Fostipur Kit 300 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fostipur Kit 300 IU powder and solvent for injectable solution

Urofollitropin

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fostipur Kit is and what it is 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 therefore, of multiple oocytes) in
  women undergoing fertility treatments.

Urofollitropin is a highly purified follicle-stimulating hormone belonging 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 using Fostipur Kit

Before starting treatment, the fertility status of both partners should be evaluated.

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 ovarian cysts not caused by a

hormonal disorder (polycystic ovary syndrome).

• Unexplained vaginal 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, malformations of the reproductive organs, or tumors of the uterus that would prevent a normal pregnancy.

Warnings and precautions

Although there is no available information on allergic reactions to Fostipur Kit, you must inform your doctor if you have ever had an allergic reaction to similar medicines.

This treatment increases the risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation occurs, treatment must be stopped and you should avoid becoming pregnant. Early signs of OHSS include abdominal pain in the lower abdomen, nausea (feeling unwell), vomiting, and weight gain. If these symptoms occur, you should see your doctor as soon as possible. In rare but severe cases, the ovaries may enlarge and fluid may accumulate in the abdomen or chest.

The medicine used to trigger final egg maturation (containing human chorionic gonadotropin, hCG) may increase the likelihood of OHSS. Therefore, hCG should not be used if ovarian hyperstimulation is developing, and you should avoid sexual intercourse—even using barrier contraceptive methods—for at least 4 days.

It should be noted that women with fertility problems have a higher rate of spontaneous abortion compared to the general population.

The occurrence of multiple pregnancies and multiple births in patients receiving ovulation induction treatment is higher than with natural conception. However, this risk can be reduced by using the recommended dose.

There is a slightly increased risk of ectopic pregnancy (pregnancy outside the uterus) in women with damaged fallopian tubes.

Multiple pregnancies and parental characteristics in fertility treatments (e.g., maternal age, sperm characteristics) may be associated with a higher risk of birth abnormalities.

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

Consult your doctor before starting treatment, especially:

• if you already know you have an increased risk of thrombosis;
• if you or a close family member has ever had thrombosis;
• if you are significantly overweight.

This medicine is prepared from human urine. The risk of transmitting infection or disease cannot be completely eliminated. However, this risk is minimized by viral elimination steps during the manufacturing process, particularly for HIV, Herpes virus, and Papillomavirus.

No cases of viral contamination have been reported.

Use of Fostipur Kit with other medicines

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

Pregnancy and breastfeeding

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

Fostipur Kit contains sodium

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

3. How to use Fostipur Kit

Dosage and duration of treatment:

Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor or pharmacist again.

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

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

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

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

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

If your doctor does not observe an adequate response after 4 weeks of treatment, this treatment cycle should be discontinued. For the next cycle, your doctor will instruct you to use a higher starting dose.

When a good response is achieved (satisfactory follicular growth), you will receive only one injection of another medication (hCG), used to induce final follicular maturation and ovulation. This will occur 24–48 hours after the last injection of Fostipur Kit. It is recommended to have sexual intercourse on the same day as the hCG administration and on the following day.

If an excessive ovarian response occurs, treatment must be stopped and hCG must not be administered (see Possible side effects). For the next cycle, your doctor will instruct you to use a lower starting dose.

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

Situation 1 – If you are menstruating

Treatment should begin on day 2 or 3 of your menstrual period (the first 2 or 3 days of the menstrual cycle).

The dose consists of 1 subcutaneous injection per day.

A commonly used superovulation dose is 150 to 225 IU of Fostipur Kit per day. Treatment continues, with dose adjustments based on your response, until adequate follicular development is achieved. This usually occurs around day 10 of treatment (an average of 5 to 20 days) and is assessed by blood sampling and/or ultrasound examinations.

The maximum dose is generally 450 IU/day.

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

Oocyte retrieval will be performed approximately 35 hours later.

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

Fostipur Kit should be started approximately 2 weeks after beginning this treatment. Both treatments are continued until adequate follicular development is achieved. One daily subcutaneous injection of Fostipur Kit is administered. For example, after 2 weeks of treatment with a GnRH agonist, 150 to 225 IU of Fostipur Kit are administered for the first 7 days. The dose is then adjusted according to ovarian response.

Instructions for administration:

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

Each vial is for single use only, and the injection must be administered immediately after preparation.

After proper instruction and adequate practice, your doctor may ask you to self-administer the Fostipur Kit injection.

First, your doctor must:

• Allow you to practice self-administering the subcutaneous injection.
• Indicate the suitable injection sites for you.
• Instruct you on how to carefully prepare the solution for injection.
• Explain how to prepare the correct dose to be administered.

Before you self-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 must be prepared just before administration. Each vial is for single use only. The medicine must be reconstituted under aseptic conditions.

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

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

Lay out the following materials on a clean surface:

• 2 alcohol swabs (not included in the package),
• 1 vial containing Fostipur Kit powder,
• 1 pre-filled 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:

Remove the cap from the pre-filled syringe; insert the reconstitution needle (long needle) into the syringe. Carefully place the syringe on a clean surface and avoid contact with the needle.

	Remove the colored plastic cap from the powder vial by gently pushing it upward. Disinfect the rubber stopper by wiping it with an alcohol-soaked cotton swab and allow it to dry.
	Take the syringe, remove the protective cap from the needle, and slowly inject the solvent into the powder vial through the center of the rubber stopper. Press the plunger firmly downward to deliver all of the solution onto the powder. The syringe plunger has a stop to prevent it from accidentally coming out and to improve syringe handling during injection administration. DO NOT SHAKE, but gently swirl the vial between your hands until the powder is completely dissolved, taking care to avoid creating foam.
	Once the powder has dissolved (this generally occurs immediately), slowly withdraw the solution into the syringe. With the needle still inserted, turn the vial upside down. Ensure the needle tip is below the liquid level. Gently pull back on the plunger to draw all the solution into the syringe. Check that the reconstituted solution is clear and colorless.

Preparation of higher doses using more than 1 vial of powder

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

When reconstituting more than one vial of Fostipur Kit, at the end of step 4 described above, draw 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 and subsequent vials until the contents of the required number of vials have dissolved, corresponding to the prescribed dose (within the limit of the maximum total dose of 450 IU, equivalent 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 corresponds to half a vial of Fostipur Kit 75 IU.

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

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

Both preparations must be injected using their respective syringes according to the following steps.

The solution must be clear and colorless.

Inject the medicine subcutaneously:

	When the syringe already contains the prescribed dose, place the needle protective cap back on. Remove the needle from the syringe and replace it with the fine needle for subcutaneous injection, including the protective cap. Firmly push the fine needle onto the syringe barrel. Then, rotate it slightly to ensure it is fully screwed on, thereby creating a secure seal.
	Remove the needle protective cap. Hold the syringe with the needle pointing upward and gently tap the sides of the syringe to move any air bubbles to the top. Push the plunger until a drop of liquid appears at the tip of the needle. • Do not use if it contains particles or if it is cloudy.

The injection site:

•Your doctor or nurse will have instructed you on which part of your body you can inject the medication.

The most common sites are the thigh or the lower abdominal wall below the navel.

• Clean the injection site with an alcohol swab.

Needle placement:

Pinch the skin firmly. With the other hand, insert the needle with a dart-like motion, at an angle of 45° or 90°.

Injection of the solution:

• Inject it under the skin as you have been shown. Do not inject it directly into a vein. Push the plunger slowly and steadily so that the solution is properly injected and the skin is not damaged.

Take all the time you need to inject the prescribed volume of 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.

Removal of the needle:

• Remove the syringe quickly and press on the injection site with a cotton swab containing disinfectant. Gently massaging the area while maintaining pressure helps disperse the Fostipur Kit solution and relieves discomfort.

Disposal of all used devices:

Any unused product or waste material must be disposed of in accordance with local requirements (after completing the injection, all needles and empty syringes must be discarded in an appropriate container).

If you use more Fostipur Kit than you should

The effects of an overdose of Fostipur Kit are unknown, although ovarian hyperstimulation syndrome may occur (see Possible side effects). If more Fostipur Kit has been administered than prescribed, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 915 620 420, indicating the medication and the amount ingested.

If you forget to use Fostipur Kit

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

If you stop treatment with Fostipur Kit

Do not stop treatment on your own initiative. Always consult your doctor if you are considering discontinuing this medication. If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Fostipur Kit can cause adverse effects, although not everyone experiences them.

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

You must stop taking Fostipur Kit and see your doctor immediately if any of the following occur:

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

• Headache,
• abdominal bloating,
• constipation,
• pain at the injection site.

Uncommon, may affect between 1 and 10 in every 1,000 people:

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

Redness, pain, and bruising may occur at the injection site (frequency not known).

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide 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 above 25°C. Store the vial and the pre-filled syringe of solvent in the outer packaging to protect from light.

Do not use this medicine after the expiry date stated on the cardboard box and on the vial.

Use immediately after reconstitution.

Do not use Fostipur Kit if you notice that the solution does not appear clear. After reconstitution, the solution must be clear and colourless.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fostipur Kit

The active substance is urofollitropin.

Each vial contains 300 IU of urofollitropin (follicle-stimulating hormone, FSH): 1 ml of reconstituted solution contains 300 IU of urofollitropin.

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

Other components are:

Powder: lactose monohydrate.

Solvent: sodium chloride and water for injections.

Appearance of the product and contents of the pack

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

Cartons containing 1, 5 or 10 kits. Each kit contains: 1 vial with powder containing 300 IU of urofollitropin, 1 pre-filled syringe with 1 ml of solvent, 1 needle for reconstitution and 1 needle for subcutaneous injection.

The powder appears as a white to off-white solid mass, and the solvent is clear and colourless.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia 2
26900 Lodi (Italy)

Manufacturer

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

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Instituto Bioquímico Ibérico IBSA S.L.
Avenida Diagonal 605,
8th Floor, Local 1,
08028 Barcelona (Spain)

This medicinal product is authorized in the European Economic Area member states under the following names (concentrations and pharmaceutical forms are identical in all countries; only the 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 most recent review of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/