Prescribing Information for Akynzeo
For full information please refer to the Summary of Product Characteristics before prescribing.
Presentations: 300 mg netupitant and palonosetron hydrochloride equivalent to 0.5 mg of palonosetron.
Indications: In adults, for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy and the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Dosage and Administration: The hard capsule should be swallowed as a whole. Adults: One 300 mg/0.5 mg capsule administered approximately one hour prior to the start of each chemotherapy cycle. The recommended oral dexamethasone dose should be reduced by approximately 50 % when co-administered with Akynzeo. Elderly: No dosage adjustment is necessary in the elderly. Caution should be exercised when using this product in patients over 75 years, due to the long half-life of the active substances and the limited experience in this population. Paediatric population: The safety and efficacy in children has not been established. Hepatic and Renal impairment: No dose adjustment is necessary for patients with impaired hepatic or renal function. No data is available for patients with end stage renal disease requiring haemodialysis. Limited data in patients with severe hepatic impairment.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy.
Precautions and Warnings for Use: Should be used with caution in severe hepatic impairment. Akynzeo may increase large bowel transit time and patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic medicinal products. Appropriate observation of patients for serotonin syndrome-like symptoms is advised. Caution should be exercised with the concomitant use of Akynzeo and drugs that increase the QT interval or in patients who are likely to develop prolongation of the QT interval. Hypokalaemia and hypomagnesaemia should be corrected prior to administration. Akynzeo should not be used to prevent or treat nausea and vomiting in the days following chemotherapy, if not associated with another chemotherapy
administration. Akynzeo should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range. Patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4. Akynzeo may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism. Contains sorbitol and sucrose. Patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May also contain lecithin derived from soya. Patients with known hypersensitivity to peanut or soya, should be monitored closely for signs of an allergic reaction. Akynzeo is contraindicated during pregnancy and should not be used during breast-feeding. Since Akynzeo may cause dizziness, somnolence and fatigue, patients should be cautioned against driving and operating machinery if such symptoms occur.
Common Side Effects: Headache, constipation, fatigue.
Prescribers should consult the Summary of Product Characteristics in relation to other adverse reactions.
Legal Category: POM.
Package Quantities and Prices: 1 x 300 mg/0.5 mg capsule (EU/1/15/1001/001) £69
Marketing Authorisation Holder: Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Republic of Ireland.
UK Distributor: Chugai Pharma UK Limited, Mulliner House, Flanders Road, Turnham Green, London W41NN.
Date of Preparation: May 2017. CPUK/AKY/0011(1)
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Adverse events should be reported.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Chugai Pharma UK Ltd at firstname.lastname@example.org.
Tel:+44 (0) 208 987 5600