Aloxi

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.

Call your doctor at once if you have any of these serious side effects:

  • fever;
  • slow or uneven heart rate, trouble breathing;
  • anxiety, agitation, shivering;
  • feeling light-headed, fainting; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • diarrhea;
  • ...

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 »


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.

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.


Aloxi Patient Information Including Side Effects

Brand Names: Aloxi

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

  • What is palonosetron (Aloxi)?
  • What are the possible side effects of palonosetron (Aloxi)?
  • What is the most important information I should know about palonosetron (Aloxi)?
  • What should I discuss with my health care provider before receiving palonosetron (Aloxi)?
  • How is palonosetron given (Aloxi)?
  • What happens if I miss a dose (Aloxi)?
  • What happens if I overdose (Aloxi)?
  • What should I avoid after receiving palonosetron (Aloxi)?
  • What other drugs will affect palonosetron (Aloxi)?
  • Where can I get more information?

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 surgery or by medicine to treat cancer (chemotherapy or radiation).

Palonosetron may also 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.

Call your doctor at once if you have any of these serious side effects:

  • fever;
  • slow or uneven heart rate, trouble breathing;
  • anxiety, agitation, shivering;
  • feeling light-headed, fainting; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • diarrhea;
  • constipation;
  • dizziness;
  • headache; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

You should not use this medication if you are allergic to palonosetron.

Before you receive palonosetron, tell your doctor if you have an electrolyte imbalance, a personal or family history of "Long QT syndrome," if you take a diuretic (water pill), or if you take a heart rhythm medication.

Tell your doctor if you have ever had an allergic reaction to dolasetron (Anzemet), granisetron (Kytril), or ondansetron (Zofran).

Call your doctor at once if you have uneven heartbeats while receiving palonosetron.

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