what is ovaleap 300 IU Used for, Side Effects

This medicine contains the active substance follitropin alfa, almost identical to a natural hormone called ‘follicle-stimulating hormone ( FSH ). FSH is a gonadotropin, a type of hormone that plays an important role in human reproduction and fertility.

In women, FSH is needed for the ovaries (follicles) in the ovaries that contain egg cells to grow and develop. In men, FSH is needed for the production of semen.

What Ovaleap is used for

In adult women, Ovaleap is used:

To promote ovulation ( release of a mature egg cell from the follicle) in women who are not ovulating and who have not responded to treatment with a drug called ‘clomiphene citrate’.
To promote the development of follicles in women undergoing assisted reproduction (measures that can help you conceive) such as ” in vitro fertilization”, “gamete transfer to fallopian tubes” or “zygote transfer to fallopian tubes”.
In combination with a drug called “lutropin alfa” (a version of another gonadotropin , “luteinizing hormone” or LH ) to promote ovulation in women who do not ovulate because their body produces too little FSH and LH .

In adult men, Ovaleap injection is used:

In combination with a drug called ‘human chorionic gonadotropin’ ( hCG ) to promote sperm production in men who are infertile due to low levels of certain hormones .

What You Need To Know Before Using Ovaleap

Do Not Use Ovaleap

If you are allergic to follitropin alfa, follicle-stimulating hormone ( FSH ) or any of the other ingredients of this medicine (listed in section 6).
If you have a tumor in your hypothalamus or pituitary gland (parts of the brain).
If you are a woman with:
- Large ovaries or fluid-filled blisters in the ovaries (ovarian cysts) of unknown origin
- Unexplained vaginal bleeding
- Cancer of the ovaries, uterus or breasts
- Any condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), fibroid tumors in the uterus or malformed reproductive organs.
If you are a man with:
- Untreatable testicular failure.

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings And Cautions

Before starting treatment, your and your partner’s fertility should be evaluated by a doctor who has experience in assessing fertility disorders.

Porphyry

Tell your doctor before starting treatment if you or someone in your family has porphyria. This is a condition that can be transmitted from parents to children and means that you cannot break down porphyrins (organic compounds).

Tell your doctor immediately if:

Your skin becomes brittle and easily gets blisters, especially skin that has often been exposed to sun and/or
If you get pain in the abdomen, arms or legs.

If you experience the above symptoms, your doctor may recommend that you stop treatment.

Ovarian hyperstimulation syndrome (OHSS)

If you are a woman, this medicine increases the risk of developing OHSS. This is when your follicles develop too much and become large cysts.

Tell your doctor immediately if:

You get pain in the lower abdomen (stomach)
You quickly gain weight
You feel sick or vomit
You have difficulty breathing

If you experience the above symptoms, your doctor may advise you to stop using this medicine (see also section 4 under “Serious side effects in women”).

If you are not ovulating and if the recommended dose and the recommended dosing schedule are followed, the occurrence of OHSS is less likely.

Ovaleap treatment rarely causes pronounced OHSS unless the medication used for final follicular maturation (containing human chorionic gonadotropin, hCG ) is given. If you develop OHSS, your doctor may not give you any hCG during this treatment cycle. You may be told not to have intercourse or to use barrier contraceptives for at least 4 days.

Multiple pregnancies

When you use this medicine, there is a greater risk that you will become pregnant with more than one child (ie “multiple pregnancies”, usually twins) than if you become pregnant naturally.

Multiple pregnancies can cause medical complications for you and your children. You can reduce the risk of multiple pregnancies by using the right dose of this medicine at the right times.

When you undergo assisted reproduction, the risk of multiple pregnancies is related to your age, the quality, and number of fertilized eggs or embryos that are placed with you.

Miscarriage

You are at greater risk of miscarriage than the average woman when you undergo assisted reproduction or your ovaries are stimulated to produce eggs.

Excessive pregnancy

You are at greater risk of developing an ectopic pregnancy (ectopic pregnancy) than the average woman when you undergo assisted reproduction and if your fallopian tubes are damaged.

Congenital malformations

The incidence of congenital malformations after assisted reproduction may be slightly higher than after natural conception. This may be related to multiple pregnancies or characteristics of the parents such as the mother’s age and sperm quality.

Problems with blood clots (thromboembolic events)

If you have ever had blood clots in your legs or lungs, a heart attack or stroke, or if your family has had any of these, tell your doctor. You may be at greater risk of having these problems or of getting worse with treatment with Ovaleap.

Men with too much FSH in their blood

If you are a man, too much natural FSH in the blood can be a sign of damaged testicles. This drug is usually not effective in this problem. If your doctor decides that you should try treatment with Ovaleap, he or she can check the effect by asking you to leave semen for analysis 4 to 6 months after the start of treatment.

Children And Young People

This medicine is not intended for use in children and adolescents under 18 years of age.

Other Drugs And Ovaleap

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you use Ovaleap with other medicines that facilitate ovulation, such as human chorionic gonadotropin ( hCG ) or clomiphene citrate, these may increase the response of your follicles .
If you are taking Ovaleap at the same time as an agonist or antagonist of ‘gonadotropin-releasing hormone’ ( GnRH ) (these medicines lower sex hormone levels and stop ovulation) you may need a higher dose of Ovaleap to produce follicles .

Pregnancy, Breastfeeding And Fertility

You should 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.

Ovaleap Contains Excipients

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. This medicine also contains benzalkonium chloride 0.02 mg/ml and benzyl alcohol 10.0 mg/ml.

If you have liver or kidney problems and are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

How To Use Ovaleap

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

This medicine is given as an injection into tissue just under the skin ( subcutaneous injection ). Your doctor or nurse will show you how to inject the medicine. If you are giving this medicine to yourself, read and follow the instructions for use carefully.

Recommended dose

Your doctor will decide how much medicine to take and how often. The doses shown below are given in International Units (IU).

Women

If you are not ovulating and have irregular or no periods

This medicine is usually given every day.
If you have irregular periods, start using this medicine within the first 7 days of your menstrual cycle. If you are not menstruating, you can start using the medicine on a day that suits you.
The usual starting dose of this medicine is 75 to 150 IU every day.
The dose of one of these medicines can be increased every 7 or 14 days by 37.5 to 75 IU, until you get the desired answer.
The maximum daily dose of this medicine is usually not higher than 225 IU.
Once you have received the desired answer, you will receive hCG or “recombinant hCG” (r‑ hCG , a hCG that is produced in the laboratory using a special DNA technique). The single injection will consist of 250 micrograms r‑ hCG or 5,000 to 10,000 IU hCG 24 to 48 hours after your last injection of Ovaleap. The best time to have intercourse is the same day as hCG injection one and the day after. Alternatively, intrauterine insemination can take place by inserting semen into the uterus.

If your doctor does not see the desired response after 4 weeks, the Ovaleap treatment cycle should be stopped. In the following treatment cycle, your doctor will give you a higher starting dose of this medicine than before.

If your body responds too strongly, treatment will be stopped and you will not receive any hCG [see section 2 under “Ovarian hyperstimulation syndrome (OHSS)”]. In the following cycle, your doctor will give you a lower dose of Ovaleap than before.

If you need to develop more eggs for collection before an assisted reproduction

The usual starting dose of this medicine is 150 to 225 IU every day, from day 2 or 3 of the menstrual cycle.
Dose one can be increased, depending on the response to treatment. The maximum daily dose is 450 IU.
The treatment continues until your eggs have reached the desired development. This usually takes about 10 days, but can take anywhere from 5 to 20 days. Your doctor will use blood samples and / or ultrasound equipment to check when this happens.
When your eggs are done, you will get hCG or raw hCG . The single injection will consist of 250 micrograms r‑ hCG or 5,000 IU to 10,000 IU hCG 24 to 48 hours after your last injection of Ovaleap. This will get your eggs ready for collection.

Otherwise, your doctor may first stop your ovulation by using a gonadotropin-releasing hormone (GnRH) agonist or antagonist. Thereafter, treatment with Ovaleap is started approximately 2 weeks after the start of agonist treatment. Then both Ovaleap and GnRH agonists are given one until your follicles develop as desired.

If you do not ovulate, have no period, and have a diagnosis of very low levels of FSH and LH hormones

The usual starting dose of Ovaleap is 75 to 150 IU together with 75 IU lutropin alfa.
You will use these two medicines every day for up to 5 weeks.
Dose one of Ovaleap can be increased every 7 or 14 days by 37.5 to 75 IU, until you get the desired answer.
Once you have the desired answer, you will receive hCG or r‑ hCG . The single injection will consist of 250 micrograms r‑ hCG or 5,000 IU to 10,000 IU hCG 24 to 48 hours after your last injection of Ovaleap and lutropin alfa. The best time to have intercourse is the same day as hCG injection one and the day after. Alternatively, intrauterine insemination can take place by inserting semen into the uterus.

If your doctor cannot see an answer after 5 weeks, the treatment cycle should be stopped. In the following cycle, your doctor will give you a higher starting dose of this medicine than before.

If your body responds too strongly, treatment with Ovaleap will be stopped and you will not receive any hCG [see section 2 under “Ovarian hyperstimulation syndrome (OHSS))”]. In the following cycle, your doctor will give you a lower dose of Ovaleap than before.

Men

The usual dose of this medicine is 150 IU together with hCG .
You use these two medicines three times a week for at least 4 months.
If you have not responded to treatment after 4 months, your doctor may suggest that you continue to use these two medicines for at least 18 months.

How are the injections given?

This medicine is given as an injection into the tissue just below the skin ( subcutaneous injection ) with the Ovaleap Pen. Ovaleap Pen is a product (a “pen”) that is used to give you injections into the tissue just under the skin.

Your doctor may suggest that you learn how to inject this medicine yourself. The doctor or nurse will inform you on how to do this and you will also find instructions in the separate instructions for use of the pen. Do not try to give yourself the medicine without having been instructed by your doctor or nurse. The very first injection of this medicine should only be given in the presence of a doctor or nurse.

Ovaleap solution for injection in cartridges, cartridges, are intended for use with the Ovaleap Pen. You must follow the separate instructions for use of the Ovaleap Pen carefully. The instructions for use of the pen are included with the Ovaleap Pen. However, the treatment of your condition requires close and continuous cooperation with your doctor.

Dispose of all needles immediately after injection.

If You Use Too Much Ovaleap

The effects of using too much Ovaleap are unknown. Nevertheless, ovarian hyperstimulation syndrome (OHSS) can be expected to occur. This is described in section 4 under “Serious adverse reactions in women”. However, OHSS only occurs if hCG has also been administered [see also section 2 under “Ovarian hyperstimulation syndrome (OHSS)”]

If You Forget To Use Ovaleap

Do not take a double dose to make up for a forgotten dose. Talk to your doctor as soon as you realize you have missed a dose. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Possible Ovaleap Side Effects

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

Important Ovaleap injection side effects are

Serious side effects are in men and women

Allergic reactions such as rash, raised, itchy skin areas and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported in very rare cases (may affect up to 1 in 10,000 people). If you think you have had such a reaction, you must immediately stop injecting one with Ovaleap and see a doctor.

Serious side effects are in women

Lower abdominal pain along with nausea or vomiting may be symptoms of ovarian hyperstimulation syndrome (OHSS). This may indicate that the ovaries are overreacting to the treatment and that large ovarian cysts have developed [see also section 2 under “Ovarian hyperstimulation syndrome (OHSS)”]. This side effect is common (may affect up to 1 in 10 people).
OHSS can be pronounced with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing and / or possible fluid accumulation in the abdominal cavity or chest. This side effect is less common (may affect up to 1 in 100 people).
Complications of OHSS, such as ovarian torsion or blood clots, can occur in rare cases (may affect up to 1 in 1,000 people).
Severe thrombotic complications (thromboembolic events), sometimes independent of OHSS, can occur in very rare cases (may affect up to 1 in 10,000 people). This can cause chest pain, shortness of breath, stroke or heart attack (see also section 2 under “Thromboembolic events”).

If you notice any of the side effects listed above, contact your doctor immediately who may ask you to stop using Ovaleap.

Other Ovaleap injection side effects are in women

Very common (may affect more than 1 user in 10)

Local reactions at the injection site, such as pain, redness , bruising, swelling and / or irritation)
Headache
Fluid-filled blisters in the ovaries (ovarian cysts)

Common (may affect up to 1 in 10 people)

Magont
Weather voltage
Abdominal cramps
Nausea
Vomiting
Diarrhea

Very rare (may affect up to 1 in 10,000 people)

Your asthma can get worse.

Other side effects are in men

Very common (may affect more than 1 user in 10)

Local reactions at the injection site, such as pain, redness , bruising, swelling and / or irritation)

Common (may affect up to 1 in 10 people)

Swollen veins above and behind the testicles (varicocele)
Breast development
Acne
Weight gain

Very rare (may affect up to 1 in 10,000 people)

Your asthma can get worse.

How To Store Ovaleap

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 or on the outer carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C).
Do not freeze.
The cartridge, cassette, is stored in the outer carton. Sensitive to light.
Before opening the package and within the shelf life, you can remove this medicine from the refrigerator and store it for up to 3 months without putting it in the refrigerator again. Do not store above 25 ° C. You must discard the medicine if it has not been used within 3 months.
After opening, the cartridge, the cartridge, during use in the pen can be stored for a maximum of 28 days. Do not store above 25 ° C. Make a note of the first use date in the patient diary that comes with the Ovaleap Pen.
Replace the cap on the Ovaleap Pen after each injection to protect the cartridge, the cartridge, from light.
Do not use this medicine if you notice that it is cloudy or contains particles.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents Of The Package And Other Information

Content Declaration

The active substance is follitropin alfa.
- Ovaleap 300 IU / 0.5 ml: Each cartridge , cassette, contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 ml solution.
- Ovaleap 450 IU / 0.75 ml: Each cartridge , cassette, contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 ml solution.
- Ovaleap 900 IU / 1.5 ml: Each cartridge , cassette, contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 ml solution.
- Each ml of solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.

The other ingredients are disodium hydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride and water for injections.

All strengths listed above contain other ingredients.

What The Medicine Looks Like And Contents Of The Pack

Ovaleap is a solution for injection ( injection ). Ovaleap is a clear and colorless solution.
Ovaleap 300 IU / 0.5 ml is available in packs containing 1 cartridge, cartridge, and 10 injection needles.
Ovaleap 450 IU / 0.75 ml is available in packs containing 1 cartridge, cartridge, and 10 injection needles.
Ovaleap 900 IU / 1.5 ml is available in packs containing 1 cartridge, cartridge, and 20 injection needles.
Not all pack sizes may be marketed.

Marketing Authorization Holder And Manufacturer

Marketing Authorisation Holder

Thermax Ireland Limited

3 ^rd Floor, Kilmore House,

Spencer Dock Park Lane,

Dublin 1

D01 YE64

Ireland

Manufacturer

Teva Biotech GmbH

Dornierstraße 10

89079 Ulm

Germany

Teva Pharmaceuticals Europe BV

Swensen 5

2031 GA Haarlem

Netherlands

Merckle GmbH

Graf-Arco-Straße 3

89079 Ulm,