February 2022

New Products

• Dinutuximab beta (Qarziba) is a chimeric monoclonal IgG1 antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta has been shown in vitro to bind to neuroblastoma cell lines known to express GD2 and to induce both complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC). In the presence of human effector cells, including peripheral blood mononuclear cells from normal human donors, dinutuximab beta was found to mediate the lysis of human neuroblastoma and melanoma cell lines expressing GD2 in a dose dependent manner. Additionally, in vivo studies demonstrated that dinutuximab beta could suppress liver metastasis in a syngeneic liver metastasis mouse model. Qarziba is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response. It is contraindicated in acute grade 3 or 4, or extensive chronic graft-versus-host disease (GvHD). Qarziba solution for infusion contains dinutuximab beta 20 mg/4.5 mL and is available in a pack size of 1 vial.
   
• Larotrectinib (Vitrakvi) is an orally-bioavailable, adenosine triphosphate (ATP)-competitive, potent and highly selective TRK kinase inhibitor that was rationally designed to avoid activity with off-target kinase. The target for larotrectinib is the TRK family of proteins inclusive of TRKA, TRKB, and TRKC that are encoded by NTRK1, NTRK2 and NTRK3 genes, respectively. Larotrectinib demonstrated potent inhibition of TRK proteins and inhibition of proliferation of tumor cells in a concentration-dependent manner. In TRK fusion-driven mouse xenograft models larotrectinib treatment induced a significant reduction of tumor growth. Vitrakvi has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have either progressed following treatment or who have no satisfactory alternative therapy. Vitrakvi capsules contain larotrectinib 25 mg or 100 mg and are available in pack sizes of 56. Vitrakvi oral solution contains larotrectinib 20 mg/mL and is available in a pack size of 100 mL.
   
• Onasemnogene abeparvovec (Zolgensma) is a gene therapy medicinal product that expresses the human survival motor neuron (SMN) protein. It is a non-replicating recombinant adeno‑associated vector serotype 9 (AAV9) containing the cDNA of the human SMN gene under the control of the cytomegalovirus enhancer/chicken-β-actin-hybrid promoter. SMA is caused by a bi‑allelic mutation in the SMN1 gene, which results in insufficient SMN protein expression. Onasemnogene abeparvovec utilises the AAV9 capsid to deliver a stable fully functional copy of the transgene encoding the human survival motor gene (SMN1) protein. The SMN1 gene present in onasemnogene abeparvovec is designed to reside as episomal DNA in the nucleus of transduced cells and is expected to be stably expressed for an extended period of time in post‑mitotic cells. Zolgensma is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi‑allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene. Zolgensma injection for intravenous infusion contains onasemnogene abeparvovec 20 trillion vector genomes/mL and is available in 5.5 or 8.3 mL volumes in packs of 2 to 9 vials (combination/ number of vials required for each patient is calculated according to the patient’s weight).

New Indications

• Empagliflozin (Jardiance) is now indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy.
   
• Lorlatinib (Lorviqua) is now indicated for the treatment of patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non small cell lung cancer (NSCLC).
   
• Recombinant varicella zoster virus glycoprotein E antigen (Shingrix) is now indicated for adults 18 years of age or older at increased risk of herpes zoster.

New Contraindications

• Heparin sodium (Baxter Heparin Sodium in 0.9% Sodium Chloride) is now contraindicated in patients who have had a diagnosis of heparin-induced thrombocytopaenia (HIT) (with or without thrombosis) within the previous 6 months, and while they test positive for HIT antibodies.

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.