WHAT IS MARQIBO?
MARQIBO is a prescription medicine used to treat adults with Philadelphia chromosome–negative (Ph‒) acute lymphoblastic leukemia (ALL) when:
Their leukemia has come back (relapsed) 2 or more times, or
Their leukemia became worse (progressed) after 2 or more anti-leukemia therapies
It is not known if MARQIBO is safe and effective in children or in older adults.
WHO SHOULD NOT TAKE MARQIBO?
Do not take MARQIBO if you have certain conditions of the nerves, including Charcot-Marie-Tooth syndrome. Talk to your doctor before receiving MARQIBO if you have a condition that affects your nerves. You should not take MARQIBO if you are allergic to vincristine sulfate or any of the ingredients in MARQIBO. See the end of the Important Safety Information for a list of the ingredients in MARQIBO. MARQIBO should not be given as an injection into your spine (intrathecal). MARQIBO causes death if given by any route other than by intravenous (IV) infusion.
WHAT SHOULD I TELL MY DOCTOR BEFORE RECEIVING MARQIBO?
Before receiving MARQIBO, tell your doctor if you:
Have had treatment containing vincristine sulfate in the past
Currently have numbness or tingling in your feet or hands or decreased sensitivity to heat, cold, or pain
Have difficulty walking or picking up and holding items with your hands
Have a change in bowel regularity or constipation, or difficulty passing urine
Have head or jaw pain
Have liver problems
Are pregnant or plan to become pregnant. MARQIBO can harm your unborn baby. You should not become pregnant while taking MARQIBO. Use an effective method of birth control during treatment with MARQIBO. Tell your doctor right away if you become pregnant while taking MARQIBO.
Are breastfeeding or plan to breastfeed. It is not known if MARQIBO passes into your milk. You and your doctor should decide whether you will take MARQIBO or breastfeed. You should not do both.
DOES YOUR DOCTOR KNOW ABOUT ALL THE MEDICINES YOU TAKE?
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. MARQIBO may affect the way other medicines work, and other medicines may affect how MARQIBO works.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
HOW WILL I RECEIVE MARQIBO?
You will receive MARQIBO as an intravenous (IV) infusion in your vein over 1 hour. MARQIBO is usually given every 7 days.
Your doctor may change your dose, give you MARQIBO less often, or stop your treatment with MARQIBO if you have certain side effects.
Your doctor should do blood tests regularly to check for side effects of MARQIBO.
WHAT SHOULD I AVOID WHILE RECEIVING MARQIBO?
MARQIBO can cause tiredness (fatigue) and nerve problems (neuropathy). You should not drive or operate machinery if you develop any of these symptoms. See “What are the possible side effects of MARQIBO?”
WHAT ARE THE POSSIBLE SIDE EFFECTS OF MARQIBO?
MARQIBO can cause serious side effects, including:
If MARQIBO leaks from your vein into the tissues around your intravenous (IV) line, it can cause damage to those tissues. Tell your doctor or nurse right away if you develop burning, redness or swelling at your IV site during or after your infusion.
NERVE PROBLEMS (NEUROPATHY)Numbness and tingling, or burning in your feet or hands
Increased or decreased feeling of sensation to pain, touch, heat, or cold in your feet or hands
Joint and muscle pain
Pain in your jaw or head
Weakness in the hands or feet
Dizziness or feeling faint when you go from lying down to sitting, or from sitting to standing
Trouble picking up or holding items with your hands
Slapping or dropping of the front part of your foot when walking forward (footdrop)
Unsteadiness when standing or walking
Constipation or a change from the normal regularity of your bowel movements
Difficulty passing urine
Difficulty with erection or ejaculation in men
Nerve problems are common with MARQIBO and may get worse over time. Your doctor may need to change your dose, or delay or stop your treatment with MARQIBO if you develop nerve problems. Symptoms may include:
LOW BLOOD CELL COUNTS
MARQIBO may cause you to have low red blood cells (anemia), low white blood cells (neutropenia), and low platelets (thrombocytopenia). Your doctor should do blood tests to check your blood cell counts before each dose of MARQIBO. Your doctor may need to change your dose of MARQIBO and treat your low blood cell counts if needed. Tell your doctor if you develop fever or cough up phlegm (productive cough).
TUMOR LYSIS SYNDROME (TLS)Kidney failure and the need for dialysis treatment
An abnormal heart beat
TLS is caused by a rapid breakdown of cancer cells. TLS can cause you to have:
Your doctor will check you for TLS during treatment with MARQIBO and treat you for this problem if it happens.
CONSTIPATION AND INTESTINAL (BOWEL) BLOCKAGEStomach area (abdomen) pain, bloating or diarrhea
Nausea or vomiting
Your doctor will prescribe a bowel regimen for you to help prevent constipation or intestinal blockage. Symptoms may include:
MARQIBO can cause severe tiredness or weariness. Your doctor may need to change your dose, or delay or stop your treatment if this happens.
LIVER PROBLEMS THAT CAN CAUSE DEATHWill monitor your liver function test during treatment with MARQIBO
May change your dose or stop your treatment with MARQIBO if you develop liver problems
MARQIBO can cause changes in liver function tests or more serious liver problems that can cause death. Your doctor:
OTHER POSSIBLE SIDE EFFECTS
Common side effects of MARQIBO include nausea, fever, diarrhea, decreased appetite, and sleep problems.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of MARQIBO. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
WHAT ARE THE INGREDIENTS IN MARQIBO?
Active ingredient: vincristine sulfate
Inactive ingredients: mannitol, sphingomyelin, cholesterol, sodium citrate, citric acid, sodium phosphate, and sodium chloride
For full Patient Information, click here.
1. Vincristine sulfate [prescribing information]. Lake Forest, IL: Hospira, Inc; August 2011.
www.drugs.com/pro/vincristine.html. Accessed July 9, 2012.
2. MARQIBO [prescribing information]. October 2012.