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New Products
- Bulevirtide (acetate) (Hepcludex) is a 47-amino acid, N-terminally myristoylated, HBV-L-protein derived, synthesized lipopeptide that blocks the entry of HBV and hepatitis delta virus (HDV) into hepatocytes by binding to and inactivating the essential HBV and HDV entry receptor, NTCP. Hepcludex is indicated for the treatment of chronic HDV infection in adults with compensated liver disease. Hepcludex powder for injection contains bulevirtide 2 mg and is available in packs of 30 vials.
- Icosapent ethyl (Vazkepa) is a stable ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid (EPA). The mechanisms of action contributing to reduction of cardiovascular events with icosapent ethyl are not completely understood. The mechanisms are likely multi-factorial including improved lipoprotein profile with reduction of triglyceride (TG)-rich lipoproteins, anti-inflammatory, and antioxidant effects, reduction of macrophage accumulation, improved endothelial function, increased fibrous cap thickness/stability, and antiplatelet effects. Icosapent ethyl improves the lipoprotein profile by suppressing cholesterol-, fatty acid- and TG-synthesising enzymes, increasing fatty acid β-oxidation, and reducing microsomal TG transfer protein, resulting in decreased hepatic TG and very low-density lipoprotein (VLDL) synthesis and release. Icosapent ethyl also increases expression of lipoprotein lipase leading to increased TG removal from circulating VLDL and chylomicron particles. However, TG reduction appears to provide only a minor contribution to the reduction in risk of cardiovascular events with icosapent ethyl. Vazkepa is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated TG (≥ 1.7 mmol/L) and either established cardiovascular disease; or diabetes and at least one other cardiovascular risk factor. Vazkepa is contraindicated in patients with hypersensitivity to soya. Vazkepa capsules contain icosapent ethyl 998 mg and are available in packs of 120.
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New Presentation
- Atezolizumab (Tecentriq SC) is now available as solution for subcutaneous injection containing atezolizumab 1875 mg/15 mL in packs of 1 vial.
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New Indications
- Ceftolozane (sulfate) and tazobactam (sodium) (Zerbaxa) is now also indicated for the treatment of paediatric (birth to less than 18 years of age) patients with complicated intra-abdominal infections in combination with metronidazole and complicated urinary tract infections including pyelonephritis, caused by designated susceptible microorganisms.
- Pembrolizumab (rch) (Keytruda) is now also indicated in combination with platinum containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment for patients with resectable Stage II, IIIA, or IIIB (T3-4N2) NSCLC; and in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma.
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New Contraindications
- Atazanavir (Reyataz) is now contraindicated for concomitant use with irinotecan and drugs that are strong inducers of CYP3A4.
- Colistin (as colistimethate sodium) (Colistin Link) is now contraindicated in patients with myasthenia gravis.
- Dorzolamide (hydrochloride) (Trusopt) is now contraindicated in patients with severe renal impairment (CrCI < 30 mL/min) or with hyperchloremic acidosis.
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Safety Related Changes
- Influenza virus (inactivated, surface Ag) quadrivalent vaccine (Influvac Tetra) is no longer contraindicated in patients with hypersensitivity to egg protein.
- Ritonavir (Norvir) is no longer contraindicated for concomitant use with piroxicam.
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This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.
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