Palonosetron hydrochloride (Aloxi)
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Palonosetron hydrochloride (Aloxi)

Aloxi®
(palonosetron HCl) Injection

DRUG DESCRIPTION

ALOXI (palonosetron hydrochloride) 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-1 Hbenz[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:

Aloxi® (palonosetron HCl) Structural Formula Illustration

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.

ALOXI (palonosetron hydrochloride) Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Each 5 mL vial of ALOXI (palonosetron hydrochloride) Injection contains 0.25 mg palonosetron base as hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. The pH of the solution is 4.5 to 5.5.

What are the possible side effects of palonosetron (Aloxi)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • headache;
  • constipation; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Aloxi »

What are the precautions when taking palonosetron hydrochloride (Aloxi)?

Before using palonosetron, tell your doctor or pharmacist if you are allergic to it; or to other serotonin blockers (e.g., ondansetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat).

Palonosetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you...

Read All Potential Precautions of Aloxi »

Last reviewed on RxList: 9/27/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Prevention of Chemotherapy-Induced Nausea and Vomiting

ALOXI (palonosetron hydrochloride) is indicated for:

  • Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
  • Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses

DOSAGE AND ADMINISTRATION

Recommended Dosing

Dosage for Adults - a single 0.25 mg I.V. dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy

Instructions for Administration

ALOXI (palonosetron hydrochloride) is supplied ready for intravenous injection. ALOXI (palonosetron hydrochloride) should not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of ALOXI (palonosetron hydrochloride) .

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

Dosage Form And Strengths

ALOXI (palonosetron hydrochloride) is supplied as a single-use sterile, clear, colorless solution in glass vials that provides 0.25 mg (free base) per 5 mL.

HOW SUPPLIED

HOW SUPPLIED/STORAGE AND HANDLING

NDC # 58063-797-25, 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton

Storage

  • Store at controlled temperature of 20-25°C (68°F-77°F). Excursions permitted to 15-30 °C (59-86°F).
  • Protect from freezing.
  • Protect from light.

Mfd by: Cardinal Health, Albuquerque, NM, USA or Pierre Fabre, Médicament Production, Idron, Aquitaine, France and Helsinn Birex Pharmaceuticals, Dublin, Ireland
HELSINN, Mfd for Helsinn Healthcare SA, Switzerland
MGI PHARMA, INC. Distributed and marketed by MGI PHARMA, INC. Bloomington, MN. 55437 under license of Helsinn Healthcare SA, Switzerland. FDA rev date: 8/30/2007

Last reviewed on RxList: 9/27/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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 reported in practice.

In clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 1374 adult patients received palonosetron. Adverse reactions were similar in frequency and severity with ALOXI (palonosetron hydrochloride) and ondansetron or dolasetron. Following is a listing of all adverse reactions reported by ≥2% of patients in these trials (Table 1).

Table 1: Adverse Reactions from Chemotherapy-Induced Nausea and Vomiting Studies ≥2% in any Treatment Group

Event Aloxi 0.25 mg
(N=633)
Ondansetron
32 mg IV
(N=410)
Dolasetron
100 mg IV
(N=194)
Headache 60 (9%) 34 (8%) 32 (16%)
Constipation 29 (5%) 8 (2%) 12 (6%)
Diarrhea 8 (1%) 7 (2%) 4 (2%)
Dizziness 8 (1%) 9 (2%) 4 (2%)
Fatigue 3 (<1%) 4 (1%) 4 (2%)
Abdominal Pain 1 (<1%) 2 (<1%) 3 (2%)
Insomnia 1 (<1%) 3 (1%) 3 (2%)

In other studies, 2 subjects experienced severe constipation following a single palonosetron dose of approximately 0.75 mg, three times the recommended dose. One patient received a 10 mcg/kg oral dose in a postoperative nausea and vomiting study and one healthy subject received a 0.75 mg IV dose in a pharmacokinetic study.

In clinical trials, the following infrequently reported adverse reactions, assessed by investigators as treatment-related or causality unknown, occurred following administration of ALOXI (palonosetron hydrochloride) to adult patients receiving concomitant cancer chemotherapy:

Cardiovascular: 1%: non-sustained tachycardia, bradycardia, hypotension, < 1%: hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles and QT prolongation. In many cases, the relationship to ALOXI (palonosetron hydrochloride) was unclear.

Dermatological: < 1%: allergic dermatitis, rash.

Hearing and Vision: < 1%: motion sickness, tinnitus, eye irritation and amblyopia.

Gastrointestinal System: 1%: diarrhea, < 1%: dyspepsia, abdominal pain, dry mouth, hiccups and flatulence.

General: 1%: weakness, < 1%: fatigue, fever, hot flash, flu-like syndrome.

Liver: < 1%: transient, asymptomatic increases in AST and/or ALT and bilirubin. These changes occurred predominantly in patients receiving highly emetogenic chemotherapy.

Metabolic: 1%: hyperkalemia, < 1%: electrolyte fluctuations, hyperglycemia, metabolic acidosis, glycosuria, appetite decrease, anorexia.

Musculoskeletal: < 1%: arthralgia.

Nervous System: 1%: dizziness, < 1%: somnolence, insomnia, hypersomnia, paresthesia.

Psychiatric: 1%: anxiety, < 1%: euphoric mood. Urinary System: < 1%: urinary retention. Vascular: < 1%: vein discoloration, vein distention.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ALOXI (palonosetron hydrochloride) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Very rare cases (<1/10,000) of hypersensitivity reactions and injection site reactions (burning, induration, discomfort and pain) were reported from postmarketing experience.

Read the Aloxi (palonosetron hydrochloride) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Palonosetron is eliminated from the body through both renal excretion and metabolic pathways with the latter mediated via multiple CYP enzymes. 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 IV palonosetron (0.75 mg) and steady state oral metoclopramide (10 mg four times daily) demonstrated no significant pharmacokinetic interaction.

In controlled clinical trials, ALOXI (palonosetron hydrochloride) injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents.

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: 9/25/2007
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity

Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists.

QTc Intervals

Although palonosetron has been safely administered to 192 patients with pre-existing cardiac impairment in the Phase 3 studies, ALOXI (palonosetron hydrochloride) should be administered with caution in patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc. These include patients with hypokalemia or hypomagnesemia, patients taking diuretics with potential for inducing electrolyte abnormalities, patients with congenital QT syndrome, patients taking anti-arrhythmic drugs or other drugs which lead to QT prolongation, and cumulative high dose anthracycline therapy.

In 3 pivotal trials, ECGs were obtained at baseline and 24 hours after subjects received palonosetron or a comparator drug. In a subset of patients ECGs were also obtained 15 minutes following dosing. The percentage of patients (< 1%) with changes in QT and QTc intervals (either absolute values of > 500 msec or changes of > 60 msec from baseline) was similar to that seen with the comparator drugs.

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week carcinogenicity study in CD-1 mice, animals were treated with oral doses of palonosetron at 10, 30 and 60 mg/kg/day. Treatment with palonosetron was not tumorigenic. The highest tested dose produced a systemic exposure to palonosetron (Plasma AUC) of about 150 to 289 times the human exposure (AUC= 29.8 ng•h/ mL) at the recommended intravenous dose of 0.25 mg. In a 104-week carcinogenicity study in Sprague-Dawley rats, male and female rats were treated with oral doses of 15, 30 and 60 mg/kg/day and 15, 45 and 90 mg/kg/day, respectively. The highest doses produced a systemic exposure to palonosetron (Plasma AUC) of 137 and 308 times the human exposure at the recommended dose. Treatment with palonosetron produced increased incidences of adrenal benign pheochromocytoma and combined benign and malignant pheochromocytoma, increased incidences of pancreatic Islet cell adenoma and combined adenoma and carcinoma and pituitary adenoma in male rats. In female rats, it produced hepatocellular adenoma and carcinoma and increased the incidences of thyroid C-cell adenoma and combined adenoma and carcinoma.

Palonosetron was not genotoxic in the Ames test, the Chinese hamster ovarian cell (CHO/HGPRT) forward mutation test, the ex vivo hepatocyte unscheduled DNA synthesis (UDS) test or the mouse micronucleus test. It was, however, positive for clastogenic effects in the Chinese hamster ovarian (CHO) cell chromosomal aberration test.

Palonosetron at oral doses up to 60 mg/kg/day (about 1894 times the recommended human intravenous dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.

Use In Specific Populations

Pregnancy

Teratogenic Effects: Category B

Teratology studies have been performed in rats at oral doses up to 60 mg/kg/day (1894 times the recommended human intravenous dose based on body surface area) and rabbits at oral doses up to 60 mg/kg/day (3789 times the recommended human intravenous dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to palonosetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, palonosetron should be used during pregnancy only if clearly needed.

Labor and Delivery

Palonosetron has not been administered to patients undergoing labor and delivery, so its effects on the mother or child are unknown.

Nursing Mothers

It is not known whether palonosetron is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and the potential for tumorigenicity shown for palonosetron in the rat carcinogenicity study, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in patients below the age of 18 years have not been established.

Geriatric Use

Population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients ≥65 years of age and younger patients (18 to 64 years). Of the 1374 adult cancer patients in clinical studies of palonosetron, 316 (23%) were ≥65 years old, while 71 (5%) were ≥75 years old. No overall differences in safety or effectiveness were observed between these subjects and the younger subjects, but greater sensitivity in some older individuals cannot be ruled out. No dose adjustment or special monitoring are required for geriatric patients.

Renal Impairment

Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters. Total systemic exposure increased by approximately 28% in severe renal impairment relative to healthy subjects. Dosage adjustment is not necessary in patients with any degree of renal impairment.

Hepatic Impairment

Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects. Dosage adjustment is not necessary in patients with any degree of hepatic impairment.

Race

Intravenous palonosetron pharmacokinetics was characterized in twenty-four healthy Japanese subjects over the dose range of 3 - 90 mcg/kg.

Total body clearance was 25% higher in Japanese subjects compared to Whites, however, no dose adjustment is required. The pharmacokinetics of palonosetron in Blacks has not been adequately characterized.

Last reviewed on RxList: 9/25/2007
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is no known antidote to ALOXI (palonosetron hydrochloride) . Overdose should be managed with supportive care.

Fifty adult cancer patients were administered palonosetron at a dose of 90 mcg/kg (equivalent to 6 mg fixed dose) as part of a dose ranging study. This is approximately 25 times the recommended dose of 0.25 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 intravenous dose of palonosetron at 30 mg/kg (947 and 474 times the human dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice. The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.

CONTRAINDICATIONS

ALOXI (palonosetron hydrochloride) is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [see ADVERSE REACTIONS]

Last reviewed on RxList: 9/25/2007
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors.

Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly when certain agents, such as cisplatin, are used. 5-HT3 receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.

Pharmacodynamics

The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in clinical trials. In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarization and to prolong action potential duration. In clinical trials, the dose-response relationship to the QTc interval has not been fully evaluated.

Pharmacokinetics

After intravenous dosing of palonosetron in healthy subjects and cancer patients, an initial decline in plasma concentrations is followed by a slow elimination from the body. Mean maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞ ) are generally dose-proportional over the dose range of 0.3-90 mcg/kg in healthy subjects and in cancer patients. Following single IV dose of palonosetron at 3 mcg/kg (or 0.21 mg/70 kg) to six cancer patients, mean (±SD) maximum plasma concentration was estimated to be 5.6 ± 5.5 ng/mL and mean AUC was 35.8 ± 20.9 ng•hr/mL. Following IV administration of palonosetron 0.25 mg once every other day for 3 doses in 11 cancer patients, the mean increase in plasma palonosetron concentration from Day 1 to Day 5 was 42±34%. Following IV administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (±SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110±45%.

Distribution

Palonosetron has a volume of distribution of approximately 8.3 ± 2.5 L/kg. Approximately 62% of palonosetron is bound to plasma proteins.

Metabolism

Palonosetron is eliminated by multiple routes with approximately 50% metabolized to form two primary metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron. These metabolites each have less than 1% of the 5-HT3 receptor antagonist activity of palonosetron. In vitro metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 are involved in the metabolism of palonosetron. However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolizers of CYP2D6 substrates.

Elimination

After a single intravenous dose of 10 mcg/kg [14C]-palonosetron, approximately 80% of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40% of the administered dose. In healthy subjects, the total body clearance of palonosetron was 160 ± 35 mL/h/kg and renal clearance was 66.5± 18.2 mL/h/kg. Mean terminal elimination half-life was approximately 40 hours.

Clinical studies

Efficacy of single-dose palonosetron injection in preventing acute and delayed nausea and vomiting induced by both moderately and highly emetogenic chemotherapy was studied in three Phase 3 trials and one Phase 2 trial. In these double-blind studies, complete response rates (no emetic episodes and no rescue medication) and other efficacy parameters were assessed through at least 120 hours after administration of chemotherapy. The safety and efficacy of palonosetron in repeated courses of chemotherapy was also assessed.

Moderately Emetogenic Chemotherapy

Two Phase 3, double-blind trials involving 1132 patients compared single-dose IV ALOXI (palonosetron hydrochloride) with either single-dose IV ondansetron (study 1) or dolasetron (study 2) given 30 minutes prior to moderately emetogenic chemotherapy including carboplatin, cisplatin ≤50 mg/m², cyclophosphamide <1500 mg/m², doxorubicin >25 mg/m², epirubicin, irinotecan, and methotrexate >250 mg/m². Concomitant corticosteroids were not administered prophylactically in study 1 and were used by 4-6% of patients in study 2. The majority of patients in these studies were women (77%), White (65%) and naïve to previous chemotherapy (54%). The mean age was 55 years.

Highly Emetogenic Chemotherapy

A Phase 2, double-blind, dose-ranging study evaluated the efficacy of single-dose IV palonosetron from 0.3 to 90 mcg/kg (equivalent to < 0.1 mg to 6 mg fixed dose) in 161 chemotherapy-naïve adult cancer patients receiving highly-emetogenic chemotherapy (either cisplatin 70 mg/m² or cyclophosphamide > 1100 mg/m²). Concomitant corticosteroids were not administered prophylactically. Analysis of data from this trial indicates that 0.25 mg is the lowest effective dose in preventing acute nausea and vomiting induced by highly emetogenic chemotherapy.

A Phase 3, double-blind trial involving 667 patients compared single-dose IV ALOXI (palonosetron hydrochloride) with single-dose IV ondansetron (study 3) given 30 minutes prior to highly emetogenic chemotherapy including cisplatin 60 mg/m², cyclophosphamide > 1500 mg/m², and dacarbazine. Corticosteroids were co-administered prophylactically before chemotherapy in 67% of patients. Of the 667 patients, 51% were women, 60% White, and 59% naïve to previous chemotherapy. The mean age was 52 years.

Efficacy Results

The antiemetic activity of ALOXI (palonosetron hydrochloride) was evaluated during the acute phase (0-24 hours) [Table 2], delayed phase (24-120 hours) [Table 3], and overall phase (0-120 hours) [Table 4] post-chemotherapy in Phase 3 trials.

Table 2: Prevention of Acute Nausea and Vomiting (0-24 hours): Complete Response Rates

Chemotherapy Study Treatment
Group
N
a
%
with Complete
Response
p-value b 97.5% Confidence Interval
ALOXI (palonosetron hydrochloride) minus Comparator c
Moderately Emetogenic 1 ALOXI
0.25 mg
189 81 0.009 Complete Response Rates  - Illustration 1
Ondansetron
32 mg IV
185 69
2 ALOXI
0.25 mg
189 63 NS
Dolasetron
100 mg IV
191 53
Highly Emetogenic 3 ALOXI
0.25 mg
223 59 NS
Ondansetron
32 mg IV
221 57

a Intent-to-treat cohort
b 2-sided Fisher's exact test. Significance level at α=0.025.
c These studies were designed to show non-inferiority. A lower bound greater than -15% demonstrates non-inferiority between ALOXI (palonosetron hydrochloride) and comparator.

These studies show that ALOXI (palonosetron hydrochloride) was effective in the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. In study 3, efficacy was greater when prophylactic corticosteroids were administered concomitantly. Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase.

Table 3: Prevention of Delayed Nausea and Vomiting (24-120 hours): Complete Response Rates

Chemotherapy Study Treatment Group N a % with Complete Response p-value b 97.5% Confidence Interval ALOXI (palonosetron hydrochloride) minus Comparator c
Moderately Emetogenic 1 ALOXI
0.25 mg
189 74 <0.001 Complete Response Rates - illustration 2
Ondansetron
32 mg IV
185 55
2 ALOXI
0.25 mg
189 54 0.004
Dolasetron
100 mg IV
191 39
a Intent-to-treat cohort
b 2-sided Fisher's exact test. Significance level at α=0.025.
c These studies were designed to show non-inferiority. A lower bound greater than -15% demonstrates non-inferiority between ALOXI (palonosetron hydrochloride) and comparator.

These studies show that ALOXI (palonosetron hydrochloride) was effective in the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.

Table 4: Prevention of Overall Nausea and Vomiting (0-120 hours): Complete Response Rates

Chemotherapy Study Treatment Group N a % with Complete Response p-value b 97.5% Confidence Interval ALOXI (palonosetron hydrochloride) minus Comparator c
Moderately Emetogenic 1 ALOXI
0.25 mg
189 69 <0.001
Ondansetron32 mg IV 185 50
2 ALOXI
0.25 mg
189 46 0.021
Dolasetron
100 mg IV
191 34
a Intent-to-treat cohort
b 2-sided Fisher's exact test. Significance level at α=0.025.
c These studies were designed to show non-inferiority. A lower bound greater than -15% demonstrates non-inferiority between ALOXI (palonosetron hydrochloride) and comparator.

These studies show that ALOXI (palonosetron hydrochloride) was effective in the prevention of nausea and vomiting throughout the 120 hours (5 days) following initial and repeat courses of moderately emetogenic cancer chemotherapy.

Last reviewed on RxList: 9/27/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

ALOXI (palonosetron hydrochloride) ™
(Ah-lock-see)
Palonosetron HCI injection

PATIENT COUNSELING INFORMATION

Instructions for Patients

  • Patients should be advised to report to their physician all of their medical conditions, especially if they have heart problems including a problem called “congenital QT syndrome” or they are taking medicines that have caused or may cause severe heart beat changes such as diuretics, anti-arrhythmics or anthracycline. [see WARNINGS and PRECAUTIONS].
  • Patients should be advised to report to their physician any pain, redness, or swelling in and around the infusion site [see ADVERSE REACTIONS].
  • Patients should be instructed to read the patient insert.

FDA-Approved Patient Labeling

Read the Patient Information that comes with ALOXI (palonosetron hydrochloride) before your treatment with ALOXI (palonosetron hydrochloride) and each time you get ALOXI (palonosetron hydrochloride) . There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have questions about ALOXI (palonosetron hydrochloride) , ask your doctor or pharmacist.

What is ALOXI (palonosetron hydrochloride) ?

ALOXI (palonosetron hydrochloride) is a medicine called an “antiemetic.” ALOXI (palonosetron hydrochloride) is used in adults to help prevent the nausea and vomiting that happens:

  • right away with certain anti-cancer medicines (chemotherapy)
  • or later with certain anti-cancer medicines

What is ALOXI (palonosetron hydrochloride) used for?

ALOXI (palonosetron hydrochloride) is used to prevent nausea and vomiting that may happen: soon after taking certain anti-cancer medicines later after taking certain anti-cancer medicines

Who should not take ALOXI (palonosetron hydrochloride) ?

Do not take ALOXI (palonosetron hydrochloride) if you are allergic to any of the ingredients in ALOXI. The active ingredient is palonosetron hydrochloride. See the end of this leaflet for a complete list of ingredients in ALOXI (palonosetron hydrochloride) .

ALOXI (palonosetron hydrochloride) has not been studied in children under 18 years of age.

What should I tell my doctor before using ALOXI (palonosetron hydrochloride) ?

Tell your doctor about all of your medical conditions, including if you:

  • have heart problems including a problem called “congenital QT syndrome”
  • have low potassium in your blood have low magnesium in your blood
  • are pregnant. It is not known if ALOXI (palonosetron hydrochloride) may harm your unborn baby. You and your doctor should decide if ALOXI (palonosetron hydrochloride) is right for you.
  • are breastfeeding. It is not known if ALOXI (palonosetron hydrochloride) passes into your milk and if it can harm your baby. You should choose to either take ALOXI (palonosetron hydrochloride) or breastfeed, but not both.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. ALOXI (palonosetron hydrochloride) should be given with caution in patients who may be taking other medicines that have caused, or may cause, severe heart beat changes.

Especially, tell your doctor if you take:

  • “water pills” (diuretics)
  • medicine to control your heartbeat (anti-arrhythmics)
  • anthracycline (an anti-cancer medicine)

How should I use ALOXI (palonosetron hydrochloride) ?

ALOXI (palonosetron hydrochloride) is given in your vein by IV (intravenous) injection. It is only given to you by a healthcare provider in a hospital or clinic. ALOXI (palonosetron hydrochloride) is usually injected into your vein about 30 minutes before you get your anti-cancer medicine (chemotherapy).

What are the possible side effects of ALOXI (palonosetron hydrochloride) ?

ALOXI (palonosetron hydrochloride) should be given with caution in patients who have or may develop severe heart beat changes from QT prolongation. This can happen in people who have certain heart or other medical problems or who take certain medicines.

The most common side effects of ALOXI (palonosetron hydrochloride) are headache and constipation. Diarrhea and dizziness have also been observed.

These are not all the side effects from ALOXI (palonosetron hydrochloride) . For more information ask your doctor or pharmacist.

General information about ALOXI (palonosetron hydrochloride)

Medicines are sometimes prescribed for conditions other than those listed in patient information leaflets. ALOXI (palonosetron hydrochloride) was prescribed for your medical condition.

This leaflet summarizes the most important information about ALOXI (palonosetron hydrochloride) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ALOXI (palonosetron hydrochloride) that is written for health professionals. You can also visit the ALOXI (palonosetron hydrochloride) web site at www.ALOXI (palonosetron hydrochloride) .com. Or visit www.ManageCINV.com. This is a web site for patients with nausea and vomiting from anti-cancer medicines.

What are the ingredients in ALOXI?

Active ingredient: palonosetron hydrochloride

Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water

Last reviewed on RxList: 9/25/2007
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

ALOXI (palonosetron hydrochloride) ™
(Ah-lock-see)
Palonosetron HCI injection

PATIENT COUNSELING INFORMATION

Instructions for Patients

  • Patients should be advised to report to their physician all of their medical conditions, especially if they have heart problems including a problem called “congenital QT syndrome” or they are taking medicines that have caused or may cause severe heart beat changes such as diuretics, anti-arrhythmics or anthracycline. [see WARNINGS and PRECAUTIONS].
  • Patients should be advised to report to their physician any pain, redness, or swelling in and around the infusion site [see ADVERSE REACTIONS].
  • Patients should be instructed to read the patient insert.

FDA-Approved Patient Labeling

Read the Patient Information that comes with ALOXI (palonosetron hydrochloride) before your treatment with ALOXI (palonosetron hydrochloride) and each time you get ALOXI (palonosetron hydrochloride) . There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have questions about ALOXI (palonosetron hydrochloride) , ask your doctor or pharmacist.

What is ALOXI (palonosetron hydrochloride) ?

ALOXI (palonosetron hydrochloride) is a medicine called an “antiemetic.” ALOXI (palonosetron hydrochloride) is used in adults to help prevent the nausea and vomiting that happens:

  • right away with certain anti-cancer medicines (chemotherapy)
  • or later with certain anti-cancer medicines

What is ALOXI (palonosetron hydrochloride) used for?

ALOXI (palonosetron hydrochloride) is used to prevent nausea and vomiting that may happen: soon after taking certain anti-cancer medicines later after taking certain anti-cancer medicines

Who should not take ALOXI (palonosetron hydrochloride) ?

Do not take ALOXI (palonosetron hydrochloride) if you are allergic to any of the ingredients in ALOXI. The active ingredient is palonosetron hydrochloride. See the end of this leaflet for a complete list of ingredients in ALOXI (palonosetron hydrochloride) .

ALOXI (palonosetron hydrochloride) has not been studied in children under 18 years of age.

What should I tell my doctor before using ALOXI (palonosetron hydrochloride) ?

Tell your doctor about all of your medical conditions, including if you:

  • have heart problems including a problem called “congenital QT syndrome”
  • have low potassium in your blood have low magnesium in your blood
  • are pregnant. It is not known if ALOXI (palonosetron hydrochloride) may harm your unborn baby. You and your doctor should decide if ALOXI (palonosetron hydrochloride) is right for you.
  • are breastfeeding. It is not known if ALOXI (palonosetron hydrochloride) passes into your milk and if it can harm your baby. You should choose to either take ALOXI (palonosetron hydrochloride) or breastfeed, but not both.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. ALOXI (palonosetron hydrochloride) should be given with caution in patients who may be taking other medicines that have caused, or may cause, severe heart beat changes.

Especially, tell your doctor if you take:

  • “water pills” (diuretics)
  • medicine to control your heartbeat (anti-arrhythmics)
  • anthracycline (an anti-cancer medicine)

How should I use ALOXI (palonosetron hydrochloride) ?

ALOXI (palonosetron hydrochloride) is given in your vein by IV (intravenous) injection. It is only given to you by a healthcare provider in a hospital or clinic. ALOXI (palonosetron hydrochloride) is usually injected into your vein about 30 minutes before you get your anti-cancer medicine (chemotherapy).

What are the possible side effects of ALOXI (palonosetron hydrochloride) ?

ALOXI (palonosetron hydrochloride) should be given with caution in patients who have or may develop severe heart beat changes from QT prolongation. This can happen in people who have certain heart or other medical problems or who take certain medicines.

The most common side effects of ALOXI (palonosetron hydrochloride) are headache and constipation. Diarrhea and dizziness have also been observed.

These are not all the side effects from ALOXI (palonosetron hydrochloride) . For more information ask your doctor or pharmacist.

General information about ALOXI (palonosetron hydrochloride)

Medicines are sometimes prescribed for conditions other than those listed in patient information leaflets. ALOXI (palonosetron hydrochloride) was prescribed for your medical condition.

This leaflet summarizes the most important information about ALOXI (palonosetron hydrochloride) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ALOXI (palonosetron hydrochloride) that is written for health professionals. You can also visit the ALOXI (palonosetron hydrochloride) web site at www.ALOXI (palonosetron hydrochloride) .com. Or visit www.ManageCINV.com. This is a web site for patients with nausea and vomiting from anti-cancer medicines.

What are the ingredients in ALOXI?

Active ingredient: palonosetron hydrochloride

Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water

Last reviewed on RxList: 9/25/2007
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Aloxi Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PALONOSETRON - INJECTION

(pal-oh-NOE-se-tron)

COMMON BRAND NAME(S): Aloxi

USES: This medication is used to prevent nausea and vomiting caused by cancer chemotherapy. It may also be used to prevent nausea and vomiting after surgery.

It works by blocking the hormone (serotonin) that causes vomiting.

HOW TO USE: This medication is given by injection into a vein by a health care professional. It is usually given 30 minutes before chemotherapy or right before anesthesia for surgery.

Disclaimer

Aloxi Consumer (continued)

SIDE EFFECTS: Headache, constipation, diarrhea, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.

A serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Aloxi (palonosetron hydrochloride) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using palonosetron, tell your doctor or pharmacist if you are allergic to it; or to other serotonin blockers (e.g., ondansetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat).

Palonosetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using palonosetron, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using palonosetron safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk or may harm a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Aloxi Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: anthracyclines (e.g., doxorubicin, daunorubicin), apomorphine.

Many drugs besides palonosetron may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), sparfloxacin, among others. Therefore, before using palonosetron, report all medications you are currently using to your doctor or pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Not applicable.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

Information last revised November 2010. Copyright(c) 2010 First Databank, Inc.

Aloxi Patient Information Including Side Effects

Brand Names: Aloxi

Generic Name: palonosetron (Pronunciation: PAL oh NOE se tron)

What is palonosetron (Aloxi)?

Palonosetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Palonosetron is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy).

Palonosetron may be used for other purposes not listed in this medication guide.

What are the possible side effects of palonosetron (Aloxi)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • headache;
  • constipation; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Aloxi (palonosetron hydrochloride) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about palonosetron (Aloxi)?

You should not use this medication if you are allergic to palonosetron or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or ondansetron (Zofran).

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

Side Effects Centers

Aloxi Patient Information including How Should I Take

What should I discuss with my health care provider before taking palonosetron (Aloxi)?

You should not use this medication if you are allergic to palonosetron or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or ondansetron (Zofran).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether palonosetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take palonosetron (Aloxi)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Palonosetron is usually taken 1 hour before chemotherapy. Follow your doctor's instructions.

Store palonosetron at room temperature away from moisture and heat.

Side Effects Centers

Aloxi Patient Information including If I Miss a Dose

What happens if I miss a dose (Aloxi)?

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Aloxi)?

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of palonosetron is not expected to produce life-threatening symptoms.

What should I avoid while taking palonosetron (Aloxi)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect palonosetron (Aloxi)?

There may be other drugs that can interact with palonosetron. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about palonosetron.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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