Alfagon 150IU Pre-Filled Syringe

✔️ Pregnancy & Lactation

Pregnancy Category X: Contraindicated in pregnancy and lactation due to potential harm to the fetus and unknown excretion in breast milk.

✔️ Contraindications

• Hypersensitivity to rFSH or excipients
• Ovarian, uterine, breast, pituitary, or hypothalamic tumors
• Undiagnosed vaginal bleeding
• Primary ovarian/testicular failure
• Pregnancy or breastfeeding
• Uterine fibroids are incompatible with pregnancy

✔️ Dosage:

For Females:

Ovulation Induction:

Start with 75 IU daily for at least 7 days.

Adjust dose in 25–75 IU increments weekly based on ultrasound and serum estradiol.

Once an adequate response is achieved, administer 5,000–10,000 IU HCG to trigger ovulation.

Recommend timed intercourse beginning one day before HCG injection.

Assisted Reproductive Technology (ART):

Initial dose: 150–300 IU/day for the first 4 days.

Adjust based on ovarian response via ultrasound and estradiol.

Final oocyte maturation induced with HCG (5,000–10,000 IU).

Perform egg retrieval 34–36 hours later.

PCOS:

Begin with 75 IU/day SC for 4–6 days.

Monitor serum estrogen and adjust cautiously in 25–75 IU steps (max 300 IU/day).

Most women respond to 75–150 IU daily.

For Males:

Spermatogenesis Induction:

Pre-treatment with HCG 2,500 IU twice weekly for 8 weeks.

If testosterone normalizes, add rFSH 300 IU/week, either as:

300 IU twice weekly, or

100 IU three times weekly,

Continue same HCG dose used for normalization.

Reconstitution Instructions

Reconstitute 75 IU vial with 1 mL sterile water for injection. Swirl gently—do not shake.

For higher doses, reconstitute up to 3 vials using 1 mL of diluent by transferring the contents sequentially into the next vial.

Ensure the solution is clear and particle-free before administration.

✔️ Adverse Effects

Common (Female):

• Abdominal/pelvic pain
• Nausea, bloating, vomiting
• OHSS symptoms: weight gain, breathing difficulty, reduced urination
• Risk of multiple pregnancies (twins or more)

Common (Male):

• Local injection site reactions
• Rare: respiratory issues, clotting disorders

✔️ Warnings & Precautions

• Confirm absence of uncontrolled endocrine disorders (thyroid, adrenal, pituitary).
• Close monitoring is essential to avoid Ovarian Hyperstimulation Syndrome (OHSS).
• Early pregnancy confirmation is necessary due to the higher risk of ectopic pregnancy and miscarriage in ART.
• Risk of multiple births is increased.
• First dose should be administered under medical supervision.
• In men, semen analysis is recommended after 4–6 months to assess efficacy.

✔️ Storage:

• Store between 2°C and 8°C.
• Do not freeze.
• Protect from light and keep out of children’s reach.