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 1 day 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 may include: 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 may include: 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 may include: Feeling dizzy, lightheaded, or faint Inflammation of the pancreas (pancreatitis) What it is: A condition that affects the pancreas Symptoms may include: 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 www.fda.gov/medwatch. SEE HOW XOSPATA CAN BE TAKEN IN YOUR OWN HOME