January 2022

New Products

• Eptinezumab (Vyepti) is a humanised monoclonal immunoglobulin G1 (IgG1) antibody that binds to α- and β- forms of human calcitonin gene-related peptide (CGRP) ligand with low picomolar affinity preventing its activation of the CGRP receptors. Elevated blood concentrations of CGRP have been associated with migraine. Vyepti is indicated for the preventive treatment of migraine in adults. Vyepti concentrated injection contains eptinezumab 100 mg/mL and is available in a pack size of 1.
   
• Fostemsavir (as trometamol) (Rukobia) is a prodrug without significant biochemical or antiviral activity that is hydrolyzed to the active moiety, temsavir, upon cleavage of a phosphonooxymethyl group in vivo. Temsavir binds directly to the gp120 subunit within the HIV‑1 envelope glycoprotein gp160 and selectively inhibits the interaction between the virus and cellular CD4 receptors, thereby preventing viral entry into, and infection of, host cells. Rukobia is indicated in combination with other antiretroviral agents for the treatment of heavily treatment-experienced adults with multidrug-resistant human immunodeficiency virus-1 (HIV-1) infection for whom it is otherwise not possible to construct a suppressive antiviral regimen due to resistance, intolerance or safety considerations. It is contraindicated in combination with strong CYP3A inducers including, but not limited to carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St. John’s wort (Hypericum perforatum, herbal supplement). Rukobia tablets contain fostemsavir 600 mg and are available in a pack size of 60.
   
• Niraparib (as tosilate monohydrate) (Zejula) is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. Niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP‑DNA complexes resulting in DNA damage, apoptosis and cell death. Zejula is indicated for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first‑line platinum-based chemotherapy; and as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Zejula capsules contain 100 mg niraparib and are available in pack sizes of 56 or 84.

New Presentation

• Tozinameran (Comirnaty (Tris/Sucrose Presentation)) contains nucleoside-modified messenger RNA formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 spike (S) antigen. Comirnaty elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against COVID-19. Comirnaty (Tris/Sucrose Presentation) has provisional approval for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV2, in individuals 5 years to < 12 years of age (dilute-to-use) and in individuals 12 years of age and older (ready-to-use). Comirnaty (Tris/Sucrose Presentation) suspension for injection contains tozinameran 10 mcg/0.2 mL after dilution (dilute-to-use vial) or 30 mcg/0.3 mL (ready-to-use vial) and is available in pack sizes of 10 or 195 multidose vials (6 doses per ready-to-use vial; 10 doses per dilute-to-use vial).

New Indications

• Nivolumab (Opdivo) is now indicated, as monotherapy, for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.
   
• Romiplostim (Nplate) is now indicated for treatment of thrombocytopenia in adult patients with primary immune thrombocytopenia (ITP) and paediatric patients aged 1 year and older with primary immune thrombocytopenia ITP for at least 6 months who are non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins; or are splenectomised and have had an inadequate response to splenectomy.
   
• Sugammadex (as sodium salt) (Bridion) is now indicated for reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.
   
• Tipranavir (Aptivus), in combination with low dose ritonavir, is now indicated for combination treatment of HIV infection in antiretroviral treatment experienced adults and adolescents aged 12 years and older who have a BSA of ≥ 1.3 m² or weight ≥ 36 kg, with evidence of viral replication, who have HIV-1 strains resistant to more than one protease inhibitor.
   
• Tocilizumab (Actemra) now has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

New Contraindications

• Voriconazole (Vfend) is now contraindicated in combination with venetoclax (during the venetoclax initiation or dose titration phases), naloxegol, tolvaptan, and lurasidone.

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.