Akynzeo

Akynzeo

netupitant + palonosetron

Manufacturer:

Mundipharma

Distributor:

Zuellig
Concise Prescribing Info
Contents
Netupitant 300 mg, palonosetron 0.5 mg
Indications/Uses
Prevention of acute & delayed nausea & vomiting associated w/ initial & repeated courses of moderately or highly emetogenic cancer chemotherapy.
Dosage/Direction for Use
Adult 1 cap approx 1 hr prior to the start of each chemotherapy cycle.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Hypersensitivity to other selective 5-HT3 receptor antagonists. Should not be used to prevent/treat nausea & vomiting following chemotherapy if not associated w/ another chemotherapy administration. Patients w/ history of constipation or signs of subacute intestinal obstruction. Concomitant use w/ medicinal products that increase QT interval or in patients who have or are likely to develop QT prolongation. Hypokalaemia & hypomagnesaemia should be corrected prior to administration. Serotonin syndrome. Concomitant use w/ CYP3A4 substrates. Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency. Monitor patients w/ known hypersensitivity to peanut or soya for signs of allergic reaction. Avoid use in patients w/ severe renal impairment or end-stage renal disease. Caution in patients w/ severe hepatic impairment. May impair ability to drive & use machines. Women of childbearing potential must use effective contraception during therapy & up to 1 mth after treatment. Discontinue breastfeeding during treatment & for 1 mth after the last dose.
Adverse Reactions
Drug Interactions
Increased exposure of CYP3A4 substrates (eg, dexamethasone, docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, ifosfamide, imatinib, vinorelbine, vinblastine, vincristine, erythromycin, midazolam, alprazolam, triazolam). Decreased efficacy w/ strong CYP3A4 inducer (eg, rifampicin). Reports of serotonin syndrome w/ other serotonergic drugs (eg, SSRIs & SNRIs). Caution is recommended when combined w/ strong CYP3A4 inhibitors (eg, ketoconazole); digoxin or w/ other P-gp substrates eg, dabigatran or colchicine; UGT2B7 substrates (eg, zidovudine, valproic acid, morphine).
MIMS Class
Antiemetics
ATC Classification
A04AA55 - palonosetron, combinations ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
Form
Akynzeo hard cap 300 mg/0.5 mg
Packing/Price
1's
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