Follitropin delta


Thông tin thuốc gốc
Chỉ định và Liều dùng
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.
Chống chỉ định
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.
Thận trọng
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.
Tác dụng không mong muốn
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).
Chỉ số theo dõi
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.
Tác dụng
Description:
Mechanism of Action: 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).
Bảo quản
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.
Phân loại MIMS
Hormon dinh dưỡng & các thuốc tổng hợp có liên quan
Phân loại ATC
G03GA10 - follitropin delta ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Tài liệu tham khảo
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.

Thông báo miễn trừ trách nhiệm: Thông tin này được MIMS biên soạn một cách độc lập dựa trên thông tin của Follitropin delta 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. © 2024 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