December 2019

New Products

• Ceftazidime (pentahydrate)/avibactam (sodium) (Zavicefta) combines ceftazidime, which inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins, leading to bacterial cell lysis and death, and avibactam, a non β-lactam, β-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis. Zavicefta is indicated for the treatment of the following infections in adults: complicated intra-abdominal infection, in combination with metronidazole; complicated urinary tract infection, including pyelonephritis; and hospital acquired pneumonia, including ventilator associated pneumonia. Zavicefta is contraindicated with severe hypersensitivity to any other type of β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems). Zavicefta powder for injection vial contains 2000 mg ceftazidime and 500 mg avibactam and is available in a pack size of 10.
   
• Glycopyrronium bromide (glycopyrrolate)/neostigmine methylsulfate (Novistig) combines glycopyrronium bromide, a synthetic anticholinergic agent, and neostigmine, an anticholinesterase agent. Novistig is indicated for the reversal of residual non-depolarising (competitive) neuromuscular block. It is contraindicated with mechanical obstruction of intestinal or urinary tract, and should not be given in conjunction with suxamethonium. Novistig solution for injection ampoules contain 0.5 mg/mL glycopyrronium bromide and 2.5 mg/mL neostigmine methylsulfate and is available in a pack size of 10.
   
• Polatuzumab vedotin (Polivy) is a Cluster of Differentiation 79B (CD79b)-targeted antibody-drug conjugate that preferentially delivers an anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells. The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanised immunoglobulin G1 (IgG1) monoclonal antibody via a cleavable linker. Upon binding CD79b, polatuzumab vedotin is internalised and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis. Polivy, in combination with bendamustine and rituximab, is indicated for the treatment of previously treated adults with diffuse large B-cell lymphoma who are not candidates for haematopoietic stem cell transplant. Polivy powder for infusion vial contains 140 mg polatuzumab vedotin and is available in a pack size of 1.
   
• Risankizumab (Skyrizi) is a humanised IgG1 monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor complex. By blocking IL-23 from binding to its receptor, risankizumab inhibits IL-23-dependent cell signaling and release of pro-inflammatory cytokines. Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults (18 years or older) who are candidates for phototherapy or systemic therapy. It is contraindicated with clinically important active infections. Skyrizi solution for subcutaneous injection prefilled syringe with needle guard contains 75 mg risankizumab in 0.83 mL and is available in a pack size of 2 (with 2 alcohol pads).

New Presentation

• Esomeprazole (magnesium trihydrate) (Nexium 24HR Once Daily Dosing) is now available as capsules containing 20 mg esomeprazole in packs of 14.
   
• Ibuprofen (Advil 12 Hour Extended Release Tablets) is now available as extended release tablets containing 600 mg ibuprofen in packs of 8 and 16.
   
• Lumacaftor/ivacaftor (Orkambi) is now available as granules containing 100 mg lumacaftor/125 mg ivacaftor or 150 mg lumacaftor/188 mg ivacaftor in packs of 56 sachets.

New Indications

• Alirocumab (rch) (Praluent) is now indicated as an adjunct to diet and exercise to reduce LDL-C in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to 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 alone 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. Praluent is also now indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies.
   
• Atezolizumab (rch) (Tecentriq), in combination with paclitaxel protein-bound, is now indicated for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumour), as determined by a validated test and who have not received prior chemotherapy for metastatic disease. This indication is approved under provisional approval based on progression free survival. 
   
• Dupilumab (rch) (Dupixent) is now indicated for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy. It is not intended for episodic use.
   
• Trastuzumab emtansine (rch) (Kadcyla), as a single agent, is now indicated for the adjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

New Contraindications

• Atazanavir (sulfate)/cobicistat (Evotaz) is now contraindicated with lomitapide.
   
• Bimatoprost/timolol (maleate) (Ganfort 0.3/5) is now contraindicated with sino-atrial nodal block, and second or third degree atrioventricular block not controlled with a pacemaker.
   
• Fentanyl (Durogesic) is now contraindicated with severe respiratory depression.

Safety Related Updates

• Inactivated quadrivalent influenza vaccine, split virion (influenza virus haemagglutinin) (FluQuadri) (containing 15 mcg haemagglutinin each of: A/Michigan/45/2015 (H1N1) pdm09-like virus, A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, B/Phuket/3073/2013-like virus and B/Brisbane/60/2008-like virus) may be used in adults and children 6 months and older for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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.