75 IU / ml 0,125, 150 IU / 0.25 ml, 225 IU / 0.375 ml, 300 IU / 0.50 ml, 450 IU / 0.75 ml injection solution in prefilled pen 
, follitropin alpha

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

1. What Bemfola is and what it is used for

What Bemfola is

This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body and is called “follicle-stimulating hormone” ( FSH ). FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of the sacs (follicles) in the ovaries where the egg cells are located. In men, FSH is needed for sperm production.

What Bemfola is used for

In adult women, Bemfola is used:

  • to help release an egg from the ovary (ovulation) in women who are not ovulating and who have not responded to treatment with a drug called ‘clomiphene citrate’.
  • together with another medicine called ‘lutropin alfa’ (‘luteinizing hormone’ or LH ) to help release eggs from the ovary (ovulation) in women who are not ovulating because their body produces very little gonadotropins ( FSH and LH ).
  • to help develop multiple follicles (each containing an egg) 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 adult men, Bemfola is used:

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

2. What you need to know before using Bemfola

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

Do not use Bemfola:

  • if you are allergic to follicle-stimulating hormone or to any of the other ingredients of this medicine (listed in section 6).
  • if you have a tumor in your hypothalamus or pituitary gland (both are parts of the brain).
  • If you are a woman :
    • with large ovaries or fluid-filled blisters in the ovaries (ovarian cysts) of unknown origin
    • with unexplained vaginal bleeding
    • with cancer of the ovaries, uterus, or breasts
    • with a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause) or malformed reproductive organs.
  • If you are a man :
    • with permanent testicular damage.

Do not use Bemfola 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

Porphyry

Tell your doctor before starting treatment if you or someone in your family has porphyria (an inability to break down porphyrins that can be transmitted from parents to children).

  • 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.

In the above events, 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. If you experience lower abdominal pain, rapid weight gain, nausea or vomiting, or difficulty breathing, talk to your doctor immediately, who may ask you to stop using this medicine (see section 4).

If you are not ovulating and if the recommended dose and the administration schedule are followed, the occurrence of OHSS is less likely. Bemfola treatment rarely causes pronounced OHSS unless the drug 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 and you may be told not to have intercourse or to use barrier contraceptives for at least four days.

Multiple pregnancies

When you use Bemfola, there is a greater risk that you will become pregnant with more than one child at the same time (“multiple births”, 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 Bemfola at the right times. When you undergo assisted reproduction, the risk of multiple pregnancies is related to your age, the quality, and the number of fertilized eggs or embryos that are placed inside you.

Miscarriage

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

Problems with blood clots (thromboembolic events)

If you have had blood clots in your legs or lungs before or recently, or a heart attack or stroke, or if someone in your family has had it, the risk of these problems may increase or worsen with Bemfola treatment.

Men with too much FSH in their blood

If you are a man and have too much FSH in your blood, this could be a sign of damaged testicles. Bemfola does not work if you have this problem. If your doctor decides to try Bemfola, you may be asked to leave semen for analysis 4 to 6 months after the start of treatment to monitor treatment.

Children and young people

Bemfola is not indicated for use by children and adolescents under 18 years of age.

Other medicines and Bemfola

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

  • If you use Bemfola with other medicines that facilitate ovulation (such as hCG or clomiphene citrate), these may increase the response of your follicles.
  • If you are taking Bemfola 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 Bemfola to produce follicles.

Pregnancy and breastfeeding

Do not use Bemfola if you are pregnant or breast-feeding.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

Bemfola contains sodium

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

3. How to use Bemfola

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

Use of this medicine

  • Bemfola is intended to be given by injection just under the skin ( subcutaneously ). Use the pen only once and then throw it away safely. Do not use the pen if the solution contains particles or if it is not ready.
  • The first injection of Bemfola should be given under the supervision of your doctor.
  • Your doctor or nurse will show you how to use Bemfola pre-filled pen to inject the medicine.
  • If you give Bemfola to yourself, read carefully, and follow the “Instructions for use”. The instructions for use are at the end of the package leaflet.

How much to use

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

Women

If you do not ovulate and have irregular or no periods

  • Bemfola is usually given every day.
  • If you have irregular periods, start using Bemfola 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 Bemfola is 75 to 150 IU (0.12 to 0.25 ml) every day.
  • Dose one of Bemfola can be increased every 7 or 14 days by 37.5 to 75 IU, until you get the desired answer or until your doctor tells you to stop, see below.
  • The maximum daily dose of Bemfola is usually no higher than 225 IU (0.375 ml).
  • Once you have received the desired response, you will receive an injection of 250 micrograms of ‘recombinant hCG’ (r- hCG, a laboratory-produced hCG using a special DNA technique) or 5,000 to 10,000 IU of hCG 24 to 48 hours after your last injection of Bemfola. The best time to have intercourse is the day of hCG – injection one day after.

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

If your body responds too strongly, treatment will be stopped and you will not receive any hCG (see section 2, OHSS). In the following cycle, your doctor will give you a lower dose of Bemfola than before.

If you are not ovulating, having no periods, and have been diagnosed with very low levels of FSH – and LH – hormone s

  • The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 ml) together with 75 IU (0.12 ml) of lutropin alfa.
  • You will use these two medicines every day for up to five weeks.
  • Dose one of Bemfola can be increased every 7 or 14 days by 37.5 to 75 IU until you get the desired answer.
  • Once you have received the desired response, you will receive an injection of 250 micrograms of ‘recombinant hCG’ (r- hCG, a laboratory-produced hCG using a special DNA technique) or 5,000 to 10,000 IU of hCG 24 to 48 hours after your last injection of Bemfola and lutropin alfa. The best time to have intercourse is the day of hCG – injection one day after. Alternatively, intrauterine insemination can be performed by inserting semen into the uterus.

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

If your body responds too strongly, Bemfola will be stopped and you will not get any hCG (see section 2, OHSS). In the following cycle, your doctor will give you a lower dose of Bemfola than before.

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

  • The usual starting dose of Bemfola is 150 to 225 IU (0.25 to 0.37 ml) every day, starting on day 2 or 3 of the treatment cycle.
  • Dose one of Bemfola may be increased, depending on the treatment response. The maximum daily dose is 450 IU (0.75 ml).
  • 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 ready, you will receive an injection of 250 micrograms of ‘recombinant hCG’ (r- hCG, a laboratory-produced hCG with a special genetic modification technique) or 5,000 IU to 10,000 IU of hCG 24 to 48 hours after your last injection of Bemfola. This prepares your eggs for collection.

Otherwise, your doctor may first stop your ovulation by using a gonadotropin-releasing hormone (GnRH) agonist or antagonist. Thereafter, treatment with Bemfola is started approximately two weeks after the start of agonist treatment. Then, given both Bemfola and GnRH – agonist one until your follicles develop as desired. For example, after two weeks of treatment with GnRH – agonist, is given 150 to 225 IU of Bemfola 7 days. Then dose one is adjusted according to the response of your ovaries. When a GnRH – antagonist used, it is given from the 5th or 6th day of treatment with Bemfola and continues to be given until ovulation has been induced.

Men

  • The usual dose of Bemfola is 150 IU (0.25 ml) 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.

If you use more Bemfola than you should

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

If you forget to use Bemfola

If you forget to use Bemfola, do not take a double dose to make up for a forgotten dose. Talk to your doctor as soon as you notice that you have missed a dose.

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

4. Possible side effects

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

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 “Take special care with Bemfola”). This side effect is common (may affect up to 1 in 10 people).
  • OHSS can become serious 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 “Problems with blood clots”).

Serious side effects are in men and women

  • Allergic reactions such as skin rash, redness of the skin, hives, swelling of the face with difficulty breathing can sometimes be serious. This side effect is very rare.

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

Other side effects are in women

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

  • Abdominal pain
  • Nausea, vomiting, diarrhea, abdominal cramps, and flatulence

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

  • Allergic reactions such as rash, redness of the skin, hives, swelling of the face with difficulty breathing may occur. These side effects can sometimes be serious.
  • Your asthma can get worse

Other side effects are in men

Very common (may affect more than 1 in 10 people):

  • 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).
  • Development of breasts, acne, or weight gain.

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

  • Allergic reactions such as rash, redness of the skin, hives, swelling of the face with difficulty breathing may occur. These side effects can sometimes be serious.
  • Your asthma can get worse.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bemfola

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 pen label and on the 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.

Store in the original package. Sensitive to light.

The unopened pen can be stored within a shelf life of up to 25 ° C for up to 3 months without being stored in the refrigerator again and must be thrown away if it has not been used after 3 months.

Do not use this medicine if you notice visible signs of deterioration if the liquid contains particles or is not clear.

Once the package has been opened, the medicine should be injected immediately.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is follitropin alfa.
  • Bemfola 75 IU / 0.125 ml: Each cartridge contains 75 IU (equivalent to 5.5 micrograms)follitropin alfa in 0.125 ml solution.
  • Bemfola 150 IU /0.25 ml: Each cartridge contains 150 IU (equivalent to 11 micrograms)follitropin alfa in 0.25 ml solution.
  • Bemfola 225 IU /0.375 ml: Each cartridge contains 225 IU (equivalent to 16.5 micrograms)follitropin alfa in 0.375 ml solution.
  • Bemfola 300 IU / 0.50 ml: Each cartridge contains 300 IU (equivalent to 22 micrograms)follitropin alfa in 0.50 ml solution.
  • Bemfola 450 IU /0.75 ml: Each cartridge contains 450 IU (equivalent to 33 micrograms)follitropin alfa in 0.75 ml solution.
  • Each ml of solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
  • The other ingredients are poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid, and water for injections.

What the medicine looks like and the contents of the pack

  • Bemfola is supplied as a clear, colorless solution for injection in a pre-filled pen.
  • Bemfola is supplied in packs of 1, 5, or 10 pre-filled pens, 1, 5, or 10 disposable needles, and 1, 5, or 10 alcohol swabs. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömrői out 19-21.

1103 Budapest

Hungary

Muhammad Nadeem

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