stituted and Diluted LUMOXITI SolutionReconstituted Solution Diluted LUMOXITI Solution in Infusion Bag
After Dilution Administration
LUMOXITI does not
contain bacteriostatic
preservatives. Use
reconstituted solution
immediately.
DO NOT STORE
reconstituted LUMOXITI
vials.
Use diluted solution
immediately or after storage at
room temperature (20°C to
25°C; 68°F to 77°F) for up to 4
hours or store refrigerated at
2°C to 8°C (36°F to 46°F) for
up to 24 hours.
PROTECT FROM LIGHT.
DO NOT FREEZE.
DO NOT SHAKE.
If the diluted solution is refrigerated
(2°C to 8°C; 36°F to 46°F), allow it to
equilibrate at room temperature (20°C
to 25°C; 68°F to 77°F) for no more
than 4 hours prior to administration.
Administer diluted solution within 24
hours of reconstitution as a 30-minute
infusion.
PROTECT FROM LIGHT.
3 DOSAGE FORMS AND STRENGTHS
For injection: 1 mg as a white to off-white lyophilized cake or powder in a single-dose vial forreconstitution and further dilution.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Capillary Leak Syndrome (CLS)
Capillary leak syndrome (CLS), including life-threatening cases, has been reported among patients treatedwith LUMOXITI and is characterized by hypoalbuminemia, hypotension, symptoms of fluid overload,and hemoconcentration. In the combined safety database of HCL patients treated with LUMOXITI, CLSoccurred in 34% (44/129) of patients, including Grade 2 in 23% (30/129), Grade 3 in 1.6% (2/129), andGrade 4 in 2% (3/129).
Most cases of CLS occurred in the first 8 days (range: 1 to 19) of a treatment cycle, however, cases havealso been reported on other days throughout the cycle. The median time to resolution of CLS was 12 days(range: 1 to 53).
Monitor patient weight and blood pressure prior to each LUMOXITI infusion and as clinically indicatedduring treatment. Assess patients for signs and symptoms of CLS, including weight gain (increase in 5.5pounds (2.5 kg) or ≥ 5% from Day 1 of current cycle), hypotension, peripheral edema, shortness of breathor cough, and pulmonary edema and/or serosal effusions. In addition, the following changes in laboratoryparameters may help identify CLS: hypoalbuminemia, elevated hematocrit, leukocytosis, andthrombocytosis [see Dosage and Administration (2.3)].
CLS may be life-threatening or fatal if treatment is delayed. Counsel patients to seek immediate medicalattention should signs or symptoms of CLS occur at any time. Patients who develop CLS should receiveappropriate supportive measures, including concomitant oral or intravenous corticosteroids, andhospitalization as clinically indicated. Withhold LUMOXITI for Grade 2 CLS until resolution, andpermanently discontinue for Grade ≥ 3 CLS [see Dosage and Administration (2.3)].
5.2 Hemolytic Uremic Syndrome (HUS)
Hemolytic Uremic Syndrome (HUS), including life threatening cases, has been reported in patientstreated with LUMOXITI and is characterized by the triad of microangiopathic hemolytic anemia,thrombocytopenia, and progressive renal failure. In the combined safety database of HCL patients treatedwith LUMOXITI, HUS occurred in 7% (9/129) of patients, including Grade 3 in 3% (4/129) and Grade 4in 0.8% (1/129).
Most cases of HUS occurred in the first 9 days (range: 1 to 16) of a treatment cycle, however, cases havealso been |
