| TAH Drug Code | IELO |
|---|---|
| Indications | Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. |
| Dosing | In the treatment of women of reproductive age, the dose of Elonva is based on weight and age. A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger. A single 150-microgram dose is recommended in women: who weigh more than 60 kilograms, regardless of age; who weigh 50 kilograms or more and who are older than 36 years of age. Women older than 36 years of age who weighed less than 50 kilograms were not studied. The recommended doses of Elonva have only been established in a treatment cycle with a GnRH antagonist that was administered from stimulation day 5 or day 6 onwards. Stimulation day 1: Elonva should be administered as a single subcutaneous injection, preferably in the abdominal wall, during the early follicular phase of the menstrual cycle. Stimulation day 5 or 6: Treatment with a Gonadotropin Releasing Hormone (GnRH) antagonist should be started on stimulation day 5 or day 6 depending on the ovarian response, i.e. the number and size of growing follicles. The concurrent determination of serum estradiol levels may also be useful. The GnRH antagonist is used to prevent premature Luteinizing Hormone (LH) surges. Stimulation day 8: Seven days after the injection with Elonva on stimulation day 1, COS treatment may be continued with daily injections of (recombinant) Follicle Stimulating Hormone ((rec)FSH) until the criterion for triggering final oocyte maturation (3 follicles > or = 17 mm) has been reached. The daily dose of (rec)FSH may depend on the ovarian response, which should be monitored by regular ultrasonographic assessments from stimulation day 5 or 6 onwards. In normal responders a daily dose of 150 IU (rec)FSH is advised. Administration of (rec)FSH on the day of human Chorionic Gonadotropin (hCG) administration can be omitted, depending on the ovarian response. In general, adequate follicular development is achieved on average by the ninth day of treatment (range 6 to 18 days). As soon as three follicles > or = 17 mm are observed, a single injection of 5,000 up to 10,000 IU urinary hCG is administered the same day or the day thereafter to induce final oocyte maturation. In case of an excessive ovarian response, see the recommendations given in Precautions in order to reduce the risk for developing ovarian hyperstimulation syndrome (OHSS). |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Hypersensitivity to the active substance or to any of the excipients. Tumors of the ovary, breast, uterus, pituitary or hypothalamus. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. Primary ovarian failure. Ovarian cysts or enlarged ovaries. Fibroid Tumors of the uterus incompatible with pregnancy. Malformations of the reproductive organs incompatible with pregnancy. Pregnancy (see Use in Pregnancy & Lactation). Risk factors of OHSS: A history of Ovarian Hyperstimulation Syndrome (OHSS); A previous COS cycle that resulted in more than 30 follicles > or = 11 mm measured by ultrasound examination; A basal antral follicle count > 20; Polycystic ovarian syndrome (PCOS). |
| Adverse Effects | Common Gastrointestinal: Nausea (2.3% ) Musculoskeletal: Discomfort, In pelvis (6% ), Pain in pelvis (2.9% ) Neurologic: Headache (4% ) Reproductive: Breast tenderness (1.3% ) Other: Fatigue (1.5% ) Serious Reproductive: Ovarian hyperstimulation syndrome (4.3% ), Torsion of ovary (0.1% to less than 1% ) |
| Pregnancy | Unknown |
| Lactation | Unknown |
| More Info | UpToDate |