Follitropin beta


Generic Medicine Info
Indications and Dosage
Parenteral
Ovulation induction
Adult: In anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure: Follistim AQ cartridge Initially, 50 IU daily via SC inj for at least the 1st 7 days of treatment. Increase by 25 or 50 IU at weekly intervals until follicular growth and/or estradiol levels indicate an adequate ovarian response. Puregon Initially, 50 IU daily via SC inj (as cartridge) or IM/SC inj (as vial) for at least the 1st 7 days. Increase gradually until follicular growth and/or plasma estradiol levels indicate an adequate response. Alternatively, 75-150 IU daily via SC or IM inj for 5-7 days; if there is no apparent ovarian response, the daily dose is gradually increased until estrogen levels start to rise. A daily increase of 40-100% is considered to be optimal. The daily effective dose is then maintained until pre-ovulatory conditions are reached. If estrogen levels rise too rapidly (i.e. more than a daily doubling for 2-3 consecutive days), the daily dose should be decreased. Dosage recommendations and routes of administration vary among countries or individual products. Refer to specific product guidelines.

Parenteral
Ovarian stimulation regimens for assisted reproduction in infertility
Adult: As part of an in vitro fertilisation or intracytoplasmic sperm inj cycle and other related procedures: Follistim AQ cartridge Initially, 200 IU daily via SC inj for at least the 1st 7 days of treatment. Subsequent doses may be adjusted based on ovarian response. Dosage reduction may be considered in high responders from the 6th day of treatment onwards according to response. Puregon Initially, 100-225 IU daily via SC inj (as cartridge) or IM/SC inj (as vial) for at least the 1st 4 days of treatment. The dose may be adjusted based on ovarian response. Alternatively, 75-300 IU daily. Dosage recommendations and routes of administration vary among countries or individual products. Refer to specific product guidelines.

Parenteral
Spermatogenesis induction
Adult: In men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure: Pre-treatment with hCG is required prior to concomitant therapy with follitropin beta and hCG. Follitropin beta therapy may be initiated after normal serum testosterone levels have been reached at a dose of 450 IU weekly (administered as 225 IU twice weekly or 150 IU 3 times weekly) via SC inj (as cartridge) or IM/SC inj (as vial) in combination with the same hCG dose used to normalise testosterone levels. Alternatively, 75 IU daily or 2-3 times weekly via SC or IM inj. Dosage recommendations and routes of administration vary among countries or individual products. Refer to specific product guidelines.
Contraindications
Undiagnosed vaginal bleeding, ovarian cyst or enlargement not associated to polycystic ovary syndrome (PCOS), fibroid tumours of the uterus or malformations of the reproductive organs incompatible with pregnancy, high FSH levels (indicating primary gonadal failure), uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders), tumours of the ovary, breast, uterus, testis, hypothalamus or pituitary gland. Pregnancy.
Special Precautions
Hypersensitivity to neomycin and/or streptomycin. Lactation.
Adverse Reactions
Significant: Abnormal ovarian enlargement, serious pulmonary conditions (e.g. acute respiratory distress syndrome, atelectasis), thromboembolic events, ovarian torsion, ovarian and other reproductive system neoplasms, multi-foetal gestation and birth, increased incidence of ectopic pregnancy, increased risk of spontaneous abortion.
Gastrointestinal disorders: Abdominal pain or distension, nausea.
General disorders and administration site conditions: Inj site reaction (e.g. induration, bruising, pain, redness, swelling, itching), fatigue, pain, influenza-like symptoms.
Nervous system disorders: Headache.
Reproductive system and breast disorders: Pelvic pain, vaginal haemorrhage, epididymal cyst, gynaecomastia.
Skin and subcutaneous tissue disorders: Acne, rash.
Potentially Fatal: Rarely, ovarian hyperstimulation syndrome (OHSS).
Parenteral/SC: X
Monitoring Parameters
Perform complete gynaecologic and endocrinologic evaluation, pregnancy evaluation in women, complete medical and endocrinologic evaluation in men; assess the couple's infertility prior to initiation of treatment. Primary ovarian failure (in females) or primary testicular failure (in males) should be excluded. Monitor for signs and symptoms of ovarian hyperstimulation syndrome (OHSS) for at least 2 weeks following hCG administration.
Drug Interactions
Concomitant use with clomifene citrate may enhance the follicular response. Higher dose of follitropin beta may be necessary to elicit an adequate follicular response after pituitary desensitisation induced by a gonadotrophin-releasing hormone (GnRH) agonist.
Action
Description: Follitropin beta is a human FSH preparation of recombinant DNA origin. FSH is required for normal follicular growth, maturation, gonadal steroid production and spermatogenesis. It stimulates ovarian follicular growth in women who do not have primary ovarian failure. It also stimulates spermatogenesis in men with hypogonadotropic hypogonadism.
Pharmacokinetics:
Absorption: Slowly absorbed after IM or SC inj. Absolute bioavailability: Approx 64-80%. Time to peak plasma concentration: Approx 13 hours (SC).
Distribution: Volume of distribution: Approx 8 L.
Excretion: Elimination half-life: 12-70 hours.
Storage
Store between 2-8°C or for a single period below 25°C for ≤3 months. Do not freeze. Protect from light. Storage recommendations may vary among countries or individual products. Refer to specific product guidelines.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA06 - follitropin beta ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
References
Anon. Follitropin Beta. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/08/2021.

Buckingham R (ed). Follicle-stimulating Hormone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/08/2021.

Follistim AQ (Organon USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/08/2021.

Organon New Zealand Limited. Puregon 150 IU, 300 IU, 600 IU, 900 IU Solution for Injection data sheet 1 December 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 31/08/2021.

Puregon 150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL and 900 IU/1.08 mL Solution for Injection (N.V. Organon). European Medicines Agency [online]. Accessed 31/08/2021.

Puregon 150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08 mL Solution for Injection (Merck Sharp & Dohme Malaysia Sdn. Bhd.). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 31/08/2021.

Puregon 50 IU/0.5 mL, 75 IU/0.5 mL, 100 IU/0.5 mL, 150 IU/0.5 mL, 200 IU/0.5 mL and 225 IU/0.5 mL Solution for Injection (N.V. Organon). European Commission. https://ec.europa.eu. Accessed 06/09/2021.

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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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