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New Products
- Ciclosporin (Cequa) is a topical ocular immunodulator. Cequa is indicated to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye) where prior use of artificial tears has not been sufficient. Cequa is contraindicated in active or suspected ocular or peri-ocular infection; and ocular or peri-ocular malignancies or premalignant conditions. Cequa eye drops contain ciclosporin 900 mcg/mL and are available in a pack size of sixty 0.25 mL single use ampoules.
- Difelikefalin (acetate) (Korsuva) is a selective kappa opioid receptor agonist with low central nervous system penetration. The pathophysiology of chronic kidney disease-associated pruritus is thought to be multifactorial, including systemic inflammation and an imbalance in the endogenous opioid system (e.g., overexpression of mu opioid receptors and concomitant downregulation of kappa opioid receptors). Opioid receptors are known to modulate itch signals and inflammation, with kappa opioid receptor activation reducing itch and producing immunomodulatory effects. The activation of kappa opioid receptors on peripheral sensory neurons and immune cells by difelikefalin are considered mechanistically responsible for the antipruritic and anti‑inflammatory effects. Korsuva is indicated for the treatment of moderate‑to‑severe pruritus associated with chronic kidney disease in adult patients on haemodialysis. Korsuva solution for injection contains difelikefalin 50 mcg/mL and is available in a pack size of twelve 1 mL single use vials.
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New Indications
- Axicabtagene ciloleucel (Yescarta) is now indicated in patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
- Cabozantinib (Cabometyx) is now indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma that has progressed during or after prior VEGFR‑targeted therapy and who are radioactive iodine refractory or ineligible.
- Empagliflozin (Jardiance) is now indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy.
- Tixagevimab and cilgavimab (Evusheld) now has provisional approval for the treatment of adults with COVID‑19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.
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New Contraindications
- Dolutegravir (sodium), abacavir (sulfate) and lamivudine (Triumeq) is now contraindicated with concurrent administration of medicinal products with narrow therapeutic windows, that are substrates of organic cation transporter 2 (OCT2), including but not limited to dofetilide, pilsicainide or fampridine.
- Parecoxib (sodium) (Dynastat) is now contraindicated in the third trimester of pregnancy or in breastfeeding.
- Piroxicam (Feldene, Feldene-D) is now contraindicated in patients in their third trimester of pregnancy and in breastfeeding.
- Sotalol hydrochloride (Sotacor) is now contraindicated in hypersensitivity to other beta blockers, severe sinus node dysfunction, sinoatrial block, hypomagnesaemia, hypotension, late stages of peripheral arterial occlusive disease, metabolic acidosis, torsades de pointes, Raynaud’s phenomenon, severe peripheral circulatory disturbance, untreated phaeochromocytoma; and with concomitant intravenous administration of verapamil or diltiazem calcium antagonists or other antiarrhythmic agents (such as disopyramide) except in the case of intensive care medicine.
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Safety Related Changes
- Axicabtagene ciloleucel (Yescarta) no longer requires two or more lines of prior systemic therapy in the treatment of relapsed or refractory large B-cell lymphoma.
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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.
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