New Products

Praluent (alirocumab (rch)) is a fully human monoclonal antibody that binds with high affinity and specificity to PCSK9. PCSK9 binds to the low density lipoprotein (LDL) receptors (LDLR) on the surface of hepatocytes to promote their degradation. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLR available to clear LDL, thereby lowering LDL cholesterol (LDL-C) levels. Praluent is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with one or more of: heterozygous familial hypercholesterolaemia, clinical atherosclerotic cardiovascular disease, or hypercholesterolemia with high or very high cardiovascular risk. In combination with a statin, or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with maximum tolerated dose of a statin; or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach LDL-C goals. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined. Praluent is contraindicated with hypersensitivity to the active substance or to any of the excipients. For contraindications related to concomitant statins or other lipid modifying therapy, refer to their current respective product information. Praluent solution for injection is supplied in a 75 mg/mL and 150 mg/mL prefilled pen, available in pack sizes of 1, 2 or 6 per carton.

Zinplava (bezlotoxumab (rch)) is a specific fully human monoclonal antibody that binds with high affinity to Clostridium difficile (C. difficile) toxin B and neutralises its activity by preventing it from binding to host cells. C. difficile colonises and infects the large intestine. Zinplava prevents C. difficile infection (CDI) recurrence by providing enhanced passive immunity against toxin produced by the outgrowth of persistent or newly acquired C. difficile spores. Zinplava is indicated for the prevention of recurrence of CDI in adults 18 years or older at high risk for recurrence of CDI who are receiving antibiotic therapy for CDI. Zinplava is not indicated for the treatment of CDI. Zinplava is not an antibacterial drug. Zinplava should only be used in conjunction with antibacterial drug treatment of CDI. The safety and efficacy of repeat administration of Zinplava in patients with CDI have not been studied. Zinplava is contraindicated with hypersensitivity to bezlotoxumab or to any of the inactive ingredients. Zinplava concentrated injection (25 mg/mL) is supplied in one single dose vial containing 1000 mg/40 mL.