November 2018

Important New Products

• Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) contains the new integrase strand transfer inhibitor (INSTI) bictegravir, that binds to the integrase active site and blocks the strand transfer step of retroviral DNA integration which is essential for the HIV replication cycle. Bictegravir has activity that is specific to HIV-1 and HIV-2. Biktarvy is indicated for the treatment of HIV-1 infection in adults who are antiretroviral therapy naïve or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies per mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of Biktarvy. Biktarvy is contraindicated with coadministration of dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life threatening events. Coadministration with rifampicin is contraindicated due to decreased bictegravir plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to Biktarvy. Biktarvy tablets contain bictegravir 50 mg/ emtricitabine 200 mg/ tenofovir alafenamide 25 mg and are available in a pack size of 30.
   
• Emicizumab (rch) (Hemlibra) is a humanised modified IgG4 monoclonal antibody with a bispecific antibody structure bridging factor IXa and factor X. Hemlibra bridges activated factor IX and factor X to restore the function of missing activated factor VIII (FVIII) that is needed for effective haemostasis. Prophylactic therapy with Hemlibra shortens the activated partial thromboplastin time (aPTT) and increases the reported FVIII activity. Emicizumab has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. Hemlibra should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders. Hemlibra is contraindicated in patients with known hypersensitivity to hamster derived proteins. Hemlibra solution for subcutaneous injection containing emicizumab 30 mg/mL (30 mg/1 mL) or 150 mg/mL (60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/1 mL) is available in a pack size of 1.
   
• Ertugliflozin/metformin hydrochloride (Segluromet) combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a member of the biguanide class. Ertugliflozin displays > 2200-fold selectivity for SGLT2 (responsible for glucose reabsorption in the kidney) over SGLT1 (responsible for glucose absorption in the gut). Segluromet 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 metformin is appropriate. Segluromet is contraindicated with the following: moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m²); acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma; acute conditions with the potential to alter renal function, such as dehydration, severe infection, shock or intravascular administration of iodinated contrast agents; acute or chronic disease which may cause tissue hypoxia, such as cardiac or respiratory failure, pulmonary embolism, recent myocardial infarction, shock, acute significant blood loss, sepsis, gangrene, pancreatitis; during or immediately following surgery where insulin is essential; due to metformin component, conditions that can lead to severe hepatic insufficiency, such as acute alcohol intoxication or alcoholism. Segluromet tablets are available in the following strengths: Segluromet 2.5/500 (ertugliflozin 2.5 mg, metformin hydrochloride 500 mg), Segluromet 2.5/1000 (ertugliflozin 2.5 mg, metformin hydrochloride 1000 mg), Segluromet 7.5/500 (ertugliflozin 7.5 mg, metformin hydrochloride 500 mg) and Segluromet 7.5/1000 (ertugliflozin 7.5 mg, metformin hydrochloride 1000 mg) in a pack size of 56.
   
• Tildrakizumab (rch) (Ilumya) is a humanised IgG1/κ monoclonal antibody that specifically binds to the p19 protein subunit of the interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine composed of 2 subunits (IL-23p19 and IL-12/23p40), that is involved in inflammatory and immune responses. Ilumya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Ilumya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Ilumya is contraindicated with clinically important active infection (e.g. active tuberculosis). Ilumya solution for injection (single use prefilled syringe) contains tildrakizumab 100 mg/1 mL and is available in a pack size of 1.

New Indications

• Nivolumab (Opdivo) as monotherapy is now indicated for the treatment of hepatocellular carcinoma after prior sorafenib therapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease related symptoms has not been established.
   
• Normal immunoglobulin (human) 20% (20 g/100 mL) (Hizentra) is now indicated for immunomodulatory therapy in chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilisation with intravenous immunoglobulin.
   
• Pertuzumab (Perjeta) is now indicated in combination with trastuzumab and chemotherapy for: early stage (either > 2 cm in diameter or node positive) breast cancer as part of a complete treatment regimen for early breast cancer; the adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.

New Contraindications

• Atazanavir (Reyataz) is now contraindicated with concomitant lurasidone; glecaprevir/pibrentasvir (co-administration may result in increased ALT elevations due to an increase in glecaprevir and pibrentasvir plasma concentrations).
   
• Ropivacaine hydrochloride/fentanyl citrate (Naropin 0.2% with Fentanyl) is now contraindicated in patients with a history of myasthenia gravis, after operative interventions in the biliary tract, and in children below the age of 12 years.
   
• Sitagliptin phosphate monohydrate/metformin hydrochloride (Janumet, Janumet XR) is now contraindicated in severe renal impairment (eGFR < 30 mL/min/1.73 m²).
   
• Vildagliptin/metformin hydrochloride (Galvumet) is now contraindicated in patients with severe renal impairment (GFR < 30 mL/min).

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)