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Urofollitropin information from DrugsUpdate  

See Available Brands of Urofollitropin in India

P - Contraindicated in pregnancy

Urofollitropin (brand names Bravelle, Fertinex, Follistim, and Gonal-F) is a purified form of follicle-stimulating hormone (FSH). FSH is important in the development of follicles (eggs) produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. It is also used with in vitro fertilization methods. The dosage is adjusted to each individual's response.

Its side effects include breast tenderness, mild diarrhea, nausea, or vomiting, constipation and hot flashes.

Pharmacodynamics

Pharmacokinetics

Urofollitropin, a gonadotrophin obtained from postmenopausal women's urine, possesses follicle-stimulating hormone (FSH) activity but almost no luteinising activity. Admin for 7-12 days results in follicular growth and maturation in females. When sufficient follicular maturation has occurred, human chorionic gonadotrophin should be given to induce ovulation.

Absorption
Peak plasma concentration: 10 hr (after multiple dosing).

Urofollitropin Indications / Urofollitropin Uses

Information Not Available

Urofollitropin Adverse Reactions / Urofollitropin Side Effects

Nausea, vomiting, joint pain, ovarian hyperstimulation syndrome, adnexal torsion, mild to moderate ovarian enlargement, abdominal pain, ovarian cysts, local reaction at inj site, headaches, haemoperitoneum, benign and malignant ovarian neoplasms, ascites, pleural effusion, hypovolaemia, thromboembolic disorders. Weight gain, acne and gynaecomastia in men.

Potentially Fatal: Ovarian cysts rupture, intraperitoneal haemorrhage.

Precautions

Information Not Available

Special Precautions

May result in multiple pregnancies. Abnormal genital bleeding, hormone sensitive malignancies, ovarian cysts not caused by polycystic ovary syndrome. Exclude and treat other causes of infertility e.g. pituitary or hypothalamic lesions, adrenal or thyroid disorders and hyperprolactinaemia.

Other Drug Interactions

Increased risk of ovarian hyperstimulation syndrome with drugs with luteinising hormone activity.

Other Interactions

Information Not Available

Dosage

Injection
Polycystic ovarian syndrome
Adult: Initially, 150 IU daily SC/IM for the first 5 days. Adjust subsequent dosing based on clinical monitoring (e.g. serum oestradiol levels and vaginal ultrasound). Dose adjustments should not be made more frequently than once every 2 days and be ≤75-150 units per adjustment. Max dose: 450 units daily and max course of treatment: 12 days. Stop treatment when adequate response obtained as determined by oestrogen monitoring or ultrasonic visualisation of follicles. A single dose of chorionic gonadotrophin 5000 to 10 000 units is given to induce ovulation after 1-2 days. Urofollitropin treatment may be tried again in future cycles.

Injection
Female infertility
Adult: Initially, 150 IU daily SC/IM for the first 5 days. Adjust subsequent dosing based on clinical monitoring (e.g. serum oestradiol levels and vaginal ultrasound). Dose adjustments should not be made more frequently than once every 2 days and be ≤75-150 units per adjustment. Max dose: 450 units daily and max course of treatment: 12 days. Stop treatment when adequate response obtained as determined by oestrogen monitoring or ultrasonic visualisation of follicles. A single dose of chorionic gonadotrophin 5000 to 10 000 units is given to induce ovulation after 1-2 days. Urofollitropin treatment may be tried again in future cycles.

Injection
In vitro fertilisation
Adult: In conjunction with other agents: 150-225 units of FSH daily SC/IM from day 2 or 3 of menstrual cycle. Alternatively, begin therapy with clomifene citrate and continue with urofollitropin; or urofollitropin may be given after gonadorelin analogue is given to suppress gonadotrophin release. Continue treatment until an adequate response is obtained and admin 5000 to 10 000 units of chorionic gonadotrophin 1-2 days after final injection of urofollitropin. Oocyte retrieval is performed 34-35 hours later.

Injection
Male infertility
Adult: In conjunction with chorionic gonadotrophin, 150 units of FSH SC/IM 3 times a wk, continue for at least 4 months.

Food(before/after)

Information Not Available

List of Contraindications

Urofollitropin and Pregnancy

Contraindicated in pregnancy.


Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Urofollitropin and Lactation

Undetermined

Urofollitropin and Children

Safety and efficacy not established

Urofollitropin and Geriatic

Safety and efficacy not established

Urofollitropin and Other Contraindications

Pregnancy, ovarian cysts or enlargement not due to polycystic ovary syndrome, primary ovarian failure, organic intracranial lesion e.g. pituitary tumour, uncontrolled thyroid and adrenal dysfunction, presence of any cause of infertility other than anovulation, abnormal bleeding of undetermined origin.

Storage

Information Not Available

Lab interference

Information Not Available

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