Download the CLS Symptom Management Card for a quick reference on how to manage CLS.
Download the CLS Management Guide for a pocket guide with important information about how to manage CLS.
Download the CLS On-Demand Deck for presentation slides with detailed guidance on how to manage CLS.
Download the CLS Video for a detailed voice over on manging the symptoms of CLS.
A CLS Alert Kit is available to healthcare professionals treating and monitoring ELZONRIS patients on an inpatient or outpatient basis, indicating that the patient is a "CAPILLARY LEAK SYNDROME RISK." Kit contains patient alert bracelet, alert sign (to be placed in inpatient room), and chart sticker.
Common signs and symptoms (incidence ≥ 20%) associated with CLS that were reported during treatment with ELZONRIS include1:
- Hypoalbuminemia
- Edema
- Weight gain
- Hypotension
CLS incidence in patients receiving ELZONRIS in clinical trial1
Overall incidence of CLS was 55% (52/94)
- 6% incidence of Grade 3 events (6/94)
- 1% incidence of Grade 4 events (1/94)
- 2% incidence of Grade 5 events (2/94)
Assess and monitor patients appropriately1
- Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin ≥ 3.2 g/dL
-
During treatment, assess patients for common signs/symptoms of CLS before each dose is given, such as
- Weight gain ≥ 1.5 kg over pretreatment weight on prior treatment day
- New onset or worsening edema, including pulmonary edema
- Hypotension or hemodynamic instability
-
Hypoalbuminemia
- Serum albumin < 3.5 g/dL or reduced by ≥ 0.5 g/dL compared to the value measured prior to dosing initiation of the current cycle
- Follow the CLS Management Guidelines found in Section 2.2 (Table 2) of the full Prescribing Information
Time of presentation | CLS sign/sympton | Recommended action | ELZONRIS dosing management |
---|---|---|---|
Prior to first dose of ELZONRIS in cycle 1 | Serum albumin |
Administer ELZONRIS when serum albumin |
|
During ELZONRIS dosing | Serum abumin |
Administer 25 g 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 resolveda |
Serum albumin reduced by |
|||
A predose body weight that is increased by |
Administer 25 g intravenous albumin (q12h or more frequently as practical) and manage fluid status as clinically indicated (eg, generally with intravenous fluids and vasopressors if hypotensive and with diuretics if normotensive or hyper | tensive) until body weight increase has resolved (ie, the increase is no longer ≥ 1.5 kg greater than the previous day’s predose weight)||
Edema, fluid overload, and/or hypotension | Administer 25 g 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 clinically indicated 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 |
aELZONRIS administration may resume in the same cycle if all CLS signs/symptoms have resolved and the patient did not require measures to treat hemodynamic 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 (eg, required administration of intravenous fluids and/or vasopressors to treat hypotension), even if resolved, and ELZONRIS administration may only resume in the next cycle if all CLS signs/symptoms have resolved, and the patient is hemodynamically stable.
- Reference:
- ELZONRIS [prescribing information]. New York, NY, US: Stemline Therapeutics, Inc.; December 2018.