Precautions during use of enantuzumab

In the clinical study of Elranatamab (Elranatamab) in the treatment of multiple myeloma (MM), warnings and precautions such as cytokine release syndrome (CRS), neurotoxicity, infection, neutropenia, hepatotoxicity, embryo-fetotoxicity appeared. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Cytokine release syndrome (CRS): Includes life-threatening or fatal reactions. Clinical signs and symptoms of CRS may include, but are not limited to, fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated liver enzymes. Initiate treatment according to an escalating dose regimen of ELREXFIO to reduce the risk of CRS and monitor patients accordingly after use of eractuzumab. Administer pretreatment medication before each dose of the ascending-dose regimen to reduce the risk ofCRS.

If you develop signs or symptoms of CRS, advise patients to seek medical care. At the first sign of CRS, immediately assess the patient for hospitalization. Manage CRS as recommended and consider further management based on current practice guidelines. Enatuzumab is only available through a restricted program under REMS.

2. Neurotoxicity, including immune effector cell-associated neurotoxic syndrome (ICANS): Neurotoxicity includes headache, encephalopathy, motor dysfunction, sensory neuropathy and Guillain-Barre syndrome. The most common clinical manifestations of ICANS include decreased level of consciousness and grade 1 or 2 immune effector cell-associated encephalopathy (ICE) score. The emergence of ICANS can occur simultaneously with CRS, after CRS is resolved, or in the absence of CRS. Advise patients to seek medical attention if signs or symptoms of neurotoxicity occur. Monitor patients for signs and symptoms of neurotoxicity during treatment with ernatumumab.

At the first sign of neurotoxicity(including ICANS), immediately evaluate and treat patients according to severity. Due to potential neurotoxicity (including ICANS), patients receiving ernatumumab are at risk for decreased level of consciousness. Advise patients not to drive or operate heavy or potentially hazardous machinery for 48 hours after completion of the first treatment dose in the 2 ascending-dose and eractuzumab ascending-dose regimens, and in the event of any new neurotoxic symptoms, until symptoms resolve.

3.Infections: The most common serious infections reported (≥5%) were pneumonia and sepsis. Do not treat patients with active infection with eractuzumab. Monitor patients for signs and symptoms of infection before and during treatment with ernatumumab and initiate appropriate treatment. Use prophylactic antimicrobial and antiviral medications according to current practice guidelines. Consider using subcutaneous or intravenous immune globulin (IVIG) for treatment as appropriate.

4. Neutropenia: can lead to neutropenia and febrile neutropenia. Monitor complete blood counts at baseline and periodically during treatment. Provides supportive care according to current practice guidelines. Monitor patients with neutropenia for signs of infection.

5. Hepatotoxicity: Eractuzumab can cause hepatotoxicity. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated.

6. Embryo-Fetal Toxicity: Based on its mechanism of action, enantuzumab may cause fetal damage when administered to pregnant women. Inform pregnant women of potential risks to the fetus. Advise females of reproductive potential to use effective contraception during treatment with eractuzumab and for 4 months after the last dose.

Reference materials:https://www.drugs.com/mtm/elranatamab.html