Follitropin alfa


Generic Medicine Info
Indications and Dosage
Subcutaneous
Anovulatory infertility
Adult: For cases in women (including polycystic ovarian syndrome [PCOS]) who are unresponsive to clomifene citrate: Start treatment within the 1st 7 days of the menstrual cycle in menstruating women. Initially, 75-150 IU daily, increased by 37.5 IU or 75 IU at 7 or 14 days intervals if needed to achieve adequate (not excessive) response. Max: 225 IU or 300 IU daily (depending on the product being used). If the patient fails to respond adequately after 4 weeks, abandon that cycle and patient must undergo further evaluation after which she may restart treatment with an initial dose higher than in the abandoned dose. If optimal response is obtained, hCG must be given 24-48 hours after the last follitropin alfa dose. If an excessive response is attained, discontinue treatment and withhold hCG administration; restart therapy in the next cycle at a dose lower than the previous cycle. Doses should be individualised according to patient response (based on follicle size measurement by ultrasound and/or estrogen secretion). Use the lowest effective dose to obtain optimal response. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Subcutaneous
Multifollicular development during assisted reproductive technology
Adult: Beginning on days 2 or 3 of the cycle, administer 150-225 IU daily until sufficient follicular development is achieved (based on ultrasound and measurement of serum estrogen or estradiol levels); adjust dose according to response. Max: 450 IU daily. Generally, adequate follicular development is attained within 10 days. Thereafter, hCG may be given to induce final follicular maturation. Pituitary downregulation with gonadotropin-releasing hormone (GnRH) agonist or antagonist may be used in other protocols; in this case, start follitropin alfa approx 2 weeks after initiating the GnRH agonist, then both are continued until follicular development is adequate. In women with suppressed endogenous gonadotropin levels: Initially, 225 IU daily, adjusted after 5 days based on ovarian response; subsequently adjust dose every 3-5 days by ≤75-150 IU additionally at each adjustment. Max: 450 IU daily. Continue therapy until adequate follicular development is evident, then administer hCG to induce final follicular maturation in preparation for oocyte retrieval. Doses should be individualised according to patient response. Use the lowest effective dose to obtain optimal response. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Subcutaneous
Spermatogenesis induction
Adult: In men who have congenital or acquired hypogonadotropic hypogonadism; or with primary or secondary hypogonadotropic hypogonadism in whom the infertility is not caused by primary testicular failure: Before starting concomitant therapy with hCG, pretreatment with hCG alone is needed to normalise serum testosterone levels (may take 3-6 months). Thereafter, initiate follitropin alfa at 150 IU 3 times weekly in combination with hCG for at least 4 months. If azoospermia persists, dose of up to Max of 300 IU 3 times weekly may be necessary. Treatment may be continued for up to 18 months. Doses should be individualised according to patient response. Use the lowest effective dose to induce spermatogenesis. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Reconstitution
Powder for solution for inj: Dissolve the contents of the vial with the provided diluent. Use immediately following reconstitution. Instruction for reconstitution may vary among individual products and between countries (refer to product-specific guidelines).
Contraindications
High levels of FSH that indicates primary gonadal failure, uncontrolled thyroid, pituitary, or adrenal dysfunction; pituitary or hypothalamus tumours, sex hormone-dependent tumours of the reproductive tract and accessory organs; gynaecological haemorrhages of unknown aetiology; ovarian cysts or enlargement not due to PCOS; primary ovarian failure, fibroid uterine tumours or sexual organ malformations that are incompatible with pregnancy; primary testicular insufficiency. Pregnancy and lactation.
Special Precautions
Patient with or family history of porphyria; risk factors for OHSS such as PCOS and large number of developing ovarian follicles; history of tubal disease; risk factors for thromboembolic events (e.g. personal or family history, thrombophilia, gonadotropin treatments, severe obesity).
Adverse Reactions
Significant: Serious hypersensitivity reactions (e.g. anaphylaxis); ovarian hyperstimulation syndrome (OHSS), abnormal ovarian enlargement, ovarian torsion; multiple pregnancy, ectopic pregnancy, pregnancy loss (by miscarriage), congenital malformations; ovarian and other reproductive organ neoplasms (benign and malignant), serious pulmonary effects (e.g. acute respiratory distress syndrome, atelectasis, asthma exacerbation); thromboembolic events.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, flatulence, abdominal pain, discomfort or distension.
General disorders and administration site conditions: Inj site reactions (e.g. swelling, irritation, erythema, pain, haematoma); fatigue (in men).
Investigations: Weight gain (in men).
Nervous system disorders: Headache.
Reproductive system and breast disorders: Ovarian cysts, pelvic pain, intermenstrual bleeding (in women); gynaecomastia, varicocele, decreased libido (in men).
Skin and subcutaneous tissue disorders: Acne, seborrhoea (in men).
Monitoring Parameters
In women: Prior to starting treatment: Confirm pregnancy status and fertility status of the male partner; perform a thorough gynaecologic and endocrinologic examination; evaluate patient for hypothyroidism, hyperprolactinaemia and adrenocortical deficiency then provide appropriate treatment. Monitor follicular growth by transvaginal ultrasound and measurement of serum estrogen or estradiol levels to determine adequate ovarian response and hCG timing. Confirm ovulation by determining direct and indirect indices of progesterone production (e.g. increase in serum or urine LH, basal body temperature and serum progesterone; menstruation after basal body temperature shift) and by sonographic evidence (e.g. fluid in cul-de-sac, collapsed follicle, features consistent with corpus luteum formation, secretory endometrium). Assess for signs and symptoms of OHSS at least 2 weeks after hCG administration. In men: Before therapy initiation: Verify the presence of azoospermia and hypogonadotropic hypogonadism, and evaluate the fertility status of the female partner; perform complete medical and endocrinologic evaluation to exclude primary testicular failure and other treatable azoospermia aetiologies. Monitor serum testosterone levels and sperm count; semen analysis 4-6 months following the start of therapy.
Drug Interactions
May enhance the follicular response when used with other agents that stimulate ovulation (e.g. clomifene citrate, hCG). Concurrent use of GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitopin alfa needed to produce an adequate ovarian response.
Action
Description: Follitropin alfa is a human FSH prepared by recombinant DNA technology. It stimulates the growth and development of ovarian follicles in women who do not have primary ovarian failure and induces spermatogenesis in men with hypogonadotropic hypogonadism.
Onset: Peak effect: Follicle development: Within the cycle. Spermatogenesis: 6.8-12.4 months (range: 2.7-18.1 months).
Pharmacokinetics:
Absorption: Slowly absorbed following SC inj. Bioavailability: Approx 66-76%. Time to peak plasma concentration: SC: 8-16 hours (female); 11-20 hours (male).
Excretion: Elimination half-life: SC: 24-53 hours (female); 32-41 hours (male).
Storage
Unopened vial: Store between 2-25°C. Protect from light. Prefilled pen: Store between 2-8°C. Do not freeze. Prior to opening and within product shelf-life, may be removed from refrigeration and stored below 25°C for up to 3 months. Protect from light. Once opened, store below 25°C for up to 28 days. Storage recommendations may vary among individual products and between countries (refer to product-specific guidelines).
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
References
Anon. Follitropin Alfa. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/08/2021.

Buckingham R (ed). Follicle-stimulating Hormone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/08/2021.

Gedeon Richter Australia Pty Ltd. Bemfola Solution for Injection data sheet 21 April 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 17/09/2021.

Gonal-F (EMD Serono, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/08/2021.

Gonal-F 450 IU/0.75 mL Powder and Solvent for Solution for Injection (Merck Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/08/2021.

Gonal-F 75 IU (5.5 mcg) Powder and Solvent for Solution for Injection (Merck Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/08/2021.

Gonal-F Powder and Solvent for Solution for Injection; Solution for Injection in Pre-filled Pen (Merck Europe B.V.). European Medicines Agency [online]. Accessed 09/08/2021.

Gonal-F RFF (EMD Serono, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/08/2021.

Gonal-F Solution for Injection in Pre-Filled Pen (Merck Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/08/2021.

Healthcare Logistics. Gonal-F Solution for Injection data sheet 9 March 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 17/09/2021.

Joint Formulary Committee. Follitropin Alfa. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/08/2021.

Disclaimer: This information is independently developed by MIMS based on Follitropin alfa 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
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