October 2023

New Products

• Enfortumab vedotin (Padcev) is an ADC targeting Nectin‑4, an adhesion protein located on the surface of epithelial cells including urothelial cancer cells. It is comprised of a fully human IgG1‑kappa antibody conjugated to the microtubule‑disrupting agent, MMAE, via a protease‑cleavable linker. Nonclinical data suggest that the anticancer activity of enfortumab vedotin is due to the binding of the ADC to Nectin‑4‑expressing cells, followed by internalisation of the ADC‑Nectin‑4 complex, and the release of MMAE via proteolytic cleavage. Release of MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptosis, and 13 immunogenic cell death. MMAE released from enfortumab vedotin targeted cells can diffuse into nearby Nectin‑4 low‑expressing cells resulting in cytotoxic cell death. Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum‑containing chemotherapy and a programmed death receptor‑1 or programmed death‑ligand‑1 inhibitor. Padcev powder for concentrate for infusion contains enfortumab vedotin 20 mg or 30 mg and is available in packs of 1 vial.
   
• Tirzepatide (Mounjaro) is a long‑acting dual glucose‑dependent insulinotropic polypeptide (GIP) and glucagon‑like peptide‑1 (GLP‑1) receptor agonist. It is a 39‑amino acid peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs half‑life. Both receptors are present on the pancreatic α and β endocrine cells, brain, heart, vasculature, immune cells (leucocytes), gut and kidney. GIP receptors are also present on adipocytes. Tirzepatide has high affinity to both the GIP and GLP‑1 receptors. The activity of tirzepatide on the GIP receptor is similar to native GIP hormone. The activity of tirzepatide on the GLP‑1 receptor is lower compared to native GLP‑1 hormone. Tirzepatide is a biased agonist at the GLP‑1 receptor with preferential signaling towards the activation of adenylyl cyclase as opposed to the recruitment of β -arrestin. Tirzepatide improves glycaemic control by lowering fasting and postprandial glucose concentrations in patients with type 2 diabetes. Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise either as monotherapy when metformin is not tolerated or contraindicated, or in addition to other medicinal products for the treatment of type 2 diabetes. Mounjaro solution for injection contains tirzepatide 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg per 0.5 mL and is available in packs of 1 vial.

New Presentations

• Azacitidine (Onureg) is now available as a tablet. It is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. Onureg is contraindicated in pregnancy and breastfeeding. Onureg tablets contain azacitidine 200 or 300 mg and are available in packs of 7.
   
• Glecaprevir and pibrentasvir (Maviret) is now available as granules containing glecaprevir 50 mg and pibrentasvir 20 mg per sachet.
   
• Vibrio cholerae vaccine (Vaxchora) contains live attenuated cholera bacteria (V. cholerae O1 classical Inaba strain CVD 103‑HgR). This attenuated strain remains able to synthesize the immunogenic non‑toxic B subunit of CT (encoded by the ctxB gene). Vaxchora vaccine is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older travelling to cholera‑affected countries. Vaxchora is contraindicated in individuals with congenital immune deficiency and in patients receiving immunosuppressive drugs or treatments. Vaxchora powder for oral suspension contains attenuated Vibrio cholerae bacteria cells (CVD 103‑HgR strain)  4 x 10⁸ to 2 x 10⁹ CFU and is available in a pack of 1 box containing 1 buffer sachet (Sachet 1) and 1 active ingredient sachet (Sachet 2). 

New Indications

• Apremilast (Otezla) is now indicated for the treatment of adult patients with plaque psoriasis (any severity) who are candidates for phototherapy or systemic therapy and adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy.
   
• Dupilumab (Dupixent) is now indicated for the treatment of moderate to severe prurigo nodularis in adults who are candidates for systemic therapy.
   
• Glecaprevir and pibrentasvir (Maviret) (granules) are now indicated for children 3 years and older. 

New Contraindications

• Arsenic trioxide (Phenasen) is now contraindicated in pregnancy or when there is a possibility of 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.