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Aloxi Capsules

Last reviewed on RxList: 12/8/2016
Aloxi Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/26/2016

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 Aloxi Capsules are discontinued, but generic versions may be available. Common side effects of Aloxi (palonosetron HCl) Capsules include headache, constipation, or tired feeling. Uncommon side effects of Aloxi (palonosetron HCl) Capsules include:

  • anemia
  • low blood pressure
  • motion sickness
  • eye swelling
  • nausea
  • vomiting
  • fever
  • chills
  • sinus infection
  • weight loss
  • joint pain or stiffness
  • dizziness
  • changes in taste
  • insomnia
  • shortness of breath
  • nosebleed
  • itching, and
  • hair loss

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.

Aloxi Capsules Consumer Information

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)

Aloxi Capsules Professional Information

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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© Aloxi Capsules Patient Information is supplied by Cerner Multum, Inc. and Aloxi Capsules Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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