IRRs/Other Safety Information With SARCLISA

Infusion-related reactions (IRRs)

IRRs were observed in 46% and 38% of patients in the IKEMA and ICARIA-MM trials, respectively.1

IRRs in patients receiving SARCLISA + Kd and SARCLISA + Pd1


Kd=carfilzomib and dexamethasone; Pd=pomalidomide and dexamethasone.

Timing of IRRs1

In ICARIA-MM, all IRRs started during the first infusion of SARCLISA. In IKEMA, IRRs occurred on the infusion day in 99% of episodes, and 95% of patients receiving SARCLISA + Kd who experienced an IRR did so during the first cycle of treatment
All IRRs resolved on the same day in 98% of cases in the ICARIA-MM trial and in 74% of cases in the IKEMA trial

Symptoms of IRRs1

The most common symptoms (≥5%) of an IRR in ICARIA-MM and IKEMA (N=329) included dyspnea, cough, nasal congestion, and nausea
– ­Anaphylactic reactions occurred in <1% of patients
Serious IRRs, including life-threatening anaphylactic reactions, have occurred with SARCLISA treatment. Severe signs and symptoms included cardiac arrest, hypertension, hypotension, bronchospasm, dyspnea, angioedema, and swelling

Dosage interruption and discontinuation due to IRRs1

Dosage interruption of SARCLISA due to IRRs occurred in 30% and 28% of patients in the IKEMA and ICARIA-MM trials, respectively
SARCLISA alone was discontinued in 3% of patients in the ICARIA-MM trial and in 0.6% of patients in the IKEMA trial due to IRRs

Managing IRRs1,2

  • To decrease the risk and severity of IRRs, premedicate patients prior to SARCLISA infusion with acetaminophen, H2 antagonists, diphenhydramine or equivalent, and dexamethasone
  • Monitor vital signs frequently during the entire SARCLISA infusion

Defining IRR grades2

IV=intravenous; NSAID=nonsteroidal anti-inflammatory drug.

Dose modifications1

Dose delay may be required to allow for recovery of blood counts in the event of hematological toxicity. For dosing instructions for combination agents administered with SARCLISA, refer to the study design descriptions for ICARIA-MM and IKEMA, and the respective manufacturer’s Prescribing Information.

View premedication information for SARCLISA

Dosing

Other adverse reactions

Infections1

  • The incidence of grade 3 or higher infections was 43% in the SARCLISA + Pd group in the ICARIA-MM trial and 38% in the SARCLISA + Kd group in the IKEMA trial
  • Pneumonia was the most commonly reported severe infection across both trials, with grade 3 reported in 22% of patients in the SARCLISA + Pd group compared with 16% in the Pd group, and in 19% of patients in the SARCLISA + Kd group compared with 15% in the Kd group. Grade 4 was reported in 3.3% of patients in the SARCLISA + Pd group compared with 2.7% in the Pd group, and in 3.4% of patients in the SARCLISA + Kd group compared with 2.5% in the Kd group
  • Discontinuations from treatment due to infection were reported in 2.6% of patients in the SARCLISA + Pd group compared with 5.4% in the Pd group, and in 2.8% of patients in the SARCLISA + Kd group compared with 4.9% in the Kd group
  • Fatal infections were reported in 3.3% of patients in the SARCLISA + Pd group compared with 4% in the Pd group, and in 2.3% of patients in the SARCLISA + Kd group compared with 0.8% in the Kd group

Neutropenia1

  • Monitor complete blood cell counts periodically during treatment
  • Consider the use of antibiotics and antiviral prophylaxis during treatment
  • Monitor patients with neutropenia for signs of infection
  • If grade 4 neutropenia occurs, consider dose delays until neutrophil count recovery to at least 1.0 × 109/L, and provide supportive care with growth factors, according to institutional guidelines

Second primary malignancies1

  • Monitor patients for the development of second primary malignancies
  • The incidence of second primary malignancies is increased in patients treated with regimens that contain SARCLISA
    • The overall incidence of second primary malignancies in all SARCLISA-exposed patients was 3.6%
    • In ICARIA-MM, second primary malignancies occurred in 3.9% of patients in the SARCLISA + Pd arm and in 0.7% of patients in the Pd arm
    • In IKEMA, second primary malignancies occurred in 7% of patients in the SARCLISA + Kd arm and in 4.9% of patients in the Kd arm
  • The most common (≥1%) second primary malignancies in ICARIA-MM and IKEMA (N=329) included skin cancers (4% with regimens that contain SARCLISA and 1.5% with comparative regimens) and solid tumors other than skin cancer (1.8% with regimens that contain SARCLISA and 1.5% with comparative regimens). All patients with skin cancer continued treatment after resection of the skin cancer

Laboratory test interference1

SARCLISA, an anti-CD38 antibody, may interfere with blood bank serological tests with false-positive reactions in indirect antiglobulin tests (indirect Coombs tests), antibody detection (screening) tests, antibody identification panels, and antihuman globulin crossmatches in patients treated with SARCLISA.

  • Conduct blood type and screen tests in patients before the first infusion of SARCLISA
  • Consider phenotyping prior to starting treatment with SARCLISA
    • If treatment with SARCLISA has already begun, inform the blood bank that the patient is receiving SARCLISA, and SARCLISA interference with blood compatibility testing can be resolved using dithiothreitol-treated red blood cells (RBCs). If an emergency transfusion is required, non–cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices
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Dosing