April 2021

New Products

• Indacaterol/glycopyrronium/mometasone furoate (Enerzair Breezhaler) combines indacaterol, a long-acting β₂-adrenergic agonist (LABA), glycopyrronium, a long-acting muscarinic receptor antagonist and mometasone furoate, an inhaled corticosteroid (ICS). Following oral inhalation, indacaterol and glycopyrronium act locally on airways to produce bronchodilation by separate mechanisms and mometasone furoate reduces pulmonary inflammation. Enerzair Breezhaler is indicated for the maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of LABA and ICS who experienced one or more asthma exacerbations in the previous year. Enerzair Breezhaler powder for inhalation is available in 2 strengths: 114/46/68 mcg or 114/46/136 mcg indacaterol/glycopyrronium/mometasone furoate per capsule, in cartons containing 30 hard capsules and 1 Breezhaler inhaler.
   
• Romosozumab (Evenity) is a humanised monoclonal antibody (IgG2) that binds and inhibits sclerostin, a negative regulator of bone formation predominantly secreted by mature osteocytes. It increases bone formation and decreases bone resorption. It also increases trabecular and cortical bone mass and improves bone structure and strength. Evenity is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture, and to increase bone mass in men with osteoporosis at high risk of fracture. Evenity is contraindicated with uncorrected hypocalcaemia and with known hypersensitivity to Chinese hamster ovary (CHO)-derived proteins. Evenity solution for injection contains romosozumab 105 mg/1.17 mL and is available in pack size of 2 prefilled syringes.

New Indications

• Avelumab (rch) (Bavencio) is now indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed with first-line platinum-based induction chemotherapy.
   
• Baricitinib (Olumiant) is now indicated for the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy.
   
• Brigatinib (Alunbrig) is now indicated for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.
   
• Nivolumab (Opdivo) is now indicated as monotherapy for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum-based chemotherapy.
   
• Olaparib (Lynparza Tablets), in combination with bevacizumab, is now indicated for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation (germline or somatic), and/or genomic instability. It is also now indicated as monotherapy for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA mutation (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. HRD and gBRCAm status should be determined by an experienced laboratory using a validated test method.

New Contraindications

• Mepivacaine HCl (Scandonest 3%) and mepivacaine HCl with adrenaline (Scandonest 2% Special) is now contraindicated in children under 3 years of age.
   
• Raltitrexed (Tomudex) is now contraindicated in patients with severe renal impairment (ClCr < 25 mL/min) and with concomitant administration of calcium folinate (folinic acid), folic acid or vitamin preparations containing these agents.
   
• Sodium tetradecyl sulfate (Fibrovein) is now contraindicated in patients with recent deep vein thrombosis or pulmonary embolism.

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.