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Introducing SARCLISA ESCENA™ (isatuximab-irfc) for Use With CirCLIQ™

Dosing ↓
Premedication ↓
Administration ↓

With the approval of SARCLISA ESCENA, HCPs can now administer an anti-CD38 therapy subcutaneously with either CirCLIQ, an on-body injector, or with manual administration.1,2

Medication vial icon.

Key features of SARCLISA ESCENA with CirCLIQ

 

  • Direct vial-to-injector assembly with CirCLIQ3
  • Fixed dose means no weight-based calculations1
  • Ready-to-use vial allows for preparation outside of pharmacy by a nurse or other HCP1
  • Formulated without hyaluronidase1

HCP=healthcare provider.

SARCLISA ESCENA dosing

Dosing schedule for SARCLISA ESCENA in combination with VRd1

A fixed dose of SARCLISA ESCENA can be administered with CirCLIQ or with manual administration in combination with VRd.

Dosing frequency for SARCLISA ESCENA transitions to once monthly*

Charts showing that dosing schedule for the induction phase (4-week cycles) is once weekly for cycle 1, and once every two weeks for cycles 2-12. Bortezomib is discontinued following the induction phase. The dosing schedule for the continuous phase (4-week cycles) is once a month for cycles 13 and beyond.

For additional dosing instructions for combination agents administered with SARCLISA ESCENA, refer to the respective manufacturer's Prescribing Information.

*Initiates after cycle 12.
NDMM=newly diagnosed multiple myeloma; RRMM=relapsed or refractory multiple myeloma; VRd=bortezomib, lenalidomide, dexamethasone.

Dosing schedule for SARCLISA ESCENA in combination with Kd or Pd1 

A fixed dose of SARCLISA ESCENA can be administered with CirCLIQ or with manual administration in combination with either Kd or Pd.

Dosing frequency for SARCLISA ESCENA decreases after cycle 1 

Weekly dosing transitions from once weekly in cycle 1 to every other week in cycle 2 and beyond.

On days when both SARCLISA ESCENA and carfilzomib are given, administer dexamethasone first, followed by administration of SARCLISA ESCENA, then followed by carfilzomib infusion.

For additional dosing instructions for combination agents administered with SARCLISA ESCENA, refer to the respective manufacturer’s Prescribing Information.

  • Continue the SARCLISA ESCENA regimen until disease progression or unacceptable toxicity
  • The dosing schedule must be carefully followed. If a planned dose of SARCLISA ESCENA is missed, administer the dose as soon as possible and adjust the treatment schedule accordingly, maintaining the treatment interval
  • See the Prescribing Information for information about administration adjustments

Kd=carfilzomib and dexamethasone; NDMM=newly diagnosed multiple myeloma; Pd=pomalidomide and dexamethasone; RRMM=relapsed or refractory multiple myeloma.

Premedication1

Recommended premedication agents should be administered 15 to 60 minutes prior to starting a subcutaneous administration of SARCLISA ESCENA. The following premedication agents should be used to reduce the risk and severity of systemic administration reactions.

Dexamethasone

SARCLISA ESCENA + VRd: 20 mg oral

SARCLISA ESCENA + Kd: 20 mg oral or IV

SARCLISA ESCENA + Pd: 40 mg oral or IV (20 mg oral or IV for patients aged ≥75 years)

Leukotriene receptor antagonist

At cycle 1 only (days 1, 8, 15, and 22)

Acetaminophen

650 mg to 1,000 mg oral

Diphenhydramine

25 mg to 50 mg oral or IV, or equivalent. The IV route for diphenhydramine is preferred for at least the first 4 administrations of SARCLISA ESCENA

  • The above recommended dose of dexamethasone (oral or IV) corresponds to the total dose to be administered before SARCLISA ESCENA administration as part of the premedication and part of the backbone treatment
  • If no systemic administration reaction occurs during cycle 1, assess patient-specific factors and consider omitting subsequent premedication during future treatment cycles

IV=intravenous.

SARCLISA ESCENA administration

Introducing SARCLISA ESCENA1

SARCLISA ESCENA, available as a 1,400-mg fixed dose, is for administration by healthcare providers only.

Illustration of 1,400-mg medication vial.

Preparing SARCLISA ESCENA1

  • SARCLISA ESCENA is a clear to slightly opalescent, colorless to slightly yellow solution that may contain a few translucent to white particles. SARCLISA ESCENA should not be used if the solution is cloudy or discolored, or if particles other than those described above are present. Inspect the vials for particulate matter and discoloration prior to administration whenever solution and container permit
  • To prevent medication errors, check the SARCLISA ESCENA vial label to ensure it is the correct medication for subcutaneous use (vial with green cap)
  • Prior to use‚ allow SARCLISA ESCENA to reach ambient temperature between 64°F and 82°F (18°C and 28°C) for approximately 20 minutes. Keep the unpunctured vial in the original carton prior to use to protect from light. Do not heat. Do not shake
  • Once the vial is taken out of the refrigerator, it must not be returned to the refrigerator. Unpunctured vials may be stored at ambient temperature between 64°F and 82°F (18°C and 28°C) for a single period of up to 24 hours
  • No dose reduction of SARCLISA ESCENA is recommended. Dose delay or omission may be required

Administering SARCLISA ESCENA1

SARCLISA ESCENA, available as a 1,400-mg fixed dose, can be administered with CirCLIQ or with a syringe and infusion set for manual administration.

Illustration of SARCLISA ESCENA with CirCLIQ and SARCLISA ESCENA syringe injection.
  • SARCLISA ESCENA is for abdominal subcutaneous administration by a healthcare provider only
  • Do not administer SARCLISA ESCENA intravenously
  • Change (rotate) the site of each subcutaneous administration at least 1 inch (2.5 cm) from previous injection site with every injection to avoid accumulation of fatty tissue
  • Do not inject other medications in the area where SARCLISA ESCENA is injected
  • Do not inject into areas where the skin is injured, tender, red, hot, has scars, or is excessively hairy
  • Administer within 4 hours (including injection time) at room temperature. Discard after 4 hours if not used

For dosing instructions of combination agents administered with SARCLISA ESCENA, see the respective manufacturer’s Prescribing Information.

Administration adjustments and monitoring for SARCLISA ESCENA1

  • No dose reduction of SARCLISA ESCENA is recommended. Dose delay or omission may be required

Systemic administration reactions
In case of grade 2 systemic administration reaction during SARCLISA ESCENA administration, stop current administration and do not complete it. Administer additional premedication, as needed, for subsequent SARCLISA ESCENA administration. In case of grade 3 systemic administration reaction during SARCLISA ESCENA administration, stop current administration and do not complete it. SARCLISA ESCENA administration may be resumed at the next planned administration. In case of a third occurrence of a grade 3 systemic administration reaction, permanently discontinue SARCLISA ESCENA treatment. In case of grade 4 systemic administration reaction, permanently discontinue SARCLISA ESCENA treatment.

Injection site reactions

  • In case of grade 2 injection site reaction during administration of SARCLISA ESCENA, interrupt it and resume it only after recovery to grade ≤1, with pauses during the administration (if using CirCLIQ) or a slower administration (if manual injection)
  • If the grade 2 injection site reaction occurs after the administration, continue SARCLISA ESCENA treatment after recovery to grade ≤1
  • In case of grade 3 or 4 injection site reaction, permanently discontinue SARCLISA ESCENA treatment

Neutropenia

In case of grade 4 neutropenia, delay or omit the dose of SARCLISA ESCENA until neutrophil count recovery to at least 1 x 10⁹/L, and provide supportive care with growth factors according to institutional guidelines. No dose reductions of SARCLISA ESCENA are recommended.

Across 3 clinical trials, injection site reactions occurred in 9% of patients (8% grade 1 and 1.5% grade 2) and in 0.86% of injections. A majority of patients (82%) who experienced an injection site reaction did so during the day of the administration, while 4.2% were delayed by at least 3 days.

View the CirCLIQ Administration Video

Vial storage and handling 

Storage requirements1,3

  • Do not use SARCLISA ESCENA after the expiration date stated on the carton and the vial
  • Store in a refrigerator at 36°F to 46°F (2°C to 8°C) until 20 minutes prior to use; do not freeze or shake
  • Store in the original package in order to protect from light
  • Unpunctured vials may be stored at ambient temperature between 64°F and 82°F (18°C and 28°C) for a single period of up to 24 hours
  • SARCLISA ESCENA should be used immediately after the vial has been punctured. If not used immediately, the vial can be stored at room temperature in ambient light for up to 4 hours including administration time. Discard after 4 hours if not used
  • Once the vial has been taken out of the refrigerator, it must not be returned to the refrigerator

Handling and disposal1
Discard all unused portions of SARCLISA ESCENA solution. All materials that have been utilized for the preparation and administration should be disposed of according to local standard requirements.

Image of SARCLISA ESCENA vials and packaging on shelf.

Read the full Instructions for Use carefully before using the SARCLISA ESCENA vial and CirCLIQ On-Body Delivery System (OBDS).

Important information you need to know before administering SARCLISA ESCENA with CirCLIQ1,3

  • See full Prescribing Information for SARCLISA ESCENA
  • The CirCLIQ system contains one 10-mL single-use on-body injector and one filling base. Device must be filled prior to use
  • The CirCLIQ system is intended for abdominal subcutaneous injection. A single dose of SARCLISA ESCENA should be administered directly into the fatty layer under the skin by an HCP
  • SARCLISA ESCENA is indicated for the treatment of appropriate adult patients with multiple myeloma. The SARCLISA ESCENA vial is not included in the CirCLIQ packaging
  • Only use the CirCLIQ system with SARCLISA ESCENA. The CirCLIQ system should not be used with any other medicines
  • Do not use the CirCLIQ system if the expiration date has passed or its packaging was previously opened
  • Do not use the CirCLIQ system components if they have been dropped on a hard surface because they could be damaged. Start again with a new CirCLIQ system
  • Do not use the CirCLIQ system if the wearer has an acrylic allergy. CirCLIQ adhesive contains acrylic
  • Use CirCLIQ as soon as possible after filling it with SARCLISA ESCENA. The injection should be completed within 4 hours once the vial is punctured. If the injection is not completed within 4 hours, discard the vial and the CirCLIQ system
  • Do not attempt to reapply CirCLIQ once it is attached to the abdomen
Image of SARCLISA ESCENA vial and CirCLIQ components.

Special precautions for storage3

Storing the CirCLIQ system

  • Keep the CirCLIQ system away from children aged 3 years and younger. The system contains small parts
  • Store and transport the CirCLIQ system in its unopened plastic packaging inside of the original carton
  • Store the CirCLIQ system in a clean, dry area away from heat and sunlight at 36°F to 86°F (2°C to 30°C)
  • Use the CirCLIQ system where the temperature is 64°F to 82°F (18°C to 28°C)

Parts of the CirCLIQ On-Body Delivery System and SARCLISA ESCENA vial3

For single use only

Illustration of 1,400-mg medication vial with text "The 1,400-mg vial (not included in the CirCLIQ system packaging)."
Diagram of filling base and CirCLIQ.
Diagram of getting to know CirCLIQ.
Diagram of underside of CirCLIQ.

View the CirCLIQ Administration Video

Please see the full Instructions for Use here

Preparing SARCLISA ESCENA for manual administration1,3

SARCLISA ESCENA is available in a 1,400-mg fixed dose in a single-use vial. 
No dose reduction of SARCLISA ESCENA is recommended. Dose delay or omission may be required. 
SARCLISA ESCENA for manual administration is ready to use. Prepare and administer SARCLISA ESCENA subcutaneously using clean technique.

  • Inspect vials of SARCLISA ESCENA for particulate matter and discoloration prior to administration whenever solution and container permit. The solution may contain a few translucent to white particles
  • Do not use SARCLISA ESCENA if the solution is cloudy or discolored, or if particles other than those described are present
  • Check the SARCLISA ESCENA vial label to ensure it is the correct medication for subcutaneous use (vial with green cap). Do not use if the expiration date has passed
  • Do not heat. Do not shake
  • Prior to use, allow SARCLISA ESCENA to reach room temperature for approximately 20 minutes

Administering SARCLISA ESCENA with a syringe1

Icon of a syringe inside a dark blue circle with a green outline.
  • Administer ready-to-use SARCLISA ESCENA using a 20-mL syringe and infusion set for manual administration
  • The syringe must be a 20-mL polypropylene syringe with Luer fitting connector
  • The transfer needle with filter must be made of 18-G stainless steel with a 5-micron filter and Luer fitting connector
  • The subcutaneous infusion set must have a 23-G stainless steel needle for administration and tubing up to 12 inches (30 cm) in length made of polyethylene or polyvinyl chloride (PVC) with a Luer fitting connector
  • Remove the green vial cap and wipe the vial’s rubber stopper with an alcohol wipe and allow it to air-dry
  • Attach the transfer needle with 5-micron filter to the syringe and withdraw the full content of the SARCLISA ESCENA vial into the 20-mL compatible syringe
  • Attach the subcutaneous infusion set to the syringe. Prime the syringe and subcutaneous infusion set with SARCLISA ESCENA

Note: To avoid needle clogging, attach the subcutaneous infusion set to the syringe immediately prior to the injection.

  • Once the syringe has been prepared and filled, administer the injection into the abdomen. Refer to the Prescribing Information for complete administration details

Note: If the syringe containing SARCLISA ESCENA is not used immediately:

  • Remove the transfer needle with filter. Attach a syringe closing cap to the syringe. Label the syringe with the SARCLISA ESCENA peel-off label provided in the vial carton and as per institutional standards
  • Store it for up to 4 hours at room temperature between 59°F and 77°F (15°C and 25°C) and ambient light, including the administration time. Discard after 4 hours, if not used
Green play icon.

See instructions for administering SARCLISA ESCENA with CirCLIQ

Watch the CirCLIQ Administration Video

Indication

SARCLISA (isatuximab-irfc) is indicated:

  • In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
  • 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
  • In combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor

Important Safety Information

CONTRAINDICATIONS
SARCLISA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
SARCLISA can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. Severe signs and symptoms include cardiac arrest, hypertension, hypotension, bronchospasm, dyspnea, angioedema, and swelling.

In clinical trials (ICARIA-MM, IKEMA, and IMROZ), in patients treated with SARCLISA (N=592), infusion-related reactions occurred in 206 patients (35%). Among these 206 patients, 92% experienced infusion-related reactions during the first infusion and 12% after the first cycle.

The most common symptoms (≥5%) of an infusion-related reaction included dyspnea and cough. Grade 1 infusion-related reactions were reported in 6% of patients, grade 2 in 28%, and grade 3 or 4 in 1.2%. Anaphylactic reactions occurred in less than 1% of patients. The total incidence of SARCLISA infusion interruptions was less than 1% and the incidence of patients with at least one SARCLISA infusion interruption due to infusion-related reactions was 26%. The median time to first SARCLISA infusion interruption was 61 minutes (range 4 to 240 minutes). SARCLISA was discontinued in 1% of patients due to infusion-related reactions. 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. For patients with grade ≥2 reactions, interrupt SARCLISA infusion and provide appropriate medical management. For patients with grade 2 or grade 3 reactions, if symptoms improve to grade ≤1, restart SARCLISA infusion at half of the initial infusion rate, with supportive care as needed, and closely monitor patients. If symptoms do not recur after 30 minutes, the infusion rate may be increased to the initial rate, and then increased incrementally. In case symptoms do not improve to grade ≤1 after interruption of SARCLISA infusion, persist or worsen despite appropriate medications, or require hospitalization, permanently discontinue SARCLISA and institute appropriate management. Permanently discontinue SARCLISA if an anaphylactic reaction or life-threatening (grade 4) IRR occurs and institute appropriate management.

Infections
SARCLISA can cause severe, life-threatening, or fatal infections. In patients who received SARCLISA at the recommended dose in ICARIA-MM, IKEMA, and IMROZ (N=592), serious infections, including opportunistic infections, occurred in 46%, grade 3 or 4 infections occurred in 43%, and fatal infections occurred in 4.7%. The most common serious infection reported was pneumonia (32%).

Monitor patients for signs and symptoms of infection prior to and during treatment with SARCLISA and treat appropriately. Administer prophylactic antimicrobials according to guidelines.

Neutropenia
SARCLISA may cause neutropenia.

In clinical trials (ICARIA-MM, IKEMA, and IMROZ), in patients treated with SARCLISA (N=592), neutropenia based on laboratory values occurred in 81%, with grade 3 or 4 occurring in 52%. Neutropenic infections occurred in 12% of patients, with grade 3 or 4 in 4.9%, and febrile neutropenia in 4%.

Monitor complete blood cell counts periodically during treatment. If needed, use antibacterial and antiviral prophylaxis during treatment. Monitor patients with neutropenia for signs of infection. In case of grade 4 neutropenia, delay SARCLISA dose until neutrophil count recovery to at least 1 x 109/L, and provide supportive care with growth factors, according to institutional guidelines. No dose reductions of SARCLISA are recommended.

Second Primary Malignancies
The incidence of second primary malignancies, during treatment and post-treatment, is increased in patients treated with SARCLISA-containing regimens. In clinical trials (ICARIA-MM, IKEMA, and IMROZ), in patients treated with SARCLISA (N=592), second primary malignancies occurred in 71 patients (12%).

In ICARIA-MM, at a median follow-up time of 52 months, second primary malignancies occurred in 7% of patients treated with SARCLISA, pomalidomide, and dexamethasone (Isa-Pd) and in 2% of patients treated with Pd.

In IKEMA study, at a median follow-up time of 57 months, second primary malignancies occurred in 10% of patients treated with SARCLISA, carfilzomib, and dexamethasone (Isa-Kd) and in 8% of patients treated with Kd.

In IMROZ study, at a median follow-up time of 60 months, second primary malignancies occurred in 16% of patients treated with SARCLISA, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) and in 9% of patients treated with VRd.

The most common (≥1%) second primary malignancies in ICARIA-MM, IKEMA, and IMROZ (N=592) included skin cancers (7% with SARCLISA-containing regimens and 3.1% with comparative regimens) and solid tumors other than skin cancer (4.6% with SARCLISA-containing regimens and 2.9% with comparative regimens). Patients with non-melanoma skin cancer continued treatment after resection of the skin cancer, except 2 patients in the Isa-VRd arm and 1 patient in the VRd arm of the IMROZ study. Monitor patients for the development of second primary malignancies.

Laboratory Test Interference
Interference with Serological Testing (Indirect Antiglobulin Test)
SARCLISA binds to CD38 on red blood cells (RBCs) and may result in a false-positive indirect antiglobulin test (indirect Coombs test). This interference with the indirect Coombs test may persist for approximately 6 months after the last infusion of SARCLISA. The indirect antiglobulin test was positive during Isa-Pd treatment in 68% of the tested patients, and during Isa-Kd treatment in 63% of patients. In patients with a positive indirect antiglobulin test, blood transfusions were administered without evidence of hemolysis. ABO/RhD typing was not affected by SARCLISA treatment.

Before the first SARCLISA infusion, conduct blood type and screen tests on SARCLISA-treated patients. Consider phenotyping prior to starting SARCLISA treatment. If treatment with SARCLISA has already started, inform the blood bank that the patient is receiving SARCLISA and that SARCLISA interference with blood compatibility testing can be resolved using dithiothreitol-treated RBCs. If an emergency transfusion is required, non–cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices.

Interference with Serum Protein Electrophoresis and Immunofixation Tests
SARCLISA is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the accuracy of the determination of complete response in some patients with IgG kappa myeloma protein.

Embryo-Fetal Toxicity
Based on the mechanism of action, SARCLISA can cause fetal harm when administered to a pregnant woman. SARCLISA may cause fetal immune cell depletion and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use an effective method of contraception during treatment with SARCLISA and for 5 months after the last dose. The combination of SARCLISA with pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide or lenalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide or lenalidomide prescribing information on use during pregnancy.

ADVERSE REACTIONS
In combination with pomalidomide and dexamethasone: The most common adverse reactions (≥20%) were upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea. The most common hematology laboratory abnormalities (≥80%) were decreased hemoglobin, decreased neutrophils, decreased lymphocytes, and decreased platelets.

In combination with carfilzomib and dexamethasone: The most common adverse reactions (≥20%) were upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. The most common hematology laboratory abnormalities (≥80%) were decreased hemoglobin, decreased lymphocytes, and decreased platelets.

In combination with bortezomib, lenalidomide, and dexamethasone: The most common adverse reactions (≥20%) were upper respiratory tract infections, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19. The most common hematologic laboratory abnormalities (≥80%) were decreased hemoglobin, decreased leukocytes, decreased lymphocytes, decreased platelets, and decreased neutrophils.

Serious adverse reactions occurred in 62% of patients receiving Isa-Pd. Serious adverse reactions in >5% of patients who received Isa-Pd included pneumonia (26%), upper respiratory tract infections (7%), and febrile neutropenia (7%). Fatal adverse reactions occurred in 11% of patients (those that occurred in more than 1% of patients were pneumonia and other infections [3%]).

Serious adverse reactions occurred in 59% of patients receiving Isa-Kd. The most frequent serious adverse reactions in >5% of patients who received Isa-Kd were pneumonia (25%) and upper respiratory tract infections (9%). Adverse reactions with a fatal outcome during treatment were reported in 3.4% of patients in the Isa-Kd group (those occurring in more than 1% of patients were pneumonia occurring in 1.7% and cardiac failure in 1.1% of patients).

Serious adverse reactions occurred in 71% of patients receiving Isa-VRd. The serious adverse reaction in >5% of patients who received Isa-VRd was pneumonia (30%). Fatal adverse reactions occurred in 11% of patients with Isa-VRd (those occurring in more than 1% of patients were pneumonia [5%]).

USE IN SPECIAL POPULATIONS
Because of the potential for serious adverse reactions in the breastfed child from isatuximab-irfc administered in combination with pomalidomide or lenalidomide and dexamethasone, advise lactating women not to breastfeed during treatment with SARCLISA.

Please see full Prescribing Information.

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Indications

SARCLISA ESCENA (isatuximab-irfc) is indicated:

  • in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
  • 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
  • in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor

Important Safety Information

CONTRAINDICATIONS
SARCLISA ESCENA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

WARNINGS AND PRECAUTIONS
Hypersensitivity and Other Administration Reactions
SARCLISA ESCENA can cause both systemic administration reactions (SARs), including severe or life-threatening reactions, and local injection-site reactions (ISRs).

Systemic Administration Reactions
In a pooled safety population of 411 patients with multiple myeloma who received SARCLISA ESCENA in combination with pomalidomide and dexamethasone (Pd); carfilzomib and dexamethasone (Kd); and bortezomib, lenalidomide, and dexamethasone (VRd) (IRAKLIA, IZALCO, and IsaSocut, respectively, N=411), SARs occurred in 3.2% (Grade 1: 2.2%, Grade 2: 0.7%, Grade 3: 0.2%) of patients. SARs occurred at the first administration in 1.9% of patients and at subsequent administrations in 1.5% of patients. The median time to onset was 4 hours (range: 12 minutes to 3 days). The most frequently reported symptoms of SARs (all below 1%) were pyrexia and dyspnea, and the most frequently reported Grade ≥3 symptom was dyspnea (not collected in IsaSocut study). In multiple myeloma clinical trials with intravenous isatuximab-irfc, anaphylactic reactions occurred in <1% of patients.

To decrease the risk and severity of SARs, premedicate patients prior to SARCLISA ESCENA administration with leukotriene receptor antagonists (at cycle 1 only), acetaminophen, diphenhydramine or equivalent, and dexamethasone.

In case of grade 2 SAR during SARCLISA ESCENA administration, stop current administration and do not complete it. Administer additional premedication, as needed, for subsequent SARCLISA ESCENA administration. In case of grade 3 SAR during SARCLISA ESCENA administration, stop current administration and do not complete it. SARCLISA ESCENA administration may be resumed at the next planned administration. In case of a third occurrence of a grade 3 SAR, permanently discontinue SARCLISA ESCENA treatment. In case of grade 4 SAR, permanently discontinue SARCLISA ESCENA treatment.

Injection Site Reactions
In clinical trials of SARCLISA ESCENA in combination with Pd, Kd, or VRd (IRAKLIA, IZALCO, and IsaSocut, respectively, N=411), injection site reactions (ISRs) with SARCLISA ESCENA administration were reported in 9% (8% Grade 1 and 1.5% Grade 2) of patients and in 0.86% of injections. Among the SARCLISA ESCENA injections with ISRs, 82% occurred the day of the administration and 4.2% were delayed by at least 3 days. With SARCLISA ESCENA + Pd and SARCLISA ESCENA + Kd, 5% of patients experienced symptoms of ISR (not collected in IsaSocut study). The most frequent (≥1%) symptoms of ISR were injection site erythema (3.3%), injection site swelling (2.1%), and injection site pain (1.5%).

In case of grade 2 ISR during administration of SARCLISA ESCENA, interrupt it and resume it only after recovery to grade ≤1 with pauses during the administration (if using OBDS) or a slower administration (if manual injection). If the Grade 2 ISR occurs after the administration, continue SARCLISA ESCENA treatment after recovery to grade ≤1. In case of grade 3 or 4 ISR, permanently discontinue SARCLISA ESCENA treatment. 

In case SARCLISA ESCENA administration using CirCLIQ OBDS needs to be paused, refer to the OBDS Instructions for Use. 

Neutropenia
Neutropenia was reported in patients receiving SARCLISA ESCENA subcutaneously in combination with Pd, Kd, or VRd. In clinical trials of SARCLISA ESCENA (IRAKLIA, IZALCO, and IsaSocut, N=411), neutropenia occurred in 86% of patients based on laboratory value. Grade 3-4 neutropenia occurred in 66% of patients based on laboratory value. Febrile neutropenia was reported in 3.4% and neutropenic infections occurred in 13% of patients.

Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. In case of grade 4 neutropenia, delay or omit SARCLISA ESCENA dose until neutrophil count recovery to at least 1 x 109/L, and provide supportive care with growth factors, according to institutional guidelines.

Infections 
SARCLISA ESCENA can cause severe, life-threatening, or fatal infections. In patients who received SARCLISA ESCENA subcutaneously in combination with Pd, Kd, or VRd (IRAKLIA, IZALCO, and IsaSocut, respectively, N=411), fatal infections occurred in 2.9% of patients, serious infections occurred in 29% of patients, and Grade ≥3 infections occurred in 29% of patients. The most commonly reported infections (≥10%) were pneumonia (21%), upper respiratory tract infection (19%), and COVID-19 (12%). The most frequent serious infection (≥5%) was pneumonia (17%). 

Patients receiving SARCLISA ESCENA should be closely monitored for signs of infection and appropriate standard therapy instituted.

Antibacterial and antiviral prophylaxis (such as herpes zoster prophylaxis) should be considered during treatment.

Second Primary Malignancies 
Second primary malignancies were reported in 3.9% of patients in clinical trials with SARCLISA ESCENA in combination with Pd, Kd, and VRd (IRAKLIA, IZALCO, and IsaSocut, respectively, N=411).

Monitor patients for the development of second primary malignancies and initiate treatment as indicated.

Laboratory Test Interference 
Interference with Serological Testing (Indirect Antiglobulin Test) 
Isatuximab-irfc binds to CD38 on red blood cells (RBCs) and may result in a false-positive indirect antiglobulin test (indirect Coombs test). This interference with the indirect Coombs test may persist for at least 6 months after the last administration of intravenous isatuximab-irfc. The indirect antiglobulin test was positive during intravenous isatuximab-irfc + Pd treatment in 68% of the tested patients, and during intravenous isatuximab-irfc + Kd treatment in 63% of patients. In patients with a positive indirect antiglobulin test, blood transfusions were administered without evidence of hemolysis. ABO/RhD typing was not affected by intravenous isatuximab-irfc treatment. 

Before the first isatuximab-irfc administration, conduct blood type and screen tests on isatuximab-treated patients. Consider phenotyping prior to starting isatuximab-irfc treatment. If treatment with isatuximab-irfc has already started, inform the blood bank that the patient is receiving isatuximab-irfc, and isatuximab-irfc interference with blood compatibility testing can be resolved using dithiothreitol-treated RBCs. If an emergency transfusion is required, non–cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices.

Interference with Serum Protein Electrophoresis and Immunofixation Tests 
Isatuximab-irfc is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays (IFE) used for the clinical monitoring of endogenous M-protein. In patients with persistent very good partial response, where interference is suspected, consider using a validated isatuximab-specific IFE assay (Sebia Hydrashift) to remove isatuximab-irfc interference and specifically visualize any remaining serum M-protein, to facilitate determination of complete response.

Embryo-Fetal Toxicity 
Based on its mechanism of action, isatuximab-irfc can cause fetal harm when administered to a pregnant woman. Isatuximab-irfc may cause fetal immune cell depletion and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with isatuximab-irfc and for 7 months after the last dose. The combination of isatuximab-irfc with pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide or lenalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide or lenalidomide prescribing information on use during pregnancy.

ADVERSE REACTIONS
In combination with pomalidomide and dexamethasone: The most common adverse reactions (≥20%) are upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea.

In combination with carfilzomib and dexamethasone: The most common adverse reactions (≥20%) are upper respiratory tract infection and musculoskeletal pain.

In combination with bortezomib, lenalidomide, and dexamethasone: The most common adverse reactions (≥20%) are peripheral neuropathy, constipation, diarrhea, fatigue, musculoskeletal pain, upper respiratory tract infections, injection site reaction, insomnia, edema, rash, and erythema.

The most common hematology laboratory abnormalities (≥40%) with SARCLISA ESCENA combination therapies are decreased neutrophils, decreased platelets, decreased hemoglobin, decreased leukocytes, and decreased lymphocytes.

Serious adverse reactions occurred in 53% of patients receiving SARCLISA ESCENA + Pd. Serious adverse reactions in ≥5% of patients who received SARCLISA ESCENA + Pd included pneumonia (20.5%). Fatal adverse reactions occurred in 4.9% of patients who received SARCLISA ESCENA + Pd, including pneumonia (1.5%), sepsis/septic shock (1.5%), death (0.8%), COVID-19, lower respiratory tract infection, hemorrhagic stroke, and sudden death (0.4% each).

Serious adverse reactions occurred in 41% of patients receiving SARCLISA ESCENA + Kd. Serious adverse reactions in ≥5% of patients included pneumonia (11%). Fatal adverse reactions occurred in 5.4% of patients who received SARCLISA ESCENA + Kd, including meningitis (1.4%), acute pulmonary edema (1.4%), acute respiratory distress syndrome (1.4%), and death from unknown cause (1.4%).

Serious adverse reactions occurred in 45% of patients who received SARCLISA ESCENA + VRd. Serious adverse reactions in >5% of patients included pneumonia (8%). Fatal adverse reactions occurred in 2.7% of patients who received SARCLISA ESCENA + VRd, including cardio-respiratory arrest (1.4%) and myocardial infarction (1.4%).

USE IN SPECIAL POPULATIONS
Based on its mechanism of action, SARCLISA ESCENA can cause fetal harm when administered to a pregnant woman. There are no available data on SARCLISA ESCENA use in pregnant women to evaluate for a drug-associated risk.

The combination of SARCLISA ESCENA and pomalidomide or lenalidomide is contraindicated in pregnant women because pomalidomide and lenalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide or lenalidomide prescribing information on use during pregnancy. Pomalidomide and lenalidomide are only available through a REMS program.

Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with SARCLISA ESCENA and for 7 months after the last dose.

Please see full Prescribing Information.

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Indication

Important Safety Information

References: 1. SARCLISA ESCENA. Prescribing information. sanofi-aventis U.S. LLC; 2026. 2. Ailawadhi S, Špička I, Spencer A, et al. Isatuximab subcutaneous by on-body injector versus isatuximab intravenous plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: phase III IRAKLIA study. J Clin Oncol. 2025;43(22):2527-2537. doi:10.1200/JCO-25-00744 3. CirCLIQ™ On-Body Delivery System. HCP instructions for use. sanofi-aventis U.S. LLC; 2026.

©2026 Sanofi. All rights reserved. SARCLISA, CareASSIST, and Sanofi are registered trademarks of Sanofi or an affiliate. SARCLISA ESCENA and CirCLIQ are trademarks of Sanofi or an affiliate. All the other trademarks on this website are the property of their respective owners, who have no affiliation or relationship with Sanofi. MAT-US-2602733-v1.0-07/2026 Last Updated: July 2026

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