Orgalutran Special Precautions

Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), have been reported with Orgalutran, as early as with the first dose, during post-marketing surveillance. These events have included anaphylaxis (including anaphylactic shock), angioedema, and urticaria (see Adverse Reactions). If a hypersensitivity reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered. In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.
The needle shield of this medicinal product contains dry natural rubber/latex which come into contact with this product and may cause allergic reactions (see Contraindications).
Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. There are no indications that the use of GnRH antagonists during ART is associated with an increased risk of congenital malformations. In clinical trials investigating more than 1000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.
The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg.
Effects on ability to drive and use machines: The effects of Orgalutran on ability to drive and use machines have not been studied.