Company: Chugai Pharma UK Ltd.
Legal category: Prescription. Hospital only. Sport permitted.
Active ingredients: Netupitant/ palonosetron hydrochloride 300/0.5mg.
Description: Opaque gelatin hard capsule with white body marked HE1 and caramel cap, filled with three tablets and one soft capsule.Presentation: 1, €100.00.
Indications: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy or moderately emetogenic cancer chemotherapy.
Pharmacology: Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors, it inhibits substance P mediated responses which are associated with delayed emesis. Palonosetron is a 5-HT3 receptor antagonist which impedes vomiting reflex initiation by serotonin.
Dosage: Adult: Swallow 1 capsule whole approximately 1 hour before start of chemotherapy. When co-administered, reduce oral dexamethasone dose by approximately 50%. Elderly: As per adults. Over 75 years, caution. Children: Not recommended.
Contraindications: Hypersensitivity to the active substances or to any of the excipients. Pregnancy, lactation; women should use contraception and not breastfeed during and for one month following treatment.
Special precautions: Do not administer to prevent/treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration. Correct hypokalaemia and hypomagnesaemia prior to administration. Avoid: End-stage renal disease requiring hemodialysis. Caution: Patients at risk of prolongation of QT interval, severe hepatic impairment. History of constipation or signs of subacute intestinal obstruction (monitor). Serotonin syndrome may occur. Severe renal impairment. Driving/using machines. Contains lecithin, sorbitol, sucrose.
Drug interactions: Avoid: Strong CYP3A4 inducers. Caution: Drugs increasing QT interval, orally administered CYP3A4 substrates with a narrow therapeutic range, strong CYP3A4 inhibitors, P-gp substrates, UGT2B7 substrates (oral). CYP3A4 inhibitors/ inducers/ substrates, docetaxel, etoposide, other serotonergics, BCRP transported substrates, CYP3A4 metabolism-activated chemotherapeutic agents.
Adverse drug reactions: Headache, constipation, fatigue.
Full prescribing information and references available from Chugai Pharma UK Ltd.
Telephone: +44 (0) 1748 827 276. E-mail: ChugaiPharmaGB@Pi-arm.co.uk