:

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.

Missed Dose:

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.

Overdose:

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.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your Stop taking
drug and call
your doctor
or pharmacist
Only if severe In all cases
Common Hot flushes*
Vaginal dryness*
No menstrual periods
Increased sweating
Difficulty falling asleep
Headache*
Depression
Decreased sex drive*
Emotional changes/irritability*
Dandruff
Reduction in breast size*
Acne*
Ankle swelling
Nausea
Viral infection
Pain
Abdominal pain
Back pain
Joint pain
Lower abdominal pain
Bruising
Dizziness
Infection of bladder and/or kidneys
Tiredness
Vomiting
Uncommon Pain
Acute abdominal pain
Chest pain
Muscle pain
Injection site reaction
Rash
Swelling in the limbs
Leg cramps
Diarrhea
Constipation and diarrhea
Joint disease
Memory loss
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:
  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701E
                     Ottawa, Ontario
                     K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.


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.

More information

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
1-855-892-8766