Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bemfola

Document Subject

Generated Narrative: MedicinalProductDefinition mp63388d6288bf341989180dcca08d726e

identifier: http://ema.europa.eu/identifier/EU/1/13/909/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-63388d6288bf341989180dcca08d726e

identifier: http://ema.europa.eu/identifier/EU/1/13/909/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - bemfola

Attesters

What is in this leaflet

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

What Bemfola is This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body 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 that contain the egg cells. In men, FSH is needed for the production of sperm.

What Bemfola is used for

In adult women, Bemfola is used:

• to help release an egg from the ovary (ovulation) in women that cannot ovulate and that did not respond to treatment with a medicine called clomiphene citrate .
• together with another medicine called lutropin alfa ( luteinising hormone or LH) to help release an egg from the ovary (ovulation) in women whose body is producing very little gonadotropins (FSH and LH).
• to help develop several follicles (each containing an egg) in women undergoing assisted reproductive technology procedures (procedures that may help you to become pregnant) such as in vitro fertilisation , gamete intra-fallopian transfer or zygote intra-fallopian transfer .

In adult men, Bemfola is used:

• together with another medicine called human chorionic gonadotropin (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.

You and your partner s fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility disorders.

Do not use Bemfola

• if you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine (listed in section 6).
• if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain).
• if you are a woman:

• with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
• with unexplained vaginal bleeding.
• with cancer in your ovaries, womb 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 damaged testicles that cannot be healed.

Do not use Bemfola if any of the above applies to you. If you are not sure, talk to your doctor before using this medicine.

Warnings and precautions Talk to your doctor or pharmacist before using Bemfola.

Porphyria Tell your doctor before you start treatment, if you or any member of your family have porphyria (an inability to break down porphyrins that may be passed on from parents to children). Tell your doctor straight away if:

• your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or
• you have stomach, arm or leg pain.

In case of the above events your doctor may recommend that you stop treatment.

Ovarian hyper-stimulation syndrome (OHSS) If you are a woman, this medicine increases your risk of developing OHSS. This is when your follicles develop too much and become large cysts. If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you have difficulty in breathing, talk to your doctor straight away who might ask you to stop using this medicine (see section 4). In case you are not ovulating, and if the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is less likely. Bemfola treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is administered. If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days.

Multiple pregnancy When using Bemfola, you have a higher risk of being pregnant with more than one child at the same time ( multiple pregnancy , mostly twins), than if you conceived naturally. Multiple pregnancy may lead to medical complications for you and your babies. You can reduce the risk of multiple pregnancy by using the right dose of Bemfola at the right times. When undergoing assisted reproductive technology, the risk of having a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you.

Miscarriage When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman.

Blood clotting problems (thromboembolic events) If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if those happened in your family, then you might have a higher risk that these problems occur or become worse with Bemfola treatment.

Men with too much FSH in their blood If you are a man, having too much FSH in your blood can be a sign of damaged testicles. Bemfola usually does not work if you have this problem. If your doctor decides to try Bemfola treatment, to monitor the treatment, they may ask you to provide semen for analysis 4 to 6 months after starting treatment.

Children and adolescents Bemfola is not indicated for use in children and adolescents below 18 years old.

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

• If you use Bemfola with other medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
• If you use Bemfola at the same time as a gonadotropin-releasing hormone (GnRH) agonist or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you may need a higher dose of Bemfola to produce follicles.

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

Driving and using machines It is not expected that this medicine will affect your ability to drive and use machines.

Bemfola contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Using this medicine

• Bemfola is intended to be given by injection just under the skin (subcutaneously). Use each pre- filled pen only once then they should be disposed of in a safe manner. Do not administered the solution if it contains particles or is not clear.
• The first injection of Bemfola should be given under supervision of your doctor.
• Your doctor or nurse will show you how to use the Bemfola pre-filled pen to inject the medicine yourself.
• If you administer Bemfola to yourself, please carefully read and follow the Instructions for Use . These instructions can be found at the end of the package leaflet.

How much to use Your doctor will decide how much medicine you will take and how often. The doses described below are stated in International Units (IU) and millilitres (mL).

Women

If you are not ovulating 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 do not have periods you can start using the medicine on any convenient day.
• The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) each day.
• Your dose of Bemfola may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
• The maximum daily dose of Bemfola is usually not higher than 225 IU (0.375 mL).
• When you get the desired response, you will be given a single injection of 250 micrograms of recombinant hCG (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5 000 to 10 000 IU of hCG, 24 to 48 hours after your last Bemfola injection. The best time to have sex is on the day of the hCG injection and the day after.

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

If your body responds too strongly, your treatment will be stopped and you will not be given any hCG (see section 2, Ovarian hyper-stimulation syndrome (OHSS) ). For the following cycle, your doctor will give you a lower dose of Bemfola than before.

If you have been diagnosed with very low levels of FSH and LH hormones

• 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 each day for up to five weeks.
• Your dose of Bemfola may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
• When you get the desired response, you will be given a single injection of 250 micrograms of recombinant hCG (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5 000 to 10 000 IU of hCG, 24 to 48 hours after your last injections of Bemfola and lutropin alfa. The best time to have sex is on the day of the hCG injection and the day after. Alternatively, intrauterine insemination or another medically assisted reproduction procedure may be performed based on your doctor s judgment.

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

If your body responds too strongly, your treatment with Bemfola will be stopped and you will not be given any hCG (see section 2, Ovarian hyper-stimulation syndrome (OHSS) ). For the following cycle, your doctor will give you a lower dose of Bemfola than before.

If you need to develop several eggs for collection prior to any assisted reproductive technology

• The usual starting dose of Bemfola is 150 to 225 IU (0.25 to 0.37 mL) each day, from day 2 or 3 of your treatment cycle.
• Bemfola dose may be increased, depending on your response. The maximum daily dose is 450 IU (0.75 mL).
• Treatment is continued until your eggs have developed to a desired point. This usually takes about 10 days but can take any time between 5 and 20 days. Your doctor will use blood tests and/or an ultrasound machine to check when this is.
• When your eggs are ready, you will be given a single injection of 250 micrograms recombinant hCG (r-hCG, an hCG made in a laboratory by a special recombinant DNA technique), or 5 000 IU to 10 000 IU of hCG, 24 to 48 hours after the last Bemfola injection. This gets your eggs ready for collection.

In other cases, your doctor may first stop you from ovulating by using a gonadotropin-releasing hormone (GnRH) agonist or antagonist. Then Bemfola is started approximately two weeks after start of agonist treatment. The Bemfola and GnRH agonist are then both given until your follicles develop as desired. For example, after two weeks of GnRH agonist treatment, 150 to 225 IU Bemfola is administered for 7 days. The dose is then adjusted according to your ovarian response.
Men

• The usual dose of Bemfola is 150 IU (0.25 mL) together with hCG.
• You will 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 using these two medicines for at least 18 months.

If you use more Bemfola than you should The effects of taking too much Bemfola are unknown. Nevertheless, one could expect ovarian hyper- stimulation syndrome (OHSS) to occur, which is described in section 4. However, the OHSS will only occur if hCG is also administered (see section 2, Ovarian hyper-stimulation syndrome (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. Please talk to your doctor as soon as you notice that you forgot a dose.

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

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

Serious side effects in women

• Lower abdominal pain together with nausea or vomiting may be the symptoms of ovarian hyper-stimulation syndrome (OHSS). This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed (see also section 2 Ovarian hyper-stimulation syndrome (OHSS) ). This side effect is common (may affect up to 1 in 10 people).
• The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest. This side effect is uncommon (may affect up to 1 in 100 people).
• Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1 000 people).
• Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely (may affect up to 1 in 10 000 people). This could cause chest pain, breathlessness, stroke or heart attack (see also section 2, Blood clotting problems(thromboembolic events) ).

Serious side effects in men and women

• Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can sometimes be serious. This side effect is very rare (may affect up to 1 in 10 000 people).

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

Other side effects in women

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

• Sacs of fluid within the ovaries (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
• Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating

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

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

Other side effects 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):

• Swelling of the veins above and behind the testicles (varicocele)
• Breast development, acne or weight gain

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

• Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty in breathing may occur. These reactions can sometimes be serious.
• Your asthma may get worse.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C). Do not freeze. Store in the original package in order to protect from light.

Within its shelf life, the unopened pen may be stored at or below 25 C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.

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

Once opened, the medicine should be injected immediately.

Do not throw any medicines away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

What Bemfola contains

• 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 the 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 Bemfola looks like and contents of the pack

• Bemfola is presented as a clear, colourless liquid for injection in a pre-filled pen (injection).
• Bemfola is supplied in packs with 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 Authorisation Holder and Manufacturer Gedeon Richter Plc. Gy mr i t 19-21. 1103 Budapest Hungary

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: