12 micrograms / 0.36 ml solution for injection
follitropin delta
What REKOVELLE is and what it is used for
REKOVELLE contains follitropin delta, a follicle-stimulating hormone belonging to the hormone family gonadotropins. Gonadotropins are involved in reproduction and fertility.
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). REKOVELLE stimulates the ovaries to grow and develop several ovaries ( follicles ), from which the eggs are collected and fertilized in the laboratory.
What you need to know before using REKOVELLE
Do not use REKOVELLE
Before starting treatment with this medicine, the causes of your and your partner’s fertility problems should be investigated by a doctor.
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 tumor in the uterus, ovaries, breasts, pituitary gland, or hypothalamus
- you have enlarged ovaries or cysts on your ovaries (not caused by polycystic ovary syndrome )
- you suffer from vaginal bleeding for no known reason
- you have reached menopause early
- you have genital malformations that make a normal pregnancy impossible
- you have muscle knots ( fibroids ) in the uterus that make a normal pregnancy impossible.
Warnings and cautions
Ovarian overstimulation syndrome
The gonadotropins contained in this medicine may cause ovarian hyperstimulation. It can cause your follicles to develop too much and become large cysts.
Talk to a doctor if you:
- have pain, discomfort, or swelling in the stomach
- feel sick
- vomiting
- gets diarrhea
- gain weight
- have difficulty breathing
Your doctor may ask you to stop using this medicine (see section 4).
If the recommended dose and administration schedules are followed, ovarian hyperstimulation syndrome is less likely.
Problems with blood clots (thromboembolic events)
Blood vessel clots (veins or arteries ) are more likely in pregnant women. Fertility treatment can increase the risk of this happening, especially if you are overweight or if you or someone in your family (parents or siblings) has a blood clot disease (thrombophilia). Tell your doctor if this is true for you.
Twisting of the ovaries
There have been reports of ovarian torsion (ovarian torsion) after assisted reproduction. Twisting of the ovaries can cut off the blood flow to the ovary.
Multiple pregnancies and birth defects
Assisted conception increases the risk of multiple births (eg twins) and is related to the number of embryos placed in the uterus, the quality of the embryos, and your age. Multiple births can lead to medical complications for you and your children. In addition, the risk of birth defects may be slightly higher after fertility treatment, which is thought to be due to characteristics of the parents (eg your age and your partner’s sperm quality) and multiple births.
Miscarriage
When you undergo assisted reproduction, you run a greater risk of having a miscarriage than if you become pregnant naturally.
Ectopic pregnancy (ectopic pregnancy)
Assisted conception increases the risk of ectopic pregnancy (ectopic pregnancy) compared to if you become pregnant naturally. If you have previously had a disease in the fallopian tubes, you have an increased risk of ectopic pregnancy.
Tumors in the ovaries and other genitals
There have been reports of tumors in the ovaries and other genitals in women who have undergone fertility treatment. It is not known whether treatment with fertility drugs increases the risk of these tumors in infertile women.
Other medical conditions
Before you start taking this medicine, tell your doctor about:
- 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)
REKOVELLE is not intended for treatment 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 breastfeeding
Do not use this medicine if you are pregnant or breastfeeding.
Driving and using machines
This medicine does not affect your ability to drive or use machines.
REKOVELLE contains sodium
REKOVELLE contains less than 1 mmol sodium (23 mg) per dose, essentially ‘sodium-free’.
How to use REKOVELLE
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor.
The dose for the first treatment cycle is calculated by your doctor and is based on the level of anti-Müllerian hormone (AMH, a marker for how your ovaries will respond to stimulation with gonadotropins ) in your blood and your body weight. Therefore, AMH results from a blood test (taken in the last 12 months) should be available before starting treatment. You will also be weighed before starting treatment. Dos en REKOVELLE is given in micrograms.
Dose one will be the same throughout the treatment period and your daily dose will neither increase nor decrease. The doctor will monitor the effect of REKOVELLE treatment, and the treatment will be stopped when there is an appropriate number of ovaries. You will normally be given an injection of a medicine called human chorionic gonadotropin ( hCG ) at a dose of 250 micrograms or 5000 IU for the final development of the ovaries.
If the body’s response to treatment is too weak or too strong, the doctor may decide to discontinue treatment with REKOVELLE. For the next treatment cycle, the doctor will then give you either a higher or a lower dose of REKOVELLE than before.
How the injections are given
REKOVELLE is developed for use in the REKOVELLE pen. The instructions for use that come with the pen must be followed carefully, including charging the multi-cylinder cartridge. Do not use an ampoule if the solution contains particles or if it is cloudy.
The first injection of one of these medicines should be given under the supervision of a doctor or a nurse. Your doctor will decide if you can give yourself the following dose of this medicine at home, but only after getting enough exercise.
This medicine should be given as an injection under the skin ( subcutaneously ), usually in the abdomen. Ampoule one can 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 occur, as described in section 4.
If you forget to use REKOVELLE
Do not take a double dose to make up for a forgotten dose. Contact your doctor as soon as you discover that you have missed a dose.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Hormones used to treat infertility, such as this medicine, can cause increased activity in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include abdominal pain, abdominal discomfort or swelling, nausea, vomiting, diarrhea, weight gain, or difficulty breathing. If you have any of these symptoms, you should contact a doctor immediately.
The risk of getting a side effect is described in the following categories:
Common (may affect up to 1 in 10 people)
- Headache
- Nausea
- Ovarian overstimulation syndrome (see above)
- Pelvic pain and pelvic discomfort, including from the ovaries
- Fatigue (exhaustion)
Uncommon (may affect up to 1 in 100 people):
- Mood swings
- Sleepiness/drowsiness
- Dizziness
- Diarrhea
- Vomiting
- Constipation
- Discomfort in the abdomen
- Vaginal bleeding
- Chest problems (includes chest pain, and breast tenderness)
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 ampoule label and carton after EXP and EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store in the original package before use. Sensitive to light.
REKOVELLE can be taken out of the refrigerator, without being refrigerated again, and stored at a maximum of 25 ° C for up to 3 months, including the period after the first injection. It must then be discarded.
After the first injection: 28 days when stored below 25 ° C. Keep the ampoule in a REKOVELLE pen.
When the treatment is completed, all unused solutions must be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is follitropin delta.
One multi-cartridge contains 12 micrograms of follitropin delta in a 0.36 ml solution. One ml solution contains 33.3 micrograms follitropin delta - The other ingredients are phenol, Polysorbate 20, L-methionine, sodium sulfate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide, and water for injections.
What the medicine looks like and the contents of the pack
REKOVELLE is a clear, colorless solution for injection. It is available in packs of one ampoule and 3 needles for a pen.
Marketing Authorisation Holder
Ferring Pharmaceuticals A / S
Kay Fiskers Square 11
2300 Copenhagen S
Denmark
Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienFerring NVTel / Tel: +32 53 72 92 00ferringnvsa@ferring.be | LithuaniaUAB PharmaSwissTel: +370 5 2790762lithuania.info@pharmaswiss.com |
| BulgariaAkvaxim ADTel: +359 2 807 5022aquachim@aquachim.bg | Luxembourg / LuxemburgFerring NVBelgium / BelgiumTel / Tel: +32 53 72 92 00ferringnvsa@ferring.be |
| Czech RepublicFerring Pharmaceuticals CZ sroTel: +420 234 701 333cz1-info@ferring.com | HungaryFerring Magyarország Gyógyszerkereskedelmi Kft.Tel: +36 1 236 3800ferring@ferring.hu |
| DenmarkFerring Lægmedel A / STel: +45 88 16 88 17 | MaltaEJ Busuttil Ltd.Tel: +356 21447184info@ejbusuttil.com |
| GermanyFerring Arzneimittel GmbHTel: +49 431 5852 0info-service@ferring.de | The NetherlandsFerring BVTel: +31 235680300infoNL@ferring.com |
| EestiPharmaSwiss Eesti OÜTel: +372 682 7400estonia.info@pharmaswiss.com | NorwayFerring Legidler ASTel: +47 22 02 08 80mail@oslo.ferring.com |
| Greece Ferring Ελλάς ΜΕΠΕ :Ηλ: +30 210 68 43 449 | AustriaFerring Drugs Ges.mbHTel: +43 1 60 8080office@ferring.at |
| SpainFerring SAUTel: +34 91 387 70 00Registros@ferring.com | PolandFerring Pharmaceuticals Poland Sp. z ooTel: +48 22 246 06 80ferring@ferring.pl |
| FranceFerring SASTel: +33 1 49 08 67 60information.medicale@ferring.com | PortugalFerring Portuguesa – Pharmaceutical Products, Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90geral@ferring.com |
| CroatiaClinres pharmacy dooTel: +385 1 2396 900 | RomaniaFerring Pharmaceuticals Romania SRLTel: +40 356 113 270 |
| IrelandFerring Ireland Ltd.Tel: +353 1 4637355inquiries.ireland@ferring.com | SloveniaSALUS, Veletrgovina, dooTel: +386 1 5899 179regulatory@salus.si |
| IcelandVistor hf.Phone: +354 535 70 00 | Slovak RepublicFerring Slovakia sroTel: +421 2 54 416 010SK0-Recepcia@ferring.com |
| ItalyFerring SpATel: +39 02 640 00 11 | Finland / FinlandFerring Lääkkeet OyPuh / Tel: +358 207 401 440info@ferring.fi |
| .ΠροςA.Potamitis Medicare Ltd:Ηλ: +357 22583333a.potamitismedicare@cytanet.com.cy | SwedenFerring Läkemedel ABTel: +46 40 691 69 00info@ferring.se |
| LatviaSIA PharmaSwiss LatviaPhone: +371 6 750 2185latvia.info@pharmaswiss.com | United KingdomFerring Pharmaceuticals Ltd.Tel: +44 844 931 0050contact2@ferring.com |