Product Dossier
GyMiso
Product Dossier for GyMiso (misoprostol, MS Health). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: MS Health
- Active ingredient: misoprostol
- Therapeutic area: Reproductive Health
- Related brand: MS-2 Step
- Related brand: ANGUSTA
- Related brand: CYTOTEC
- Same area: ESTRADOT
- Same area: PROVERA
What it is
GyMiso is misoprostol 200 microgram oral tablets indicated in females of childbearing age for the medical termination of a developing intrauterine pregnancy in sequential combination with a mifepristone 200 mg tablet, up to 49 days of gestation.
Approved indications
— Medical termination of a developing intrauterine pregnancy in females of childbearing age in sequential combination with mifepristone 200 mg, up to 49 days of gestation.
Key safety warnings
GyMiso is contraindicated in pregnancy, or in patients in whom pregnancy has not been excluded. Misoprostol induces uterine contractions and is associated with abortion, premature birth, and foetal death. Miscarriages caused by misoprostol may be incomplete, which could lead to potentially dangerous bleeding, hospitalisation, surgery, infertility or death. Use of misoprostol has been associated with birth defects. The most frequent adverse events are diarrhoea, abdominal pain, and loose stools, occurring in approximately one-tenth of patients receiving misoprostol 800 micrograms daily. These events are usually transient and mild to moderate in severity. Diarrhoea, when it occurs, usually develops early in the course of treatment, is dose-related and self-limiting, and requires discontinuation of the medicine in less than 2% of patients, though it has occasionally been reported to lead to severe dehydration. Misoprostol should not be administered to breastfeeding mothers because the excretion of misoprostol acid could cause undesirable effects such as diarrhoea in breastfeeding infants.
Contraindications
GyMiso should not be administered to anyone with a known hypersensitivity to misoprostol or any other ingredient of the product, or to other prostaglandins. GyMiso is contraindicated in pregnancy, or in patients in whom pregnancy has not been excluded.
Regulatory history
GyMiso received TGA approval on 2012-08-07 following a comprehensive evaluation of submission details, quality, and nonclinical findings. The TGA found no objections regarding the chemistry, quality control, and biopharmaceutic aspects, and nonclinical studies generally supported the proposed indication and raised no particular genotoxic concerns. The medicine was first listed on the ARTG on 2012-08-29 under licence category RE.