Fostipur 75 IU/ml, powder and solvent for solution for injection

UROFOLLITROPIN (FSH)

In this leaflet:
1. What Fostipur 75IU/ml is and what it is used for
2. Before you use Fostipur 75 IU/ml
3. How to use Fostipur 75 IU/ml
4. Possible side effects
5. Storing Fostipur 75 IU/ml
6. Additional information

1- WHAT Fostipur 75 IU/ml IS AND WHAT IT IS USED FOR
- Fostipur is used in the induction of ovulation in women that do not ovulate and who do not respond to other treatments (clomiphene citrate).
- In the induction of multifollicular development (and consequently of several ovules) in women on fertility treatment.
Urofollitropin is a highly purified follicle-stimulating hormone that belongs to the therapeutic group of the gonadotropins.
This medicine should be used under strict medical control.

2- BEFORE YOU USE Fostipur 75 IU/ml
Before starting treatment, the couple's fertility should be assessed.

Do not use Fostipur if you have any of the following problems:
- Increase in the size of ovaries or cysts in the ovary without it being a consequence of a
hormone disorder (polycystic ovary syndrome)
- Unknown origin haemorrhage
- Ovary, uterus or breast cancer
- Abnormal swelling (tumour) of the pituitary gland or hypothalamus (in the brain)
- Hypersensitivity (allergy) to urofollitropin any of the ingredients of Fostipur

This medicine should not be used if disorders such as premature menopause, malformation of the sexual organs or matrix specific tumours that prevent a normal pregnancy.

Take special care with Fostipur 75 UI/ml:
This treatment increases the risk of developing a disease known as ovarian hyperstimulation syndrome (OHSS). This is quite infrequent if you are not ovulating and your treatment is given as recommended. However, if unexpected ovarian hyperstimulation takes place, treatment should be interrupted and pregnancy avoided. The initial signs in ovarian hyperstimulation are pain in the lower abdominal region and nausea (sensation of malaise), vomiting and weight gain. If these symptoms occur you should be examined as soon as possible. In serious, albeit rare, cases in ovarian hyperstimulation syndrome, the ovaries may increase and liquid may accumulate in the abdomen or in the thoracic cavity.

The appearance of multiple pregnancies and births in patients that receive ovulation induction treatment increases in comparison with natural conception. However, this risk may be reduced if the recommended dose is used.

Multiple pregnancies and the characteristics of the parents on fertility treatments (such as the mother's age, sperm characteristics) may be associated with an increased risk of birth defects. There is a slight increased risk of extrauterine pregnancy in women with damaged fallopian tubes.

We should warn that woman with fertility problems have a higher index of miscarriages than the normal population.

Woman with a risk of blood clots must talk to their doctor about treatment, since gonadotrophins may increase their risk.

Although no information on allergic reactions with Fostipur is available, you should tell your doctor if you have allergic reactions to similar medicines.

This medicine is prepared with human urine. The risk of transmission of infection or disease to the organism cannot be fully eliminated. However, this risk is limited by the virus elimination phase in the manufacturing process, particularly in AIDS, Herpesvirus and Papillomavirus.

No cases of contamination have been published.

See your doctor, even if any of the above circumstances have only happened once.

Use of other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and lactation:
Ask your doctor or pharmacist for advice before taking any medicine.
Fostipur should not be used if you are pregnant or are breast-feeding.

Driving and using machines
Fostipur does not seem to affect the ability to drive or operate machinery.

Important information about some of the ingredients of Fostipur:
This medicine contains lactose. If your doctor has told you that you suffer from intolerance to certain sugars, consult him before using this medicine.

3- HOW TO USE Fostipur

Doses and duration of the treatment
Follow your doctor's instructions strictly. If in doubt, see your doctor or pharmacist.

Women that no not ovulate and have irregular or incomplete menstruations:
If you are menstruating, you should begin the treatment within the 7 days following the beginning of menstruation (the first 7 days of the menstrual cycle).
The dosage consists of 1 injection a day under the skin (subcutaneous) or in the muscle (intramuscular).
There is no fixed dosage regimen for all woman, although a common starter dose of 75 IU up to 75 IU of FSH (Fostipur) a day is used. This dose may be increased, if necessary, from 37.5 to 75 IU in a 7-day or preferably 14-day interval to obtain a suitable response.
The maximum daily dose of FSH should not generally surpass 225 IU.
If your doctor finds that the response is not suitable after 4 weeks of treatment, this treatment cycle should be interrupted. For the following cycle your doctor will indicate a treatment with a higher starting dose.
When a good response is obtained (satisfactory follicular growth), you will be given an injection of another medicine (hCG) used to induce follicular maturation and ovule release. This will take place 24-48 hours after the last injection of Fostipur. Sexual intercourse is recommended on the same day the hCG is given and on the following day.

If the ovarian response obtained is excessive, the treatment should be interrupted and no hCG given. A barrier contraception method should be used or sexual intercourse avoided until the menstrual cycle begins. For the following cycle your doctor will indicate a lower starting dose.

Women on ovarian stimulation by multiple follicular development prior to in vitro fertilisation or other assisted reproduction techniques:

Situation 1- When a gonadotropin-releasing hormone agonist is used (GnRH)
Fostipur should be given approximately 2 weeks after the initiation of this treatment. Both treatments are maintained until suitable follicular development is reached. A once-daily intramuscular or subcutaneous injection of Fostipur will be given. For example, after 2 weeks of treatment with a GnRH agonist, 75 to 225 IU of Fostipur will be given over the first 7 days. The dose will be titrated according to ovarian response. The cells will be retrieved 35 hours later.

Situation 2 - If you are menstruating
You must begin the treatment 2 or 3 days after beginning your menstruation (the first 2 or 3 days of the menstrual cycle).
Dosage consists of 1 subcutaneous or intramuscular injection a day.
A commonly used dose of superovulation consists of the administration of 75 to 225 IU of Fostipur a day. The treatment continues with the titration of the dose according to your response until suitable follicular development is reached. This is generally achieved by the 10th day of treatment (an average of 5 to 20 days) and is evaluated by means of blood samples and/or ultrasound examinations.
Once follicular development has been achieved, a single injection of a medicine used to induce final follicular maturation will be given. This medicine contains up to 10,000 IU of human chorionic gonadotropin (hCG). It will be given between 24-48 hours after the last injection of Fostipur.

How to give Fostipur
Fostipur is given slowly both under the skin (subcutaneous) as into the muscle (intramuscular).
Each vial is single-use and the injection should be given immediately following its preparation.

After he has duly advised you and practiced with you, your doctor may ask you to do the injection of Fostipur yourself. First of all, your doctor should:
- Let you practice by giving yourself the subcutaneous injection.
- Show you the possible areas for the injection.
- Show you how to prepare the solution for the injection very thoroughly.
- Show you how to prepare the right dose.

Before you give yourself the injection of Fostipur, read the following instructions carefully:

How to prepare and inject 1 vial of Fostipur
The injection should be prepared immediately before application with the solvent (0.9% sodium chloride solution in water for injections) contained in each case of Fostipur.

Prepare a clean surface and wash your hands. It is important that both your hands and the devices to be used are as clean as possible.

Lay the following devices on a clean surface:
- 2 pieces of cotton (not supplied in the box)
- 1 vial containing the Fostipur powder
- 1 bottle of solvent
- 1 syringe (not supplied in the box)
- 1 needle to prepare the injection (not supplied in the box)
- 1 fine needle for the subcutaneous injection (not supplied in the box)

Preparation of your injection:

Open the bottle of solvent that contains the transparent liquid: On the neck of the solvent bottle you will see a small colour mark designed to be easily broken. Tap the lid of the bottle gently to empty any liquid remaining on the end. Press the bottle firmly above the neck and break it by levering on the colour mark. Carefully place the open bottle on the clean surface.

Bottle of solvent

Extraction of the solvent: Place the needle in the syringe to prepare the injection. With the syringe in one hand, hold the open bottle of solvent with the other hand, insert the needle and extract all the solvent. Place the syringe carefully on the surface, making sure you do not touch the needle.

Preparation of the solution for injection: 1. Remove the aluminium from the capsule of the vial containing the Fostipur powder and disinfect the rubber plug area with a piece of cotton.

Vial of Fostipur

2. Take the syringe and slowly inject the solvent into the vial with the powder through the rubber plug.

3. Once the powder has dissolved (normally immediately), extract the solution slowly into the syringe. The solution should be transparent and colourless.

Subcutaneous injection of the solution: - Remove the needle and replace it with the fine needle for the injection. - Now complete the Safety Control: Extract any air bubbles by pointing the syringe with the needle upwards. Tap the syringe gently until all the air flows to the top and push the plunger very slowly until a drop of liquid appears on the end of the needle. - Adjust the quantity of Fostipur, as indicated by your doctor, in the syringe for injection.

Your doctor or nurse will already have explained where you should make the injection (for example, in the stomach, at the front of the thigh). Clean the injection area with a piece of cotton. Pinch the skin firmly while you insert the needle at an angle of 45º or 90º with a quick movement. Inject under the skin as instructed. Do not inject directly into the vein. Inject the solution by pushing the plunger gently. Take the time you need to inject all the solution indicated by your doctor. Remove the needle immediately and clean the skin, at the injection area, with a piece of cotton wetted with alcohol, making circular movements.

Disposal of all the devices used:
On finishing the injection, dispose of all the needles and empty bottle immediately in a suitable container. The remaining solution should be disposed of.

If you use more Fostipur than you should:
The effects of an overdose of Fostipur are unknown, although ovarian hyperstimulation syndrome may be expected (see section 2). If you take more Fostipur than you should, contact your doctor or pharmacist. Consult the Toxicological Information Service on 91 562 04 20, indicating the medicine and the amount taken.

If you forgot to take Fostipur:
Take the next injection as scheduled. Do not use additional amount to make up for the doses you forgot.

4- POSSIBLE SIDE EFFECTS
Like all medicines, Fostipur can have side effects, although not everyone has them.

• Very frequent: Occurring in more than 1 in every 10 patients
• Frequent: Occurring in between 1 and 10 patients in every 100 patients
• Quite infrequent: Occurring in between 1 and 10 patients in every 1,000 patients
• Rare: Occurring in between 1 and 10 patients in every 10,000 patients
• Very rare: Occurring in less than 1 in every 10,000 patients
  

The side effects reported are:

• Frequent: Headache, swelling sensation, diarrhoea, ovarian hyperstimulation syndrome
  and pain at the injection site.
• Quite infrequent: Nauseas, abdominal pain, tiredness, breathing difficulty (dyspnoea).
  Local reactions at the injection site (flare and itch), increased breast size, breast pain, suffocation, dizziness, sensation of lack of energy (lethargy), mood changes, somnolence, cysts, increased activity of the thyroid gland, redness, itch, nose bleeds and increase bleeding time.

On rare occasions the appearance of blood clots with similar medicines has been observed.

If you notice side effects not mentioned in this leaflet, or if you have any of the side effects described in a serious form, tell your doctor or pharmacist.

5- STORING Fostipur
Keep Fostipur out of the reach and sight of children.
Do not store above 25ºC. Keep the container in the outside packing, protected from the light.
Do not use after the expiry date indicated on the vials. The expiry date is the last day of the month indicated.
Use immediately after preparation.
Do not use Fostipur if the solution does not look transparent.

Medicines should not be thrown into waste waters or the refuse. Ask your pharmacist about how to dispose of the packs and the medicines you do not need. In this way you will help to protect the environment.

6- ADDITIONAL INFORMATION

What does Fostipur contain?:
The active substance is urofollitropin (follicle-stimulating hormone - FSH); 1 ml of reconstituted solution contains 75 IU of urofollitropin.
Each vial with powder contains 75 IU of FSH and the excipient lactose monohydrate.
Each bottle of solvent contains water for preparations for injection and sodium chloride.

Appearance of the product and contents of the container:
Fostipur is presented in:
Containers of 1 vial with powder like a hardened white or whitish mass and 1 bottle of solvent with transparent colourless solution.
Containers of 5 vials with powder like a hardened white or whitish mass and 5 bottles of solvent with transparent colourless solution.
Containers of 10 vials with powder like a hardened white or whitish mass and 10 bottles of solvent with transparent colourless solution.
Probably not all the presentations will be marketed.

Marketing and manufacturing authorisation holder

Marketing Authorisation holder:

FARMA-LEPORI, S.A. C/ Osi, 7 - 08034 Barcelona (Spain)

Manufacturer:

LABORATOIRES GENEVRIER S.A. 280, rue de Goa - Zone Industrielle les Trois Moulins - Parc de Sophia-Antipolis 06600 Antibes (France)

This leaflet was approved in September 2006

FARMA-LEPORI S.A. C/OSI, 7 - 08034 BARCELONA

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