REKOVELLE 36MCG
Generic Name/API: follitropin delta
Manufacturer: Ferring GmbH
Dosage Forms & Strength & Pack Size:
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen
Storage:
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original package in order to protect from light.
REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at or below 25 °C for up to 3 months including the period after first use. It must be discarded afterwards.
REKOVELLE® (follitropin delta injection), the first recombinant FSH (rFollicular Stimulating Hormone) for controlled ovarian stimulation derived from a human cell line, is used in women undergoing assisted reproductive technologies (ART) such as in vitro fertilization (IVF).
REKOVELLE® is the first gonadotropin to use an evidence-based, personalized dosing algorithm based on a woman’s anti-Müllerian hormone (AMH) level and body weight to achieve a predictable ovarian response. This is particularly valuable since ovarian response to stimulation varies considerably from woman to woman, and unexpected extreme responses have implications on efficacy and safety.
REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from which eggs are collected and fertilised in the laboratory.
Warnings and precautions
Talk to your doctor before using REKOVELLE.
Ovarian hyperstimulation syndrome
Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your follicles develop too much and become large cysts.
Talk to your doctor if you:
• have abdominal pain, discomfort or swelling
• have nausea
• are vomiting
• get diarrhoea
• gain weight
• have difficulty in breathing
Your doctor may ask you to stop using this medicine (see section 4).
If the recommended dose and schedule of administration are followed, ovarian hyperstimulation syndrome is less likely.
Blood clotting problems (thromboembolic events)
Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility treatment can increase the risk of this happening, especially if you are overweight or you or someone in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor if you think this applies to you.
Twisting of ovaries
There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive technology treatment. Twisting of the ovary could cut off the blood flow to the ovary.
Multiple pregnancy and birth defects
When undergoing assisted reproductive technology treatment the possibility of having a multiple pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility treatment, which is thought to be due to characteristics of the parents (such as your age, and your partner’s sperm characteristics) and multiple pregnancy.
Pregnancy loss
When undergoing assisted reproductive technology treatment, you are more likely to have a miscarriage than if you conceive naturally.
Pregnancy outside the uterus (ectopic pregnancy)
When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal disease, you have an increased risk of ectopic pregnancy.
Ovarian and other reproductive system tumours
There have been reports of ovarian and other reproductive system tumours in women who had undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of these tumours in infertile women.
Other medical conditions
Before starting to use this medicine, tell your doctor if:
• you have been told by another doctor that pregnancy would be dangerous for you
• you have kidney or liver disease
Children and adolescents (under 18 years of age)
This medicine is not indicated in children and adolescents.
Other medicines and REKOVELLE
Tell your doctor if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant or breast-feeding.
Driving and using machines
This medicine does not affect your ability to drive and use machines.
REKOVELLE contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
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