75 IU, 150 IU powder and solvent for injection, solution
Urofollitropin

1. What Fostimon is and what it is used for

  • Fostimon is used to induce ovulation in women who are not ovulating and who have not responded to any other drug treatment (clomiphene citrate).
  • Fostimon is used to develop more follicles (egg vesicles), and thus more eggs, in women undergoing assisted reproduction.

The active substance urofollitropin is a very pure human follicle-stimulating hormone ( FSH ) that belongs to a group of medicines called gonadotropins.

Fostimon should only be used under a doctor’s supervision.

2. What you need to know before using Fostimon

Before starting treatment, your and your partner’s fertility should be evaluated.

Do not use Fostimon if you have any of the following conditions:

  • enlargement of the ovaries or ovarian cysts not caused by a hormonal disorder ( polycystic ovary syndrome ),
  • gynecological bleeding, where the cause is unknown,
  • malignant tumor of the ovaries, uterus, or breasts,
  • abnormal swelling ( tumor ) in pituitary gland or hypothalamus (brain),
  • if you are allergic (hypersensitive) to urofollitropin or any of the other ingredients of Fostimon.

Fostimon should not be used during early menopause (when a woman’s menstruation ceases), genital malformations, or at muscle knots ( fibroids ) in the uterus that would make a normal pregnancy impossible.

Take special care with Fostimon:

Although no allergic reactions have been reported with Fostimon, tell your doctor if you have had any allergic reactions to similar medicines.

Treatment increases the risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see section Possible side effects ). If hyperstimulation of the ovaries occurs, treatment should be discontinued and pregnancy avoided. The first signs of ovarian hyperstimulation are pain in the lower abdomen as well as nausea, vomiting, and weight gain. If these symptoms occur, contact your doctor as soon as possible. In severe but rare cases of ovarian hyperstimulation syndrome, the ovaries may become enlarged and fluid may accumulate in the abdomen or thoracic cavity.

The drug used to achieve the final release of fully developed eggs (contains human chorionic gonadotropin – hCG ) may increase the likelihood of OHSS. It is therefore not advisable to be treated with hCG where OHSS has developed and you should not have intercourse, even if you use a barrier contraceptive method for at least 4 days.

It should be noted that miscarriages are more common in women with fertility problems than in the rest of the population.

In patients undergoing ovulation stimulation, the incidence of multiple births or multiple births increases compared with natural conception but can be minimized by using the recommended dose.

Women with damaged fallopian tubes have a slightly increased risk of ectopic pregnancy.

Multiple births and characteristics of parents undergoing fertility treatment (eg mother’s age, sperm quality) can be associated with an increased risk of congenital malformations.

Treatment with Fostimon can, just like the pregnancy itself, increase the risk of getting a blood clot. Thrombosis is the formation of a blood clot in a blood vessel, usually in the veins of the legs or lungs.

Discuss this with your doctor before starting treatment, especially:

  • if you already know that you have an increased risk of getting a blood clot
  • if you, or anyone else in your immediate family, has had a thrombosis
  • if you are severely overweight.

This medicine is made from human urine. The risk of transmission of infectious substances, which can cause infection or disease, can not be completely ruled out. This risk is limited by the use of manufacturing methods that include removal of viruses, in particular HIV, herpes virus, and papillomavirus.

No cases of viral infection have been reported following treatment with Fostimon.

Other medicines and Fostimon

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

Pregnancy and breastfeeding

Fostimon should not be used if you are pregnant or breast-feeding.

3. How to use Fostimon

Dosage and duration of treatment:

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

Women who do not ovulate and have irregular periods or do not menstruate:

If you are menstruating, treatment should be started within the first 7 days after menstruation begins (the first 7 days of the menstrual cycle).

You get an injection every day, either under the skin ( subcutaneously ) or in a muscle ( intramuscularly ).

The usual starting dose is 75-150 IU FSH (Fostimon) every day. If necessary, this dose can be increased by 37.5-75 IU at 7 or preferably 14-day intervals to achieve the appropriate treatment response.

The maximum daily dose is usually not higher than 225 IU.

If the doctor does not see any effect after 4 weeks of treatment, the treatment cycle will be interrupted. In the next cycle, your doctor will prescribe a treatment with a higher starting dose than in the previous cycle.

To induce final follicular maturation when sufficient effect is achieved (sufficient growth of the follicles), an injection of another drug (containing hormone et hCG ) is given. This happens 24-48 hours after the last Fostimon injection. You are recommended to have sexual intercourse on the day of hCG – injection a given and even the next day.

If the effect becomes too strong, treatment should be discontinued and hCG will not be given (see Possible side effects ). In the next cycle, your doctor will prescribe a dose that is lower than the one in the previous cycle.

Women undergoing ovarian stimulation for multiple follicle development before in vitro fertilization or other assisted reproduction techniques:

Option 1  If you are menstruating:

Treatment should be started 2 or 3 days after the start of menstruation (days 2 to 3 of the menstrual cycle).

Dose a given as a subcutaneous or intramuscular injection every day.

The usual dose for overstimulation of the ovaries is 150-225 IU Fostimon every day. The treatment continues with a dose that is adapted to your individual needs until appropriate follicle development has been achieved. This is achieved on average on the tenth day of treatment (may vary from 5-20 days) and checked with blood tests and/or ultrasound examination.

The maximum daily dose is usually 450 IU.

When satisfactory follicular maturation has been achieved, an injection of another drug is given to induce final follicular maturation. This medicine contains up to 10,000 IU human chorionic gonadotropin ( hCG ). It is given 24-48 hours after the last Fostimon injection.

Egg cells will be collected about 35 hours later.

Option 2. When using a gonadotropin-releasing hormone agonist ( GnRH – agonist ):

This medicine is given approximately 2 weeks after treatment with GnRH – agonist one started. Both treatments continue until appropriate follicular development is achieved. Fostimon treatment is given as a subcutaneous or intramuscular injection every day.

Example: After 2 weeks of treatment with GnRH agonist, 150-225 IU Fostimon can be given for the following 7 days. Then dose one is adjusted according to the response from the ovaries.

How to give Fostimon:

Fostimon is given as a slow subcutaneous (under the skin) or intramuscular (in a muscle) injection. Each bottle is for single use only and the solution should be given immediately after reconstitution.

After appropriate training, your doctor may ask you to inject Fostimon yourself.

Then the doctor must first:

  • let you practice how to proceed to give a subcutaneous injection
  • show you suitable injection sites on the body
  • show how to prepare the injection solution, a
  • Be sure to show you how to make the right dose of the injection solution, a

In addition to ampoules, other forms of medicine should be considered when self-administering patients.

Carefully read the following instructions before injecting Fostimon yourself:

Preparation and injection of 1 bottle of Fostimon, using 1 powder bottle:

Injection one should be prepared just before you are ready to take it, use the liquid in ampoule one (the solvent, which is 0.9% sodium chloride in water for injections) contained in each pack.

Prepare a clean work surface and wash your hands. The hands and tools you use must be as clean as possible.

Place the following equipment on the work surface:

  • 2 alcohol wipes (cotton swabs or compresses with alcohol) (not included in the package)
  • 1 vial of Fostimon powder
  • 1 ampoule with diluent
  • 1 syringe (not included in the package)
  • 1 injection needle for the preparation of solution for injection one (not included in the package)
  • 1 thin injection needle for subcutaneous injection (not included in the package)

Preparation of solution for injection with 1 powder vial

Prepare the injection solution:

Step 1:The neck of the ampoule is specially designed to break more easily under the colored dot. Gently tap the top of the ampoule so that any liquid stuck in the upper part of the ampoule runs down. Hold the ampoule one with the colored dot facing away from you and break off the top of the ampoule one shown in the picture. Use a cloth or ampoule opener to hold the ampoule and protect your fingers.
Carefully place the ampoule upright on the cleaned work surface.
Remove the protective cap from the needle. Attach the coarser needle to the syringe. Hold the syringe in one hand and the opened ampoule one with diluent in the other hand. Insert the needle and draw up all the diluent in the syringe. Attach the protective cap to the needle. Carefully place the syringe on the clean work surface.
Step 2:Remove the colored plastic cap from the Fostimon bottle by gently pushing it upwards. Wipe the rubber stopper with an alcohol swab and allow it to dry.
Step 3:Pick up the syringe, remove the protective cap from the needle, and push the needle through the rubber stopper in the center of the Fostimon bottle cap. Press the plunger firmly down and spray all diluent on the powder. DO NOT SHAKE, but rotate the vial gently until the solution is clear. Avoid foaming.
Step 4:When the powder is dissolved (which usually happens immediately), the solution is slowly drawn up into the syringe: While the needle is still in place, turn the bottle upside down. Check that the needle tip is below the fluid level. Gently pull the plunger to soak up any Fostimon solution in the syringe. Check that the solution is clear and colorless.

Preparation of higher dos, when using more than 1 powder bottle.

If your doctor has recommended a higher dose for you, this can be accomplished by using more than 1 powder vial of the ampoule of diluent.

When preparing more than 1 vial of Fostimon, at the end of step 4 above, the reconstituted contents of the first vial in the syringe are pulled up and slowly injected into a second vial. Repeat steps 2 to 4 for the second and subsequent powder bottles until the contents of the required number of bottles corresponding to the prescribed dose one are dissolved (within the limit of the maximum dose one of 450 IU, which corresponds to a maximum of 6 ampoules for Fostimon 75 IU or 3 ampoules for Fostimon 150 IU).

Your doctor may increase your dose by 37.5 IU. This dosage can be achieved with 0.5 ml of Fostimon 75 IU solution.

To do this, dissolve the contents of a 75 IU vial according to steps 2 to 3 as described above and withdraw half of this reconstituted solution (0.5 ml) back into the syringe according to step 4.

In this situation you will have two solutions to inject: the first dissolved in 1 ml and the second containing 37.5 IU in 0.5 ml.

Both solutions should be injected with their own syringes according to the following steps.

The solution must be clear and colorless.

Inject the drug subcutaneously (under the skin):

The picture shows how to replace the needle from the syringe with the thin injection needle
  • When the syringe contains the prescribed dose one, put the protective cap on the needle. Remove the needle from the syringe and replace it with the thin subcutaneous injection needle including its protective cap.
  • Press the thin needle firmly onto the syringe plunger, then turn it slightly to ensure it is secure and to provide a tight seal.
The picture shows how to prepare the syringe for injection
  • Remove the protective cap from the needle. Hold the syringe with the needle pointing upwards and tap the side of the syringe gently to force any air bubbles to the syringe tip.
  • Then push the plunger upwards until a drop of liquid appears on the syringe tip.
  • Do not inject the solution if it contains particles or is cloudy.

Injection site:

  • Your doctor or nurse has already shown you where to inject the medicine. Common places are the thigh, the lower abdomen below the navel.
  • Wipe the injection site with an alcohol swab (alcoholic compress ).

Insert the needle:

  • Pinch the skin together. Insert the needle with the other hand with a quick movement at an angle of 45 ° to 90 °.
The picture shows how to pinch the skin and insert the needle

Inject the solution:

  • Inject under the skin as shown. Do not inject directly into a vein. Press the plunger down slowly and at a steady pace, so that the solution is injected correctly and the skin is not damaged.

Take the time you need to inject the volume prescribed by your doctor. As described in the preparation instructions: depending on the dose prescribed by your doctor, you may not take the full volume of the solution.

Remove the needle:

  • Quickly pull out the needle and press the injection site with an alcohol swab. Massage the injection site gently while still maintaining pressure. It helps to distribute the solution and reduces discomfort.

Discard all used material:

Once you have finished injecting one, immediately throw all the needles and empty ampoules into a provided waste container. Any remaining solution should be disposed of by local requirements.

If you use more Fostimon than you should 

The effect of an overdose of Fostimon is not known, but overstimulation of the ovaries can be expected (see section 4 “Possible side effects”). If you take more Fostimon than you should, talk to a doctor or pharmacist.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Fostimon

Take dose one at the next predetermined injection. Do not take double dose to compensate for missed dose .

If you stop taking Fostimon

Do not quit on your own initiative. Always consult your doctor if you are considering stopping this medicine. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effect is serious and requires immediate treatment if you experience it. You should stop taking Fostimon and contact your doctor immediately if the following occur:

Common, affects 1 to 10 users in 100:

  • Ovarian hyperstimulation syndrome (see section 2 for more information)

The following side effects have also been reported:

Common, affects 1 to 10 users in 100:

Uncommon, affects 1 to 10 users in 1,000:

Redness , pain and bruising at the injection site may occur.

See section 2 for more information on the risk of blood clots, ectopic pregnancies, multiple pregnancies and miscarriages.

5. How to store Fostimon

Keep out of sight and reach of children.

Do not store above 25 ° C. Store the powder bottle and ampoule one with solvent in the outer carton. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. and the label after EXP. The expiration date is the last day of the specified month.

Prepared solution should be used immediately.

Only use Fostimon if the liquid is clear and colorless.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

The medicine 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 

Urofollitropin

1 vial contains 75 IU urofollitropin (follicle-stimulating hormone , FSH ): 1 ml reconstituted solution contains either 75 IU, 150 IU, 225 IU, 300 IU, 375 IU or 450 IU urofollitropin when 1, 2, 3, 4, 5 or 6 vials have been used for dilution in 1 ml of diluent .

1 vial contains 150 IU urofollitropin (follicle-stimulating hormone , FSH ): 1 ml reconstituted solution contains either 150 IU, 300 IU or 450 IU urofollitropin when 1, 2 or 3 vials have been used for dilution in 1 ml diluent .

The specific in vivo activity is equal to or greater than 5000 IU FSH per mg protein .

Other ingredients are :

Powder: Lactose monohydrate .

Diluent: Sodium chloride and water for injections

What the medicine looks like and contents of the pack

Fostimon is supplied as a powder and diluent . 1 set containing powder in the vial (75 IU or 150 IU) and the diluent in vial (1 mL) – Föpackningsstorlekar of 1, 5 or 10 sets.

The powder is white to off-white and the diluent is clear and colorless.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2, 26900 Lodi

ITALY

Manufacturer and release:

IBSA FARMACEUTICI ITALIA SrL

Via Martiri di Cefalonia

26900 LODI (LO)

Italy

This medicinal product is authorized under European Economic Cooperation under the names:

Austria: Fostimon

Belgium: Fostimon

Cyprus: Fostimon

Denmark: Fostimon

Finland: Fostimon

France: Fostimon

Luxembourg: Fostimon

Ireland: Fostimon

The Netherlands: Fostimon

Norway: Fostimon

Spain: Fostipur

United Kingdom: Fostimon

Muhammad Nadeem

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