ng if nottreated right away. Get emergency medical help right away if you develop any of thefollowing symptoms of CLS:
o swelling of your face, arms, or legs
o fast weight gain (increase in 5.5pounds from Day 1 of your currentcycle)
o weakness or dizziness
o shortness of breath or trouble breathing
o cough
o low blood pressure Your healthcare provider will check your weight and blood pressure before you receiveeach dose of LUMOXITI and as needed during treatment.
Hemolytic Uremic Syndrome (HUS). Hemolytic uremic syndrome is a condition thataffects 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 followingsymptoms of HUS:
o decrease in the amount of urine ordark urine (tea-colored)
o unusual bleeding or bruising of yourskin
o stomach pain
o vomiting
o fever
o feeling tired
o changes in mood or behavior
o confusion
o seizures
o shortness of breath
o fast heartbeat
Your healthcare provider will do blood tests to check your blood cells and kidneys beforeyou 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 monitoryou in the hospital.
Getting medical treatment right away may help keep these problems from becomingmore serious.
Your healthcare provider will check you for these problems during your treatment withLUMOXITI.
Your healthcare provider may delay or completely stop treatment with LUMOXITIif you have severe side effects.
See “What are the possible side effects of LUMOXITI?” below for other side effects ofLUMOXITI.
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, andhave received at least 2 other treatments, including a type of medicine called purinenucleoside analog (PNA).
It is not known if LUMOXITI is safe and effective in children.
Before you receive LUMOXITI, tell your healthcare provider about all your medicalconditions, including if you:
have had conditions that affect your blood and blood vessels called HUS or severethrombotic microangiopathy (TMA)have kidney problemsare pregnant or plan to become pregnant. LUMOXITI may harm your unborn baby.
o If you are a female who can become pregnant, you should use effective birth controlduring treatment with LUMOXITI and for at least 30 days after your last dose ofLUMOXITI.
o If you are a female who can become pregnant, your healthcare provider will performa pregnancy test before you start treatment with LUMOXITI.
o Tell your healthcare provider right away if you become pregnant during treatmentwith LUMOXITI.
are breastfeeding or plan to breastfeed. It is not known if LUMOXITI passes into yourbreast 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 andover-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of your medicines with you and show it to yourhealthcare provider when you get a new medicine.
How will I receive LUMOXITI?
Your healthcare provider will give you LUMOXITI into your vein through an intravenous(IV) line over 30 minutes.
LUMOXITI is us |
