Patient Medication Information: uses, side effects, how to take - Lutrepulse Pws 0.8mg/Vial
ABOUT THIS MEDICATION
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 important nonmedicinal ingredients are:
Mannitol
Hydrochloric acid 10%
What dosage forms 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:
IMPORTANT: PLEASE READ
PrLutrepulse Page 24 of 24
If there is a suspected overdose of the pump is not working properly and delivers too much medication, please contact your doctor, emergency room of the nearest hospital, or poison control centre.
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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
Rare ($0.01% - <0.1%) | Hypersensitivity Reddening at the injection site Ovarian hyperstimulation | T T T | ||
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 | T T T T | T T T T T T T | |
This is not a complete list of side effects. For any unexpected effects while taking LUTREPULSE, contact your doctor or pharmacist.
HOW TO STORE IT
Both Lutrepulse and 0.9% sodium chloride for injection are stable when stored at room temperature
(15°- 30°C) in the unopened package.
REPORTING SUSPECTED 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.