Isatuximab
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From MedlinePlus, U.S. National Library of Medicine
CD38-directed Cytolytic Antibody
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Preparation SARCLISA ESCENA is only for abdominal subcutaneous administration using: CirCLIQ On-Body Delivery System (OBDS ) OR 20 mL syringe and infusion set (manual administration using commercially available syringe and infusion set). SARCLISA ESCENA should be administered by a healthcare provider. To prevent medication errors, check SARCLISA ESCENA vial label to ensure it is the correct medication for subcutaneous use (vial with green cap).
Do not administer SARCLISA ESCENA intravenously. SARCLISA ESCENA is ready to use and should not be diluted. Prepare and administer SARCLISA ESCENA subcutaneously using clean technique. Prior to use‚ allow SARCLISA ESCENA to reach ambient temperature between 18°C to 28°C (64°F to 82°F) 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 has been taken out of the refrigerator, it must not be returned to the refrigerator. Unpunctured vials may be stored at ambient temperature between 18°C to 28°C (64°F to 82°F) for a single period of up to 24 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The solution 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 [see Dosage Forms and Strengths ] . Preparation with CirCLIQ On-Body Delivery System Refer to the Instructions for Use for CirCLIQ OBDS provided with the device for full preparation and administration information.
Once the vial is punctured, the injection with the CirCLIQ On-Body Injector should be performed as soon as possible. If the injection is not completed within 4 hours, discard the vial and the On-Body Delivery System. Preparation with syringe and infusion set for manual administration Before you begin, collect your supplies: The syringe must be a 20 mL polypropylene syringe with Luer-fitting connector.
The transfer needle with filter must be made of 18G stainless steel with 5-micron filter and Luer-fitting connector. The subcutaneous infusion set must have a 23G stainless steel needle for administration and tubing up to 12 inches (30 cm) length made of polyethylene, or polyvinyl chloride (PVC), with a Luer-fitting connector.
Check the expiration date. Remove green vial cap and wipe vial rubber stopper with an alcohol wipe and allow to air dry. Attach the transfer needle with 5-micron filter to the syringe and fill the syringe. Withdraw the full content of the SARCLISA ESCENA vial into a 20 mL compatible syringe. 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 15°C to 25°C (59°F to 77°F) and ambient light, including the administration time. Discard after 4 hours, if not used.
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 injection.
Preparation and administration
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Recommended Dosage Administer premedications before SARCLISA ESCENA administration [see Dosage and Administration ] . SARCLISA ESCENA should be administered by a health care professional [see Warnings and Precautions ] . Patients currently receiving intravenous isatuximab-irfc may transition to SARCLISA ESCENA solution for injection after the completion of the first cycle.
The recommended dose of SARCLISA ESCENA is 1,400 mg administered as a subcutaneous injection with the CirCLIQ On-Body Delivery System (OBDS) or with a syringe and infusion set for manual administration, in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone, or in combination with bortezomib, lenalidomide, and dexamethasone.
SARCLISA ESCENA dosing schedules are provided in Tables 1 and 2 [see Clinical Studies ] . [See table below.] [See table below.] Treatment is repeated until disease progression or unacceptable toxicity. SARCLISA ESCENA is used in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone or in combination with bortezomib, lenalidomide, and dexamethasone.
For dosing instructions of combination agents administered with SARCLISA ESCENA, see Clinical Studies and manufacturer's prescribing information. Missed SARCLISA ESCENA Doses 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.
Administration On the days when both SARCLISA ESCENA and carfilzomib are administered, administer dexamethasone first, followed by SARCLISA ESCENA administration, then followed by carfilzomib infusion. SARCLISA ESCENA is only for abdominal subcutaneous administration. Data are only available with an injection performed into the abdomen.
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.
Administration with CirCLIQ On-Body Delivery System Refer to the Instructions for Use for CirCLIQ OBDS provided with the device for full preparation and administration information. Do not inject other medications in the area where SARCLISA ESCENA is injected. Administration with syringe and infusion set for manual administration Prepare injection site and insert needle.
Wipe injection site with an alcohol swab and allow it to dry. Avoid injecting within 2 inches (5 cm) around the belly button. Remove protective needle cover. Pinch skin at the injection site on the abdomen. It is important to pinch enough skin to inject under the skin and not into the muscle. Insert needle at a 45-degree angle with a quick, dart-like motion.
Note: Try to limit needle and syringe movement during the injection. If needed, secure the subcutaneous infusion set in place with a bandage. Inject 10 mL of SARCLISA ESCENA subcutaneously into the abdomen, over approximately 6 minutes. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by pausing or slowing down delivery rate, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.
Drug interactions
Check isatuximab against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Laboratory Test Interference Interference with Serological Testing Isatuximab-irfc, an anti-CD38 antibody, may interfere with blood bank serologic 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 isatuximab-irfc [see Warnings and Precautions (5.5) ] .
Interference with Serum Protein Electrophoresis and Immunofixation Tests Isatuximab-irfc may be incidentally detected by serum protein electrophoresis and immunofixation assays used for the monitoring of M-protein and may interfere with accurate response classification based on International Myeloma Working Group (IMWG) criteria [see Warnings and Precautions (5.5) ] . Because of this interference, Hydrashift assay was routinely used in IRAKLIA and IZALCO clinical studies for efficacy assessment to determine the complete response in patients with IgG kappa myeloma protein.
In patients with persistent very good partial response, where interference is suspected, consider using an FDA-cleared isatuximab-irfc-specific IFE assay to distinguish isatuximab-irfc from any remaining endogenous M-protein in the patient's serum to facilitate determination of a complete response.
Contraindications
4 CONTRAINDICATIONS SARCLISA ESCENA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients [see Warnings and Precautions (5.1) ] . Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury although a potential cause of reactivation of hepatitis B.
Isatuximab is a cytolytic monoclonal antibody to CD38 used in the therapy of multiple myeloma in combination with pomalidomide and dexamethasone. The addition of isatuximab to pomalidomide and dexamethasone increases the rate of severe infections and serious adverse events associated with pomalidomide and dexamethasone alone, but does not increase the rate of serum ALT, AST or bilirubin elevations. Since its more widespread clinical use, isatuximab has not been implicated in cases clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1) ] , 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 assessment of isatuximab-irfc-associated risks is based on its mechanism of action and data from target antigen CD38 knockout animal models (see Data ). No animal reproduction studies were conducted with isatuximab-irfc. Advise pregnant women of the potential risk to a fetus. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 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. Clinical Considerations Fetal/neonatal adverse reactions Immunoglobulin G1 monoclonal antibodies are known to cross the placenta.
Based on its mechanism of action, SARCLISA ESCENA may cause depletion of fetal CD38-positive immune cells and decreased bone density. Defer administration of live vaccines to neonates and infants exposed to SARCLISA ESCENA in utero until a hematology evaluation is completed. Data Animal data Mice that were genetically modified to eliminate all CD38 expression (CD38 knockout mice) had reduced bone density which recovered 5 months after birth. Data from studies using CD38 knockout animal models also suggest the involvement of CD38 in regulating humoral immune responses (mice), feto-maternal immune tolerance (mice), and early embryonic development (frogs).
Breastfeeding (LactMed)
No information is available on the use of isatuximab during breastfeeding. Because isatuximab is a large protein molecule with a molecular weight of about 148,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. However, because it is given with pomalidomide or lenalidomide and dexamethasone, it is recommended that breastfeeding be discontinued during therapy.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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