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Gonal-F

Gonal-F300

Injection

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Medicine overview

Indications of Gonal-F 300

Women: Follitropin alfa is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin alfa is also indicated ... Read moreWomen: Follitropin alfa is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin alfa is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.Men: Follitropin alfa for injection is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Theropeutic Class

Drugs for Infertility

Pharmacology

Follitropin alfa is a human FSH preparation of recombinant DNA origin.

Absorption

It stimulates ovarian follicular growth in women who do not have primary ovarian failure and stimulates spermatogenesis in men with hypogonadotrophic hypogonadism.

Dosage & Administration of Gonal-F 300

Female infertility
Dosage:Dose should be individualised
Recommended initial
Dosage:75 IU/day; may increase by up to 37.5 IU after 14 days; further increases of the same magnitude may be made every 7 days, if needed
Max
Dosage:300 IU/day
Notes:If response is appropriate, administer hCG 1 day after the last dose
Assisted reproductive technologies Initial
Dosage:150-225 IU/day for at least 4 days, to be started on day 2 or 3 of cycle, until follicular development is adequate
Notes:Adjust dose based on ovarian response
Usual max
Dosage:450 IU/day
Notes:Once follicular development is adequate, administer hCG to induce final follicular maturation. Withhold hCG if ovaries are abnormally enlarged. Spermatogenesis induction 150 IU 3 times/week with continued chorionic gonadotrophin for at least 4 mth
Max
Dosage:300 IU 3 times/week

Dosage of Gonal-F 300

Female infertility
Dosage:Dose should be individualised
Recommended initial
Dosage:75 IU/day; may increase by up to 37.5 IU after 14 days; further increases of the same magnitude may be made every 7 days, if needed
Max
Dosage:300 IU/day
Notes:If response is appropriate, administer hCG 1 day after the last dose
Assisted reproductive technologies Initial
Dosage:150-225 IU/day for at least 4 days, to be started on day 2 or 3 of cycle, until follicular development is adequate
Notes:Adjust dose based on ovarian response
Usual max
Dosage:450 IU/day
Notes:Once follicular development is adequate, administer hCG to induce final follicular maturation. Withhold hCG if ovaries are abnormally enlarged. Spermatogenesis induction 150 IU 3 times/week with continued chorionic gonadotrophin for at least 4 mth
Max
Dosage:300 IU 3 times/week

Interaction of Gonal-F 300

Other ovulation stimulating agents (eg hCG, clomiphene citrate) may potentiate the follicular response, concurrent use of GnRH agonist-induced pituitary desensitisation may increase the dosage of Gonal-f needed to elicit an adequate ovarian response.

Contraindications

Hypersensitivity. Abnormal genital bleeding of undetermined origin, sex hormone sensitive malignancies of the reproductive tract and accessory organs, an organic intracranial lesion e.g. pituitary tumor, ovarian cysts or enlargement of undetermined origin, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, pregnancy, lactation.

Side Effects of Gonal-F 300

Ovarian cysts, mild to severe Inj site reactions, headache, mild to moderate ovarian hyperstimulation syndrome (OHSS), abdominal pain, GI disturbances. Rarely, severe OHSS, ovarian torsion, thromboembolism, mild systemic allergic reactions.

Pregnancy & Lactation

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.

Precautions & Warnings

May result in multiple births. Ovarian hyperstimulation syndrome, serious pulmonary conditions and thromboembolic events may occur. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, pituitary and hypothalamic tumors before starting therapy.

Storage Conditions

Store at 2-25° C.

Drug Classes

Drugs for Infertility

Mode Of Action

Follitropin alfa is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure and stimulates spermatogenesis in men with hypogonadotrophic hypogonadism.

Pregnancy

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.

Frequently Asked Questions

What is Gonal-F 300 used for?

Women: Follitropin alfa is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin alfa is also indicated ... Read moreWomen: Follitropin alfa is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infert…

What is the dosage of Gonal-F 300?

Female infertility: Dose should be individualised. Recommended initial: 75 IU/day; may increase by up to 37.5 IU after 14 days; further increases of the same magnitude may be made every 7 days, if needed. Max: 300 IU/day. If response is appropriate, administer hCG 1 day after the last dose. Assisted reproductive technologies Initial: 150-225 IU/day for at least 4 days, to be started on day 2 or 3 …

What are the side effects of Gonal-F 300?

Ovarian cysts, mild to severe Inj site reactions, headache, mild to moderate ovarian hyperstimulation syndrome (OHSS), abdominal pain, GI disturbances. Rarely, severe OHSS, ovarian torsion, thromboembolism, mild systemic allergic reactions.

Who should not take Gonal-F 300?

Hypersensitivity. Abnormal genital bleeding of undetermined origin, sex hormone sensitive malignancies of the reproductive tract and accessory organs, an organic intracranial lesion e.g. pituitary tumor, ovarian cysts or enlargement of undetermined origin, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, pregnancy, lactation.

What precautions should be taken with Gonal-F 300?

May result in multiple births. Ovarian hyperstimulation syndrome, serious pulmonary conditions and thromboembolic events may occur. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, pituitary and hypothalamic tumors before starting therapy.

Is Gonal-F 300 safe during pregnancy and breastfeeding?

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.

Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.

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