Follitropin beta: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

Parenteral
Ovulation induction

Adult: IM or SC admin: Initiate with 75 IU daily for up to 14 days, may increase by 37.5 IU at wkly intervals. Once follicular growth or serum estradiol levels indicates an adequate response, administer a single dose of hCG (5,000-10,000 IU) after the last dose to induce ovulation. Withhold hCG if the ovaries are abnormally enlarged or if abdominal pain occurs. Max: 300 IU/day.

Parenteral
Assisted reproductive technologies

Adult: IM or SC admin: 150-225 IU /day for at least 1st 4 days of treatment. Adjust dose based on individual ovarian response. Usual maintenance dose: 75-300 IU for 6-12 days; 375-600 IU for poor responders. Max (clinical studies): 600 IU/day. Upon adequate follicular development, a single dose of hCG (5,000-10,000 IU) is administered for final oocyte maturation. Oocyte retrieval can be done 34-36 hr later. Withhold hCG if ovaries are abnormally enlarged on the last day of follicular treatment.

Contraindications

Abnormal genital bleeding of undetermined origin, hormone sensitive malignancies; ovary, breast, uterus, hypothalamus, testes or pituitary gland tumor; ovarian cysts or enlargement not due to the polycystic ovary syndrome; high levels of FSH indicating primary gonadal failure (ovarian or testicular); uncontrolled thyroid or adrenal dysfunction; presence of any cause of infertility other than anovulation; hypersensitivity; pregnancy, lactation.

Special Precautions

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

Adverse Reactions

Ovarian cysts, mild to severe inj site reactions, headache, mild to moderate OHSS, abdominal pain, GI disturbances. Rarely, severe OHSS, ovarian torsion, thromboembolism, mild systemic allergic reactions.

Pregnancy Category (US FDA)

Parenteral/SC: X

Overdosage

May lead to OHSS and multiple gestations.

Action

Description: Follitropin beta is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure.
Pharmacokinetics:
Absorption: 76% (IM); 78% (SC).
Excretion: Elimination haIf-life: 44 hr (IM; single dose), 27-30 hr (IM; multiple doses); 33 hr (SC; single dose).

Storage

Store at 2-8°C.

MIMS Class

Trophic Hormones & Related Synthetic Drugs

Disclaimer: This information is independently developed by MIMS based on Follitropin beta from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com