Usual Adult Dose for Hairy Cell Leukemia

0.04 mg/kg IV over 30 minutes on Days 1, 3, and 5 of each 28-day cycle for a maximum of 6 cycles, disease progression, or unacceptable toxicity

Recommended Concomitant Treatment:

• Hydrate with 1 L of isotonic solution (e.g., 5% dextrose injection, and 0.45% or 0.9% sodium chloride injection) over 2 to 4 hours before and after each infusion. -Administer 0.5 L to patients under 50 kg.
• Advise patients to hydrate with up to 3 L of oral fluids (e.g., water, milk, or juice) per 24 hours on Days 1 through 8 of each 28-day cycle. In patients under 50 kg, up to 2 L per 24 hours is recommended.

• Premedicate 30 to 90 minutes prior to each infusion with and antihistamine (e.g., hydroxyzine or diphenhydramine), acetaminophen, and a histamine-2 receptor antagonist (e.g., ranitidine, famotidine, or cimetidine).
• Consider oral antihistamines and antipyretics for up to 24 hours following the infusion and an oral corticosteroid (e.g., 4 mg dexamethasone) to decrease nausea and vomiting. Maintain adequate oral fluid intake.
• Monitor fluid balance and serum electrolytes.
• Consider low-dose aspirin on Days 1 through 8 of each 28-day cycle.
• Monitor for thrombosis.

Renal Dose Adjustments

See RENAL within WARNINGS and DOSE ADJUSTMENTS.

Liver Dose Adjustments

Data not available

Dose Adjustments

If a severe infusion related reaction (IRR) occurs, interrupt the infusion and manage medically. Administer an oral or IV corticosteroid 30 minutes before
resuming, and before each infusion thereafter.

MONITORING FOR CAPILLARY LEAK SYNDROME (CLS):

• Before every infusion check weight and blood pressure.
• If weight has increased by 5.5 pounds (2.5 kg) or 5% or greater from Day 1 of the cycle and the patient is hypotensive, check for peripheral edema, hypoalbuminemia, and respiratory symptoms, including shortness of breath and cough.
• CLS is suspected, check for a decrease in oxygen saturation and pulmonary edema and/or serosal effusions.

• Grade 2 CLS: Delay dosing until recovery.
• Grade 3 CLS: Discontinue therapy.
• Grade 4 CLS: Discontinue therapy.

• Before every infusion check hemoglobin levels, platelet counts, and serum creatinine.
• If HUS is suspected, check blood LDH, indirect bilirubin, and blood smear schistocytes for hemolysis.
• Discontinue therapy in patients with HUS. Treat with supportive measures and fluid replacement, and monitor blood chemistry, complete blood counts, and renal function until resolution.

• For patients with baseline serum creatinine within normal limits, delay dosing for Grade 2 or higher creatinine increases (greater than 1.5-times baseline or the upper limit of normal); resume therapy upon recovery to Grade 1 (1- to 1.5-times baseline, or between the upper limit of normal and 1.5-times the upper limit of normal).
• For patients with baseline serum creatinine of Grades 1 or 2, delay dosing for creatinine increases to Grade 3 or higher (greater than 3-times baseline or the upper limit of normal); resume therapy upon recovery to baseline grade or lower.

Precautions

US BOXED WARNINGS:

• Capillary Leak Syndrome (CLS), including life-threatening cases, has occurred. Monitor weight and blood pressure; check labs, including albumin, if CLS is suspected. Delay dosing or discontinue this drug as necessary.
• Hemolytic Uremic Syndrome (HUS), including life-threatening cases, has occurred. Monitor hemoglobin, platelet count, serum creatinine, and ensure

• None

Dialysis

Data not available

Other Comments

Storage requirements:

• Refrigerate this drug and IV Solution Stabilizer at 2C to 8C (36F to 46F), in original carton to protect from light.
• Do not freeze.
• Do not shake.

• Weight
• Blood pressure
• Albumin hemoglobin levels
• Platelet counts
• Serum creatinine

• Read patient labeling.
• Maintain a high fluid intake.
• Contact your healthcare provider immediately for infusion related reactions or electrolyte abnormalities (e.g., muscle cramping, paresthesias, irregular or fast heartbeat, nausea, seizures).

Frequently asked questions

• What type of drug is Lumoxiti?