MIMS

July 2019.

New Product

• Peramivir (Rapivab) is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells. Rapivab is indicated for the treatment of acute influenza infection in adults and children ≥ 2 years who have been symptomatic for no more than two days. Clinical trials have not established the efficacy of repeated doses of Rapivab in patients with serious influenza requiring hospitalisation. Rapivab concentrate for intravenous infusion is available as 200 mg/20 mL vials in packs of 3.

New Presentation

• Brivaracetam (Briviact) is now available as a solution for injection in 50 mg/5 mL vials in packs of 10.

New Indications

• Atezolizumab (rch) (Tecentriq), in combination with bevacizumab, paclitaxel and carboplatin, is now indicated for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC), or after failure of appropriate targeted therapies in patients with EGFR mutant or ALK-positive NSCLC; as monotherapy for treatment of adults with locally advanced or metastatic NSCLC after prior chemotherapy. It is also now indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are considered cisplatin ineligible and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥ 5% of the tumour area), as determined by a validated test, or are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumour PD-L1 expression.

• Brivaracetam (Briviact) is now indicated as add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 4 years of age with epilepsy.

• Cabozantinib (Cabometyx) is now indicated as monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib.  Certolizumab pegol (rbe) (Cimzia) is now indicated for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

• Dabrafenib (Tafinlar) in combination with trametinib (Mekinist) is now indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer with a BRAF V600 mutation and with no satisfactory locoregional treatment options, and for the treatment of advanced NSCLC with a BRAF V600 mutation.

• Pertussis Vaccine-Acellular Combined with Diphtheria and Tetanus Toxoids (Adsorbed) (Adacel) may now be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

New Contraindications

•Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (as fumarate) (Genvoya) and tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat (Stribild) is now contraindicated with lomitapide.

• Ritonavir (Norvir) is now contraindicated with lomitapide and neratinib.

• Tenofovir disoproxil fumarate/emtricitabine/efavirenz (Atripla) is now contraindicated with elbasvir/grazoprevir.

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.