Akynzeo

Akynzeo

netupitant + palonosetron

Manufacturer:

Mundipharma

Distributor:

DKSH
Concise Prescribing Info
Contents
Netupitant 300 mg, palonosetron 0.5 mg
Indications/Uses
Prevention of acute & delayed nausea & vomiting associated w/ initial & repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
Dosage/Direction for Use
Adult Highly emetogenic chemotherapy including cisplatin based chemotherapy 1 cap approx 1 hr prior to the start of chemotherapy w/ dexamethasone 12 mg administered orally 30 min prior to chemotherapy on day 1 & 8 mg orally once daily on days 2-4. Anthracyclines & cyclophosphamide based chemotherapy & chemotherapy not considered highly emetogenic 1 cap approx 1 hr prior to the start of chemotherapy w/ dexamethasone 12 mg administered orally 30 min prior to chemotherapy on day 1.
Administration
May be taken with or without food.
Special Precautions
Hypersensitivity including anaphylaxis w/ or w/o known hypersensitivity to other 5-HT3 receptor antagonists. Serotonin syndrome associated w/ concomitant use of serotonergic (eg, SSRIs, SNRIs, MAOIs, mirtazapine, fentanyl, lithium, tramadol & methylene blue (IV). Severe hepatic impairment & severe renal impairment or end-stage renal disease. Pregnancy & lactation. Elderly.
Adverse Reactions
Dyspepsia, fatigue, constipation, erythema; headache, asthenia.
Drug Interactions
Increased plasma conc of CYP3A4 substrate. Increased in the systemic exposure of dexamethasone. Increased systemic exposure  of netupitant w/ midazolam & chemotherapy agents (eg, docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, ifosfamide, imatinib, vinorelbine, vinblastine & vincristine). Decreased efficacy in concomitant use w/ strong CYP3A4 inducer. Concomitant use w/ strong CYP3A4 inhibitor (eg, ketoconazole) may increase systemic exposure to the netupitant component.
MIMS Class
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 cap
Packing/Price
1's
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