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Aloxi Capsules

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Aloxi Capsules

Aloxi Capsules

Aloxi Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aloxi (palonosetron HCl) Capsule is an antiemetic and antinauseant drug used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy). The brand name of this medication is discontinued, but generic versions may be available. Common side effects include headache, constipation, or tired feeling.

The dosage of Aloxi for adults is one 0.5 mg capsule administered approximately one hour prior to the start of chemotherapy. Aloxi may interact with other drugs. Tell your doctor all medications and supplements you use. Aloxi is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Aloxi (palonosetron HCl) Capsule Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aloxi Capsules in Detail - Patient Information: Side Effects

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 entire detailed patient monograph for Aloxi Capsules (Palonosetron HCl Capsules) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aloxi Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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 entire FDA prescribing information for Aloxi Capsules (Palonosetron HCl Capsules) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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