Possible Side Effects

What Are Possible Serious Side Effects of XOSPATA?

Differentiation syndrome

What it is

  • A condition that affects your blood cells
    • May be life-threatening or lead to death if not treated
    • Can happen as early as 2 days after starting XOSPATA and during the first 3 months of treatment
    • Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the symptoms of differentiation syndrome

Symptoms

  • Fever
  • Cough
  • Trouble breathing
  • Rash
  • Dizziness or lightheadedness
  • Rapid weight gain
  • Swelling of arms or legs
  • Decreased urination

Posterior reversible encephalopathy syndrome (PRES)

What it is

  • A condition that affects the brain
    • If PRES is suspected, your doctor will do a test to check for it
    • If you develop PRES, your doctor will stop treatment with XOSPATA

Symptoms

  • Seizure
  • Headache
  • Decreased alertness
  • Confusion
  • Reduced eyesight, blurred vision, or other visual problems

Changes in the electrical activity of your
heart (QTc prolongation)

What it is

  • Can cause irregular heartbeats that can be life-threatening
    • Your doctor will do a test before you start taking XOSPATA and during your treatment with XOSPATA
    • More likely to happen in people with low blood magnesium or low blood potassium levels

Symptoms

  • Feeling dizzy, lightheaded, or faint

Inflammation of the pancreas (pancreatitis)

What it is

  • A condition that affects the pancreas

Symptoms

  • Severe stomach (abdomen) pain that does not go away
  • Pain may happen with or without nausea and vomiting

What Are the Most Common Side Effects of XOSPATA?

  • Changes in liver function tests
  • Joint or muscle pain
  • Tiredness
  • Fever
  • Pain or sores in mouth or throat
  • Swelling of arms or legs
  • Rash
  • Diarrhea
  • Shortness of breath
  • Nausea
  • Cough
  • Constipation
  • Eye problems
  • Headache
  • Dizziness
  • Low blood pressure
  • Vomiting
  • Decreased urination

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking XOSPATA if you develop certain side effects during treatment with XOSPATA.

These are not all of the possible side effects of XOSPATA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or .