Patient Medication Information: uses, side effects, how to take - Lutrepulse
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-dependent 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 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:
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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
It is important to use LUTREPULSE exactly as prescribed by your doctor.
Usual starting dose: 5 µg every 90 minutes.
LUTREPULSE can be injected under the skin (subcutaneous) by an infusion pump. If you use the infusion pump, your doctor should show you how to use and care for the pump.
The pump used with LUTREPULSE is called the LUTREPULSE System:
The LUTREPULSE System consists of two parts;
- 1) The OmniPod (POD) and the 2) Drug Delivery Manager (DDM)
The following instructions should only be used following full training from your Healthcare provider:
Controlling the LUTREPULSE Manager
Use the Up/Down Controller buttons to move around the Home and other screens.
The messages on these screens:
- Describe system operation
- List the menu choices
- Explain how to perform a certain task
About the POD; it is;
- Oval in shape and has an adhesive backing.
- Wireless pump to deliver the patients LUTREPULSE without tubing.
- Waterproof
- Delivers LUTREPULSE based on personalized settings
- Hands-free, automated insertion—and priming
About the Drug Delivery Manager (DDM)
- Manages LUTREPULSE delivery wirelessly with a handheld controller.
LUTREPULSE is to be reconstituted with 3.2 ml of the diluent immediately before use.
Directions for Use
Your healthcare provider will now take you through the process of preparing the LUTREPULSE Manager and loading the Pod with medication.
Assemble the following:
- Vial of LUTREPULSE powder
- Vial of LUTREPULSE solvent
- Long needle and syringe to reconstitute LUTREPULSE
- New POD pack (this contains a new POD, and a short needle and syringe used to fill the POD).
Wash your hands and wash the infusion area.
Preparing a new POD (removing active POD)
Loading the LUTREPULSE System with LUTREPULSE
LUTREPULSE 3.2 mg reconstitution
Loading a New Pod
Beginning LUTREPULSE delivery
After the POD is loaded with LUTREPULSE, it is ready to be attached to the body and is ready for use. Normally, the abdomen is the preferred site.
Note: a new site at least 2.5 cm away from the previous site should be used for each new POD.
Troubleshooting Alerts
The LUTREPULSE System uses safety checks upon start-up and during operation to advise the user when an issue needs attention. Use the Manager to obtain details on how to respond to these alerts by selecting Pod Status from the Home screen. A constant audible alert from the Pod signifies that the Pod should be changed, wehreas the intermittent audible alert indicates the need to use the Manager to obtain Pod status for guidance.
The most important LUTREPULSE alerts are described below; for other alerts consult your healthecare provider or full LUTREPULSE System User Guide.
The LUTREPULSE System is an extremely safe and reliable device. The device uses safety checks upon start-up and during operation to advise the user when an issue needs attention. See System User Guide for direction
Overdose:
| If there is a suspected overdose or the pump is not working properly and delivers too much medication, please contact your doctor or your regional 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.
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.
Please discard any unused sodium chloride or reconstituted solution.
| 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 | √ √ √ | ||
Very Rare <0.01%) | Severe Allergic Reaction (Anaphylactic shock) Inflammation Neurological symptoms such as agitation, change in mood (depression) Headache Nausea Increased menstrual bleeding Abdominal pain | √ √ √ √ | √ √ √ √ √ √ √ | |
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:
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 provided by contacting the sponsor, Ferring Pharmaceuticals., at: 1-866-384-1314.
® LUTREPULSE is a registered trademark of Ferring B.V.