• Hemolytic Uremic Syndrome (HUS). Hemolytic uremic syndrome is a condition that affects your blood cells and kidneys and may be life-threatening if not treated right away. Get emergency medical help right away if you develop any of the following symptoms of HUS:

• decrease in the amount of urine or dark urine (tea-colored)
• unusual bleeding or bruising of your skin
• stomach pain
• vomiting
• fever

• feeling tired
• changes in mood or behavior
• confusion
• seizures
• shortness of breath
• fast heartbeat

Your healthcare provider will do blood tests to check your blood cells and kidneys before you receive each dose of LUMOXITI and during treatment as recommended by your healthcare provider.

If you develop any of these symptoms of CLS or HUS, your healthcare provider may monitor you in the hospital.

Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during your treatment with LUMOXITI. Your healthcare provider may delay or completely stop treatment with LUMOXITI if you have severe side effects.

• Kidney problems. LUMOXITI may cause kidney problems. People who have HUS, are 65 years of age or older, or those who have kidney problems before starting treatment with LUMOXITI may have an increased risk of worse kidney problems after treatment with LUMOXITI. Tell your healthcare provider right away if you have any changes in the amount you urinate. Your healthcare provider will do tests to check your kidneys before you receive each dose of LUMOXITI and as needed during treatment. Your healthcare provider may delay your treatment with LUMOXITI if you have severe kidney problems.

• Infusion reactions. LUMOXITI can cause infusion reactions that are common but can also be serious. Infusion reactions may happen on the day you receive your LUMOXITI infusion. Signs and symptoms of infusion reactions may include:

• chills
• cough
• dizziness
• shortness of breath or wheezing
• feeling hot or flushing
• fast heartbeat

• headache
• changes in blood pressure
• muscle pain
• nausea
• fever
• vomiting

Your healthcare provider may give you medicines to take before and after each LUMOXITI infusion.

• Electrolyte problems. Tell your healthcare provider if you get any of the following symptoms of electrolyte problems:

• muscle cramps
• numbness or tingling
• abnormal or fast heartbeat

• nausea
• seizures

Your healthcare provider will do blood tests to check your electrolytes before you receive each dose of LUMOXITI and during treatment as recommended by your healthcare provider.

• have had conditions that affect your blood and blood vessels called HUS or severe thrombotic microangiopathy (TMA)
• have kidney problems
• are pregnant or plan to become pregnant. LUMOXITI may harm your unborn baby.
  • If you are a female who can become pregnant, you should use effective birth control during treatment with LUMOXITI and for at least 30 days after your last dose of LUMOXITI.
  • If you are a female who can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with LUMOXITI.
  • Tell your healthcare provider right away if you become pregnant during treatment with LUMOXITI.
• are breastfeeding or plan to breastfeed. It is not known if LUMOXITI passes into your breast milk. You and your healthcare provider should decide if you will receive LUMOXITI or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• swelling in your face, arms, or legs
• nausea
• feeling tired
• headache

• fever
• constipation
• low red blood cells (anemia)
• diarrhea

These are not all the possible side effects of LUMOXITI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.