Fostimon

Package Leaflet: Information for the Patient

FOSTIMON 75IU/vial + 1 ml solvent
powder and solvent for solution for injection
(Urofollitropin)
You should carefully read the contents of this leaflet before using the medicine, as it contains important information for you.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Fostimon and what is it used for
• 2. Important information before using Fostimon
• 3. How to use Fostimon
• 4. Possible side effects
• 5. How to store Fostimon
• 6. Contents of the pack and other information

1. What is Fostimon and what is it used for

Fostimon is used to stimulate ovulation in women who have not responded to treatment with clomiphene citrate.
It is used until several follicles (and therefore several eggs) are produced in women undergoing infertility treatment.
Fostimon consists of a powder in a vial and a solvent in an ampoule, which are used to prepare a solution for injection. Urofollitropin is a purified human follicle-stimulating hormone belonging to a group of medicines called gonadotropins.
Fostimon must be used under strict medical supervision.

Indications for use of Fostimon:

• Lack of ovulation (including polycystic ovary syndrome, PCOS) in women who have not responded to clomiphene citrate treatment.
• Multi-follicular stimulation in patients undergoing assisted reproduction (ART) such as in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT).

2. Important information before using Fostimon

The patient and her partner will be examined for infertility before starting treatment.

When not to use Fostimon:

Do not use Fostimon in the following cases:

• If the patient is allergic to FSH or any of the other components of this medicine (listed in section 6),
• Ovarian enlargement or ovarian cysts unrelated to polycystic ovary syndrome,
• Genital bleeding of unknown origin,
• Ovarian, uterine, or breast tumors,
• Pituitary or hypothalamic tumors.

Warnings and precautions

Treatment increases the risk of developing ovarian hyperstimulation syndrome (OHSS) (see "Possible side effects").
It is not recommended to use hCG in cases where OHSS occurs; in this case, sexual intercourse should be avoided, even with the use of mechanical contraceptive measures, for at least 4 days.
In patients treated with Fostimon for ovulation induction in assisted reproduction, the occurrence of multiple pregnancies is more frequent compared to natural fertilization methods.
In women treated with FSH, the incidence of miscarriages is higher than in the general population. Ectopic pregnancy also occurs more frequently.
Although there are no reports of allergic reactions after using Fostimon, you should inform your doctor about any allergic reactions after using similar medicines.
Before starting treatment, the causes of infertility in the couple and potential contraindications to pregnancy should be diagnosed. In particular, hypothyroidism, adrenal insufficiency, hyperprolactinemia, and pituitary or hypothalamic tumors should be excluded. Appropriate treatment should be applied.
The occurrence of congenital malformations may be slightly more frequent after ART than after natural fertilization. This is probably due to differences in characteristics of the parents (e.g., maternal age, sperm characteristics) and multiple pregnancy.
In women with recognized risk factors for thromboembolism, such as family history, significant obesity (BMI > 30 kg/m2), or tendency to thrombosis, there may be an increased risk of venous or arterial thromboembolism during treatment with gonadotropins. In these women, the benefits and risks of gonadotropin administration should be weighed.
This medicine is obtained from human urine. The risk of transmitting infectious agents that can cause infection or disease cannot be completely excluded, but it is very limited due to the use of virus-inactivating methods in the manufacturing process, especially for HIV, Herpesvirus, and Papillomavirus.
There are no reports of viral contamination.

Fostimon and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Fostimon should not be used during pregnancy and breastfeeding.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of prepared solution, which means it is considered "sodium-free". The sodium content in the solvent supplied with the packaging should be taken into account.

3. How to use Fostimon

This medicine should always be used exactly as prescribed by your doctor. If you are unsure, ask your doctor.
Lack of ovulation (including polycystic ovary syndrome, PCOS) in women who have not responded to clomiphene citrate treatment.
Usually, the initial dose is 75 IU to 150 IU of FSH (Fostimon) per day. This dose may be increased if necessary by 37.5 IU to 75 IU at 7- or 14-day intervals to achieve the desired response.
The maximum daily dose of FSH usually does not exceed 225 IU.
If, after 4 weeks of treatment, the doctor does not observe an adequate response, treatment should be discontinued. In the next treatment cycle, the doctor will prescribe a higher initial dose.
If the response to treatment is satisfactory (adequate follicular development), a single injection of another medicine (hCG) will be administered to induce final follicular maturation and egg release. This injection should be performed 24 to 48 hours after the last injection of Fostimon. On the day of hCG injection and the next day, sexual intercourse should occur.
If the response to treatment is too strong, treatment will be discontinued, and hCG will not be administered (see "Possible side effects"). In the next treatment cycle, the doctor will recommend a lower initial dose.
Multi-follicular stimulation in patients undergoing assisted reproduction (ART) such as in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT).
The dose and method of administration will be decided by the doctor.

How to administer Fostimon:

Fostimon is administered by subcutaneous or intramuscular injection. Each vial is for single use. The solution should be injected immediately after preparation.

After receiving appropriate instructions from the doctor and training, the patient can self-administer the injections.

First, the doctor should:

• allow the patient to practice subcutaneous injections
• show the patient the injection sites
• show how to prepare the solution for injection
• explain how to prepare the correct dose of the medicine

Before self-administering Fostimon, carefully read the following instructions.

How to prepare and inject Fostimon:

The solution must be prepared immediately before injection using the solvent (0.9% sodium chloride solution for injection) provided with each package of Fostimon.
To prepare the solution, ensure a clean area; before starting the preparation, wash your hands thoroughly. It is essential that your hands and all items needed to prepare the solution are clean.
Place all necessary items for preparing the solution on a clean surface:

• two swabs soaked in disinfectant (not included in the packaging)
• one vial containing Fostimon powder
• one ampoule with solvent
• one needle for preparing the solution for injection (not included in the packaging)
• one thin needle for subcutaneous injection (not included in the packaging)

Preparing the solution:

Open the ampoule with the solvent containing a clear liquid:
There is a colored mark on the ampoule - break the top of the ampoule at this mark.
Before doing so, gently tap the ampoule to ensure all the liquid is at the bottom. Firmly press the top of the ampoule and break it off at the marked area. Carefully put the open ampoule aside.
Draw the solvent from the ampoule:
Attach the needle to the syringe. Hold the syringe in one hand and the open ampoule with the solvent in the other. Insert the needle into the ampoule and draw all the solvent into the syringe. Put the syringe aside carefully, trying not to touch the needle.
Prepare the solution for injection:

• 1 - Remove the aluminum cap from the vial containing Fostimon powder and disinfect the rubber stopper with a swab soaked in disinfectant.
• 2 - Take the syringe and slowly inject the solvent into the vial with the powder through the rubber stopper.
• 3 - Gently roll the vial between your hands until the powder is completely dissolved, being careful not to create foam.
• 4 - Once the powder is dissolved (which usually happens immediately), slowly draw the solution back into the syringe.

If the doctor has prescribed a subcutaneous injection of more than one vial of Fostimon at a time, slowly inject the solution from the first vial into the next vial containing the powder and repeat the above steps until the prescribed dose is reached. Up to 3 vials of Fostimon can be dissolved in 1 ml of solvent.

Subcutaneous injection of the solution:

• 1. Remove the thicker needle from the syringe and replace it with a thinner needle for subcutaneous injection.
• 2. Now check for safety: all air bubbles must be removed from the syringe by holding it with the needle upwards, gently tapping it, which will make the air bubbles rise, then slowly and gently push the plunger until a drop of solution appears at the tip of the needle.
• 3. Adjust the amount of Fostimon in the syringe to the dose prescribed by the doctor.
• 4. The doctor or nurse should show you where to inject the solution (e.g., abdomen, thigh). Disinfect the area with a swab soaked in disinfectant. Firmly pinch the skin with two fingers and insert the needle at a 45-degree angle. Inject the solution subcutaneously, following the doctor's instructions. Do not inject directly into a vein. Inject slowly and gently, without rushing, lightly pressing the plunger. Then, remove the needle and rub the area with a swab soaked in disinfectant using circular motions.

Disposal of all used items:

Any unused medicine and all waste should be disposed of in accordance with local regulations (after injection, needles and empty ampoules should be disposed of in an appropriate container).

Using more Fostimon than prescribed:

The effects of overdosing Fostimon are unknown, but it can be expected to cause ovarian hyperstimulation syndrome (see "Side effects"). If a higher dose of Fostimon is used than prescribed, consult a doctor or pharmacist.

Missing a dose of Fostimon:

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Fostimon can cause side effects, although not everybody gets them.
In case of ovarian hyperstimulation syndrome, whose first sign is pain in the lower abdomen and nausea, vomiting, and weight gain, the patient should be examined by a doctor as soon as possible.
The frequency of side effects is categorized as follows: very common (≥1/10), common (≥1/100 to <1>

Reactions at the injection site (pain, redness, and bruising) have been observed rarely.
In rare cases, arterial thromboembolism has been associated with menotropin/gonadotropin treatment.
The incidence of miscarriages during gonadotropin treatment is comparable to that in women with other fertility disorders. A slightly higher incidence of ectopic pregnancy and multiple pregnancy has been observed.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Fostimon

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 25°C.
• Do not use Fostimon after the expiry date stated on the packaging. The expiry date is stated as month/year. The expiry date refers to the last day of the stated month.
• Use immediately after preparing the solution.
• Do not use this medicine if you notice that the solution is not clear.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fostimon contains

The active substance is urofollitropin in a quantity of 75 IU/vial

Other ingredients of the medicine are

Powder:
lactose monohydrate
Solvent:
water for injections,
sodium chloride

What Fostimon looks like and contents of the pack

1 vial and 1 ampoule or 10 vials and 10 ampoules in a cardboard box.
Alternatively, the medicinal product may contain a solvent in an ampoule.

Marketing Authorization Holder

IBSA FARMACEUTICI ITALIA S.R.L.
VIA MARTIRI DI CEFALONIA 2
26900 LODI
Italy

Importer

IBSA FARMACEUTICI ITALIA S.R.L.
VIA MARTIRI DI CEFALONIA 2
26900 LODI
Italy
Imed Poland Sp. z o.o.
ul. Puławska 314
02-819 Warsaw
To obtain more detailed information about this medicine, please contact the local representative of the Marketing Authorization Holder:
IBSA Poland Sp. z o.o.
Al. Jana Pawła II 29, 00-867 Warsaw
00-078 Warsaw
phone: +48 22 653 68 60

Date of last revision of the leaflet: