December 2018

CRITICAL UPDATE

Panadol (Children) Liquid Formulations - Please be informed of a critical correction in the Panadol (Children) Liquid Formulations dosage information in MIMS.

Important New Products

• Benralizumab (rch) (Fasenra) is a humanised monoclonal antibody selective for the alpha subunit of the human interleukin-5 receptor (IL-5Rα). The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. Benralizumab reduces eosinophilic inflammation through immune effector cell mediated apoptosis of eosinophils and basophils. Fasenra is indicated as add-on therapy in patients aged ≥ 12 years with severe eosinophilic asthma (blood eosinophil count ≥ 300 cells/microlitre or ≥ 150 cells/microlitre if on oral corticosteroid treatment). Fasenra should be prescribed by a healthcare professional in consultation with a specialist physician experienced in the diagnosis and treatment of severe asthma. Treatment with high dose inhaled corticosteroids and long-acting β-agonists should be optimised prior to commencement of treatment with Fasenra. Fasenra solution for subcutaneous injection prefilled syringe contains benralizumab 30 mg/1 mL and is available in a pack of 1.
   
• Ertugliflozin (pyroglutamic acid) (Steglatro) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Steglatro is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy when metformin is considered inappropriate due to intolerance; in combination with other antihyperglycaemic agents. Steglatro is contraindicated in patients with chronic kidney disease (CKD) receiving dialysis; eGFR < 30 mL/min/1.73 m² or eGFR persistently < 45 mL/min/1.73 m² (CKD stage 3B, 4 and 5). The efficacy of Steglatro is dependent on renal function. Steglatro tablets contain ertugliflozin 5 mg or 15 mg in a pack size of 28.
   
• Ertugliflozin (pyroglutamic acid)/sitagliptin (phosphate monohydrate) (Steglujan) combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin (a SGLT2 inhibitor) and sitagliptin (a dipeptidyl peptidase-4 [DPP-4] inhibitor). Steglujan is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. Steglujan is contraindicated in patients with CKD receiving dialysis; eGFR < 30 mL/min/1.73 m² or eGFR persistently < 45 mL/min/1.73 m² (CKD stage 3B, 4 and 5). The efficacy of Steglujan is dependent on renal function. Steglujan tablets contain ertugliflozin 5 mg/sitagliptin 100 mg (Steglujan 5/100) or ertugliflozin 15 mg/sitagliptin 100 mg (Steglujan 15/100) in a pack size of 28.
   
• Migalastat (Galafold) is a pharmacological chaperone that selectively and reversibly binds with high affinity to the active sites of certain mutant (abnormally folded and unstable) forms of lysosomal enzyme α-galactosidase A (α-Gal A), stabilising the mutant enzymes. Mutations in the GLA gene result in a deficiency of α-Gal A in the lysosomal storage disorder Fabry disease. Galafold is indicated for long-term treatment of adults and adolescents ≥ 16 years with a confirmed diagnosis of Fabry disease (α-Gal A deficiency) and who have an amenable mutation. Galafold capsules contain migalastat 123 mg and are available in a pack size of 14.
   
• Tenofovir alafenamide (fumarate) (Vemlidy) is a phosphonamidate prodrug of tenofovir. Intracellular tenofovir is phosphorylated to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits hepatitis B virus (HBV) replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. Tenofovir has antiviral activity specific to HBV and human immunodeficiency virus (HIV-1 and HIV-2). Vemlidy is indicated for the treatment of chronic hepatitis B in adults. Vemlidy tablets contain tenofovir alafenamide 25 mg and are available in a pack size of 30.

New Indications

• Cabozantinib ((S)-malate) (Cabometyx) is now indicated for the treatment of advanced renal cell carcinoma in treatment naïve adults with intermediate or poor risk.
   
• Lenvatinib (mesylate) (Lenvima) is now indicated for the first-line treatment of unresectable hepatocellular carcinoma.
   
• Pembrolizumab (Keytruda) is now indicated for the treatment of adult and paediatric patients with refractory primary mediastinal B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapy. The approval of this indication is on the basis of objective response rate and duration of response from non-randomised studies.
   
• Quadrivalent influenza vaccine (split virion, inactivated) (Fluarix Tetra) is now indicated for active immunisation of children from 6 months of age for the prevention of influenza disease caused by the influenza virus types A and B contained in the vaccine.
   
• Venetoclax (Venclexta) in combination with rituximab is now indicated for the treatment of adults with chronic lymphocytic leukaemia who have received at least one prior therapy.

New Contraindications

• Pralatrexate (Folotyn) is now contraindicated in pregnancy.
   
• Protamine sulfate (Fisons Protamine Sulfate Injection BP) is now contraindicated with hypersensitivity to protamine (including protamine contained in insulin NPH [Neutral Protamine Hagedorn]).
   
• Tretinoin (ReTrieve Cream, Stieva-A) is now contraindicated in pregnancy and women planning a pregnancy.

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)