Follitropin beta


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IM/SC Ovulation induction Initial: 75 IU/day for up to 14 days, may increase by 37.5 IU/wk. Max: 300 IU/day. If follicular growth or serum estradiol levels indicates an adequate response, administer hCG after the last dose. Withhold hCG if the ovaries are abnormally enlarged or if abdominal pain occurs. Max: 300 IU/day. Assisted reproductive technologies 150-225 IU/day for at least 1st 4 days, adjust dose based on ovarian response. Maintenance: 75-300 IU/day for 6-12 days. Max: 600 IU/day. If response is adequate, administer hCG after the last dose. Withhold hCG if ovaries are abnormally enlarged on the last day of follicular treatment.
Dosage Details
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.
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.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Puregon
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in