Akynzeo For Injection

— THERAPEUTIC CATEGORIES —
  • Nausea

Akynzeo For Injection Generic Name & Formulations

General Description

Fosnetupitant, palonosetron; 235mg/0.25mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.

Pharmacological Class

Substance P/NK1 receptor antagonist + 5-HT3 receptor antagonist.

How Supplied

Tabs—1, 4; Single-dose vials (pwd or soln)—1

Generic Availability

NO

Akynzeo For Injection Indications

Indications

Prevention of acute and delayed nausea and vomiting due to initial and repeat courses of highly emetogenic chemotherapy.

Limitations of Use

Not studied for prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

Akynzeo For Injection Dosage and Administration

Adult

Infuse over 30mins. ≥18yrs: Highly emetogenic chemotherapy (including cisplatin-based): 1 vial approx. 30mins prior to chemotherapy with oral dexamethasone 12mg given 30mins before chemotherapy on Day 1, then 8mg orally once daily on Days 2–4.

Children

<18yrs: not established.

Akynzeo For Injection Contraindications

Not Applicable

Akynzeo For Injection Boxed Warnings

Not Applicable

Akynzeo For Injection Warnings/Precautions

Warnings/Precautions

Monitor for symptoms of serotonin syndrome; discontinue and treat if occurs. Severe hepatic or renal impairment, ESRD: avoid. Elderly. Pregnancy. Nursing mothers.

Akynzeo For Injection Pharmacokinetics

See Literature

Akynzeo For Injection Interactions

Interactions

Increased risk of serotonin syndrome with concomitant other serotonergic drugs (eg, SSRIs, SNRIs, MAOIs, mirtazapine, fentanyl, lithium, tramadol, IV methylene blue). May potentiate CYP3A4 substrates (eg, dexamethasone [use reduced dose], midazolam, alprazolam, triazolam, docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, ifosfamide, imatinib, vinorelbine, vinblastine, vincristine); caution and monitor. Avoid concomitant strong CYP3A4 inducers (eg, rifampin). Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole). Concomitant warfarin: monitor INR and adjust dose as needed. Inj: incompatible with divalent cation-containing solutions, Lactated Ringer's Injection, Hartmann's Solution.

Akynzeo For Injection Adverse Reactions

Adverse Reactions

Headache, asthenia, dyspepsia, fatigue, constipation, erythema; hypersensitivity reactions.

Akynzeo For Injection Clinical Trials

See Literature

Akynzeo For Injection Note

Not Applicable

Akynzeo For Injection Patient Counseling

See Literature