Simulect Special Precautions

Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Experience with the use of Simulect with immunosuppressive agents other than ciclosporin for microemulsion and corticosteroids is limited. Simulect, in the recommended dosage regimen, has been co-administered with azathioprine in a limited number of patients, and other patients have received mycophenolate mofetil or antibody therapy eg, OKT3 or ATG/ALG, at various times after transplantation. While these patients exhibited no symptoms of overimmunosuppression, the concomitant use of Simulect with immunosuppressive agents other than ciclosporin for microemulsion and corticosteroids may increase the potential for overimmunosuppression.
Effects on the Ability to Drive or Operate Machinery: Simulect is not expected to affect the ability to drive or use machines.
Use in Pregnancy & Lactation: No studies have been performed in pregnant or lactating women. Simulect should not be given to pregnant women except in cases where the potential benefit for the mother outweighs the potential risk for the foetus.
Since Simulect is an immunoglobulin G (IgG_1k) antibody, it may cross the human placenta and may be excreted in human milk. Women receiving Simulect should not breastfeed for 8 weeks following the 2nd dose.