Package Insert: Information for the User

Fostipur Kit300 UIpowder and solvent for injectable solution

Urofolitropina

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

• Fostipur Kit is used forstimulating ovulationin women who do not ovulate and who do not

respond to other treatments (clomifene citrate).

• In the induction of multifollicular development (and, consequently, of several oocytes) in

women undergoing fertility treatments.

The urofolitropin is a highly purified foliculostimulating hormone that belongs to a group of medications called gonadotropins.

This medication must be used under the control of your doctor.

Before starting treatment, the couple's fertility should be evaluated.

Do not use Fostipur Kit

• If you are allergic to urofolitropin or any of the other components of this medication (including those listed in section 6).
• Increased size of ovaries or ovarian cysts not resulting from a hormonal disorder (polycystic ovary syndrome).

trastorno hormonal (síndrome del ovario poliquístico).

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

This medication should not be used if you have conditions such as premature menopause, organ malformation, or tumors of the uterus that prevent a normal pregnancy.

Warnings and precautions

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

This treatment increases the risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects).If OHSS occurs, you should discontinue treatment and avoid becoming pregnant. The first signs of OHSS are lower abdominal pain, 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 become enlarged and fluid may accumulate in the abdomen or chest.

The medication used to achieve the final release of mature oocytes (containing human chorionic gonadotropin, hCG) may increase the likelihood of OHSS.Therefore, it is not recommended to use hCG in cases where OHSS is developing, and you should not engage in sexual intercourse, even with barrier contraceptive methods, for at least 4 days.

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

Consult your doctor before starting treatment, especially:

• if you already know you have a higher risk of developing thrombosis;
• if you or a close relative have had thrombosis in the past;
• if you have excessive weight.

This medication is prepared with human urine. The risk of transmission of 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 HIV, Herpes virus, and Papillomavirus.

No cases of viral contamination have been reported.

Use of Fostipur Kit with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

Fostipur Kit contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

Dosage and treatment duration:

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Women who do not ovulate and have irregular or incomplete menstruation:

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

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

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

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

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

When a good response (satisfactory follicular growth) is obtained, you will be administered only one injection of another medication (hCG), used to induce final follicular maturation and ovule 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 of hCG administration and the next day.

If an excessive ovary response is obtained, the treatment should be interrupted and hCG should not be administered (see Possible adverse 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 reproductive techniques:

Situation 1– If you have your period

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

The dosage consists of 1 injection per day, subcutaneously.

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

The maximum dose is generally 450 UI per day.

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

Oocyte puncture will be performed approximately 35 hours later.

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

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

Administration instructions:

Fostipur Kit is administered by subcutaneous injection under the skin.

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.

In the first place, your doctor must:

• Leave you to practice administering the subcutaneous injection to yourself.
• Indicate which areas are possible for you to administer the injection.
• Indicate how to prepare the solution for the injection carefully.
• Explain how to prepare the correct dose to be administered.

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

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

The solution must be prepared just before administering the injection. Each vial is for single use. The medication must be reconstituted under aseptic conditions.

Fostipur Kit must be reconstituted only 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.

Extend the following materials on a clean surface:

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

Reconstitution of the injection solution using 1 vial of powder.

Preparing the injection solution:

Preparing higher doses, using more than 1 vial of powder

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

When reconstituting more than 1 vial of Fostipur Kit, at the end of phase 4 described above, introduce the reconstituted content of the first vial back into the syringe, and inject it slowly into a second vial. Repeat phases 2 to 4 for the second vial and subsequent ones until the content of the required number of vials equivalent to the prescribed dose (within the maximum total dose limit of 450 UI, corresponding to a maximum of 6 vials of Fostipur Kit 75 UI, 3 vials of Fostipur Kit 150 UI, or 2 vials of Fostipur Kit 225 UI) is dissolved.

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

To do this, you must reconstitute the content of the 75 UI vial according to phases 2 to 3 described above and introduce half of this reconstituted solution (0.5 ml) into the syringe according to phase 4.

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

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

The solution must be transparent and colorless.

Inject the medication subcutaneously:

The injection site:

•Your doctor ornurse will haveindicated which part ofyour body can be usedto inject the medication.

Common areas arethe thigh orthe lower abdominal wallbelow the navel.

• Clean theinjection sitewithan alcohol-soaked cotton swab.

Needle placement:

Injection of the solution:

•Inject itunder the skinas you were taught.Do not inject itdirectly into a vein.Push theplunger slowly and steadily, so thatthe solution isinjected correctlyand the skinis not damaged.

Take all the timeyou needto inject the prescribed volume of solution.Tal como se describe en la preparación de la solución, dependiendo de la dosis prescrita por su médico, puede que no tenga que utilizar el volumen total de la solución.

Needle extraction:

• Pull the syringe quickly and press on the injection site with an alcohol-soaked cotton swab. A gentle massage on the site, while still maintaining pressure, helps to disperse the Fostipur Kit solution and alleviates discomfort.

Disposal of all used utensils:

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

If you use more Fostipur Kit than you should

The effects of a Fostipur Kit overdose are unknown, although it is assumed that a hyperstimulation syndrome could occur (see Possible adverse effects). If more Fostipur Kit is administered than necessary, contact your doctor or pharmacist.

For accidental overdose or ingestion, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone:915 620 420, indicating the medication and the amount ingested.

If you forgot to use Fostipur Kit

Put the next injection, at the scheduled time. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Fostipur Kit

Do not interrupt treatment on your own initiative. Consult your doctor if you are considering stopping using this medication. If you have any other doubts about using this medication, consult your doctor or pharmacist.

Like all medications, Fostipur Kitmay cause adverse effects, although not everyone will experience them.

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

You must discontinue administration of Fostipur Kit and visit your doctor immediately if the following occurs:

Frequent, may affect between 1 and 10 in 100 people:

• Ovarian Hyperstimulation Syndrome (see Section 2 of Additional Information)

The following adverse effects have also been reported:

Frequent, may affect between 1 and 10 in 100 people:

• Headache,
• feeling of bloating in the abdomen,
• constipation,
• pain at the injection site.

Rare, may affect between 1 and 10 in 1000 people:

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

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

See Section 2 of Additional Information for the risk of blood clots, ectopic pregnancy, multiple pregnancies, and miscarriage.

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

Adverse Effect Reporting:

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

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

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

Do not store at a temperature above25ºC. Store the vial and preloaded syringe with solvent in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the carton box 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 must be transparent and colorless.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fostipur Kit

The active principle is urofolitropin.

Each vial contains 300 IU of urofolitropin (FSH hormone): 1 ml of reconstituted solution contains 300 IU of urofolitropin.

The specific activity in vivo is 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 contents of the package

Fostipur Kit is presented in powder and solvent for injectable solution.

Boxes with 1, 5 or 10 kits. Each kit contains: 1 vial with powder containing 300 IU of urofolitropin, 1 preloaded syringe with 1 ml of solvent, 1 needle for reconstitution and 1 subcutaneous injection needle.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia 2

26900 Lodi (Italy)

Responsible for manufacturing

IBSA Farmaceutici Italia Srl., Via Martiri di Cefalonia, 2 - 26900 Lodi (Italy)

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

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

8th floor, Local 1,

08028 Barcelona (Spain)

This medication is authorized in the member states of the European Economic Area with the following names (the concentrations and pharmaceutical forms are identical in all countries, only the commercial names change)

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

Last review date of this leaflet: February 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/