pectively. Sixty-four patients (80%) had normalization of hematologic parameters and achievedhematologic remission, with a median time to hematologic remission of 1.1 months (range: 0.2 to 13) andwith a median duration of hematologic remission not reached (range: 0.3 to 48.2+).
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
LUMOXITI (moxetumomab pasudotox-tdfk) for injection is supplied as a sterile, preservativefree,white to off-white lyophilized cake or powder in a 1 mg single-dose vial. Each carton(NDC 0310-4700-01) contains one single-dose vial.
IV Solution Stabilizer is supplied as a sterile, preservative-free, colorless to slightly yellow, clearsolution free from visible particles in a 1 mL single-dose vial. The IV Solution Stabilizer ispackaged separately from LUMOXITI. Each carton (NDC 0310-4715-11) contains one singledosevial. Do not use the IV Solution Stabilizer to reconstitute LUMOXITI.
Only one vial of IV Solution Stabilizer should be used per administration of LUMOXITI.
Storage and Handling
Refrigerate LUMOXITI and IV Solution Stabilizer at 2°C to 8°C (36°F to 46°F), in original carton toprotect from light. Do not freeze. Do not shake.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Capillary Leak Syndrome
Advise patients on the risk of developing capillary leak syndrome. Advise patients to immediately reportany symptoms suggestive of capillary leak syndrome, such as difficulty breathing, rapid weight gain,hypotension, or swelling of their arms, legs, and/or face to their healthcare provider for further eva luation[see Warnings and Precautions (5.1)].
Hemolytic Uremic Syndrome
Advise patients on the risk of developing hemolytic uremic syndrome. Advise patients on the importanceof maintaining high fluid intake, and the need for frequent monitoring of blood chemistry values [seeWarnings and Precautions (5.2)].
Renal Toxicity Inform patients that taking LUMOXITI may cause decreased renal function. Advise patients to report anychanges to urine output to their healthcare provider for further eva luation [see Warnings and Precautions(5.3) and Adverse Reactions (6.1)].
Infusion Related ReactionsAdvise patients to contact their healthcare provider immediately for signs or symptoms of infusion relatedreactions [see Warnings and Precautions (5.4)].
Electrolyte Abnormalities
Advise patients to report symptoms of electrolyte abnormalities (e.g., muscle cramping, paresthesias,irregular or fast heartbeat, nausea, seizures) to their healthcare provider immediately [see Warnings andPrecautions (5.5)].
Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-151 85
U.S. License No. 2059
LUMOXITI is a trademark of the AstraZeneca group of companies.
© AstraZeneca 2018
MEDICATION GUIDE
LUMOXITI™ (loo-MOCKS-eh-tee)
(moxetumomab pasudotox-tdfk)
for injection
What is the most important information I should know about LUMOXITI?
LUMOXITI can cause serious side effects, including:
Capillary Leak Syndrome (CLS). LUMOXITI can cause fluid to leak from small bloodvessels 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-threateni |
