100 micrograms and 150 micrograms solution for injection 
korifollitropin alfa

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Elonva is and what it is used for 
2. What you need to know before you use Elonva 
3. How to use Elonva 
4. Possible side effects 
5. How to store Elonva 
6. Contents of the packaging and other information 

1. What Elonva is and what it is used for

Elonva contains the active substance korifollitropin alfa and belongs to the group of medicines called gonadotropins. Gonadotropins play an important role in human fertility and reproduction. One of these gonadotropins is a follicle-stimulating hormone( FSH ) which is needed for follicles (small round sacs in the ovaries that contain eggs) to grow and develop in women.

Elonva is used to help get pregnant in women undergoing infertility treatment, such as in-vitro fertilization (IVF). IVF involves picking eggs from the ovaries, fertilizing the eggs in the laboratory, and transferring embryos to the uterus a few days later. Elonva allows several follicles to grow and develop simultaneously through controlled stimulation of the ovaries.

2. What you need to know before you use Elonva

Do not use Elonva if you:

  • is allergic (hypersensitive) to corifollitropin alfa or any of the other ingredients of this medicine (listed in section 6)
  • have cancer of the ovaries, breasts, uterus, or brain ( pituitary gland or hypothalamus )
  • recently had unexpected abdominal bleeding that is not menstrual and where the cause is unknown
  • have ovaries that do not work due to a condition called primary ovarian failure
  • have cysts on the ovaries or enlarged ovaries
  • have genital malformations that make a normal pregnancy impossible
  • has muscle knots ( fibroids ) in the uterus that make a normal pregnancy impossible
  • has risk factors for OHSS (OHSS is a serious medical problem that can occur when the ovaries are overstimulated, see below for further explanation.):
    • has polycystic ovary syndrome ( PCOS )
    • have had ovarian hyperstimulation syndrome (OHSS)
    • has previously undergone a treatment cycle with controlled stimulation of the ovaries which resulted in the growth of more than 30 follicles with a size of 11 mm or larger
    • has a basal number of antral follicles (the number of small follicles present in the ovaries at the start of the menstrual cycle) that is higher than 20

Warnings and cautions

Talk to your doctor before using Elonva.

Ovarian hyperstimulation syndrome (OHSS)

Treatment with gonadotropins like Elonva can cause ovarian hyperstimulation syndrome (OHSS). This is a serious medical condition caused by the ovaries being overstimulated and the growing follicles becoming larger than normal. In rare cases, severe OHSS can be life-threatening. It is therefore very important that you are closely monitored by a doctor. To monitor the effects of the treatment, the doctor performs ultrasound examinations of the ovaries. Your doctor may also check your hormone levels in your blood (see also section 4).

  • OHSS causes fluid to suddenly accumulate in the stomach and chest area and can cause blood clots to form. Contact a doctor immediately if you get:
  • severe abdominal swelling and pain in the abdominal area (abdomen)
  • nausea
  • vomiting
  • sudden weight gain due to fluid retention
  • diarrhea
  • decreased urine flow
  • breathing difficulties.

You should only take Elonva once during the same treatment period, as otherwise, the risk of developing OHSS may increase.

Before you start taking this medicine, tell your doctor if you have ever had ovarian hyperstimulation syndrome (OHSS).

Ovarian torsion

Ovarian torsion is a twisting of an ovary. Twisting of the ovary can cause the blood flow to the ovary to be shut off.

Before you start using this medicine, tell your doctor if you:

– have ever had ovarian hyperstimulation syndrome (OHSS)

– is pregnant or thinks you may be pregnant

– ever had surgery on the stomach (abdomen)

– ever had a twisted ovary

have or have had cysts in your ovary or ovaries.

Blood clot ( thrombosis )

Treatment with gonadotropins like Elonva may (like a pregnancy) increase the risk of developing a blood clot ( thrombosis ). Thrombosis is the formation of a blood clot in a blood vessel.

Blood clots can cause serious medical conditions such as:

– blockage of the lungs ( pulmonary embolism )

– stroke ( stroke )

– heart attack

– vascular problems ( thrombophlebitis )

– poor blood flow (deep vein thrombosis ) can lead to loss of your arm or leg.

Discuss this with your doctor, before starting treatment, especially if:

  • you know you already have an increased risk of thrombosis
  • you or someone else in your immediate family has ever had a thrombosis
  • you are severely overweight.

Multiple births and malformations

There is an increased risk of having twins or even more than two children even when only one embryo is transferred to the uterus. Multiple pregnancies mean an increased health risk for both the mother and her children. Multiple pregnancies and specific characteristics of couples with fertility problems (eg a woman’s age, certain sperm problems, genetic background in both parents) may also be associated with an increased risk of malformations.

Pregnancy complications

If treatment with Elonva results in pregnancy, there is an increased risk of ectopic pregnancy (ectopic pregnancy). Therefore, your doctor should perform an early ultrasound examination to rule out the risk of ectopic pregnancy.

Tumor in the ovaries and other parts of the reproductive system

Tumors in the ovaries and other parts of the reproductive system have been reported in women who have undergone infertility treatment. It is not known whether treatment with fertility drugs increases the risk of these tumors in infertile women.

Other medical conditions

Before using this medicine, also tell your doctor if you:

– has kidney disease

– has uncontrolled pituitary or hypothalamic problems

– has an underactive thyroid gland ( hypothyroidism )

– have adrenal glands that do not work properly (adrenal cortex insufficiency)

– has high prolactin levels in the blood ( hyperprolactinemia )

– have any other medical condition (eg diabetes, heart disease, or any other long-term illness)

– has been told by a doctor that a pregnancy would be dangerous for you.

Other medicines and Elonva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

If you do a pregnancy test during your infertility treatment with Elonva, the test may incorrectly show that you are pregnant. Your doctor will advise you on when you can start performing pregnancy tests. If a pregnancy test shows positive, contact your doctor.

Pregnancy and breastfeeding

You should not use Elonva if you are already pregnant or if you think you may be pregnant, or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Elonva may cause dizziness. If you feel dizzy, do not drive or use machines.

Elonva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per injection, ie essentially ‘sodium-free’.

3. How to use Elonva

Always use Elonva exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Elonva is used in women undergoing infertility treatment such as in vitro fertilization (IVF). During treatment, Elonva is used in combination with a drug (called a GnRH – antagonist ), which prevents premature ovulation from your ovaries. Treatment with GnRH – antagonist, one usually starts 5-6 days after injection, one with Elonva.

Treatment with Elonva in combination with a GnRH – agonist (another medicine used to prevent premature ovulation from your ovaries) is not recommended.

Dosage

In the treatment of women of childbearing potential, the dose is one of Elonva based on weight and age.

  • A single dose of 100 micrograms is recommended for women weighing 60 kg or less and who are 36 years of age or younger.

  • A single dose of 150 micrograms is recommended for women:
    • weighing more than 60 kg, regardless of age.
    • weighing 50 kg or more and older than 36 years.

Studies have not been performed in women older than 36 years and weighing less than 50 kg.

  Bodyweight
Less than 50 kg 50 – 60 kg More than 60 kg
Age 36 years or younger 100 micrograms 100 micrograms 150 micrograms
Older than 36 years Not studied 150 micrograms 150 micrograms

For the first seven days after Elonva injection, no ( recombinant ) follicle-stimulating hormone ((rec) FSH ) should be used. Seven days after injecting Elonva, your doctor may decide to continue your stimulation cycle with another gonadotropin, such as (rec) FSH. This treatment can be continued for a few days until there are enough follicles of the right size. It can be checked by an ultrasound examination. Treatment with (rec) FSH is then discontinued and final egg maturation is induced by giving hCG( human chorionic gonadotropin ). The eggs are picked from the ovaries 34-36 hours later.

How Elonva is given

Elonva treatment should be supervised by a doctor who has experience in the treatment of fertility problems. Elonva should be injected under the skin ( subcutaneously ) into a fold of skin (which you pinch between your thumb and forefinger), preferably just below the navel. The injection can be given by a healthcare professional (eg a nurse), your partner, or yourself if detailed instructions have been given by your doctor. Always use Elonva exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. A step-by-step “user manual” is provided at the end of this leaflet.

Do not inject Elonva into a muscle.

Elonva is supplied in pre-filled syringes that have an automatic safety system to help prevent needle stick injuries after use.

If you use more Elonva or (rec) FSH then you should

If you think you have used too much Elonva or (rec) FSH, contact your doctor immediately.

If you forget to use Elonva

If you forget to inject Elonva on the day you should have done so, contact your doctor immediately. Do not inject Elonva without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

A possible complication of treatment with gonadotropins, such as Elonva, is the unintentional overstimulation of the ovaries. The risk of getting this complication can be reduced by careful monitoring of the number of follicles that mature. Your doctor will perform ultrasound examinations of your ovaries to closely monitor the number of follicles that mature. Your doctor may also check your hormone levels in your blood. The first symptoms of overstimulation of the ovaries can be felt as pain in the stomach (abdomen), nausea, or diarrhea. Ovarian overstimulation can develop into a medical condition called ovarian hyperstimulation syndrome (OHSS) which can be a serious medical problem. In more severe cases, it can lead to enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest (which can lead to sudden weight gain due to fluid accumulation), or clots in the blood vessels.

Contact a doctor immediately if you have abdominal (abdominal) pain or any of the other symptoms of ovarian hyperstimulation, even if they occur a few days after the injection.

The risk of suffering a side effect is described according to the following categories:

Common (may affect up to 1 in 10 women)

  • Ovarian hyperstimulation syndrome (OHSS)
  • Pelvic pain
  • Nausea
  • Headache
  • Pelvic discomfort
  • Tenderness in the breasts
  • Fatigue

Uncommon (may affect up to 1 in 100 women)

  • Rotation of an ovary (ovarian torsion)
  • Elevated liver enzymes
  • Miscarriage
  • Pain after picking eggs
  • Pain during treatment
  • Premature ovulation
  • Stretched abdomen
  • Vomiting
  • Diarrhea
  • Constipation
  • Back pain
  • Chest pain
  • Bruising or pain at the injection site
  • Irritability
  • Mood swings
  • Dizziness
  • Hot flashes

Has been reported (occurs in an unknown number of users)

  • Allergic reactions ( hypersensitivity reactions, both local and general, including rash).

Ectopic pregnancy (ectopic pregnancy) and multiple pregnancies have also been reported. These side effects are not considered to be related to the use of Elonva but assisted reproductive technology (ART) or subsequent pregnancy.

In rare cases, treatment with Elonva, like treatment with other gonadotropins, has been associated with the loosening of blood clots ( thrombi ) formed in one blood vessel and moving in the bloodstream to clog another blood vessel (thromboembolism).

5. How to store Elonva

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 label after “EXP” (expiry date) and the carton after “EXP”. The expiration date is the last day of the specified month.

Storage in pharmacies

Store in a refrigerator (2 ° C-8 ° C). Do not freeze.

Storage by patient

There are two options:

Store in a refrigerator (2 ° C-8 ° C). Do not freeze.

Store at or below 25 ° C for a maximum of one month. Make a note of when you start storing the product outside the refrigerator and use it within one month from that date.

Store the syringe in the outer carton. Sensitive to light.

Do not use Elonva

  • if it has been stored outside the refrigerator for more than a month.
  • if it has been stored outside the refrigerator at a temperature above 25 ° C.
  • if you notice that the solution is not clear/transparent.
  • if you notice that the syringe or needle is broken.

An empty or unused syringe 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is corifollitropin alfa. Each Elonva 100 micrograms solution for injection filled with syringe contains 100 micrograms in 0.5 milliliters (ml) solution for injection. Each Elonva 150 micrograms solution for injection filled with syringe contains 150 micrograms in 0.5 milliliters (ml) solution for injection.
  • The other ingredients are sodium citrate, sucrose, polysorbate 20, methionine, and water for injections. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

What the medicine looks like and the contents of the pack

Elonva is a clear and colorless aqueous solution for injection ( solution for injection ) in a pre-filled syringe with an automatic safety system, which prevents needle stick injuries after use. The syringe is packaged together with a sterile injection needle. Each syringe contains 0.5 ml of solution.

The pre-filled syringe is available in packs of one syringe.

Elonva is supplied in two strengths: 100 micrograms and 150 micrograms solution for injection.

Marketing Authorisation Holder

Merck Sharp & Dohme BV 
Waarderweg 39 
2031 BN Haarlem The 
Netherlands

Manufacturer

NV Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands.

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMSD Belgium BVBA / SPRLTel / Tel: +32 (0) 27766211dpoc_belux@merck.com LithuaniaUAB Merck Sharp & DohmeTel: + 370 5 2780247msd_lietuva@merck.com
BulgariaMark Harp and Doom Bulgaria BulgariaTel .: + 359 2 819 37 37info-msdbg@merck.com Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel / Tel: +32 (0) 27766211dpoc_belux@merck.com
Czech RepublicMerck Sharp & Dohme sroTel .: +420 233 010 111dpoc_czechslovak@merck.com HungaryMSD Pharma Hungary Kft.Tel .: + 36 1 888-5300hungary_msd@merck.com
DenmarkOrganon Denmark ApSTel: + 45 4484 6800info.denmark@organon.com MaltaMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com
GermanyMSD SHARP & DOHME GMBHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)e-mail@msd.de The NetherlandsMerck Sharp & Dohme BVTel: 0800 99 99 000 (+ 31 23 5153153)medicalinfo.nl@merck.com
EestiMerck Sharp & Dohme OÜTel: + 372 6144 200msdeesti@merck.com NorwayMSD (Norway) ASTel: + 47 32 20 73 00msdnorge@msd.no
GreeceMSD Α.Φ.Β.Ε.Ε:Ηλ: + 30 210 98 97 300dpoc_greece@merck.com AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
SpainOrganon Salud, SLTel: +34 91 591 12 79 PolandMSD Polska Sp.z ooTel .: +48 22 549 51 00msdpolska@merck.com
FranceOrganon FranceTel: + 33 (0) 1 57 77 32 00
PortugalMerck Sharp & Dohme, LdaTel: + 351 214465700inform_pt@merck.com
CroatiaMerck Sharp & Dohme dooTel: + 385 1 6611 333croatia_info@merck.com RomaniaMerck Sharp & Dohme Romania SRLTel: + 40 21 529 29 00msdromania@merck.com
IrelandMerck Sharp & Dohme Ireland ( HumanHealth) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, an innovative freelance dooTel: + 386 1 5204201msd_slovenia@merck.com
IcelandVistor hf.Phone: + 354 535 7000
Slovak RepublicMerck Sharp & Dohme, sroTel: + 421 (2) 58282010dpoc_czechslovak@merck.com
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: + 358 (0) 9 804650info@msd.fi
LatviaSIA Merck Sharp & Dohme LatvijaTel: + 371 67 364224msd_lv@merck.com United KingdomMerck Sharp & Dohme LimitedTel: +44 (0) 1992 467272medicalinformationuk@msd.com

Muhammad Nadeem

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