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.

• Astrazeneca

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.

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

Medications can interact with certain foods. In some cases, this may be harmful, and your doctor may advise you to avoid certain foods. In the case of Lumoxiti, there are no specific foods that you must exclude from your diet when receiving this medication.

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
• have or have had a recent or active infection
• 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. Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.

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.

Your healthcare provider will give you Lumoxiti into your vein through an intravenous (IV) line over 30 minutes.

Lumoxiti is usually given on Day 1, Day 3, and Day 5 of a 28-day treatment cycle. This is 1 treatment cycle. You may receive up to 6 treatment cycles.

Your healthcare provider will give you medicines and IV fluids before and after your infusions.

It is important for you to drink the additional prescribed amount of fluids (water, milk, or juice) of up to twelve 8-oz glasses every 24 hours on Days 1 through 8 of each 28-day treatment cycle when you receive Lumoxiti infusions.

Your healthcare provider will decide how many treatment cycles you need.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

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. 

If Lumoxiti is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

This page was written by Mariela Silva, PharmD Candidate 2020 | UT Austin College of Pharmacy

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).