R fsh 75 IU Injection

✔️ Uses of rFSH Injection

In Women

• Ovulation induction: Helps stimulate the growth and development of ovarian follicles in women who have difficulty ovulating, including those who have undergone pituitary suppression. Human chorionic gonadotropin (hCG) may be administered afterward to trigger ovulation.
• Assisted reproductive technology (ART): Used during fertility treatments such as IVF to stimulate the development of multiple ovarian follicles and support the production of several mature eggs.
• PCOS-related infertility: May be prescribed to induce ovulation in women with polycystic ovary syndrome (PCOS) who experience infertility due to ovulatory problems.

In Men

• Induction of spermatogenesis: Used in combination with hCG to stimulate sperm production in men with hypogonadotropic hypogonadism, a condition involving inadequate stimulation of the testes by reproductive hormones.

✔️ Dosage & Administration

The dose of rFSH varies considerably between patients. Treatment must be individualized according to the patient's age, medical condition, ovarian or testicular response, and fertility treatment plan.

• rFSH is administered by subcutaneous injection.
• The injection should be given slowly to reduce discomfort and leakage.
• Injection sites should be rotated to help prevent tissue changes, including lipoatrophy.
• Any unused reconstituted solution should be discarded according to the product instructions.
• Self-administration may be possible after proper training and only when approved by the treating physician.
• The first injection should generally be administered under medical supervision.

✔️ Side Effects

rFSH may cause side effects, particularly because it stimulates the reproductive organs. Possible adverse effects include:

• Pelvic or abdominal pain.
• Bloating.
• Nausea or vomiting.
• Breast tenderness.
• Headache.
• Injection-site pain or irritation.
• Ovarian enlargement.
• Multiple pregnancy, including twins or higher-order pregnancies.

✔️ Dosage in Women

Ovulation Induction

A commonly used starting dose is 75 IU daily, administered subcutaneously for at least the first seven days. The dose may be adjusted in increments of 25 or 75 IU at weekly intervals, depending on follicular growth and serum estradiol levels.

Once adequate follicular development has been achieved, hCG may be administered to induce final egg maturation and ovulation. The usual hCG dose may range from 5,000 to 10,000 IU, depending on the treatment plan.

Sexual intercourse may be advised around the expected time of ovulation. The exact timing should be determined by the fertility specialist.

Assisted Reproductive Technology (ART)

For controlled ovarian stimulation during IVF or other ART procedures, treatment may begin with approximately 150–300 IU daily for at least the first four days. Subsequent doses are adjusted according to ovarian response, ultrasound findings, and estradiol levels.

Once the follicles have reached the appropriate stage of development, hCG or another suitable medication may be used to trigger final oocyte maturation. Egg retrieval is generally performed approximately 34–36 hours after the trigger injection.

PCOS-Related Infertility

Women with PCOS may be started on a low dose, commonly around 75 IU daily, to encourage gradual follicular development. Treatment may continue for several days before the response is assessed through ultrasound and hormone testing.

If the ovaries do not respond adequately, the dose may be increased cautiously under specialist supervision. Dosage adjustments must be made carefully to reduce the risk of excessive ovarian stimulation and multiple pregnancy.

✔️ Contraindications

rFSH should not be used in patients with certain conditions, including:

• Tumors of the ovaries, breasts, uterus, pituitary gland, or hypothalamus when contraindicated by the treating specialist.
• Pregnancy.
• Breastfeeding, unless specifically assessed and advised by a specialist.
• Unexplained vaginal bleeding.
• Known hypersensitivity to FSH or any component of the formulation.
• Primary ovarian failure.
• Uterine fibroids that are incompatible with pregnancy.
• Primary testicular failure in men.

Underlying endocrine disorders, such as uncontrolled thyroid, adrenal, or pituitary conditions, should be evaluated before treatment begins.

✔️ For a 75 IU vial of lyophilized rFSH:

1. Use the prescribed sterile water for injection according to the product instructions.
2. Add the required volume of diluent to the vial using an aseptic technique.
3. Gently swirl the vial until the powder has completely dissolved. Do not shake vigorously.
4. Inspect the solution before use. It should be clear and free from visible particles or unusual discoloration.
5. Do not use the solution if it appears cloudy, discolored, or contains particles.
6. Prepare and administer the injection only as instructed by a qualified healthcare professional.
7. Any unused solution should be discarded according to the product's instructions.

Combining contents from multiple vials should only be performed when specifically prescribed and instructed by a healthcare professional. The manufacturer's approved reconstitution procedure must be followed.

✔️ Pregnancy and Lactation

Pregnancy: Recombinant FSH must not be used during pregnancy. It is intended to support conception and has no therapeutic role after pregnancy has been established.

Breastfeeding: The safety of rFSH during lactation has not been established. Consult a healthcare professional before using this medicine while breastfeeding.

✔️ Ovarian Hyperstimulation Syndrome (OHSS)

In some women, the ovaries may respond excessively to rFSH. This can lead to ovarian hyperstimulation syndrome, which may cause:

• Severe pelvic or abdominal pain.
• Significant bloating.
• Rapid weight gain.
• Reduced urine output.
• Nausea or vomiting.
• Difficulty breathing.
• Fluid accumulation in the abdomen or lungs.
• Increased risk of blood clots.

✔️ Administration Instructions

In women who do not have primary ovarian failure, rFSH treatment commonly stimulates ovarian follicular growth over approximately 7–12 days, although the duration varies between patients.

The medicine generally promotes follicular development and maturation. Once sufficient follicular growth has been achieved, hCG or another appropriate trigger medication may be administered to induce final egg maturation and ovulation.

Regular ultrasound examinations and hormone testing are essential during treatment to monitor the response and reduce the risk of ovarian hyperstimulation.

✔️ Dosage in Men

For men with hypogonadotropic hypogonadism, hCG treatment is generally given first to stimulate testosterone production and normalize testosterone levels.

Once an adequate testosterone response has been achieved, rFSH may be added to stimulate sperm production. A specialist may prescribe approximately 150–300 IU per week, divided into multiple subcutaneous injections, alongside the appropriate hCG regimen.

Treatment may require several months, and semen analysis is commonly performed approximately four to six months after treatment begins to assess the response.

Dosages must be determined and adjusted by a qualified fertility specialist.

✔️ Precautions and Warnings

• Treatment should be initiated and monitored by a fertility specialist.
• The first injection should preferably be administered under direct medical supervision.
• Ovarian response must be monitored through ultrasound and, when appropriate, serum estradiol testing.
• Excessive ovarian stimulation may result in OHSS, which can cause serious complications.
• hCG should be withheld if unwanted ovarian hyperstimulation develops, as it may worsen OHSS.
• Gonadotropin treatment increases the risk of multiple pregnancy.
• Women undergoing ART may have a higher risk of ectopic pregnancy, particularly when tubal abnormalities are present. Early ultrasound assessment is important to confirm the location of pregnancy.
• Pregnancy loss may occur more frequently in women undergoing assisted reproductive procedures than in the general population.
• Although allergic reactions are uncommon, severe hypersensitivity, including anaphylaxis, is possible.
• Underlying thyroid, adrenal, and pituitary disorders should be assessed and appropriately controlled before treatment.
• Men receiving rFSH should undergo periodic semen analysis to evaluate sperm production.
• Patients should report severe abdominal pain, breathing difficulties, sudden weight gain, or reduced urine output immediately.

✔️ Storage:

• Store in a refrigerator at 2°C–8°C, according to the product label.
• Do not freeze.
• Keep away from direct light.
• Keep out of the reach and sight of children.
• Follow the manufacturer's instructions regarding storage after reconstitution.
• Do not use the medicine after its expiry date or if the solution is damaged or unsuitable for injection.