What is it?
What is Lixafert®?
Lixafert® contains a medicine called “cetrorelix acetate”. This medicine stops your body from releasing an egg from your ovary (ovulation) during your menstrual cycle. Lixafert® belongs to a group of medicines called “anti-gonadotropin-releasing hormones”.
How does Lixafert® work?
Lixafert® blocks a natural hormone in your body called LHRH (Luteinizing Hormone-Releasing Hormone).
• LHRH controls another hormone called LH (Luteinizing Hormone).
• LH stimulates ovulation during your menstrual cycle.
This means that Lixafert® stops the chain of events that leads to an egg being released from your ovary. When your eggs are ready to be collected, another medicine will be given to you that will release them (ovulation induction).
Contraindications
Who should not use Lixafert®?
Do not use Lixafert® if:
• You are allergic to cetrorelix acetate or any of the other ingredients of this medicine (Mannitol).
• You are allergic to medicines similar to Lixafert® (any other peptide hormones).
• You are pregnant or breast-feeding.
• You have severe kidney disease.
• You have moderate to severe hepatic function impairment.
• You have moderate renal function impairment.
Do not use Lixafert® if any of the above applies to you. If you are not sure, talk to your doctor before using this medicine.
Important information
What should you know about taking Lixafert®?
Warnings and Precautions
Tell your doctor before using Lixafert® if you have an active allergy or have had allergies in the past. Treatment is not recommended in patients with severe allergic conditions.
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Ovarian Hyper-Stimulation Syndrome (OHSS)
Lixafert® is used together with other medicines that stimulate your ovaries to develop more eggs ready to be released. During or after you receive these medicines, you may develop OHSS. This is when your follicles develop too much and become large cysts.
Experience of using Lixafert® during more than one cycle is small. Your doctor will carefully look at the benefits and risks for you if you need to have Lixafert® during more than one cycle.
The prevalence of congenital anomalies after the use of Assisted Reproductive Technologies (ART) with or without GnRH (Gonadotropin hormone-Releasing Hormone) antagonists may be slightly higher than after spontaneous conceptions, although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures. Limited data from clinical follow-up studies in 316 newborns of women administered cetrorelix for infertility treatments suggest that cetrorelix does not increase the risk of congenital anomalies in the offspring.
Tell your doctor before using Lixafert® if you have a liver disease. Lixafert® has not been investigated in patients with hepatic disease.
Tell your doctor before using Lixafert® if you have a kidney disease. Lixafert® has not been investigated in patients with kidney disease. Lixafert® is contraindicated in patients with severe renal impairment.
Children and Adolescents
Lixafert® is not indicated for use in children and adolescents.
Other Medicines and Lixafert®
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Pregnancy and Breast-Feeding
Do not use Lixafert® if you are pregnant, think you may be pregnant, or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and Using Machines
Lixafert® is not expected to affect your ability to drive and use machines.
If you use more Lixafert® than you should
Bad effects are not expected if you accidentally inject more of this medicine than you should. The effect of the medicine will last for longer. No specific measures are usually required.
If you forget to use Lixafert®
• Inject it as soon as you remember and talk to your doctor.
• Do not inject a double dose to make up for a forgotten dose.
How to use Lixafert®?
• Each Lixafert® box contains 2 sterile vials in the form of lyophilized white powder, and each vial contains 250 micrograms of cetrorelix, which requires preparation before injection.
• Your doctor must supervise your first injection. However, you may give Lixafert® yourself, in which case you will get the appropriate training on how to prepare and inject the medicine.
• Your doctor must supervise your first injection. However, you may give Lixafert® yourself, in which case you will get the appropriate training on how to prepare and inject the medicine.
• Talk to your doctor or nurse if you have any questions about injecting yourself. It is important not to try to inject yourself until you have been trained by your doctor or nurse.
• Lixafert® is only for injection just under the skin of your belly (subcutaneous).
• Injection should be preferably around the navel (but staying about 5 cm from the navel).
• To reduce skin irritation, select a different part of your belly each day.
How much to use?
• Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
• You start by using another medicine on day 1 of your treatment cycle. You then start using Lixafert® a few days later.
• 0.25 mg (one vial) of Lixafert® is given once daily in the morning or evening of ovarian stimulation day 5, or in the morning of ovarian stimulation day 6.
• It is best to use the medicine at the same time each day, leaving 24 hours between each dose.
• Continue 0.25 mg once daily until the day of ovulation trigger is administered.
Side Effects
What are the possible side effects of Lixafert®?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Allergic reactions:
Warm, red skin, itching (often in your groin or armpits), red, itchy, raised areas (hives), runny nose, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing or serious difficulty breathing, or dizziness. You may be having a possible serious, life-threatening allergic reaction to the medicine. This is uncommon.
If you notice any of the side effects above, stop using Lixafert® and contact your doctor immediately.
• Ovarian Hyper-Stimulation Syndrome (OHSS):
This may occur due to the other medicines that you are using to stimulate your ovaries.
Lower abdominal pain, together with feeling sick (nausea) or being sick (vomiting), may be the symptoms of OHSS. This may indicate that the ovaries overreacted to the treatment and that large ovarian cysts developed. This event is common.
The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing or fluid in your stomach or chest. This event is uncommon.
If you notice any of the side effects above, contact your doctor immediately.
Other Side Effects
Common (it may affect up to 1 in 10 women):
• Mild and short-lasting skin irritation, like redness, itching or swelling, may occur at the injection site.
Storage
How to store Lixafert®
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on the vial after EXP.
• Store in a refrigerator (2-8°C). Do not freeze or place it next to the freezer compartment.
• Store in the original package in order to protect from light.
• The unopened product may be stored in the original package at room temperature (not above 30°C) for up to 3 months.
• The solution should be used immediately after preparation.
• Do not use this medicine if you notice that the white powder in the vial has changed in appearance.
• Do not use the prepared solution in the vial if it is not clear and colourless or if it has particles in it.