Follitropin delta


Generic Medicine Info
Indications and Dosage
Subcutaneous
Ovarian stimulation regimens for assisted reproduction in infertility
Adult: For the development of multiple follicles in women undergoing assisted reproductive technologies such as in vitro fertilisation or intracytoplasmic sperm inj cycle: 1st treatment cycle: Doses are based on the serum anti-Mullerian hormone (AMH) concentration (within the last 12 months) and body weight; doses must be maintained throughout the stimulation period: AMH <15 pmol/L: 12 mcg daily, irrespective of body weight; AMH ≥15 pmol/L: Daily dose decreases from 0.19 to 0.10 mcg/kg by increasing AMH concentration; refer to specific product guidelines. Max: 12 mcg daily. Initiate treatment on day 2 or 3 after the start of menstrual bleeding, continued until adequate follicular development which is usually obtained by the 9th day of treatment (range: 5-20 days); thereafter, hCG should be given to induce final follicular maturation. For patients with excessive ovarian response, stop treatment and induction of final follicular maturation with hCG. Subsequent treatment cycles: Daily doses are based on patient's ovarian response to the previous cycle: Adequate response: Maintain daily dose; Hypo-response: Increase daily dose by 25% or 50%; Hyper-response: Decrease daily dose by 20% or 33%. Doses are adjusted based on the observed extent of response. Max: 24 mcg daily.
Contraindications
Tumour of the hypothalamus, pituitary gland, ovary, breast, or uterus; ovarian enlargement or cysts not related to polycystic ovarian syndrome, gynaecological haemorrhages of unknown aetiology; malformations of sexual organs or fibroid tumours of uterus incompatible with pregnancy; primary ovarian failure. Pregnancy and lactation.
Special Precautions
Patient with polycystic ovarian syndrome; history of or current thromboembolic disease, risk factors for thromboembolic events (e.g. personal or family history, severe obesity [BMI >30 kg/m2], thrombophilia); history of tubal disease.
Adverse Reactions
Significant: Ovarian enlargement, torsion, or neoplasms (benign and malignant); pregnancy loss (by miscarriage or abortion); multiple pregnancy; ectopic pregnancy (patient with tubal abnormalities); thromboembolic events; serious pulmonary conditions (e.g. atelectasis, acute respiratory distress syndrome, exacerbation of asthma).
Gastrointestinal disorders: Nausea, abdominal discomfort, constipation, diarrhoea, vomiting.
General disorders and administration site conditions: Fatigue.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Mood swings.
Reproductive system and breast disorders: Pelvic pain or discomfort, adnexa uteri pain, breast pain or tenderness.
Potentially Fatal: Ovarian hyperstimulation syndrome (OHSS).
Monitoring Parameters
Evaluate pregnancy status, couple's infertility; perform endocrinologic and gynaecologic assessment (including pelvic anatomy); obtain serum AMH; rule out primary ovarian failure before starting therapy. Assess for hypothyroidism and hyperprolactinemia. Monitor for sufficient follicular maturation by sonographic visualisation of the ovaries and endometrial lining or measuring serum estradiol levels. Monitor for signs and symptoms of ovarian hyperstimulation syndrome (OHSS) for at least 2 weeks after administration of hCG.
Action
Description: Follitropin delta, a human FSH preparation of recombinant DNA origin, stimulates the growth of ovarian follicles in women who do not have primary ovarian failure.
Pharmacokinetics:
Absorption: Bioavailability: Approx 64% (SC). Time to peak plasma concentration: SC: 20 hours (single dose); 10 hours (once daily for 7 days).
Distribution: Volume of distribution: 25 L (SC).
Excretion: Elimination half-life: SC: 40 hours (single dose); 28 hours (multiple dose).
Storage
Store between 2-8°C. Do not freeze. Protect from light. May remove from refrigerator and store at or below 25°C for up to 3 months. Do not re-refrigerate. Opened/in-use: Store at or below 25°C for up to 28 days. Storage recommendations may vary among countries. Refer to specific product guidelines.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA10 - follitropin delta ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
References
Anon. Follitropin Delta. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/09/2021.

Buckingham R (ed). Follicle-stimulating Hormone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/09/2021.

Joint Formulary Committe. Follitropin Delta. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/09/2021.

Pharmaco (NZ) Ltd. Rekovelle Solution for Injection in Pre-Filled Pen data sheet Jul 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 01/09/2021.

Rekovelle Solution for Injection in a Pre-Filled Pen (Ferring Pharmaceuticals A/S). European Medicines Agency [online]. Accessed 01/09/2021.

Rekovelle Solution for Injection in a Pre-Filled Pen (Ferring Pharmaceuticals Co., Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 01/09/2021.

Rekovelle Solution for Injection in Pre-Filled Pen (Vetter Pharma-Fertigung GmbH & Co. Kg). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/09/2021.

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