Lumoxiti is a prescription medication used to treat adult patients with hairy cell leukemia (HCL) that came back or did not get better with at least two other systemic treatments. Lumoxiti contains a monoclonal antibody called moxetumomab that binds to a protein called CD22, which is found on B cells (a type of white blood cell) and some types of leukemia cells. It also contains a bacterial toxin called PE38, which may help kill cancer cells. Lumoxiti is a type of immunotoxin.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare professional. Lumoxiti is usually given on Day 1, Day 3, and Day 5 of a 28-day treatment cycle. You may receive up to 6 treatment cycles.

Common side effects of Lumoxiti include swelling, nausea and tiredness.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more
information.

The recommended dose of Lumoxiti for the treatment of hairy cell leukemia (HCL) is 0.04 mg/kg administered as an intravenous infusion for 30 minutes on Day1, 3 and 5 of each 28-day cycle. Continue Lumoxiti treatment for a maximum of 6 cycles, disease progression, or unacceptable toxicity. 

WARNING: CAPILLARY LEAK SYNDROME AND HEMOLYTIC UREMIC SYNDROME 

• Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving Lumoxiti. Monitor weight and blood pressure; check labs, including albumin, if CLS is suspected. Delay dosing or discontinue Lumoxiti as recommended.
• Hemolytic Uremic Syndrome (HUS), including life-threatening cases, occurred in patients receiving Lumoxiti. Monitor hemoglobin, platelet count, serum creatinine, and ensure adequate hydration. Discontinue Lumoxiti in patients with Hemolytic Uremic Syndrome (HUS).

Serious side effects have been reported with Lumoxiti including the following:

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
• Weakness or dizziness
• Shortness of breath or trouble breathing
• Cough
• Low blood pressure

Hemolytic Uremic Syndrome (HUS) is a condition that affects your blood cells and kidney and can be life threatening. Tell your healthcare provider right away if you have some or all of the following symptoms:

• 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

Serious side effects have been reported with Lumoxiti. See the “Drug Precautions” section.

Common side effects of Lumoxiti include:

• Infusion related reactions
• Edema
• Nausea
• Fatigue
• Headache
• Fever
• Constipation
• Low red blood cells (Anemia)
• Diarrhea
• Electrolyte problems

This is not a complete list of Lumoxiti side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side
effects to the FDA at 1-800-FDA-1088.

No Lumoxiti drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported, and new drug interactions are continually being reported.

Tell your doctor if you are pregnant or plan to become pregnant. There are no well done studies that have been done in humans with Lumoxiti. In animal studies, pregnant animals were given this medication and babies were born with problems. See "Drug Precautions" section for more information.

It is not known if Lumoxiti crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Lumoxiti.