FAQs

Frequently Asked Questions About SARCLISA

SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1 For more information, view the ICARIA-MM phase 3 trial design.

SARCLISA is indicated, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.1 For more information, view the IKEMA phase 3 trial design.

In the phase 3 IKEMA trial, SARCLISA + Kd demonstrated superior PFS (not reached vs 20.27 months with Kd alone), HR=0.548 (95% CI: 0.37, 0.82; P=0.0032).1

Patients in the IKEMA trial achieved deep responses (ORR: 87% with SARCLISA + Kd [95% CI: 0.81, 0.91] vs 83% with Kd alone [95% CI: 0.75, 0.89; P=0.3859]; ≥VGPR: 73% with SARCLISA + Kd vs 56% with Kd alone). As ORR did not reach statistical significance, CR, VGPR, and PR were not tested for significance.1,2 For more information, view the IKEMA phase 3 trial results.

CR=complete response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; VGPR=very good partial response.

SARCLISA + Kd was studied in a phase 3, multicenter, multinational, randomized, open-label study. Patients had received 1 to 3 prior lines of therapy.1,2

Patients received either SARCLISA 10 mg/kg administered as an intravenous infusion in combination with Kd (n=179) or Kd alone (n=123), administered weekly in the first cycle and every 2 weeks thereafter. Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.1 For more information, view the IKEMA phase 3 trial design.

In the phase 3 trial, SARCLISA + Pd demonstrated significantly superior median PFS (11.53 months with SARCLISA + Pd vs 6.47 months with Pd alone, HR=0.596, 95% CI: 0.44, 0.81). An improvement in ORR (60.4% with SARCLISA + Pd vs 35.3% with Pd alone), as well as ≥VGPR (31.8% with SARCLISA + Pd vs 8.5% with Pd alone) were also shown in this population.1 For more information, view the ICARIA-MM phase 3 trial results.

ORR=overall response rate; PFS=progression-free survival; VGPR=very good partial response.

SARCLISA + Pd was studied in a multicenter, open-label, randomized, phase 3 study. Patients received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor.1

Patients received either SARCLISA 10 mg/kg administered as an intravenous infusion in combination with Pd (n=154) or Pd alone (n=153), administered weekly in the first cycle and every 2 weeks thereafter. Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.1 For more information, view the ICARIA-MM phase 3 trial design.

Patients in both the ICARIA-MM and IKEMA phase 3 trials included those with impaired renal function and high cytogenetic risk, as well as those who were refractory to lenalidomide, and those ≥65 years of age.1

*Poor prognostic factors may include renal insufficiency, older age, high cytogenetic risk, and refractoriness to prior therapies.3,4

The recommended dose of SARCLISA is 10 mg/kg actual body weight administered as an intravenous infusion in combination with Kd or Pd. Weekly dosing transitions to every other week after the first cycle. Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity.1 For more information, view dosing.

SARCLISA is a 250-mL fixed-volume infusion. Based on the infusion rates and incremental escalations, and in the absence of infusion-related reactions, the first infusion lasts 3 hours and 20 minutes, followed by 1 hour and 53 minutes for the second infusion, and 75 minutes for the third infusion onward.1 For more information, view infusion times.

In the IKEMA phase 3 trial, the most common adverse reactions (≥20%) were1,2:

  • Upper respiratory tract infection (67% SARCLISA + Kd; 57%, Kd)
  • IRRs (46% SARCLISA + Kd; 3.3%, Kd)
  • Fatigue (42% SARCLISA + Kd; 32%, Kd)
  • Hypertension (37% SARCLISA + Kd; 32%, Kd)
  • Diarrhea (36% SARCLISA + Kd; 29%, Kd)
  • Pneumonia (36% SARCLISA + Kd; 30%, Kd)
  • Dyspnea (29% SARCLISA + Kd; 24%, Kd)
  • Insomnia (24% SARCLISA + Kd; 23%, Kd)
  • Bronchitis (24% SARCLISA + Kd; 13%, Kd)
  • Cough (23% SARCLISA + Kd; 15%, Kd)
  • Back pain (22% SARCLISA + Kd; 21%, Kd)
For more information, view IKEMA safety.

The most frequent adverse reactions (≥20%) in the ICARIA-MM phase 3 trial were upper respiratory tract infection (57% with SARCLISA + Pd vs 42% with Pd), infusion-related reaction (38% with SARCLISA + Pd vs 0% with Pd), pneumonia (31% with SARCLISA + Pd vs 23% with Pd), and diarrhea (26% with SARCLISA + Pd vs 19% with Pd).1 For more information, view ICARIA-MM safety.

SARCLISA is an anti-CD38 mAb that targets a specific epitope, resulting in multimodal effects. Selective binding triggers multiple mechanisms, leading to the death of CD38-expressing tumor cells. Preclinical evidence suggests that SARCLISA induces distinct antitumor activity.1,5,6 For more information, view the mechanism of action.

SARCLISA is supplied as 100 mg/5 mL and 500 mg/25 mL single-dose vials. SARCLISA should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake. Any unused portion of the solution should be discarded, and all materials that have been utilized for dilution and administration should be disposed of according to standard procedures.1 Please refer to the full Prescribing Information for more information.

CareASSIST by Sanofi Genzyme for SARCLISA offers resources and support for your eligible patients, including access and reimbursement within the insurance landscape, financial assistance that can help mitigate the cost of SARCLISA, and resource support for both patients and caregivers.

To see the full scope of CareASSIST offerings and to find out if your patients are eligible, visit the CareASSIST website .

SARCLISA is available from authorized specialty distributors and specialty pharmacies. For a list of specialty distributors and specialty pharmacies, please refer to the Product Acquisition and Returns Flashcard or the Billing and Coding Guide.

CareASSIST by Sanofi Genzyme for SARCLISA can help determine insurance coverage and options for patients and offers programs and services that can help eligible patients with the cost of SARCLISA. For more information and to see the full scope of CareASSIST offerings, visit the CareASSIST website .

Sanofi Genzyme is committed to responsible pricing while bringing new therapies to patients. Aligned with these principles, SARCLISA is priced responsibly, taking into consideration providers, patients, payers, and society. For more information, please contact a representative.

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