Drug: Aloxi Capsules
ALOXI (palonosetron HCl) Capsules is an antiemetic and antinauseant agent. It is a serotonin subtype 3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula: Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Each light beige opaque soft gelatin ALOXI (palonosetron hcl capsules) Capsule contains 0.56 mg of palonosetron HCl equivalent to palonosetron 0.5 mg. Inactive ingredients are: mono- and di-glycerides of capryl/capric acid, glycerin, polyglyceryl oleate, water, and butylated hydroxyanisole.
Source: http://www.rxlist.com
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy, 693 adult patients received oral palonosetron in doses ranging from 0.25 mg to 0.75 mg. Following is a listing of drug related adverse reactions reported by ≥ 2% of patients from two clinical trials. Table 1: Adverse Reactions ≥ 2% from Chemotherapy-Induced Nausea and Vomiting Studies
Event 0.25 mg
(N=157) 0.5 mg
(N=161) 0.75 mg
(N=375) 0.25 mg I.V.
(N=163) Headache 6 (3.8%) 6 (3.7%) 21 (5.6%) 14 (8.6%) Constipation 1 (0.6%) 1 (0.6%) 9 (2.4%) 5 (3.1%) The infrequently reported adverse reactions listed below, assessed by investigators as treatment-related or causality unknown/missing, occurred following administration of ALOXI (palonosetron hcl capsules) Capsules to adult patients receiving concomitant cancer chemotherapy. Of these adverse events, fatigue (incidence 1%), was the only adverse event reported at an incidence of ≥ 1%. In general, adverse reactions were similar between oral and I.V. formulations. Blood and Lymphatic System: <1%: anemia. Cardiovascular: <1%: hypertension, transient arrhythmia, first degree atrioventricular block, second degree atrioventricular block, QTc prolongation. Hearing and Labyrinth: <1%: motion sickness. Eye: <1%: eye swelling. Gastrointestinal System: <1%: gastritis, nausea, vomiting. General: 1%: fatigue, <1%: chills, pyrexia. Infections: <1%: sinusitis. Liver: <1%: transient, asymptomatic increases in bilirubin. Nutrition: <1%: anorexia. Musculoskeletal: <1%: joint stiffness, myalgia, pain in extremity. Nervous System: <1%: postural dizziness, dysgeusia. Psychiatric: <1%: insomnia. Respiratory System: <1%: dyspnea, epistaxis. Skin: <1%: generalized pruritus, erythema, alopecia. Very rare cases (<1/10,000) of hypersensitivity reactions have been reported for I.V. ALOXI (palonosetron hcl capsules) from post-marketing experience. Read the Aloxi Capsules (palonosetron hcl capsules) Side Effects Center for a complete guide to possible side effectsLearn More »
Event 0.25 mg
(N=157) 0.5 mg
(N=161) 0.75 mg
(N=375) 0.25 mg I.V.
(N=163) Headache 6 (3.8%) 6 (3.7%) 21 (5.6%) 14 (8.6%) Constipation 1 (0.6%) 1 (0.6%) 9 (2.4%) 5 (3.1%) The infrequently reported adverse reactions listed below, assessed by investigators as treatment-related or causality unknown/missing, occurred following administration of ALOXI (palonosetron hcl capsules) Capsules to adult patients receiving concomitant cancer chemotherapy. Of these adverse events, fatigue (incidence 1%), was the only adverse event reported at an incidence of ≥ 1%. In general, adverse reactions were similar between oral and I.V. formulations. Blood and Lymphatic System: <1%: anemia. Cardiovascular: <1%: hypertension, transient arrhythmia, first degree atrioventricular block, second degree atrioventricular block, QTc prolongation. Hearing and Labyrinth: <1%: motion sickness. Eye: <1%: eye swelling. Gastrointestinal System: <1%: gastritis, nausea, vomiting. General: 1%: fatigue, <1%: chills, pyrexia. Infections: <1%: sinusitis. Liver: <1%: transient, asymptomatic increases in bilirubin. Nutrition: <1%: anorexia. Musculoskeletal: <1%: joint stiffness, myalgia, pain in extremity. Nervous System: <1%: postural dizziness, dysgeusia. Psychiatric: <1%: insomnia. Respiratory System: <1%: dyspnea, epistaxis. Skin: <1%: generalized pruritus, erythema, alopecia. Very rare cases (<1/10,000) of hypersensitivity reactions have been reported for I.V. ALOXI (palonosetron hcl capsules) from post-marketing experience. Read the Aloxi Capsules (palonosetron hcl capsules) Side Effects Center for a complete guide to possible side effectsLearn More »
Source: http://www.rxlist.com
Recommended Dosing Dosage for Adults - one 0.5 mg capsule administered approximately one hour prior to the start of chemotherapy. ALOXI (palonosetron hcl capsules) can be taken with or without food.
Source: http://www.rxlist.com
Palonosetron is eliminated from the body through both renal excretion and metabolic pathways with the latter mediated via multiple CYP enzymes. Further in vitro studies indicated that palonosetron is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 and CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6, or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with palonosetron appears to be low. A study in healthy volunteers involving single-dose I.V. palonosetron (0.75 mg) and steady state oral metoclopramide (10 mg four times daily) demonstrated no significant pharmacokinetic interaction. Concomitant administration of an antacid (Maalox® liquid 30 mL) had no effect on the oral absorption or pharmacokinetics of a single capsule of palonosetron 0.75 mg in healthy subjects. In controlled clinical trials, ALOXI (palonosetron hcl capsules) Capsules have been safely administered with chemotherapeutic agents, systemic corticosteroids, analgesics, and drugs for gastrointestinal disorders including function gastrointestinal disorders, acid-related disorders, and antiemetics/antinauseants. Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. Last reviewed on RxList: 9/19/2008
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Prevention of Chemotherapy-Induced Nausea and Vomiting ALOXI (palonosetron hcl capsules) Capsules are indicated for:
- Moderately emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses
Source: http://www.rxlist.com
ALOXI (palonosetron hcl capsules) is contraindicated in patients known to have hypersensitivity to the drug or any of its components. Last reviewed on RxList: 9/19/2008
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
There is no known antidote to ALOXI (palonosetron hcl capsules) . Overdose should be managed with supportive care. Thirty-three adult cancer patients were administered oral palonosetron at a dose of 90 µg/kg (equivalent to 6 mg fixed dose) as part of a dose ranging study. This is approximately 12 times the recommended oral dose of 0.5 mg. This dose group had a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose. A single oral dose of palonosetron at 500 mg/kg in rats and 100 mg/kg in dogs (7673 and 5115 times the recommended human oral dose, respectively, based on body surface area) was lethal. The major signs of toxicity included convulsions, labored breathing, and salivation.
Source: http://www.rxlist.com
Dosage Forms And Strengths Capsules, 0.5 mg NDC #62856-799-05, ALOXI (palonosetron hcl capsules) Capsules, 0.5 mg (free base), are supplied as light beige opaque soft gelatin capsules, five capsules per bottle, each bottle packaged in a small carton. Storage
This monograph has been modified to include the generic and brand name in many instances.
- Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
- Protect from light.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Hypersensitivity Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists. Hypersensitivity reactions have been very rarely reported postmarketing for intravenous palonosetron: dyspnea, bronchospasm, swelling/edema, erythema, pruritus, rash, urticaria. No hypersensitivity reactions have been reported for oral palonosetron. Patient Counseling Information See FDA-Approved Patient Labeling Instructions for Patients
This monograph has been modified to include the generic and brand name in many instances.
- Patients should be instructed to read the patient insert.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
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