How To Use

How to use Bemfola Injection Prefilled Pen

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 the prefilled pen only once then it 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.

How much to use

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).

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 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

If you are not ovulating, have no periods and 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 may be performed by placing the sperm into the womb cavity

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 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.

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.