What Trelstar is used for and how to use it
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Trelstar - 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

What the medication is used for:

Your doctor has prescribed TRELSTAR as part of the treatment for your advanced hormone-dependent prostate cancer.

What it does:

TRELSTAR belongs to a class of drugs called gonadotropin- releasing hormone (GnRH) agonists.

TRELSTAR works to reduce the level of sex hormones, such as testosterone, in your body. A reduction in testosterone may help reduce the bone pain, urinary problems and other symptoms of prostate cancer.

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.
  • Do not use TRELSTAR for women who are or may become pregnant, for nursing mothers, and for women in general. In pregnant women, TRELSTAR may cause harm to the baby.

What the medicinal ingredient is:

Triptorelin pamoate

What the important non-medicinal ingredients are:

Poly-d,l-lactide-co-glycolide, mannitol, carboxymethylcellulose sodium and polysorbate 80.

What dosage forms it comes in:

TRELSTAR is sterile powders stored in vials.

TRELSTAR 3.75 mg 1 month slow-release (triptorelin for injectable suspension) contains 3.75 mg of triptorelin (as pamoate).

TRELSTAR 11.25mg 3 month slow-release (triptorelin for injectable suspension) contains 11.25 mg of triptorelin (as pamoate).

TRELSTAR 22.5 mg 6 month slow-release (triptorelin for injectable suspension) contains 22.5 mg of triptorelin (as pamoate).

Warnings and precautions

Serious Warnings and Precautions

TRELSTAR should be prescribed by a doctor experienced with this type of drugs.
TRELSTAR may cause:
  • worsening of symptoms of prostate cancer at the beginning of treatment
  • bone thinning (osteoporosis)

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 injection
  • You have a strong family history of osteoporosis, have low bone density (BMD), or take any medication that causes thinning of the bones, or use alcohol or tobacco. TRELSTAR may increase your risk of osteoporosis and bone fractures
  • You have or have had kidney and/or liver disease
  • You have a history of heart disease or disorders, or have a genetic heart condition called “long QT syndrome”
  • You have high blood sugar (diabetes), TRELSTAR may affect your blood sugar and you may need to test your blood sugar more frequently while receiving treatment with TRELSTAR
  • You have low red blood cell counts, TRELSTAR may cause a decrease in red blood cells (anemia)

TRELSTAR has not been studied in children under 18 years of age.

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 if you are taking drugs for abnormal heart rhythms, psychosis, nausea resulting from chemotherapy, asthma, antibiotics, or antifungal drugs or any other drugs, including non prescription 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

TRELSTAR is given into your muscle (intramuscular injection) by a healthcare professional under the supervision of your doctor.

Usual Dose:

TRELSTAR 3.75 mg on a specified day, generally once every 28 days

TRELSTAR 11.25 mg on a specified day, generally once every 84 days

TRELSTAR 22.5 mg on a specified day, generally once every 168 days.

Missed Dose:

If you forget to have TRELSTAR on the specified day, call your doctor as soon as you can.

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 some unwanted or side effects.

TRELSTAR may cause an increase in the blood levels of testosterone during the first weeks after treatment begins. As a result, symptoms related to your prostate cancer may temporarily get worse. This increase in blood levels of testosterone and any associated symptoms should decrease over time after the first injection of TRELSTAR. Consult your doctor immediately if you develop severe or increased pain, numbness or weakness of the limbs, or persistent difficulty in urinating.

Expected side effects related to decreased testosterone levels in your body may include hot flushes, reduction in sex drive and inability to develop and maintain an erection (impotence). If these side effects continue to make you feel uncomfortable, consult your doctor.

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.

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 / effectTalk with your doctor or pharmacistStop
taking
drug and
call your
doctor or
pharmacist
Only if severeIn all cases
Very commonHot flushes
CommonPain (Bone, leg, breast, back, joint, muscle)
Injection site pain, hardening, or bruising
Eye pain, eye infection
Headache
High blood pressure
Difficult/painful urination
Nausea
Tiredness
Dizziness
Swelling in the limbs
Constipation
Diarrhea
Depression
Loss of appetite
Difficulty breathing
Racing/abnormal heartbeat
Infection of the bladder and/or kidneys
Indigestion
Leg cramps
Enlargement of breasts
Coughing
Abnormal liver function
High blood sugar/diabetes
Inflammation of the throat
Itching of the skin
Unable tourinate
Reduced size of genitalia
UncommonInjection site reaction
Feeling unwell/uneasy
Muscle weakness
Infection of the nose
Abnormal skin changes
Blood in the urine
Abdominal discomfort or pain
Increase in weight
Muscle stiffness
Pain associated with cancer
Fainting
Inflammation of the testicles
Difficulty falling asleep
Tingling or numbness
Rash

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 3.75 mg, TRELSTAR 11.25 mg and TRELSTAR 22.5 mg vials supplied with MIXJECT Dose Delivery System (with Sterile Water for Injection) at 20-25oC; excursions permitted: 15 - 30oC.

Store TRELSTAR 3.75 mg, TRELSTAR 11.25 mg and TRELSTAR 22.5 mg vials (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