Bemfola
follitropin alfa
follitropin alfa
Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects,talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Bemfola is and what it is used for
What you need to know before you use Bemfola
How to use Bemfola
Possible side effects
How to store Bemfola
Contents of the pack and other information
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.
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 that are not ovulating because their 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”.
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.
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 or pharmacist before using this medicine.
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 conceive naturally. A 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.
Bemfola is not indicated for use in children and adolescents under 18 years of age.
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 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.
Do not use Bemfola if you are pregnant or breast-feeding.
It is not expected that this medicine will affect your ability to drive and use machines.
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.
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.
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.
Your doctor will decide how much medicine you will use and how often. The doses described below are stated in International Units (IU) and millilitres (mL).
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 or your doctor tells you to stop, see below.
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, OHSS). For the following cycle, your doctor will give you a lower dose of Bemfola than before.
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 may be performed by placing the sperm into the womb cavity.
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, OHSS). For the following cycle, your doctor will give you a lower dose of Bemfola than before.
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. When GnRH antagonist is used, it is administered from the 5th or 6th day of Bemfola treatment and continued until ovulation induction.
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.
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, under ‘OHSS’).
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.
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 “Take special care with Bemfola”). This side effect is common (may affect up to 1 in 10 people).
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 under ‘Blood clotting problems’).
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
If you notice any of the above-listed side effects you should immediately contact your doctor, who might ask you to stop using Bemfola.
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
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.
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 to protect the environment.
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.
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.
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest Hungary
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Before starting to use your pre-filled pens, please read the full Instructions for use and the package leaflet carefully.
Each pre-filled pen is only for your single use – do not let anyone else use it.
The numbers on the dose display of the pre-filled pens are measured in International Units or IU. Your doctor will have told you how many IU to inject each day.
Give yourself the injection around the same time each day.
Take one of your pens out of the fridge 5 to 10 minutes before using it.
If the medicine is frozen, then please do not use it.
Wash your hands with soap and warm water, and dry them.
It is important that your hands and the things you use to get your pen ready are as clean as possible.
A good place is a clean table or surface.
Perform the injection every day around the same time. Take the pen out of the fridge 5 to 10 minutes before using it.
Note: Please check that the medicine is not frozen.
Get a new needle - only use the single-use needles supplied in the package. Hold the outer needle cap firmly.
Check in all cases that the peel-off seal on the outer needle cap is not damaged or loose. Remove the peel-off seal from the injection needle.
Caution: If the peel-off seal is damaged or loose, do not use the needle. Throw it away in a sharps disposal container. Get a new needle.
Attach the needle.
Hold the pen by its sides and keep the needle in line with it while attaching the needle and
firmly snap the needle on to the tip of the
pen. Make sure that the needle is properly secured on the pen in a straight position.
Caution: Despite the fact that there is a thread at the end of the pen, never try to twist the needle to the pen, as this may lead to the incorrect positioning of the needle.
Do not push the dosage knob in while attaching the needle.
Remove the outer needle cap (G). Keep it for later. You will need it after the injection to discard the pen.
Remove the inner needle cap (F).
Make sure that the needle is in the correct position.
Correct position of the needle
Incorrect position of the needle
First, hold the pen so that the needle is pointing upwards. To remove the air bubbles from the system, gently tap the side of the pen to make the existing air bubbles rise to the top.
Still holding the pen upright, push the dosage knob in until the activation bar with the small arrow disappears. You should also hear a click, and some liquid will splash out (this is normal).The pen is now ready to set the dose.
Caution: If no liquid splashes out, or liquid leakage is detected at the junction of the needle and the pen, the pen should not be used. Tell your doctor or pharmacist if you notice any problems.
Gently turn the dosage knob until the bar of your prescribed dose is in line with the middle of the indent on the pen.
Note: For the Bemfola 75 IU/0.125 mL pre-filled pen, the dosage knob cannot go around completely, but it can still be rotated backwards. The pen is now ready for injection.
Caution: Do not push the dosage knob in any further, at this point.
Clean the injection site with the alcohol swab available in the package, using a circular motion. Wait for a few seconds until the alcohol has evaporated from the skin and it is dry before injecting.
Check again that the correct dose is displayed on the pen. Lightly pinch the skin of the injection area. Hold the pen at approximately a right angle (900 angle) and insert the needle completely in one steady movement into your skin.
Caution: Do not push the dosage knob, while inserting the needle and do not change the direction of the needle as it goes in.
Once the needle is fully inserted in the injection site, push in the dosage knob slowly and continuously until it stops, and the bar of the set dose has disappeared.
Do not remove the needle immediately, wait at least
for 5 seconds, before
pulling it out to ensure you have injected the full dose.
After the withdrawal of the
needle: clean the skin with an alcohol swab using a circular motion at the injection site.
Caution: If liquid leakage is detected at the junction of the needle and the pen during injecting, tell your doctor or pharmacist.
Replace the outer needle cap onto the needle carefully.
You can use the pre-filled injection pen only once and must discard the pen even if any liquid remains in the pen after injection.
Throw away the packaging box, inner needle cap, peel tab, alcohol swab and the Instructions for use in the normal household waste. Do not throw away any medicines via your sink, toilet or in your household waste. The used pen needs to be discarded in a sharps container and returned to the pharmacy for a correct disposal. Ask your pharmacist how to dispose of medicines you no longer use.