Fostimon 75 IU
Indonesia • Dexa Medica
Indication
- Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.
- Controlled ovarian hyperstimulation to induce the development of multiple follicles in Assisted Reproductive Technologies (ART) such as in vitro fertilisation (IVF), Gamete Intra-fallopian Transfer (GIFT) and Zygotes Intra-fallopian Transfer (ZIFT).
Composition
One vial contains 75 IU of urofollitropin (follicle-stimulating hormone FSH): 1 ml of reconstituted solution contains either 75 IU, 150 IU, 225 IU, 300 IU, 375 IU or 450 IU of urofollitropin when respectively 1, 2, 3, 4, 5 or 6 vials are reconstituted in 1 ml of solvent.
Package
Dosage Forms
Powder for InjectionATC Classification
Warning
Self-injections of FOSTIMON should be performed only by motivated, trained and well informed patients. Prior to self-injections, the patient must be shown how to perform a subcutaneous injection, showing her where the injection can be given and how to prepare the solution to be injected. The first injection of FOSTIMON should be performed under direct medical supervision. Particularly, in patients with known hypersensitivity to gonadotropins anaphylactic reactions might occur. In these patients, the first injection of FOSTIMON should be performed by a physician in settings with facilities for cardio-pulmonary resuscitation.
Before starting the treatment, the couple’s infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, for which appropriate specific treatments are given.
Dosage
Treatment with FOSTIMON should be initiated under the supervision of a physician experienced in the treatment of infertility problems. There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotropins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasonography and may also include monitoring of oestradiol levels.
Anovulation (including PCOS)
The objective of a treatment with FOSTIMON is to develop a single mature de Graaf follicle from which the ovum will be released after the administration of human chorionic gonadotropin (hCG). FOSTIMON can be administered by daily injection. In menstruating patients the treatment should begin within the first 7 days of the menstrual cycle, starts at 75 to 150 IU of FSH per day and is increased if necessary by 37.5 IU (up to 75 IU), with intervals of 7 or 14 days preferably, in order to achieve an adequate but not excessive response.Maximum daily dosages of FSH should generally not exceed 225 IU.
Controlled ovarian hyperstimulation during ART
In a commonly used protocol the administration of FOSTIMON begins approximately two weeks after the start of the agonist treatment, both treatments are then continued until adequate follicular development has been achieved. For example, following two weeks of pituitary downregulation with agonist, 150 to 225 IU of FSH are administered for the first seven days. The dose is then adjusted according to the patient’s ovarian response, usually not higher than 450 IU daily. Adequate follicular development is usually achieved on average around the tenth day of treatment (5 to 20 days). When an optimal response is obtained a single injection of 5,000 IU to 10,000 IU of hCG administered 24 to 48 hours after the last FOSTIMON injection, to induce final follicular maturation. Oocyte retrieval is performed 34-35 hours later.