e; 38°C Withhold ELZONRIS until body temperature is
< 38°C.
Hypersensitivity
reactions
Mild or moderate
Withhold ELZONRIS until resolution of any
mild or moderate hypersensitivity reaction.
Resume ELZONRIS at the same infusion rate.
Severe or life-threatening Discontinue ELZONRIS permanently.
Table 2. CLS Management Guidelines
Time of Presentation CLS
Sign/Symptom
Recommended
Action
ELZONRIS
Dosing
Management
Prior to first dose of
ELZONRIS in cycle 1 Serum albumin < 3.2 g/dL Administer ELZONRIS when serum albumin ≥ 3.2 g/dL.
During ELZONRIS
dosing
Serum albumin < 3.5 g/dL
Administer 25g intravenous albumin (q12h or
more frequently as practical) until serum albumin
is ≥ 3.5 g/dL AND not more than 0.5 g/dL lower
than the value measured prior to dosing initiation
of the current cycle.
Interrupt
ELZONRIS
dosing until the
relevant CLS
sign/symptom has
resolved1
Serum albumin reduced by
≥ 0.5 g/dL from the albumin
value measured prior to
ELZONRIS dosing initiation of
the current cycle
A predose body weight that is
increased by ≥ 1.5 kg over the
previous day’s predose weight
Administer 25g intravenous albumin (q12h or
more frequently as practical), and manage fluid
status as indicated clinically (e.g., generally with
intravenous fluids and vasopressors if
hypotensive and with diuretics if normotensive
or hypertensive), until body weight increase has
resolved (i.e. the increase is no longer ≥ 1.5 kg
greater than the previous day’s predose weight).
Edema, fluid overload and/or
hypotension
Administer 25g intravenous albumin (q12h, or
more frequently as practical) until serum
albumin is ≥ 3.5 g/dL.
Administer 1 mg/kg of methylprednisolone (or
an equivalent) per day, until resolution of CLS
sign/symptom or as indicated clinically.
Aggressive management of fluid status and
hypotension if present, which could include
intravenous fluids and/or diuretics or other blood
pressure management, until resolution of CLS
sign/symptom or as clinically indicated. 1 ELZONRIS administration may resume in the same cycle if all CLS signs/symptoms have resolved and the patient did not require measures to treathemodynamic instability. ELZONRIS administration should be held for the remainder of the cycle if CLS signs/symptoms have not resolved or the
patient required measures to treat hemodynamic instability (e.g. required administration of intravenous fluids and/or vasopressors to treathypotension) (even if resolved), and ELZONRIS administration may only resume in the next cycle if all CLS signs/symptoms have resolved, and thepatient is hemodynamically stable.
2.3 Preparation for Administration
Assure the following components required for dose preparation and administration are available prior to
thawing ELZONRIS:
• One empty 10 mL sterile vial
• 0.9% Sodium Chloride Injection, USP (sterile saline)
• Three 10 mL sterile syringes
• One 1 mL sterile syringe
• One mini-bifuse Y-connector
• Microbore tubing
• One 0.2 micron polyethersulfone in-line filter
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior toadministration, whenever solution and container permit. Thawed ELZONRIS appearance should be a clear,colorless liquid that may contain a few white to translucent p |
