December 2023

New Products

• Nelarabine (Nelarabine-Reach) is a pro-drug of the deoxyguanosine analogue ara-G. Nelarabine-Reach is indicated for the treatment of patients with relapsing/ refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. The TGA has approved the supply of Nelarabine-Reach until 30 April 2024, through early access to a medicine under evaluation for inclusion on the ARTG. It is available as a 250 mg/50 mL solution for infusion in packs of single vials. Please contact the Australian sponsor, Reach Pharmaceuticals, for more information about this product.

New Presentation

• Omeprazole (Omeprazole ADVZ) is now available as a powder for oral suspension. It is indicated in adults for the treatment and relapse prevention of duodenal and gastric ulcers, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease in combination with appropriate antibiotics, treatment of NSAID‑associated gastric and duodenal ulcers, prevention of NSAID‑associated gastric and duodenal ulcers in patients at risk, treatment of reflux oesophagitis, long‑term management of patients with healed reflux oesophagitis, and treatment of symptomatic gastro‑oesophageal reflux disease (GORD). It is indicated in children over 1 month of age for the treatment of reflux oesophagitis and symptomatic treatment of heartburn and acid regurgitation in GORD; and in children over 4 years of age and adolescents for the treatment of duodenal ulcer caused by H. pylori in combination with antibiotics. Omeprazole ADVZ is contraindicated in patients with hypersensitivity to substituted benzimidazoles and in patients taking cilostazol. After reconstitution, Omeprazole ADVZ contains omeprazole 2 mg/mL or 4 mg/mL in 90 mL of suspension. It is available in packs of 1 bottle.

New Contraindications

• Dexamethasone (Dexmethsone) is now contraindicated in bacteraemia.
   
• Prochlorperazine maleate or mesilate (Stemetil) is now contraindicated in simultaneous administration with desferrioxamine. It is also contraindicated in children as an intramuscular injection, in paediatric surgery, and in conditions for which dosage has not been established.
   
• Trimethoprim (Triprim) is now contraindicated in severe hepatic insufficiency.

Safety Related Changes

• Alteplase (Actilyse) is no longer contraindicated in patients with known hypersensitivity to gentamicin.

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.