November 2019

New Products

• Dolutegravir (as sodium)/lamivudine (Dovato) contains dolutegravir, a human immunodeficiency virus (HIV) integrase inhibitor, and lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), and potent, selective inhibitor of HIV-1 and HIV-2. Dovato is indicated for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults and adolescents (from 12 years of age weighing at least 40 kg) who have no known or suspected resistance to either antiretroviral component. Dovato is contraindicated in combination with dofetilide or pilsicainide. Dovato tablets contain dolutegravir 50 mg and lamivudine 300 mg and are available in a pack size of 30.
   
• Fremanezumab (Ajovy) is a fully humanised IgG2Δa/kappa monoclonal antibody that potently and selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks both α‑and β‑CGRP isoforms from binding to the CGRP receptor, preventing the activation of the trigeminal system. While the precise mechanism of action by which fremanezumab prevents migraine attacks is unknown, it is believed that the prevention of migraine is obtained by its effect modulating the trigeminal system. Ajovy is indicated for the prevention of migraine in adults. Ajovy solution for injection contains fremanezumab 225 mg/1.5 mL in a pack size of 1 prefilled syringe.
   
• Galcanezumab (Emgality) is a humanised IgG4 monoclonal antibody that binds CGRP and prevents its biological activity without blocking the CGRP receptor. Elevated blood concentrations of CGRP have been associated with migraine. In addition, CGRP infusions can induce migraine-like attacks in some individuals with a history of migraine. Emgality is indicated for the prophylaxis of migraine in adults. Emgality solution for injection contains galcanezumab 120 mg/mL and is available in a pack size of 1 prefilled pen.
   
• Teduglutide (Revestive) is an analogue of human glucagon-like peptide (GLP)-2. GLP-2 is known to increase intestinal and portal blood flow, decrease intestinal motility and inhibit gastric acid secretion. Teduglutide binds to the GLP-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators, including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). Teduglutide preserves mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth. Revestive is indicated for the treatment of short bowel syndrome in adults dependent on parenteral support. Revestive is contraindicated with active gastrointestinal tract, hepatobiliary, or pancreatic malignancy; or a history of gastrointestinal tract malignancy, including the hepatobiliary system, within the last 5 years. Revestive powder for injection contains teduglutide 5 mg and is available in a pack size of 28 vials with 28 prefilled syringes containing 0.5 mL diluent.

New Presentation

• Ocriplasmin (Jetrea RTU) is now available as a ready to use solution for intravitreal injection in packs of 1 vial containing ocriplasmin 0.375 mg/0.3 mL.
   
• Pegaspargase (Oncaspar) is now available as a powder for injection in packs of 1 vial containing pegaspargase 3750 units/5 mL.

New Indications

• Enzalutamide (Xtandi) is now indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
   
• Pembrolizumab (rch) (Keytruda), in combination with lenvatinib (Lenvima), is now indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

New Contraindications

• Dapagliflozin (as propanediol monohydrate)/metformin hydrochloride (Xigduo XR) is now contraindicated with acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis, with or without coma; eGFR persistently < 45 mL/min/1.73m².
   
• Dexamethasone (as sodium metasulfobenzoate)/framycetin sulfate/gramicidin (Otodex, Sofradex) is now contraindicated with viral and fungal infections; acute purulent, untreated infections.
   
• Lopinavir/ritonavir (Kaletra) is now contraindicated with apalutamide.
   
• Armodafinil (Nuvigil) and Modafinil (Modavigil) is now contraindicated in women who may become pregnant.
   
• Ritonavir (Norvir) is now contraindicated with venetoclax and apalutamide.

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.