Follitropin beta


Thông tin thuốc gốc
Chỉ định và Liều dùng
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.
Chống chỉ định
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.
Thận trọng
Hypersensitivity to neomycin and/or streptomycin. Lactation.
Tác dụng không mong muốn
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).
Chỉ số theo dõi
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.
Tương tác
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.
Tác dụng
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.
Bảo quản
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.
Phân loại MIMS
Hormon dinh dưỡng & các thuốc tổng hợp có liên quan
Phân loại ATC
G03GA06 - follitropin beta ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Tài liệu tham khảo
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.

Thông báo miễn trừ trách nhiệm: Thông tin này được MIMS biên soạn một cách độc lập dựa trên thông tin của Follitropin beta từ nhiều nguồn tài liệu tham khảo và được cung cấp chỉ cho mục đích tham khảo. Việc sử dụng điều trị và thông tin kê toa có thể khác nhau giữa các quốc gia. Vui lòng tham khảo thông tin sản phẩm trong MIMS để biết thông tin kê toa cụ thể đã qua phê duyệt ở quốc gia đó. Mặc dù đã rất nỗ lực để đảm bảo nội dung được chính xác nhưng MIMS sẽ không chịu trách nhiệm hoặc nghĩa vụ pháp lý cho bất kỳ yêu cầu bồi thường hay thiệt hại nào phát sinh do việc sử dụng hoặc sử dụng sai các thông tin ở đây, về nội dung thông tin hoặc về sự thiếu sót thông tin, hoặc về thông tin khác. © 2022 MIMS. Bản quyền thuộc về MIMS. Phát triển bởi MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in