What Decapeptyl is used for and how to use it
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Decapeptyl - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: Canada
Condition: Amenorrhea, Endometriosis, Prostate Cancer, Uterine Fibroids
Class: Gonadotropin releasing hormones, Hormones/antineoplastics
Form: Liquid solution, Subcutaneous (SC)
Ingredients: Triptorelin acetate, are sodium chloride, acetic acid (glacial), water for injection.

Triptorelin Acetate Injection 0.1 mg/mL

About This Medication

What the Medication is Used For

DECAPEPTYL is used in women undergoing assisted reproduction techniques (ART) for downregulation and prevention of premature luteinizing hormone (LH) surges.

What It Does

DECAPEPTYL contains triptorelin, a synthetic analogue of the natural gonadotropin releasing hormone (GnRH), which blocks GnRH action, thereby reducing premature ovulation (release of egg cells).

When It Should not be Used

DECAPEPTYL should not be used if you are:

  • allergic (hypersensitive) to triptorelin acetate or any of the other ingredients of DECAPEPTYL
  • allergic (hypersensitive) to GnRH or any other GnRH analogue (medicines similar to DECAPEPTYL).
  • pregnant
  • breastfeeding

What the Medicinal Ingredient Is

Triptorelin acetate.

What the Nonmedicinal Ingredients Are

The nonmedicinal ingredients are sodium chloride, acetic acid (glacial) and water for injection.

What Dosage Forms It Comes In

This medicine is a clear colourless liquid in a glass syringe of 1 ml to which a needle is connected. Syringe and needle are closed with a rubber stopper and a needle shield. It is available in cartons containing 7 or 28 prefilled syringes.

Warnings and Precautions

DECAPEPTYL should be prescribed and managed by a doctor experienced in the treatment of infertility.

DECAPEPTYL may increase the risk of:

  • Ectopic pregnancy (pregnancy outside of the womb)
  • Miscarriage
  • Multiple pregnancies (twins, triplets, etc.)
  • Physical defects in the baby at birth (congenital malformation)
  • Ovarian hyperstimulation Syndrome (OHSS)

Before you use DECAPEPTYL talk to your doctor or pharmacist if you:

  • are pregnant or may be pregnant
  • are breast-feeding
  • have an active allergic condition or suffer easily from allergic reactions.DECAPEPTYL may cause severe allergic reactions, including anaphylactic shock and angioedema.
  • have bone thinning or take any medication for bone loss or thinning
  • have depression or mood changes
  • have ovarian cysts

Interactions With This Medication

Tell your doctor if you are taking or have recently taken, any other medicines including medicines obtained without non-prescription.

Proper Use of This Medication

You should follow instructions on how to inject DECAPEPTYL given by your clinic. However, the first injection of DECAPEPTYL should be given under the supervision of your doctor.

Usual Dose

The usual dosage is one injection (0.1 mg) under the skin of your lower abdomen. Treatment can be started on day 2 or 3 or day 21 to 23 of the menstrual cycle (or 5-7 days before the expected start of menstruation). After 2 to 4 weeks other hormones will be given in order to stimulate follicle growth (egg sack growth). In general, DECAPEPTYL treatment will continue until follicles have reached a suitable size. This will last usually 4 to 7 weeks.

If enough egg sacs are present, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) to induce ovulation (release of an egg).

Your doctor will closely monitor your progress for at least 2 weeks after you have received the hCG injection.

Monitoring and Testing While Taking Decapeptyl

While you are being treated with DECAPEPTYL, your doctor will normally arrange for you to have ultrasound scans and sometimes blood tests to monitor your response to treatment.

Overdose

If you use more DECAPEPTYL than you should or in case of a suspected drug overdose, contact your doctor, or nurse, or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget to use DECAPEPTYL, please tell your doctor or nurse. Do not double dose.

If You Stop Using Decapeptyl

Do not stop using DECAPEPTYL yourself and carefully follow the instructions of your doctor. If you stop too quickly, it will diminish your changes on getting pregnant. If you have any further questions on the use of this product, ask your doctor.

Side Effects and What to Do About Them

Like all medicines, DECAPEPTYL can cause side effects. 
Very common side effects includes: headache, abdominal pain, vaginal bleeding/spotting, nausea, inflammation at the injection site.

Common side effects includes: infection of the upper respiratory tract, flu-symptoms, pharyngitis, dizziness, hot flushes, vomiting, swollen abdomen, back pain, abortion, pelvic pain, overstimulation of the ovaries (high levels of activity in the ovaries), ovarian cysts (in the beginning of the treatment), pain during menstruation, pain or other reaction at the injection site, and tiredness.

The following side effects may occur during treatment with DECAPEPTYL: sleep disorder, mood alterations, vulvovaginal dryness, excessive sweating, libido decreased, breast pain, muscle spasms, joint pain, weight gain, abdominal discomfort, weakness and blurred eye vision, itching, rash and swelling (beneath the skin), injection site redness, painful sexual intercourse, and irregular and prolonged periods.

If you administer DECAPEPTYL yourself, you should be aware of possible allergic reactions (itching, skin rash, fever).

Contact your doctor immediately if you get:

  • Severe pain in the abdomen
  • Swelling in the abdomen
  • Severe nausea
  • Severe vomiting
  • Diarrhea
  • Weight gain
  • Difficulty breathing
  • Decreased urination

Tell your doctor straight away, even if the symptoms develop some days after the last injection has been given. These can be signs of high levels of activity in the ovaries (OHSS) which might become severe. If these symptoms become severe, the infertility treatment should be stopped and you should receive treatment in hospital.

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking drug
and call your
doctor or
pharmacist
Only if
severe
In all
cases
Very CommonHeadache
Vaginal Bleeding/Sp otting
Inflammatio n at the Injection Site
Abdominal Pain
Nausea
CommonInfection of the Upper Respiratory Tract
Pharyngitis
Hot Flushes
Abdominal Bloating
Abortion
Overstimulat ion of ovaries
Pain during menstruation
Tiredness
Flu-like symptoms
Dizziness
Vomiting
Back pain
Pelvic Pain
Ovarian cysts (in the beginning of treatment)
Injection site pain or reaction
Not KnownAbdominal discomfort
Excessive sweating
Allergic Reactions
Sleep disorder
Blurred Eye Vision
Itching
Rash
Angioedema (swelling that occurs beneath the skin)
Enlargement of ovaries
Spotting between periods
Mood alterations
Decrease libido
Shortness of breath
Visual impairment
Heavy, prolonged and/or irregular periods
Vulvovagina l dryness*
Painful sexual intercourse
Weakness
Muscle
spasms
Joint pain
Breast pain
Injection site
redness
Weight gain

*Are considered expected side effects related to the hormone-suppressing action of DECAPEPTYL

This is not a complete list of side effects. For any unexpected effects while taking DECAPEPTYL, contact your doctor or pharmacist.

How to Store It

DECAPEPTYL should be stored in a refrigerator (2oC – 8oC). Do not freeze. Store in original container to protect from light. Keep out of the reach and sight 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 0701D 
      Ottawa, Ontario 
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect 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:
http://www.website.document 
or by contacting the sponsor, Ferring Inc., at:
1-800-263-4057