Fostimon Set (Urofollitropin)
FSH gonadotropin for ovulation induction and assisted reproduction
Quick Facts about Fostimon Set
Key Takeaways about Fostimon Set
- Specialist supervision required: Fostimon Set must only be used under the care of a physician experienced in fertility treatment, with regular ultrasound and hormone monitoring throughout treatment
- OHSS risk awareness: Ovarian hyperstimulation syndrome is the most significant risk; early symptoms include abdominal pain, nausea, vomiting, and weight gain – contact your doctor immediately if these occur
- Multiple pregnancy risk: Gonadotropin therapy increases the chance of twins or higher-order multiples; careful dose adjustment and monitoring help minimise this risk
- Self-injection after training: After appropriate instruction from your healthcare team, you may be able to administer Fostimon Set subcutaneously at home using the pre-filled syringe and injection supplies provided
- Immediate use after reconstitution: The powder must be dissolved in the supplied solvent immediately before injection; the reconstituted solution cannot be stored for later use
What Is Fostimon Set and What Is It Used For?
Fostimon Set contains urofollitropin, a highly purified human follicle-stimulating hormone (FSH) belonging to the gonadotropin class of medicines. It is used to induce ovulation in women with anovulatory infertility who have not responded to clomifene citrate, and to stimulate multiple follicular development in women undergoing assisted reproductive techniques such as IVF.
Fostimon Set is a fertility medication that contains urofollitropin as its active substance. Urofollitropin is a highly purified preparation of human follicle-stimulating hormone (FSH) extracted from the urine of postmenopausal women. FSH is one of the key hormones that regulate the reproductive system, and it plays an essential role in the growth and maturation of ovarian follicles – the fluid-filled sacs in the ovaries that each contain an egg (oocyte).
In a normal menstrual cycle, FSH is produced by the pituitary gland in the brain and stimulates the ovaries to develop one dominant follicle, which eventually releases a mature egg during ovulation. In women who have difficulty ovulating (anovulation), this natural process is disrupted. Fostimon Set provides an exogenous source of FSH to replace or supplement the body's own hormone production, thereby promoting follicular growth and restoring the ability to ovulate.
The specific in vivo activity of Fostimon Set is equivalent to or exceeds 5,000 IU of FSH per milligram of protein, reflecting its high degree of purification. Unlike earlier urinary gonadotropin preparations (such as human menopausal gonadotropin, or hMG), urofollitropin contains minimal luteinising hormone (LH) activity, making it a purer FSH preparation. This high purity is advantageous in clinical settings where precise FSH dosing is required without the confounding effects of LH.
Fostimon Set is used in two primary clinical scenarios:
- Ovulation induction: For women who do not ovulate and have failed to respond to treatment with clomifene citrate (an oral anti-oestrogen that is typically the first-line treatment for anovulatory infertility). In these women, Fostimon Set stimulates the development of a single dominant follicle, which is then triggered to release the egg using a separate injection of human chorionic gonadotropin (hCG).
- Controlled ovarian hyperstimulation for assisted reproduction: For women undergoing in vitro fertilisation (IVF), intracytoplasmic sperm injection (ICSI), or other assisted reproductive technologies (ART). In this setting, the goal is to develop multiple follicles simultaneously so that several eggs can be retrieved for fertilisation in the laboratory.
Fostimon Set is manufactured by IBSA Farmaceutici Italia S.r.l. and is approved across the European Economic Area under various trade names including Fostimon Set (Denmark, Finland, Netherlands, Norway, Sweden), Fostimon PFS (Austria, Cyprus, Ireland, United Kingdom), Fostimon Kit (Belgium, France, Luxembourg), and Fostipur Kit (Spain). The medication is available in packs of 1, 5, or 10 injection sets, each containing a vial of powder, a pre-filled syringe of solvent, a reconstitution needle, and a fine subcutaneous injection needle.
Fostimon Set must only be prescribed and administered under the supervision of a physician experienced in the treatment of fertility problems. Regular monitoring with transvaginal ultrasound and serum oestradiol measurements is essential throughout the treatment cycle to assess follicular response and reduce the risk of complications such as ovarian hyperstimulation syndrome (OHSS).
What Should You Know Before Using Fostimon Set?
Before starting treatment with Fostimon Set, your doctor will evaluate your fertility and that of your partner. You should not use Fostimon Set if you have ovarian cysts unrelated to polycystic ovary syndrome, unexplained vaginal bleeding, ovarian/uterine/breast cancer, or pituitary/hypothalamic tumours. Your risk of ovarian hyperstimulation, multiple pregnancy, thrombosis, and ectopic pregnancy must be carefully considered.
A thorough fertility evaluation for both you and your partner should be completed before treatment with Fostimon Set begins. This typically includes assessment of ovarian reserve, tubal patency, uterine anatomy, and semen analysis. Your doctor will use this information to determine whether gonadotropin therapy is appropriate and to establish the best treatment protocol for your individual situation.
Contraindications
You must not use Fostimon Set if any of the following conditions apply to you:
- Ovarian enlargement or cysts: Enlarged ovaries or ovarian cysts that are not caused by polycystic ovary syndrome (PCOS). Pre-existing cysts could enlarge further with FSH stimulation, potentially leading to serious complications.
- Unexplained vaginal bleeding: Any gynaecological bleeding where the underlying cause has not been identified, as this may indicate a condition that should be investigated before fertility treatment.
- Cancer of the ovaries, uterus, or breasts: Malignant tumours of the reproductive organs or breasts, as hormonal stimulation could potentially promote tumour growth.
- Pituitary or hypothalamic tumours: Abnormal swelling or tumours of the pituitary gland or hypothalamus (areas of the brain that regulate hormone production).
- Allergy to urofollitropin: Known hypersensitivity to urofollitropin or any of the other ingredients in Fostimon Set (listed in the Contents section).
- Primary ovarian failure (premature menopause): Fostimon Set cannot be effective if the ovaries are no longer functioning.
- Uterine malformations or fibroid tumours: Structural abnormalities of the uterus or certain uterine tumours that would make a normal pregnancy impossible.
Warnings and Precautions
Talk to your doctor before using Fostimon Set if you have previously experienced allergic reactions to similar medications. To date, no allergic reactions have been reported specifically in association with Fostimon Set, but as with any biological product derived from human sources, the possibility of hypersensitivity cannot be excluded.
The following important warnings and precautions apply to treatment with Fostimon Set:
Ovarian Hyperstimulation Syndrome (OHSS)
Ovarian hyperstimulation syndrome is the most significant medical risk associated with gonadotropin therapy. OHSS occurs when the ovaries over-respond to hormonal stimulation, becoming significantly enlarged and causing fluid to shift from the bloodstream into the abdominal cavity and, in severe cases, the chest cavity. The early signs of OHSS include pain in the lower abdomen, nausea, vomiting, and weight gain. If you experience any of these symptoms, contact your doctor immediately.
In severe but rare cases of OHSS, the ovaries can become markedly enlarged and fluid may accumulate in the abdomen (ascites) or chest (pleural effusion). Severe OHSS can also lead to blood clots, kidney dysfunction, and in very rare instances can be life-threatening. The risk of OHSS is increased by the hCG injection used to trigger final follicular maturation and ovulation. Therefore, if OHSS begins to develop, hCG should not be administered, and you should abstain from sexual intercourse for at least 4 days even if using barrier contraception.
Multiple Pregnancy
In women undergoing ovulation stimulation with gonadotropins, the incidence of multiple pregnancies (twins, triplets, or more) is significantly higher than with natural conception. The risk can be minimised by using the lowest effective dose and by careful monitoring with ultrasound. If too many follicles develop during an ovulation induction cycle, your doctor may decide to withhold the hCG trigger injection to avoid the risk of high-order multiple pregnancy.
Miscarriage
It should be noted that the rate of miscarriage is higher in women with fertility problems compared to the general population. This applies regardless of the treatment used and is not specifically caused by Fostimon Set.
Ectopic Pregnancy
Women with a history of tubal disease (damage to the fallopian tubes) have a slightly increased risk of ectopic pregnancy (a pregnancy that implants outside the uterus, typically in a fallopian tube), whether conceived naturally or through assisted reproduction.
Congenital Malformations
Multiple pregnancy and parental characteristics associated with fertility treatment (such as maternal age and sperm quality) may be associated with a slightly increased risk of congenital malformations compared to the general population.
Thromboembolic Events
Treatment with Fostimon Set may, like pregnancy itself, increase the risk of thrombosis (the formation of blood clots in blood vessels, most commonly in the veins of the legs or lungs). Discuss this risk with your doctor before starting treatment, particularly if you have a known increased risk of blood clots, a personal or family history of thrombosis, or if you are significantly overweight.
Biological Product Safety
Fostimon Set is manufactured from human urine. While the risk of transmitting infectious agents cannot be entirely eliminated, it is minimised through manufacturing processes that include viral removal steps, particularly targeting HIV, herpes viruses, and papillomavirus. No cases of viral transmission have been reported with Fostimon Set.
Pregnancy and Breastfeeding
Fostimon Set should not be used if you are already pregnant or breastfeeding. The medication is specifically intended to help achieve pregnancy, but once pregnancy has been confirmed, treatment must be discontinued. If you become pregnant during a treatment cycle, your doctor will provide appropriate monitoring and care for the early stages of pregnancy.
Driving and Using Machines
You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness while using Fostimon Set. The medication itself has not been shown to directly impair driving ability, but you should be aware that some side effects such as headache, dizziness, or fatigue could potentially affect your concentration. Read all information in this guide and discuss any concerns with your doctor or pharmacist.
Fostimon Set contains less than 1 mmol sodium (23 mg) per dose, making it essentially sodium-free. This is relevant for patients on sodium-restricted diets.
How Does Fostimon Set Interact with Other Drugs?
Fostimon Set has relatively few direct drug interactions. It is most commonly used in combination with GnRH agonists/antagonists and hCG as part of fertility treatment protocols. Clomifene citrate may enhance the ovarian response to FSH. Always inform your doctor about all medications you are taking, including herbal supplements.
The drug interaction profile of Fostimon Set is relatively limited because urofollitropin is a naturally occurring hormone (FSH) administered by injection, and it is not metabolised through the hepatic cytochrome P450 enzyme system that is responsible for many drug-drug interactions. However, several medications are commonly used alongside Fostimon Set as part of fertility treatment protocols, and it is important to understand how they interact.
The following table summarises the most important known interactions and co-administered medications:
| Interacting Drug | Effect | Clinical Significance | Recommendation |
|---|---|---|---|
| Clomifene citrate | May augment ovarian follicular response to FSH when used sequentially | Major | Used in some protocols; careful monitoring of follicular response required |
| GnRH agonists (e.g. leuprorelin, buserelin) | Pituitary down-regulation prevents premature LH surge; FSH administered after down-regulation is achieved | Major | Standard protocol in IVF; Fostimon Set started approximately 2 weeks after GnRH agonist initiation |
| GnRH antagonists (e.g. cetrorelix, ganirelix) | Prevents premature ovulation during controlled stimulation | Major | Added during stimulation when follicles reach threshold size; standard IVF protocol |
| Human chorionic gonadotropin (hCG) | Triggers final follicular maturation and ovulation; may increase OHSS risk | Major | Given 24–48 hours after last Fostimon Set dose; withheld if OHSS risk is high |
| Progesterone | Used for luteal phase support after embryo transfer; no direct interaction with FSH | Minor | Commonly co-prescribed; no dose adjustment needed |
Important Considerations for Drug Interactions
Always tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take. This includes prescription medicines, over-the-counter drugs, vitamins, and herbal supplements. Some herbal preparations (such as those containing phytooestrogens) may theoretically interfere with the hormonal balance during fertility treatment, although direct clinical evidence of interaction with urofollitropin is limited.
It is also important to note that while Fostimon Set does not have significant pharmacokinetic interactions with most common medications, the overall hormonal milieu during fertility treatment is complex. Your fertility specialist will carefully coordinate all aspects of your treatment protocol, including the timing and dosing of each medication, to optimise the chance of a successful outcome while minimising risks.
What Is the Correct Dosage of Fostimon Set?
Fostimon Set dosing is highly individualised and depends on whether it is used for ovulation induction or assisted reproduction. For ovulation induction, the typical starting dose is 75–150 IU daily by subcutaneous injection, adjusted based on ovarian response. For IVF/ART, the starting dose is usually 150–225 IU daily. The maximum daily dose is generally 225 IU for ovulation induction and 450 IU for IVF. Always follow your doctor's specific instructions.
The dosage and duration of treatment with Fostimon Set must always be determined by your doctor based on your individual ovarian response. Treatment is guided by regular monitoring with transvaginal ultrasound (to measure follicle size and number) and blood tests (to measure serum oestradiol levels). The goal is to achieve optimal follicular development while minimising the risk of ovarian hyperstimulation.
Ovulation Induction
For women who do not ovulate and have irregular menstruation or amenorrhoea (absence of menstruation):
| Parameter | Recommendation | Notes |
|---|---|---|
| Treatment start | Within the first 7 days of menstruation | If menstruation is present; otherwise as directed by physician |
| Starting dose | 75–150 IU daily | One subcutaneous injection per day |
| Dose adjustment | Increase by 37.5–75 IU | At intervals of 7 days, preferably 14 days |
| Maximum daily dose | 225 IU | Higher doses rarely provide additional benefit |
| Maximum treatment duration | 4 weeks per cycle | If no response, cycle is cancelled; next cycle starts with higher dose |
| hCG trigger | Given 24–48 hours after last Fostimon Set injection | When adequate follicular development is achieved; withheld if over-response |
When your doctor determines that sufficient follicular growth has been achieved (typically one or two dominant follicles of appropriate size), a separate injection of human chorionic gonadotropin (hCG) is given 24 to 48 hours after the last Fostimon Set injection to trigger final follicular maturation and ovulation. You are recommended to have intercourse on the day of the hCG injection and the following day.
If the ovarian response is excessive (too many follicles developing), treatment will be stopped and hCG will not be administered. In the next treatment cycle, your doctor will prescribe a lower starting dose than in the previous cycle to avoid over-stimulation.
Controlled Ovarian Stimulation for IVF/ART
For women undergoing ovarian stimulation for multiple follicle development prior to in vitro fertilisation or other assisted reproductive techniques:
| Protocol | Starting Dose | Duration | Maximum Dose |
|---|---|---|---|
| Standard protocol (no GnRH agonist) | 150–225 IU daily | Average 10 days (range 5–20 days) | 450 IU daily |
| Long GnRH agonist protocol | 150–225 IU daily, starting ~2 weeks after GnRH agonist | 7+ days, adjusted to response | 450 IU daily |
In the standard protocol, treatment typically begins on day 2 or 3 of the menstrual cycle. The dose is adjusted based on your individual ovarian response, assessed through ultrasound scans and hormone blood tests, until adequate follicular development has been achieved. This usually occurs around the tenth day of treatment but can range from 5 to 20 days.
When satisfactory follicular maturation is confirmed, a single injection of up to 10,000 IU hCG is given 24 to 48 hours after the last Fostimon Set injection to trigger final follicular maturation. Oocyte (egg) retrieval is typically performed approximately 35 hours later.
In the long GnRH agonist protocol, Fostimon Set is started approximately 2 weeks after beginning treatment with a GnRH agonist, once pituitary down-regulation has been confirmed. Both treatments continue until adequate follicular development has been achieved.
How to Prepare and Inject Fostimon Set
Fostimon Set is administered as a subcutaneous (under the skin) injection. Each vial is for single use only, and the solution should be prepared immediately before injection. After appropriate training by your healthcare team, you may self-administer the injections at home.
The injection kit includes a vial of powder, a pre-filled syringe containing solvent (1 ml), a reconstitution needle (for mixing), and a fine needle for subcutaneous injection. To prepare the injection:
- Wash your hands thoroughly and prepare a clean work surface.
- Attach the reconstitution needle to the pre-filled syringe of solvent.
- Clean the rubber stopper on the powder vial with an alcohol swab and allow it to dry.
- Slowly inject the solvent into the powder vial through the rubber stopper. Do not shake – gently roll the vial between your hands until the powder is completely dissolved.
- With the needle still in place, turn the vial upside down and slowly draw the solution back into the syringe, ensuring the needle tip is below the liquid level.
- Check that the solution is clear and colourless. Do not inject if it is cloudy or contains particles.
- Replace the reconstitution needle with the fine subcutaneous injection needle.
- Hold the syringe with the needle pointing upward, gently tap the side to move any air bubbles to the top, and press the plunger gently until a small drop of liquid appears at the needle tip.
- Clean the injection site (usually the thigh or lower abdomen below the navel) with an alcohol swab.
- Pinch the skin and insert the needle at a 45° to 90° angle. Inject the solution slowly and steadily.
- Remove the needle quickly and press an alcohol swab against the injection site. Gently massage the area.
If your doctor has prescribed a dose requiring more than one vial (for example, 150 IU using two 75 IU vials), dissolve the contents of the first vial as described above, then draw the solution back into the syringe and inject it into the second vial of powder. Repeat the dissolution process and draw up the final solution. Up to six 75 IU vials can be dissolved in the 1 ml of solvent from a single pre-filled syringe (maximum dose 450 IU per injection).
For a dose of 37.5 IU (half a 75 IU vial), dissolve the contents of one 75 IU vial as described and draw up only half (0.5 ml) of the reconstituted solution for injection.
Missed Dose
If you forget to inject a dose, take it at the next scheduled injection time. Do not take a double dose to make up for a missed one. If you miss doses frequently, inform your doctor as this may affect the treatment outcome.
Overdose
The effects of an overdose of Fostimon Set are not fully characterised, but ovarian hyperstimulation is expected to occur (see the Side Effects section). If you use more Fostimon Set than prescribed, contact your doctor, pharmacist, or poison control centre immediately for assessment and advice.
Do not stop using Fostimon Set on your own initiative. Stopping treatment prematurely may compromise the treatment cycle. Always consult your doctor if you are considering discontinuing treatment, and follow their instructions regarding dosage adjustments or cycle cancellation.
What Are the Side Effects of Fostimon Set?
Like all medicines, Fostimon Set can cause side effects, although not everyone experiences them. The most serious side effect is ovarian hyperstimulation syndrome (OHSS), which is common and requires immediate medical attention. Other common side effects include headache, bloating, constipation, and injection site pain. Contact your doctor immediately if you experience severe abdominal pain, nausea with vomiting, or rapid weight gain.
Fostimon Set is generally well tolerated when used under appropriate medical supervision with regular monitoring. However, because it directly stimulates the ovaries, it carries specific risks related to ovarian over-response. The following overview of side effects is organised by frequency, using internationally standardised categories.
Signs of ovarian hyperstimulation syndrome (OHSS): severe lower abdominal pain, nausea, vomiting, sudden weight gain, abdominal swelling, difficulty breathing, or reduced urine output. OHSS can be serious and potentially life-threatening if left untreated. Stop using Fostimon Set and contact your doctor immediately.
Common Side Effects
- Ovarian hyperstimulation syndrome (OHSS) – see Warnings section
- Headache
- Bloating (abdominal distension)
- Constipation
- Injection site pain
Uncommon Side Effects
- Overactive thyroid (hyperthyroidism)
- Mood swings
- Fatigue
- Dizziness
- Shortness of breath (dyspnoea)
- Nosebleed (epistaxis)
- Nausea, indigestion (dyspepsia), abdominal pain
- Skin rash, itching (pruritus)
- Hot flushes
- Cystitis (urinary tract infection)
- Breast enlargement, breast pain
- Difficulty stopping bleeding (prolonged bleeding time)
Not Known (Frequency Cannot Be Estimated)
- Redness, pain, and bruising at the injection site
Ovarian Hyperstimulation Syndrome (OHSS) – Detailed Information
OHSS is the most clinically significant adverse effect of gonadotropin therapy and deserves particular attention. It occurs when the ovaries produce an excessive response to hormonal stimulation, resulting in enlarged ovaries, increased capillary permeability, and fluid shifts from the intravascular space into body cavities. The European Society of Human Reproduction and Embryology (ESHRE) classifies OHSS as mild, moderate, or severe.
Mild OHSS is relatively common and typically presents with lower abdominal discomfort, mild bloating, and slightly enlarged ovaries. This usually resolves spontaneously within a few days. Moderate OHSS involves more pronounced symptoms including nausea, vomiting, significant abdominal distension from ascites (fluid in the abdomen), and ovarian enlargement. Severe OHSS is rare but can be life-threatening, with massive ascites, pleural effusion, haemoconcentration, electrolyte imbalances, renal impairment, and thromboembolic complications.
The risk of OHSS is increased by the administration of hCG to trigger ovulation. Current international guidelines recommend strategies to reduce OHSS risk, including low-dose step-up protocols, GnRH antagonist protocols with agonist trigger (instead of hCG trigger), and cycle cancellation when excessive follicular response is detected. If OHSS is suspected, hCG must not be administered.
Thromboembolic Events
Treatment with gonadotropins, including Fostimon Set, may increase the risk of venous thromboembolism (blood clots in the veins), particularly in association with OHSS and pregnancy. Risk factors include personal or family history of thromboembolism, severe OHSS, obesity, and immobility. Symptoms of deep vein thrombosis include leg pain, swelling, warmth, and redness; symptoms of pulmonary embolism include sudden breathlessness, chest pain, and coughing up blood. Seek immediate medical attention if you experience any of these symptoms.
Multiple Pregnancy and Pregnancy Complications
As noted in the Warnings section, gonadotropin therapy is associated with an increased rate of multiple pregnancies, ectopic pregnancies, and miscarriage compared to spontaneous conception. These are inherent risks of fertility treatment rather than specific side effects of the medication itself, but they are important considerations for any woman undergoing treatment with Fostimon Set.
Reporting Side Effects
If you experience any side effects, including those not listed here, talk to your doctor or pharmacist. You can also report side effects to your national medicines regulatory authority. Reporting helps improve knowledge about the safety of medications and contributes to ongoing pharmacovigilance.
How Should You Store Fostimon Set?
Store Fostimon Set below 25°C (77°F). Keep the pre-filled syringe with solvent in the outer carton to protect from light. The reconstituted solution must be used immediately. Do not use after the expiry date. Keep out of reach of children.
Proper storage of Fostimon Set is essential to maintain the stability and effectiveness of the medication. The powder vials and pre-filled solvent syringes should be stored at room temperature, not exceeding 25°C (77°F). Unlike some other gonadotropin preparations, Fostimon Set does not require refrigeration, which is convenient for patients who need to travel during their treatment cycle.
Keep the pre-filled syringe containing the solvent in the outer carton to protect it from light exposure, as the solvent is light-sensitive. Always store the medication in its original packaging until you are ready to use it, and keep it out of the sight and reach of children.
Do not use Fostimon Set after the expiry date printed on the carton and vial. The expiry date refers to the last day of that month. Once reconstituted (powder dissolved in solvent), the solution must be used immediately and cannot be stored for later use. If you do not use the reconstituted solution right away, it must be discarded.
Always check that the reconstituted solution is clear and colourless before injecting. Do not use if it appears cloudy, discoloured, or contains visible particles.
Do not dispose of medications via wastewater or household waste. Ask your pharmacist about proper disposal methods for unused medicines and used needles and syringes. These measures help protect the environment and prevent accidental needlestick injuries.
What Does Fostimon Set Contain?
Each vial of Fostimon Set contains 75 IU of urofollitropin (highly purified human FSH) as the active ingredient. The powder also contains lactose monohydrate. The solvent consists of sodium chloride and water for injections. The kit includes a reconstitution needle and a fine subcutaneous injection needle.
Understanding the composition of your medication is important, particularly if you have known allergies or intolerances to specific ingredients. Below is a detailed breakdown of what Fostimon Set contains.
Active Ingredient
The active substance is urofollitropin, which is a highly purified form of human follicle-stimulating hormone (FSH) extracted from the urine of postmenopausal women. Each vial contains 75 IU of urofollitropin. The specific in vivo activity is equivalent to or exceeds 5,000 IU FSH per milligram of protein, reflecting the high purity of the preparation.
When reconstituted with 1 ml of the supplied solvent, the resulting solution contains the following concentrations depending on the number of vials used:
- 1 vial (75 IU): 75 IU per ml
- 2 vials (150 IU): 150 IU per ml
- 3 vials (225 IU): 225 IU per ml
- 4 vials (300 IU): 300 IU per ml
- 5 vials (375 IU): 375 IU per ml
- 6 vials (450 IU): 450 IU per ml (maximum)
Inactive Ingredients (Excipients)
- Lactose monohydrate: A sugar derived from milk, used as a stabiliser and filler for the freeze-dried powder. Patients with rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should discuss this with their doctor.
Solvent Composition
- Sodium chloride: A salt used to make the solution isotonic (compatible with body fluids)
- Water for injections: Sterile, pyrogen-free water used as the dissolving medium
Product Description
| Component | Description | Quantity per Set |
|---|---|---|
| Powder vial | White to off-white powder containing 75 IU urofollitropin | 1 vial |
| Solvent syringe | Pre-filled syringe containing 1 ml clear, colourless solution | 1 syringe |
| Reconstitution needle | Longer needle for dissolving powder in vial | 1 needle |
| Injection needle | Fine needle for subcutaneous injection | 1 needle |
Fostimon Set is available in packs of 1, 5, or 10 sets. Not all pack sizes may be marketed in every country.
Fostimon Set is manufactured by IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900 Lodi, Italy. The medication is approved across the European Economic Area and is available under various trade names including Fostimon Set, Fostimon PFS, Fostimon Kit, and Fostipur Kit depending on the country.
Frequently Asked Questions about Fostimon Set
Fostimon Set is a fertility medication containing urofollitropin, a highly purified form of human follicle-stimulating hormone (FSH). It is used for two main purposes: (1) to induce ovulation in women who do not ovulate naturally and who have not responded to treatment with clomifene citrate, and (2) to stimulate the development of multiple follicles in women undergoing assisted reproductive techniques such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). The medication is administered by daily subcutaneous injection under the supervision of a fertility specialist.
Fostimon Set contains urofollitropin, which is a highly purified urinary-derived FSH with minimal LH activity. This distinguishes it from human menopausal gonadotropin (hMG) preparations that contain both FSH and LH, and from recombinant FSH products (such as follitropin alfa and follitropin beta) that are produced using genetic engineering technology. Clinical studies, including Cochrane systematic reviews, have generally shown comparable efficacy between urinary and recombinant FSH preparations for both ovulation induction and IVF, although individual patient response may vary. Your fertility specialist will choose the most appropriate product based on your clinical situation.
OHSS is a potentially serious complication where the ovaries over-respond to FSH stimulation, becoming enlarged and causing fluid to shift into the abdominal and chest cavities. Symptoms range from mild bloating and discomfort to severe pain, breathing difficulties, and blood clots. Prevention strategies include using the lowest effective dose, careful monitoring with ultrasound and blood tests, withholding the hCG trigger injection if too many follicles develop, using GnRH antagonist protocols, and “coasting” (temporarily withholding FSH while monitoring). If OHSS develops, your doctor may recommend bed rest, increased fluid intake, and in severe cases, hospital admission.
Yes, after receiving proper training from your healthcare team, you can self-administer Fostimon Set at home. Your doctor or nurse will show you how to prepare the injection, identify suitable injection sites (usually the thigh or lower abdomen), and demonstrate the correct subcutaneous injection technique. You should only self-inject once you feel confident in the procedure. The pre-filled syringe and separate needles in the kit make the preparation process relatively straightforward. Always use the medication immediately after reconstitution and dispose of needles and syringes safely.
No, Fostimon Set does not require refrigeration. It should be stored at room temperature below 25°C (77°F). Keep the pre-filled solvent syringe in the outer carton to protect from light. This room-temperature storage requirement is convenient for patients who need to travel during their treatment cycle. However, once the powder has been reconstituted with the solvent, the solution must be used immediately and cannot be stored for later use.
Regular monitoring is essential throughout treatment with Fostimon Set. This typically includes transvaginal ultrasound examinations to measure follicle size and number, and blood tests to measure serum oestradiol (estrogen) levels. Monitoring usually begins a few days after starting treatment and continues every 1 to 3 days depending on your response. The results help your doctor adjust the dose, decide when to trigger ovulation with hCG, or determine if the cycle should be cancelled due to over-response or poor response. This close monitoring is the key safety measure for preventing OHSS and high-order multiple pregnancies.
References
All medical information in this article is based on peer-reviewed research, international clinical guidelines, and authoritative pharmaceutical references. The following sources were used:
- European Medicines Agency (EMA). Urofollitropin – Summary of Product Characteristics. EMA; 2024.
- ESHRE (European Society of Human Reproduction and Embryology). Ovarian Stimulation for IVF/ICSI – Guideline of the European Society of Human Reproduction and Embryology. Hum Reprod Open. 2020;2020(2):hoaa009. doi:10.1093/hropen/hoaa009
- van Wely M, Kwan I, Burt AL, et al. Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles. Cochrane Database Syst Rev. 2011;(2):CD005354. doi:10.1002/14651858.CD005354.pub2
- Humaidan P, Quartarolo J, Papanikolaou EG. Preventing ovarian hyperstimulation syndrome: guidance for the clinician. Fertil Steril. 2010;94(2):389-400. doi:10.1016/j.fertnstert.2010.03.028
- NICE (National Institute for Health and Care Excellence). Fertility Problems: Assessment and Treatment – Clinical Guideline [CG156]. NICE; 2017 (updated 2024).
- World Health Organization (WHO). WHO Laboratory Manual for the Examination and Processing of Human Semen, 6th edition. Geneva: WHO; 2021.
- Practice Committee of the American Society for Reproductive Medicine. Prevention and treatment of moderate and severe ovarian hyperstimulation syndrome: a guideline. Fertil Steril. 2016;106(7):1634-1647. doi:10.1016/j.fertnstert.2016.08.048
- IBSA Farmaceutici Italia S.r.l. Fostimon Set – Prescribing Information and Patient Information Leaflet. IBSA; 2024.
- British National Formulary (BNF). Urofollitropin. NICE/BNF; 2025.
- Drugs.com. Urofollitropin – Drug Information. Updated 2025.
Editorial Team
This article was written and medically reviewed by the iMedic Medical Editorial Team, comprising licensed physicians specialising in reproductive endocrinology, gynaecology, and clinical pharmacology.
iMedic Medical Editorial Team
Specialists in Reproductive Endocrinology
iMedic Medical Review Board
Independent medical expert panel
Level 1A Evidence
GRADE Framework Applied
WHO, EMA, ESHRE, NICE
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