Details for: DECAPEPTYL
Company: FERRING INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02389282 | DECAPEPTYL | TRIPTORELIN ACETATE | 0.1 MG / ML | SOLUTION | SUBCUTANEOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 non-medicinal ingredients are
The nonmedicinal ingredients are sodium chloride, acetic acid (glacial) and water for injection.
What dosage form 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 nonprescription.
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
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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Very Common | |||
| Headache | ✔ | ||
| Vaginal Bleeding/Sp otting | ✔ | ||
| Inflammatio n at the Injection Site | ✔ | ||
| Abdominal Pain | ✔ | ||
| Nausea | ✔ | ||
| Common | |||
| Infection 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 Known | |||
| Abdominal discomfort | ✔ | ||
| Excessive sweating | ✔ | ||
| Allergic Reactions | ✔ | ||
| Sleep disorder | ✔ | ||
| Blurred Eye Vision | ✔ | ||
| Itching | ✔ | ||
| Sleep disorder | ✔ | ||
| Rash | ✔ | ||
| Angioedema (swelling that occurs beneath the skin) | ✔ | ||
| Enlargement of ovaries | ✔ | ||
| Sleep disorder | ✔ | ||
| 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
DECAPEPTYL should be stored in a refrigerator (2°C – 8°C). Do not freeze. Store in original container to protect from light. Keep out of the reach and sight of children.
Reporting 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 three 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 ON 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: http://www.website.document or by contacting the sponsor, Ferring Inc., at: 1-800-263-4057
This leaflet was prepared by:
Ferring Inc. 200 Yorkland Boulevard Suite 800 North York, Ontario M2L 5C1
Last revised: July 4, 2012