Details for: REKOVELLE
Company: FERRING INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02487462 | REKOVELLE | FOLLITROPIN DELTA | 12 MCG / 0.36 ML | SOLUTION | SUBCUTANEOUS |
| 02487470 | REKOVELLE | FOLLITROPIN DELTA | 36 MCG / 1.08 ML | SOLUTION | SUBCUTANEOUS |
| 02487489 | REKOVELLE | FOLLITROPIN DELTA | 72 MCG / 2.16 ML | SOLUTION | SUBCUTANEOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
REKOVELLE is used to treat female infertility and is used in women undergoing assisted reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI).
What it does
REKOVELLE stimulates the ovaries to grow and develop many egg sacs / follicles, from which eggs are collected and fertilised in the laboratory (in vitro).
When it should not be used
Do not use REKOVELLE if:
- You are allergic to follicle stimulating hormone or any of the other ingredients of this medicine
- 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 are pregnant or breastfeeding
- You have experienced an early menopause
- You have abnormal shape of the sexual organs which make a normal pregnancy impossible
- You have fibroids of the uterus which make a normal pregnancy impossible.
What the medicinal ingredient is
follitropin delta
What the non-medicinal ingredients are
disodium hydrogen phosphate dodecahydrate, L-methionine, sodium sulphate decahydrate, phenol, polysorbate 20, phosphoric acid, sodium hydroxide, water for injection.
What dosage form it comes in
Cartridge pen
REKOVELLE is a clear colourless solution for injection. It is provided in a glass cartridge. Cartridges are available in the following strengths and packages:
- 12 µg/0.36 mL Pack of 1 cartridge and 3 needles
- 36 µg/1.08 mL Pack of 1 cartridge and 6 needles
- 72 µg/2.16 mL Pack of 1 cartridge and 9 needles
Prefilled pen
REKOVELLE is a clear colourless solution for injection. It is provided in a multi-dose prefilled
pen.
Pre-filled pens are available in the following strengths and packages:
- 12 µg/0.36 mL Pack of 1 pen and 3 needles
- 36 µg/1.08 mL Pack of 1 pen and 6 needles
- 72 µg/2.16 mL Pack of 1 pen and 9 needles
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional
before you take REKOVELLE. Talk about any health conditions or problems you may
have, including:
Ovarian Hyperstimulation Syndrome (OHSS)
Gonadotropins like REKOVELLE may cause ovarian hyperstimulation syndrome (OHSS). This
is when your follicles develop too much and become large cysts.
Talk to your doctor if you:
- Experience abdominal pain, discomfort or swelling
- Experience nausea
- Are vomiting
- Experience diarrhoea
- Gain weight
- Have difficulty in breathing
Blood clotting problems (thromboembolic events) 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 an ovary (Ovarian torsion)
There have been reports of ovarian torsion (twisting of an ovary) following assisted reproductive technology treatment. Twisting of the ovary could cause the blood flow to the ovary to be cut off.
Multiple pregnancy and birth defects
When undergoing assisted reproductive technology treatment, the risk of having a multiple pregnancy (such as twins) is mainly related to the number 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 if applicable) and multiple pregnancy.
Pregnancy loss
When undergoing assisted reproductive technology treatment, you are more likely to have a miscarriage than if you conceive naturally.
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
In addition, before starting to use this medicine, tell your doctor if you have been told by a doctor that pregnancy would be dangerous for you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
No interaction studies have been performed with REKOVELLE.
Proper use of this medication
How to take REKOVELLE:
The separate instructions for using the prefilled pen must be followed carefully. Do not use if
the solution contains particles or if the solution is not clear.
REKOVELLE is intended to be given by injection just under the skin (subcutaneously) and the
normal administration site is the abdominal wall. The prefilled pen or cartridge can be used for several
injections.
The first injection of this medicine should be given under the supervision of a doctor or a nurse.
Hereafter your doctor will decide if you can administer REKOVELLE by self-administration at
home, but only after receiving adequate training.
If you have any further questions on the use of this medicine, ask your doctor.
Usual Dose
The REKOVELLE dose applicable to your first treatment cycle will be calculated by your doctor
using the level of anti-Müllerian 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 daily REKOVELLE dose is fixed throughout the treatment period. Treatment is stopped
when an appropriate number of egg sacs are present.
Your doctor will monitor the effect of REKOVELLE treatment. Depending on your response to
the treatment, your doctor may decide to stop treatment with REKOVELLE and not give you
the hCG injection.
Overdose
The effects of taking too much REKOVELLE are unknown. Nevertheless one could expect ovarian hyperstimulation syndrome (OHSS) to occur.
Missed Dose
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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking REKOVELLE. If you
experience any side effects not listed here, contact your healthcare professional. Please also
see Warnings and Precautions.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
Hormones used in treatment of infertility such as REKOVELLE may cause a high level of
activity in the ovaries (ovarian hyperstimulation syndrome, OHSS). Symptoms may include
pain, discomfort or swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or
difficulty breathing. If you experience 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 (OHSS)
- Pelvic pain and discomfort
- Ovarian or tubal pain
- Tiredness (fatigue)
- Mood swings
- Sleepiness / drowsiness
- Dizziness
- Diarrhoea
- Vomiting
- Constipation
- Discomfort of the abdomen
- Vaginal bleeding
- Breast complaints (include breast pain, breast tenderness)
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Ovarian hyperstimulation syndrome (OHSS) | ✔ | ✔ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad
enough to interfere with your daily activities, talk to your healthcare professional.
Do not use this medicine after the expiry date which is stated on the cartridge label or carton.
The expiry date refers to the last day of that month.
How to store
Store refrigerated (2°C – 8°C). Do not freeze.
Before use, store in the original package in order to protect from light.
When cartridge is in use, keep it in the REKOVELLE injection pen.
Within the shelf life, REKOVELLE may be removed from the refrigerator, and stored at or
below 25°C for up to 3 months including the 28 day in-use period. After this period, do not
refrigerate again and discard the product.
After first injection, store REKOVELLE at or below 25°C for up to 28 days. After this period,
discard any unused material.
Keep in a safe place and out of reach and sight of children
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about REKOVELLE:
- Talk to your healthcare professional
- Find the most recent version of the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; (www.canada.ca/en/health-canada), the manufacturer’s website (www.ferring.ca/en/products/), or by calling 1-866-384-1314.
This leaflet was prepared by Ferring Inc.
Last Revised: