October 2024

New Products

• Selpercatinib (Retevmo) is an orally available, small molecule inhibitor of the rearranged during transfection (RET) receptor tyrosine kinase. Chromosomal rearrangements involving in-frame fusions of RET with various partners can result in constitutively activated chimeric RET fusion proteins that can act as oncogenic drivers, promoting cell proliferation and survival in tumor cell lines. Point mutations in RET can also result in constitutively activated RET proteins that can promote cell growth and survival in tumor cell lines. Retevmo has provisional approval for the treatment of adult patients with locally advanced or metastatic RET fusion positive non-small cell lung cancer. Retevmo capsules contain selpercatinib 40 mg or 80 mg and are available in packs of 56.
   
• Zilucoplan (tetrasodium) (Zilbrysq) inhibits the effects of C5 through a dual mechanism of action. In generalised myasthenia gravis patients, binding of anti-acetylcholine receptor (AChR) auto-antibodies (mainly IgG1 and IgG3) to AChR results in uncontrolled and inappropriate activation of the classical complement pathway and subsequent injury to the neuromuscular endplate, leading to failure of neuromuscular transmission. Zilucoplan specifically binds to complement protein C5, thereby inhibiting its cleavage by the C5 convertase to C5a and C5b, which results in a downregulation of the assembly and cytolytic activity of the membrane attack complex (MAC). Additionally, by binding to the C5b moiety of C5, zilucoplan sterically hinders binding of C5b to C6, which prevents the subsequent assembly and activity of the MAC, should any C5b be formed. Zilbrysq is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis in adult patients who are AChR antibody positive. Zilbrysq is contraindicated in patients with unresolved Neisseria meningitidis infection and in patients who are not currently vaccinated against Neisseria meningitidis, unless they receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose. Zilbrysq solution for injection contains zilucoplan 16.6 mg per 0.416 mL, 23 mg per 0.574 mL or 32.4 mg per 0.81 mL, and is available in packs of 7 or 28 prefilled syringes.

New Presentation

• Tirzepatide (Mounjaro) is now available as a multidose prefilled pen that delivers four 0.6 mL doses containing tirzepatide 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg.

New Indication

• Tirzepatide (Mounjaro) is now indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management, including weight loss and weight maintenance, in adults with an initial body mass index of ≥ 30 kg/m² (obesity) or ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes mellitus).

New Contraindications

• Dorzolamide (hydrochloride) and timolol (maleate) (Cosopt) is now contraindicated in patients with sick sinus syndrome, severe renal impairment (CrCI < 30 mL/min) and hyperchloraemic acidosis.
   
• Gemcitabine (hydrochloride) (DBL Gemcitabine Solution for Injection) is now contraindicated in pregnancy and breastfeeding.
   
• Glecaprevir and pibrentasvir (Maviret) is now contraindicated for concomitant use with products containing more than 20 mcg of ethinylestradiol.
   
• Trandolapril (Gopten) is now contraindicated in liver cirrhosis with ascites.

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.