July 2021

New Products

• Trifarotene (Aklief) is a chemically stable, terphenyl acid derivative with retinoid-like activity. It is a relatively potent retinoid acid receptor γ (RARγ) agonist, characterised by its high specificity to this receptor over RARα and RARβ (65- and 16-fold, respectively, with no retinoid X receptor activity). In addition, trifarotene modulates retinoid target genes (differentiation and inflammatory processes) in human immortalised keratinocytes and human reconstructed epidermis. Aklief is indicated for the topical treatment of acne vulgaris of the face and/or trunk in patients ≥ 12 years, when many comedones, papules and/or pustules are present. Aklief is contraindicated in pregnancy and women planning a pregnancy. Aklief cream contains trifarotene 50 mcg/g and is available as a 75 g pump.

New Indications

• Ceftazidime (pentahydrate)/avibactam (sodium) (Zavicefta) is now indicated for the treatment of the following infections in infants and paediatric patients (≥ 3 months to < 18 years): complicated intra-abdominal infection in combination with metronidazole, and complicated urinary tract infection including pyelonephritis.
   
• Encorafenib (Braftovi), in combination with cetuximab, is now indicated for the treatment of adults who have metastatic colorectal cancer with a BRAF V600E mutation as detected by a validated test, and who have received prior systemic therapy.
   
• Ferric carboxymaltose (Ferinject) is now indicated for the treatment of iron deficiency when there is a clinical need to deliver iron rapidly.
   
• Fluticasone furoate/umeclidinium (bromide)/vilanterol (trifenatate) (Trelegy Ellipta) is now indicated for the maintenance treatment of asthma in adults who are not adequately controlled with a combination of an inhaled corticosteroid and a long-acting β₂-agonist.
   
• Nivolumab (rch) (Opdivo), in combination with ipilimumab (rch) (Yervoy), is now indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.
   
• Tezacaftor/ivacaftor and ivacaftor (Symdeko) is now indicated for the treatment of patients with cystic fibrosis aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

New Contraindications

• Dolutegravir (sodium)/rilpivirine (HCl) (Juluca) and Dolutegravir (sodium)/abacavir (sulfate)/lamivudine (Triumeq) are now contraindicated in combination with medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2) including, but not limited to, dofetilide, pilsicainide or fampridine.
   
• Empagliflozin (Jardiance) and Empagliflozin/linagliptin (Glyxambi) is now contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²), end-stage renal disease, and patients on dialysis.
   
• Empagliflozin/metformin HCl (Jardiamet) is now contraindicated in patients with severe renal failure (ClCr < 30 mL/min).
   
• Fluorouracil (DBL Fluorouracil Injection BP) is now contraindicated in patients with known complete dihydropyrimidine dehydrogenase deficiency.
   
• Ibuprofen/paracetamol (Mersynofen) is now contraindicated in patients with unclarified blood-formation disturbances, cerebrovascular or other active bleeding, and in patients undergoing treatment of perioperative pain in the setting of coronary artery bypass surgery (CABG).

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.