MIMS December prescribing update

Safety-related changes

- Interstitial lung disease has been reported rarely during treatment with Arava, Arabloc (leflunomide). The risk of its occurrence is increased in patients with a history of interstitial lung disease.

- Arava, Arabloc (leflunomide) must not be given to pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with Arabloc and for a certain period of time thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/L, unless undergoing washout treatment.

- Use of Ciloxan, CiloQuin (ciprofloxacin) eye drops in neonates with ophthalmia neonatorum of gonococcal or chlamydial origin is not recommended as it has not been evaluated in such patients. 

- Efficacy and safety in children younger than one year old have not been assessed with the use of Ciloxan (ciprofloxacin) ear drops.

- Administration of live or