March 2019

Important New Products

• Tisagenlecleucel (Kymriah) is an autologous, immunocellular cancer therapy that involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19 expressing cells (malignant and normal B cells). Upon binding to CD19 expressing cells, the CAR transmits a signal to promote T cell expansion, activation, target cell elimination and Kymriah persistence. Kymriah is indicated for the treatment of: paediatric and young adults up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant, or in second or later relapse; adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah is not indicated for patients with primary central nervous system lymphoma. Kymriah is contraindicated with known hypersensitivity to tisagenlecleucel or to any component of the product formulation, including dimethyl sulfoxide or dextran 40. Each bag of Kymriah contains tisagenlecleucel at a batch dependent concentration of autologous genetically modified T cells, with 1-3 infusion bags containing a total of 1.2 x 10⁶ to 6.0 x 10⁸ CAR-positive viable T cells in 10 to 50 mL.

New Indications

• Daptomycin (Cubicin) is now indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.
   
• Inactivated quadrivalent influenza vaccine (split virion) (Afluria Quad) is now indicated for use only in persons aged 5 years and over.

New Contraindications

• Cladribine (Litak) is now contraindicated in patients less than 18 years of age; moderate to severe renal or hepatic impairment; concomitant use of other myelosuppressive medicinal products.
   
• Darunavir/cobicistat (Prezcoxib) is now contraindicated with dapoxetine, ivabradine, lomitapide, naloxegol.
   
• Inactivated quadrivalent influenza vaccine (split virion) (Afluria Quad) is now contraindicated in children less than 5 years of age; individuals who have previously experienced anaphylaxis following a dose of any influenza vaccine.
   
• Norethisterone (Primolut N) is now contraindicated with use of direct-acting antiviral medicinal products containing ombitasvir, paritaprevir or dasabuvir, or combination of these.
   
• Pilocarpine nitrate (Minims Pilocarpine Nitrate Eye Drops) is now contraindicated with pupillary block glaucoma; iridocyclitis; use of soft contact lenses.

Safety Related Changes

• Daptomycin (Cubicin) is not indicated for treatment of patients less than 1 year of age. Daptomycin has not been studied in treatment of infective endocarditis in children 1 to 17 years of age.

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.

Active Ingredient Naming Changes

In this release, MIMS Australia will be including the following INNs (International Non-proprietary Names) as well as Australian Approved Names (AANs) as part of our push to support the Therapeutic Goods Administration (TGA) active ingredient name changes project.  

MIMS will begin referring to these ingredients by their new names, however, users may continue to search by the old AANs if preferred. ...(more)