December 2020

New Products

• Beclometasone dipropionate/formoterol fumarate dihydrate (Fostair) combines beclomethasone dipropionate, a glucocorticoid anti-inflammatory, and formoterol, a selective β₂‑adrenergic agonist. Fostair is indicated in adults (18 years and older) in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting β₂‑agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled rapid-acting β₂‑agonist, or patients already adequately controlled on both inhaled corticosteroid and long-acting β₂‑agonist. It is also indicated for the symptomatic treatment of adults with severe COPD (FEV₁ < 50% predicted normal) with a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. Fostair metered dose inhaler with dose counter contains beclomethasone dipropionate 100 mcg/dose and formoterol fumarate dihydrate 6 mcg/dose (equivalent to a delivered dose of beclomethasone dipropionate 84.6 mcg and formoterol fumarate dihydrate 5 mcg), and is available in a pack size of 120 doses.
   
• Defibrotide (Defitelio) is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions. It primarily acts through reducing excessive endothelial cell activation (endothelial dysfunction), thereby modulating endothelial homeostasis and maintaining the thrombo-fibrinolytic balance. However, the exact mechanism of action of defibrotide is not fully elucidated. Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome), with haematopoietic stem-cell transplantation (HSCT) therapy in adults, adolescents, children and infants (1 month of age and above). Defitelio is contraindicated with the concomitant use of thrombolytic therapy, e.g. tissue plasminogen activator. Defitelio concentrated solution for infusion contains defibrotide 200 mg/2.5 mL per vial and is available in a pack size of 10.
   
• Selexipag (Uptravi) is an oral, selective, prostacyclin (IP) receptor agonist, and is structurally and pharmacologically distinct from prostacyclin and its analogues. The vasculo-protective effects of prostacyclin (PGI2) are mediated by the IP receptor. Decreased expression of IP receptors and synthesis of prostacyclin contribute to the pathophysiology of pulmonary arterial hypertension (PAH). Stimulation of the IP receptor by selexipag and the active metabolite leads to vasodilatory, anti-proliferative and anti-fibrotic effects. Uptravi is indicated for the treatment of idiopathic or heritable PAH, or PAH associated with connective tissue disease, congenital heart disease with repaired shunts, or drugs and toxins in patients with WHO functional class II, III or IV symptoms. Uptravi is contraindicated in patients with severe hepatic impairment (Child-Pugh class C); severe coronary heart disease or unstable angina; myocardial infarction within the last 6 months; decompensated cardiac failure not under close medical supervision; severe arrhythmias; cerebrovascular events, e.g. transient ischaemic attack, stroke, within the last 3 months; congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension; and with concomitant strong CYP2C8 inhibitors, e.g. gemfibrozil. Uptravi tablets contain selexipag 200 mcg (available in packs of 10, 60 and 140), 400, 600, 800, 1000, 1200, 1400 or 1600 mcg (available in packs of 60).
   
• Tafamidis (Vyndamax) is a selective stabiliser of transthyretin (TTR). It binds with negative cooperativity to the two thyroxine binding sites on the native tetrameric form of TTR preventing dissociation into monomers, the rate-limiting step in the amyloidogenic process. Vyndamax is indicated for the treatment of adults with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM). Vyndamax capsules contain micronised tafamidis 61 mg and are available in a pack size of 30.

New Indications

• Apalutamide (Erlyand) is now indicated for the treatment of metastatic castration-sensitive prostate cancer.
   
• Dolutegravir (as sodium)/lamivudine (Dovato 50/300) is now indicated for the treatment
  of HIV-1 infection in adults and adolescents (from 12 years of age weighing at least 40 kg)
  to replace current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure
  and with no known or suspected resistance to the integrase inhibitor class or lamivudine.
   
• Pembrolizumab (rch) (Keytruda), as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, is now indicated for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥ 1] as determined by a validated test. Keytruda is also indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy and whose tumours express PD-L1 [CPS ≥ 1] as determined by a validated test.
   
• Rifampicin (Rimycin) is now indicated for the treatment of Mycobacterium ulcerans infections (Buruli ulcer). Rimycin must be used in combination with another anti-Mycobacterium ulcerans antibiotic.

New Contraindications

• Alemtuzumab (rch) (Lemtrada) is now contraindicated in patients with severe active infection; uncontrolled hypertension; history of arterial dissection of the cervicocephalic arteries, stroke, angina pectoris or myocardial infarction; or with known coagulopathy or on concomitant anticoagulant therapy.
   
• Dolutegravir (as sodium)/lamivudine (Dovato 50/300) must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), including fampridine.
   
• Ibuprofen/paracetamol (Mersynofen) is now contraindicated in patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
   
• Orlistat (Xenical) is now contraindicated during pregnancy and breastfeeding.
   
• Teriflunomide (Aubagio) is now contraindicated in patients who have or have had a drug reaction with eosinophilia and systemic symptoms.
   
• Voriconazole (Vfend) is now contraindicated with concomitant ivabradine.

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.