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AKYNZEO is a brand name for Palonosetron, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE.............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Akynzeo® (netupitant/palonosetron) is contraindicated in patients who are hypersensitive to these drugs or to any ingredient in the formulation or component of the container. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING.
Akynzeo is contraindicated during pregnancy. Akynzeo should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by netupitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions (see DRUG INTERACTIONS).
WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Drug interactions may occur with medicinal products, including chemotherapeutic agents (see WARNINGS AND PRECAUTIONS) that are metabolized through CYP3A4 (see DRUG INTERACTIONS).
General Akynzeo® contains sorbitol and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. Akynzeo may also contain a trace of lecithin derived from soya.
Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction. Carcinogenesis and Mutagenesis Long-term studies in animals to evaluate carcinogenic potential have not been performed with netupitant.
Netupitant was not genotoxic in the Ames test, the mouse lymphoma cell mutation test, or the in vivo rat micronucleus test (see TOXICOLOGY, Genotoxicity). Statistically significant increased incidences of a variety of different tumors affecting the adrenal, liver, mammary gland, and other tissues and organs were observed at high doses of palonosetron in a rat carcinogenicity study.
In the mouse study, the findings were not attributed to palonosetron treatment (see TOXICOLOGY, Carcinogenicity). Experimental evidence indicates that palonosetron is non-mutagenic (see TOXICOLOGY, Genotoxicity). 5 mg respectively. 5 mg) (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacodynamics).
Page 5 of 36 Many drugs that cause QTc prolongation are suspected to increase the risk of torsade de pointes, a polymorphic ventricular tachyarrhythmia that may be asymptomatic or experienced by the patient as dizziness, palpitations, syncope, or seizures.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Palonosetron in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
If sustained, torsade de pointes can progress to ventricular fibrillation and sudden cardiac death. Caution should be exercised in patients who have or are likely to develop prolongation of the QT interval. , congestive heart failure, myocardial ischemia, conduction system disease), and bradycardia or bradyarrhythmia.
Caution should also be observed in patients taking anti-arrhythmic medicinal products, other medicinal products that lead to QT prolongation or electrolyte abnormalities, or drugs that inhibit the metabolism of netupitant or palonosetron (see DRUG INTERACTIONS).
Hypokalemia, hypocalcemia, and hypomagnesemia should be corrected prior to administration. g. docetaxel). Therefore, patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4, including irinotecan.
Furthermore, netupitant may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism. Constipation As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration.
Hypersensitivity Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists. Psychomotor Impairment Akynzeo may influence the ability to drive and use machines.
Since it may induce dizziness, somnolence or fatigue, patients should be cautioned not to drive or use machines until they know how they react to Akynzeo. Serotonin Syndrome/Neuroleptic Malignant Syndrome-like Events Cases of life-threatening serotonin syndrome or neuroleptic malignant syndrome-like events have been reported with 5-HT3 receptor antagonist antiemetics, particularly when given in combination with other serotonergic and/or neuroleptic drugs.
, nausea, vomiting, diarrhea). As these syndromes may result in potentially life-threatening conditions, treatment should be discontinued if such events occur and supportive symptomatic treatment should be initiated. If Page 6 of 36 concomitant treatment of Akynzeo with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see DRUG INTERACTIONS).
Special Populations Women of Childbearing Potential/Contraception in Women:
Pregnant women or women intending to become pregnant should not take Akynzeo. A pregnancy test should be performed on all pre-menopausal women prior to treatment. Women of childbearing potential must […]