FOSTIPUR KIT 75 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Fostipur Kit75 IUpowder and solvent for solution for injection

Urofollitropin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

Contents of the pack

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

1. What is Fostipur Kit and what is it used for

• Fostipur Kit is used to stimulate ovulation in women who do not ovulate and who do not

respond to other treatments (clomiphene citrate).

• In the induction of multifollicular development (and, consequently, multiple eggs) in

women undergoing fertility treatments.

Urofollitropin is a highly purified follicle-stimulating hormone that belongs to a group of medicines called gonadotropins.

This medicine should be used under the supervision of your doctor.

2. What you need to know before you use Fostipur Kit

Before starting treatment, the fertility of the couple should be assessed.

Do not use Fostipur Kit

• If you are allergic to urofollitropin or any of the other components of this medicine (listed in section 6).
• Enlargement of the ovaries or cysts in the ovary not due to a hormonal disorder (polycystic ovary syndrome).

Unknown origin bleeding.

• Ovarian, uterine, or breast cancer.
• Abnormal swelling (tumor) of the pituitary gland or hypothalamus (in the brain).

You should not use this medicine if you have conditions such as premature menopause, malformation of the sexual organs, or tumors of the uterus that prevent a normal pregnancy.

Warnings and precautions

Although there is no information on allergic reactions with Fostipur Kit, you should inform your doctor if you have any allergic reaction to similar medicines.

This treatment increases the risk of developing a disease known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation occurs, you should stop treatment and avoid becoming pregnant. The first signs of ovarian hyperstimulation are pain in the lower abdomen, as well as nausea (discomfort), vomiting, and weight gain. If these symptoms appear, you should be examined by your doctor as soon as possible. In severe cases, although rare, the ovaries may increase in size and fluid may accumulate in the abdomen or chest.

The medicine used to achieve the final release of mature eggs (which contains human chorionic gonadotropin, hCG) may increase the likelihood of OHSS. Therefore, it is not advisable to use hCG in cases where ovarian hyperstimulation is developing, and you should not have sexual intercourse, even using barrier contraceptives, for at least 4 days.

It should be noted that women with fertility problems have a higher rate of spontaneous abortions than the normal population.

The occurrence of multiple pregnancies and births in patients receiving ovulation induction treatment increases compared to natural conception. However, this risk can be reduced if the recommended dose is used.

There is a slight increase in the risk of ectopic pregnancy in women with damaged Fallopian tubes.

Multiple pregnancies and the characteristics of parents undergoing fertility treatments (e.g., mother's age, sperm characteristics) may be associated with a higher risk of birth defects.

Treatment with Fostipur Kit, like pregnancy itself, may increase the risk of thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most often in the veins of the legs or in the lungs.

Consult your doctor before starting treatment, especially:

This medicine is prepared from human urine. The risk of transmitting infection or disease to the body cannot be completely eliminated. However, this risk is limited by the virus elimination phases in the manufacturing process, particularly AIDS, Herpes virus, and Papillomavirus.

No cases of viral contamination have been reported.

Using Fostipur Kit with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

Fostipur Kit should not be used if you are pregnant or breastfeeding.

Fostipur Kit contains sodium

This medicine contains less than 1mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free).

3. How to use Fostipur Kit

Dose and duration of treatment:

Follow your doctor's instructions for administering this medicine exactly. If in doubt, consult your doctor or pharmacist again.

Women who do not ovulate and have irregular or incomplete menstrual periods:

If you have your menstrual period, treatment should start within 7 days of the start of your menstrual period (the first 7 days of the menstrual cycle).

The dose consists of 1 injection per day, under the skin (subcutaneously).

The initial common dose is 75 IU to 150 IU of FSH (Fostipur Kit) per day. This dose may be increased if necessary, by 37.5 to 75 IU at 7-day or, preferably, 14-day intervals, to obtain an adequate response.

The maximum daily dose of FSH should not generally exceed 225 IU.

If your doctor does not find an adequate response after 4 weeks of treatment, this treatment cycle should be discontinued. For the next cycle, your doctor will indicate a treatment with a higher initial dose.

When a good response is obtained (satisfactory follicular growth), you will be given a single injection of another medicine (hCG) used to induce follicular maturation and egg release. This will take place 24-48 hours after the last injection of Fostipur Kit. It is recommended to have sexual intercourse on the same day as the administration of hCG and the next day.

If an excessive ovarian response is obtained, treatment should be discontinued and hCG should not be administered (see Possible side effects). For the next cycle, your doctor will indicate a lower initial dose.

Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilization or other assisted reproduction techniques:

Situation 1 - If you have your menstrual period

Treatment should start 2 or 3 days after the start of your menstrual period (the first 2 or 3 days of the menstrual cycle).

The dose consists of 1 injection per day, subcutaneously.

A commonly used dose for superovulation consists of the administration of 150 to 225 IU of Fostipur Kit per day. Treatment continues, with dose adjustment according to your response, until adequate follicular development is achieved. This is usually achieved on the 10th day of treatment (an average of 5 to 20 days) and is evaluated by blood tests and/or ultrasound examinations.

The maximum dose is generally 450 IU/day.

Once follicular development is achieved, a single injection of a medicine used to induce final follicular maturation will be administered; this medicine contains up to 10,000 IU of human chorionic gonadotropin (hCG). It will be administered 24-48 hours after the last injection of Fostipur Kit.

Egg retrieval will be performed approximately 35 hours later.

Situation 2 - When a gonadotropin-releasing hormone (GnRH) agonist is used

Fostipur Kit should be administered approximately 2 weeks after the start of this treatment. Both treatments are maintained until adequate follicular development is achieved. An injection of Fostipur Kit will be administered subcutaneously every day. For example, after 2 weeks of treatment with a GnRH agonist, 150 to 225 IU of Fostipur Kit will be administered for the first 7 days. The dose will then be adjusted according to the ovarian response.

Administration instructions:

Fostipur Kit is administered by injection under the skin (subcutaneously).

Each vial is for single use and the injection should be administered immediately after preparation.

After advising and practicing conveniently, your doctor may ask you to administer the Fostipur Kit injection yourself.

First, your doctor should:

• Let you practice administering the subcutaneous injection yourself.
• Indicate which areas of your body you can inject the medicine into.
• Explain how to carefully prepare the solution for injection.
• Explain how to prepare the correct dose to be administered.

Before you administer the Fostipur Kit injection, carefully read the following instructions:

How to prepare and inject 1 vial of Fostipur Kit, using 1 vial of powder:

The solution should be prepared just before injecting. Each vial is for single use. The medicine should be reconstituted under aseptic conditions.

Fostipur Kit should only be reconstituted with the solvent provided in the kit.

Prepare a clean surface and wash your hands before reconstituting the solution. It is essential that both your hands and the utensils you will use are as clean as possible.

Lay out the following materials on a clean surface:

• 2 pieces of cotton wool with alcohol (not included in the box),
• 1 vial containing the Fostipur Kit powder,
• 1 pre-filled syringe with solvent,
• 1 needle for preparing the injection,
• 1 fine needle for subcutaneous injection.

Reconstitution of the solution for injection using 1 vial of powder

Preparing the solution for injection:

Preparation of higher doses, using more than 1 vial of powder

If your doctor has recommended higher doses, you can achieve this by using more than 1 vial of powder with a pre-filled syringe of solvent.

When reconstituting more than 1 vial of Fostipur Kit, after completing the above steps, introduce the reconstituted contents of the first vial back into the syringe and slowly inject it into a second vial. Repeat steps 2 to 4 for the second vial and subsequent ones until the contents of the required number of vials equivalent to the prescribed dose are dissolved (within the limit of the maximum total dose of 450 IU, corresponding to a maximum of 6 vials of Fostipur Kit 75 IU, 3 vials of Fostipur Kit 150 IU, or 2 vials of Fostipur Kit 225 IU).

Your doctor may increase your dose by 37.5 IU, which represents half of a vial of Fostipur Kit 75 IU.

To do this, you should reconstitute the contents of the 75 IU vial according to the above steps and introduce half of this reconstituted solution (0.5 ml) into the syringe.

In this situation, you will have two preparations to inject: the first reconstituted preparation in 1 ml and the second containing 37.5 IU in 0.5 ml.

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

The solution should be transparent and colorless.

Inject the medicine subcutaneously:

The injection site:

• Your doctor or nurse will have indicated where on your body you can inject the medicine. The most common places are the thigh or the lower abdominal wall below the navel.
• Clean the injection site with an alcohol swab.

Placing the needle:

Injecting the solution:

• Inject the solution under the skin as you were taught. Do not inject it directly into a vein. Push the plunger slowly and steadily, so that the solution is injected correctly and the skin is not damaged.

Take all the timeyou needto inject the prescribed volume of the solution.As described in the preparation of the solution, depending on the dose prescribed by your doctor, you may not need to use the entire volume of the solution.

Removing the needle:

• Remove the syringe quickly and press on the injection site with an antiseptic swab. Gentle massage at the site, while maintaining pressure, helps to disperse the Fostipur Kit solution and relieve discomfort.

Disposal of all used utensils:

Any unused product or waste material should be disposed of according to local requirements (once the injection is complete, all needles and empty syringes should be disposed of in an appropriate container).

If you use more Fostipur Kit than you should

The effects of an overdose of Fostipur Kit are unknown, although it is likely that ovarian hyperstimulation syndrome (OHSS) could occur (see Possible side effects). If you administer more Fostipur Kit than you should, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount ingested.

If you forget to use Fostipur Kit

Take the next injection at the scheduled time. Do not use a double dose to make up for forgotten doses.

If you stop treatment with Fostipur Kit

Do not stop treatment 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 medicine, ask your doctor or pharmacist.

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4. Possible Adverse Effects

Like all medicines, Fostipur Kit can cause adverse effects, although not all people suffer from them.

The following adverse effects are important and will require immediate action if you experience them.

You should stop administering Fostipur Kit and visit your doctor immediately if the following occurs:

Frequent, may affect up to 1 in 10 people:

• Ovarian Hyperstimulation Syndrome (see Section 2 of the additional information)

The following adverse effects have also been reported:

Frequent, may affect up to 1 in 10 people:

• Headache,
• feeling of swelling in the abdomen,

• constipation,
• pain at the injection site.

Uncommon, may affect up to 1 in 100 people:

• Increased activity of the thyroid gland,
• mood changes,
• fatigue,
• dizziness,
• difficulty breathing (dyspnea),
• nosebleeds,
• nausea, indigestion, abdominal pain,
• redness, itching,
• flushing,
• cystitis,
• breast enlargement, breast pain,
• difficulty stopping bleeding.

Redness, pain, and hematoma may occur at the injection site (frequency not established).

See Section 2 of the additional information regarding the risk of blood clots, ectopic pregnancy, multiple pregnancies, and abortions.

If you consider any of the adverse effects you are suffering from to be serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fostipur Kit

Keep this medicine out of the sight and reach of children.

Do not store at a temperature above 25°C. Keep the vial and the pre-filled syringe of solvent in the outer packaging to protect it from light.

Do not use this medicine after the expiration date shown on the carton and on the vial.

Use immediately after reconstitution.

Do not use Fostipur Kit if you notice that the solution does not appear transparent. After reconstitution, the solution should be transparent and colorless.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Fostipur Kit

The active ingredient is urofolitropin.

Each vial contains 75 IU of urofolitropin (FSH follicle-stimulating hormone): 1 ml of reconstituted solution contains 75 IU, 150 IU, 225 IU, 300 IU, 375 IU, or 450 IU of urofolitropin, when 1, 2, 3, 4, 5, or 6 vials of product are reconstituted, respectively, in 1 ml of solvent.

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

The other components are:

Powder: lactose monohydrate.

Solvent: sodium chloride and water for injectable preparations.

Appearance of the Product and Package Contents

Fostipur Kit is presented as a powder and solvent for injectable solution.

Boxes with 1, 5, or 10 kits. Each kit contains: 1 vial with powder containing 75 IU of urofolitropin, 1 pre-filled syringe with 1 ml of solvent, 1 needle for reconstitution, and 1 needle for subcutaneous injection.

The appearance of the powder is a hardened white to off-white mass, and the solvent is transparent and colorless.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia 2

26900 Lodi (Italy)

Manufacturer

IBSA Farmaceutici Italia S.r.L, Via Martiri di Cefalonia - 26900 Lodi (Italy)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

Planta 8, Local 1,

08028 Barcelona (Spain)

This medicine is authorized in the Member States of the European Economic Area under the following names (concentrations and pharmaceutical forms are identical in all countries, only trade names differ)

Austria: Fostimon PFS

Belgium: Fostimon

Cyprus: Fostimon PFS

Denmark: Fostimon Set

Finland: Fostimon Set

France: Fostimonkit

Luxembourg: Fostimon

Ireland: Fostimon PFS

Netherlands: Fostimon Set

Norway: Fostimon Set

Spain: Fostipur Kit

Sweden: Fostimon Set

United Kingdom: Fostimon PFS

Date of the last revision of this prospectus:February 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/