SITE MAP - LUMOXITI™ (moxetumomab pasudotox-tdfk) for Patients

IMPORTANT SAFETY INFORMATION

LUMOXITI can cause serious side effects, including:

Capillary Leak Syndrome (CLS). LUMOXITI can cause fluid to leak from small blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening if not treated right away. Get emergency medical help right away if you develop any of the following symptoms of CLS:

swelling of your face, arms, or legs
fast weight gain (increase in 5.5 pounds from Day 1 of your current cycle)

weakness or dizziness
shortness of breath or trouble breathing
cough
low blood pressure

Your healthcare provider will check your weight and blood pressure before you receive each dose of LUMOXITI and as needed during treatment.

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.

LUMOXITI can cause other serious side effects, including:

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.

Before you receive LUMOXITI, tell your healthcare provider about all your medical conditions, including if you:

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.

The most common side effects of LUMOXITI include:

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.

What is LUMOXITI?

LUMOXITI is a prescription medicine used to treat adults with hairy cell leukemia (HCL)

that has come back or has not responded to previous treatment, and
have received at least 2 other treatments, including a type of medicine called purine nucleoside analog (PNA).

It is not known if LUMOXITI is safe and effective in children.

Please see full Prescribing Information, including Boxed WARNING and Patient Information (Medication Guide).

You may report side effects related to LUMOXITI by calling the Medical Information Call Center 888-501-0998. If you prefer to report these to the FDA, either visit MedWatch or call 1-800-FDA-1088.