April 2020

New Products

• Buprenorphine (Sublocade) is a mu opioid receptor partial agonist, kappa opioid receptor antagonist. Its activity in opioid maintenance treatment is attributed to its slow dissociation from the mu receptors in the brain which reduces craving for opioids and opioid withdrawal symptoms. This minimises the need of the opioid dependent patient for illicit opioid medicines. Sublocade is indicated for the maintenance treatment of opioid dependence, within a framework of medical, social and psychological treatment. Sublocade is contraindicated in patients with severe hepatic or respiratory insufficiency; acute intoxication with alcohol, other central nervous system (CNS) depressants; or under 18 years of age. Sublocade modified release solution for injection contains buprenorphine 100 mg/0.5 mL or 300 mg/1.5 mL and is available in a pack size of 1 prefilled syringe.
• Cidofovir (Empovir) suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Empovir is indicated in adults for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Empovir is contraindicated with direct intraocular injection; in patients with renal impairment [serum creatinine > 1.5 mg/dL or ClCr ≤ 55 mL/min or proteinuria ≥ 100 mg/dL (≥ 2+ proteinuria)]; concomitant potentially nephrotoxic agents, e.g. amphotericin B, foscarnet, IV pentamidine, IV aminoglycoside antibiotics, vancomycin and nonsteroidal anti-inflammatory agents (patients should discontinue such agents at least 7 days before starting treatment with cidofovir); a history of clinically significant hypersensitivity to probenecid or other sulfur-containing medicines; and during pregnancy. Empovir concentrated injection for infusion contains cidofovir 375 mg/5 mL and is available in pack size of 1 vial.
   
• Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide (Symtuza) consists of the human immunodeficiency virus (HIV) protease inhibitor, darunavir, the pharmacokinetic enhancer, cobicistat, the nucleoside reverse transcriptase inhibitor, emtricitabine, and the nucleotide reverse transcriptase inhibitor, tenofovir alafenamide. Symtuza is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Symtuza should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and have a narrow therapeutic index, including alfuzosin, antiarrhythmic drugs (e.g. amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine), apixaban, astemizole, cisapride, colchicine (in patients with renal and/or hepatic impairment), dapoxetine, dronedarone, elbasvir/grazoprevir, ergot alkaloids (e.g. dihydroergotamine, ergotamine, ergonovine and methylergonovine), ivabradine, lomitapide, lovastatin, lurasidone, naloxegol, oral midazolam, pimozide, ranolazine, sildenafil (when used for the treatment of pulmonary arterial hypertension), simvastatin, terfenadine and triazolam; or with products containing carbamazepine, phenobarbital, phenytoin, rifampin or St John's wort. Symtuza film-coated tablets contain 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide, and is available in pack size of 30.
   
• Human C1 esterase inhibitor (Berinert SC) is a plasma glycoprotein, which belongs to the group of serine proteases. A major function of C1 esterase inhibitor is the inhibition of the complement system to prevent spontaneous activation. Berinert SC for subcutaneous injection is indicated for the prevention of recurrent hereditary angioedema attacks in adults and adolescents with C1 esterase inhibitor deficiency. Berinert SC powder for injection vial contains 2000 IU or 3000 IU human C1 esterase inhibitor and is available in a pack size of 1. 

New Indications

• Atezolizumab (rch) (Tecentriq), in combination with nab-paclitaxel and carboplatin, is now indicated for first-line treatment of patients with metastatic non-squamous non-small cell lung cancer who do not have tumour EGFR or ALK genomic aberrations.
   
• Epoetin beta (rch) (NeoRecormon) is now indicated for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate.
   
• Venetoclax (Venclexta), as part of combination therapy, is now indicated for the treatment of newly diagnosed adults with acute myeloid leukaemia who are ineligible for intensive chemotherapy.

New Contraindications

• Citalopram hydrobromide (Cipramil) is now contraindicated in combination with linezolid unless there are facilities for close observation and monitoring of blood pressure.
   
• Methylphenidate hydrochloride (Concerta) is now contraindicated in patients with cardiomyopathies.
   
• Milnacipran hydrochloride (Joncia) is now contraindicated with the co-administration of pethidine.
   
• Phleum pratense allergen extract (Grazax) is now contraindicated in patients who have experienced a severe asthma exacerbation within the last 3 months.
   
• Telmisartan/ hydrochlorothiazide (Micardis Plus) is now contraindicated in patients with anuria.

Safety Related Changes

• Omega-3-acid ethyl esters (Omacor) are no longer indicated for the adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy.

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.

New restrictions on prescribing hydroxychloroquine for
COVID-19

The recent interest in hydroxychloroquine as a potential treatment for COVID-19 has led to increased off-label prescribing and concerns for potential shortage in Australia. New restrictions have been placed on the initiation of hydroxychloroquine therapy to limit its use to currently approved indications and to help maintain supply.

Effective from 24 March 2020, initiation of hydroxychloroquine is restricted to specialists in dermatology, intensive care medicine, paediatrics and child health, physician, and emergency medicine. Repeats may continue to be prescribed in line with the approved indications by general practitioners, and other medical practitioners (e.g. hospital Resident Medical Officers, and doctors in training), for patients in whom hydroxychloroquine was initiated prior to 24 March 2020. From 24 March 2020, general practitioners, and doctors in training, can only prescribe hydroxychloroquine for the continued treatment of patients initiated on this medicine by an authorised specialist.

For more information, see https://www.tga.gov.au/alert/new-restrictions-prescribing-hydroxychloroquine-covid-19.