Details for: LUTREPULSE PWS 0.8MG PER VIAL
Company: FERRING INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02046210 | LUTREPULSE PWS 0.8MG/VIAL | GONADORELIN ACETATE | 0.8 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02046210 | LUTREPULSE PWS 0.8MG/VIAL | GONADORELIN ACETATE | 0.8 MG / VIAL | POWDER FOR 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
Lutrepulse is used for induction of ovulation in women with primary hypothalamic amenorrhea. These women do not have a menstrual period because they are not producing enough Gonadotropin-Releasing Hormone (GnRH), a hormone released by an area of the brain called the hypothalamus.
What it does
Lutrepulse contains gonadorelin acetate, a synthetic Gonadotropin- Releasing Hormone (GnRH).
When it should not be used
Do not use Lutrepulse if you:
- are allergic to gonadorelin acetate or any of the ingredients in Lutrepulse
- have a condition that could be worsened by pregnancy such as tumours of the pituitary gland
- have ovarian cysts
- have a condition that could be worsened by reproductive hormones (e.g., estrogen or progesterone), such as hormone-dependant tumours
What the medicinal ingredient is
Gonadorelin acetate
What the non-medicinal ingredients are
Mannitol
Hydrochloric acid 10%
What dosage form it comes in
Lutrepulse is available as lyophilized, sterile powder for injection. Lutrepulse is supplied in a package containing one 10 ml vial of either 0.8 mg or 3.2 mg Gonadorelin acetate, and one 10 ml vial of diluent that is sterile sodium chloride for injection.
Warnings and precautions
Serious Warnings and Precautions
Lutrepulse should be prescribed and managed by a doctor
experienced in the use of drugs to induce ovulation.
Lutrepulse may cause:
- Ovarian Hyperstimulation Syndrome (OHSS). OHSS is a condition when too many follicles grow, which can cause abdominal or pelvic pain, nausea, vomiting, weight gain, difficulty breathing, diarrhea. If you experience any of these symptoms, contact your doctor immediately. OHSS can progress rapidly and may become serious.
- Ovarian cancer has been reported in very small number of patients receiving fertility drugs. However it is not known if it is related to the fertility drug
The use of Lutrepulse may result in multiple births. Talk to your
doctor about the risks of multiple births before beginning
treatment.
Before you use Lutrepulse, talk to your doctor or pharmacist if
you:
- Are pregnant. Lutrepulse should be used during pregnancy only as part of the fertility treatment
- Are breastfeeding
Interactions with this medication
Talk to your doctor or pharmacist about all other medications that you are taking, including the ones you bought without prescription, herbal products, or any supplements. Lutrepulse should not be used together with other medications used to stimulate ovulation.
Proper use of this medication
Usual dose
It is important to use Lutrepulse exactly as prescribed by your
doctor.
Usual dose: 5 μg every 90 minutes.
Lutrepulse can be injected under the skin (subcutaneous) or into a
vein (intravenous) by an infusion pump. If you use the infusion
pump, your doctor should show you how to use and care for the
pump.
Lutrepulse is to be reconstituted with 8 ml of the diluent
immediately before use.
Overdose
Missed Dose
If you miss a dose do not double the dose. Contact your physician for advice.
Side effects and what to do about them
A causal relationship between treatment of fertility drugs and ovarian cancer has not been established.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Rare (≥0.01% - <0.1%) | |||
| Hypersensitivity | ✔ | ||
| Reddening at the injection site | ✔ | ||
| Ovarian hyperstimulation | ✔ | ||
| Very rare <0.01%) | |||
| Formulation of antibodies (long term treatment) | ✔ | ||
| Severe Allergic Reaction (Anaphylactic shock) | ✔ | ||
| Inflammation | ✔ | ||
| Neurological symptoms such as agitation, change in mood (depression) | ✔ | ||
| Headache | ✔ | ||
| Nausea | ✔ | ✔ | |
| Increased menstrual bleeding | ✔ | ✔ | |
| Abdominal pain | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking LUTREPULSE, contact your doctor or pharmacist.
How to store
Both Lutrepulse and 0.9% sodium chloride for injection are stable
when stored at room temperature
(15°- 30°C) in the unopened package.
Reporting side effects
To monitor drug safety, Health Canada through the Vigilance
Program collects information on serious and unexpected side
effects of drugs. If you suspect you have had a serious or
unexpected reaction to this drug you may notify Canada
Vigilance:
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 0701C
Ottawa, ON 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 the side effect, please contact your health care provider before notifying Canada Vigilance. 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.
Last revised: August 17, 2010