Cequa

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (

Instill one drop of CEQUA twice daily (approximately 12 hours apart) into each eye. CEQUA can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard the vial immediately after using in both eyes. (

Ophthalmic solution containing cyclosporine 0.9 mg/mL (

There are no adequate and well-controlled studies of CEQUA administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data].

Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 3200 and 21000 times higher than the maximum recommended human ophthalmic dose (MRHOD) of 1.5 mcg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 1800 and 6400 times higher than the MRHOD, respectively).

An oral dose of 45 mg/kg/day cyclosporine (approximately 4800 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (approximately 1600 times greater than the MRHOD).

To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces (