n via the syringe pump at thepre-specified flow to push remaining ELZONRIS dose out of the infusion line to complete delivery.
3 DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mcg in 1 mL clear colorless solution in a single-dose vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Capillary Leak Syndrome
Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patientstreated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was55% (52/94), including Grade 1 or 2 in 46% (43/94), Grade 3 in 6% (6/94), Grade 4 in 1% (1/94) and 2 fatal
events (2/94, 2%). Common signs and symptoms (incidence ≥ 20%) associated with CLS that were reportedduring treatment with ELZONRIS include hypoalbuminemia, edema, weight gain, and hypotension.
Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serumalbumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levelsprior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients forother signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonaryedema, hypotension or hemodynamic instability [see Dose Modifications (2.2)].
5.2 Hypersensitivity Reactions
ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials,hypersensitivity reactions were reported in 46% (43/94) of patients treated with ELZONRIS and were Grade ≥ 3in 10% (9/94). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, stomatitis,
and wheezing. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. InterruptELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur [seeDose Modifications (2.2)].
5.3 Hepatotoxicity
Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRISin clinical trials, elevations in liver enzymes occurred in 88% (83/94) of patients, including Grade 1 or 2 in 48%(45/94), Grade 3 in 36% (34/94), and Grade 4 in 4% (4/94). Monitor alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily ifthe transaminases rise to greater than 5 times the upper limit of normal and resume treatment uponnormalization or when resolved [see Dose Modifications (2.2)].
6 ADVERSE REACTIONS
The following serious adverse drug reactions are described elsewhere in the labeling:
• Capillary Leak Syndrome [see Warnings and Precautions (5.1)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.2)]
• Hepatotoxicity [see Warnings and Precautions (5.3)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.
Safety of ELZONRIS was assessed in a single-arm clinical trial that included 94 adults with newly-diagnosed orrelapsed/refractory myeloid malignancies, including 58 with BPDCN, treated with ELZONRIS 12 mcg/kg dailyfor 5 days of a 21-day cycle. The overall median number of cycles administered was 2 (range, 1-4 |
