Patient leaflet - REKOVELLE 12 MICROGRAMS / 0.36 ML SOLUTION FOR INJECTION
Rekovelle
▼This medicine is subject to additional monitoring. This —will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do _____ not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
----What is in this leaflet
_ 1. What REKOVELLE is and what it is used for
2. What you need to know before you use REKOVELLE
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3.How to use REKOVELLE
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4. Possible side effects
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5. How to store REKOVELLE
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6.Contents of the pack and other information
1. what rekovelle is and what it is used for
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.
2. what you need to know before you use rekovelle
Before starting treatment with this medicine, a doctor should check you and your partner for possible causes of your fertility problems.
“Do not use REKOVELLE if:
- you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine (listed in section 6)
- you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus
- you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian disease)
- you suffer from bleeding from the vagina without any known cause
- you have had an early menopause
- you have malformations of the sexual organs which make a normal pregnancy impossible
- you have fibroids of the uterus which make a normal pregnancy impossible.
Warnings and precautions
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
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 taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant or breastfeeding.
Driving and using machines
This medicine does not affect your ability to drive and use _ machines.
REKOVELLE contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”. —
3. how to use rekovelle
Always use this medicine exactly as your doctor has — told you and at the dose your doctor has told you. Check with your doctor if you are not sure.
The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level of anti-Mullerian hormone (AMH, a marker of how your ovaries will respond to stimulation with gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample (taken within the last 12 months) should be available before _ you start treatment. Your body weight will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms.
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 250 micrograms or 5,000 IU for final development of the follicles.
If your body's response to treatment is too weak or too strong, your doctor may decide to stop treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you either a higher or a lower daily dose of REKOVELLE than before.
How are injections given
REKOVELLE is developed for use in the REKOVELLE injection pen. The instructions for using the injection pen supplied with the pen including loading the cartridge must be followed carefully. Do not use the cartridge if the solution contains particles or if the solution does not look clear.
The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your doctor will decide if you can give yourself further doses of this medicine at home, but only after receiving adequate training.
This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen. The cartridge may be used for several injections.
If you use more REKOVELLE than you should
The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome may possibly occur, which is described in section 4. —
If you forget to use REKOVELLE
Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you notice that you forgot a dose.
If you have any further questions on the use of this medicine, ask your doctor.
4. possible side effects _
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
Hormones used in the treatment of infertility such as this medicine may cause a high level of activity in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have any of these symptoms you should contact a doctor immediately.
The risk of having a side effect is described by the following categories:
Common (may affect up to 1 in 10 people):
- Headache
- Nausea
- Ovarian hyperstimulation syndrome (see above)
- Pelvic pain and discomfort, including of ovarian origin
- Tiredness (fatigue)
Uncommon (may affect up to 1 in 100 people):
- Mood swings
- Sleepiness/drowsiness
- Dizziness
- Diarrhoea
- Vomiting
- Constipation
- Discomfort of the abdomen
- Vaginal bleeding
- Breast complaints (include breast pain, breast tenderness)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly _ (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website:
women.
5. How to store REKOVELLE
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 cartridge label and carton after EXP. The expiry date refers to the last day of that month.
Store in refrigerator (2 °C - 8 °C). Do not freeze.
“Before first use, store in the original package in order to protect from light.
REKOVELLE may be stored at or below 25 °C for up to
3 months including the period after first use. It must not be refrigerated again and must be discarded if it has not been used after 3 months.
After first use: 28 days when stored at or below 25 °C. Keep the cartidge in the REKOVELLE injection pen.
_At the end of the treatment any unused solution must be discarded.
Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
_What REKOVELLE contains
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– The active substance is follitropin delta. Each multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution. One millilitre of solution contains 33.3 micrograms of follitropin delta in each millilitre of solution.
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– The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric _ acid, sodium hydroxide and water for injections.
What REKOVELLE looks like and contents of the pack
REKOVELLE is a clear and colourless solution for injection (injection). It is available in packs of 1 cartridge and 3 pen injection needles.Marketing Authorisation Holder in EU:
Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
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— 2300 Copenhagen S
Denmark
Tel: +45 88 33 88 34
EU/1/16/1150/001
Marketing Authorisation Holder in GB:
Ferring Pharmaceuticals Ltd
Drayton Hall, Church Road,
_West Drayton, UB7 7PS, United Kingdom
PLGB 03194/0130
Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
_Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
Ferring Pharmaceuticals Ltd.
Tel: +44 844 931 0050
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— Ireland