isatuximab (Rx)

Brand and Other Names:Sarclisa, isatuximab-irfc
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 20mg/mL (5-mL, 25-mL single-dose vial)

Multiple myeloma

Indicated, in combination with pomalidomide and dexamethasone, for multiple myeloma in adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor

Each cycle is 28 days

Use in combination with pomalidomide and dexamethasone

Cycle 1

  • 10 mg/kg (actual body weight) IV qWeek (eg, Day 1, 8, 15, 22)

Cycle 2 and beyond

  • 10 mg/kg IV q2Weeks (eg, Day 1, 15)
  • Continue until disease progression or unacceptable toxicity

Dosage Modifications

No dose reduction recommended; dose delay may be required to allow recovery of blood counts if hematological toxicity occurs

Refer to prescribing information for pomalidomide and dexamethasone for dosage modifications

Safety and efficacy not established

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Interactions

Interaction Checker

and isatuximab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Adverse reactions occurred in combination with pomalidomide and dexamethasone

            >10%

            All grades

            • Anemia (99%)
            • Neutropenia (96%)
            • Lymphopenia (92%)
            • Thrombocytopenia (84%)
            • Upper respiratory tract infection (57%)
            • Infusion-related reactions (38%)
            • Pneumonia (31%)
            • Diarrhea (26%)
            • Dyspnea (17%)
            • Nausea (15%)
            • Vomiting (12%)
            • Febrile neutropenia (12%)

            Grade 3-4

            • Neutropenia (24-61%)
            • Lymphopenia (13-42%)
            • Anemia (32%)
            • Pneumonia (3.3-22%)
            • Thrombocytopenia (14-16%)
            • Febrile neutropenia (1.3-11%)

            1-10%

            Grade 3-4

            • Upper respiratory tract infections (9%)
            • Dyspnea (5%)
            • Diarrhea (2%)
            • Infusion-related reactions (1.3%)
            • Vomiting (1.3%)
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            Warnings

            Contraindications

            Severe hypersensitivity to isatuximab or to any of its excipients

            Cautions

            Neutropenia reported; monitor complete blood cell counts periodically; consider antibiotics and antiviral prophylaxis during treatment; if grade 4 neutropenia occurs, delay dose until neutrophil count recovery to at least 1 x 109/L, and provide supportive care with growth factors, according to institutional guidelines

            Second primary malignancies (SPMs) reported; monitor for the development of SPM, as per International Myeloma Working Group guidelines

            Can cause fetal harm

            Infusion-related reactions

            • Infusion-related reactions have been observed
            • All infusion-related reactions started during the first infusion and resolved within the same day
            • Premedicate before infusion to decrease the risk and severity of the reactions; monitor vital signs frequently during the entire infusion
            • For Grade 1 or 2 reactions, interrupt infusion and provide appropriate medical support
            • If symptoms improve, restart infusion and reduce rate by half, with supportive care as needed, and closely monitor
            • If symptoms do not recur after 30 min, then increase infusion rate to the initial rate, and then increase incrementally
            • In case symptoms do not improve or recur after interruption, permanently discontinue and institute appropriate management
            • Permanently discontinue therapy if a grade 3 or higher infusion-related reaction occurs and institute appropriate medical management

            Drug interaction overview

            • Serological testing (indirect antiglobulin test)
              • Isatuximab binds to CD38 on red blood cells (RBCs) and may result in a false-positive indirect antiglobulin test (indirect Coombs test)
              • Type and screen patients before starting treatment
              • Inform blood bank that the patient is receiving isatuximab
              • If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices
            • Serum protein electrophoresis and immunofixation tests
              • Isatuximab is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays used for clinical monitoring of endogenous M-protein
              • This interference may affect the accuracy of the determination of complete response in some patients with IgG kappa myeloma protein
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            Pregnancy & Lactation

            Pregnancy

            Based on the mechanism of action, fetal harm may occur when isatuximab is administered to a pregnant woman

            No data available on use in pregnant women to evaluate drug-associated risks

            Animal reproduction toxicity studies have not been conducted

            Clinical considerations

            • IgG1 monoclonal antibodies are known to cross the placenta

            • Based on its mechanism of action, isatuximab may cause depletion of fetal CD38-positive immune cells and decrease bone density monoclonal antibodies are known to cross the placenta

            Contraception

            • Females: advise females of reproductive potential to use effective contraception during treatment and for at least 5 months after the last dose
            • Also see prescribing information for pomalidomide for further information

            Lactation

            Data not available on presence of isatuximab in human milk, on milk production, or effects on the breastfed child

            Maternal IgF is known to be present in human milk; effects of local gastrointestinal exposure in the breastfed infant are unknown

            Advise lactating women not breastfeed during treatment

            Refer to the prescribing information of pomalidomide and dexamethasone for further recommendations

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Anti-CD38 monoclonal antibody; monoclonal antibody that targets a specific epitope on the CD38 receptor on plasma cells that promote apoptosis and immunomodulatory activity

            Absorption

            Peak plasma concentration: 351 mcg/mL

            AUC: 72,600 mcg⋅hr/hr

            Median steady-state reached at 8 weeks

            Distribution

            Vd: 8.13 L

            Metabolism

            Expected to metabolized into small peptides by catabolic pathways

            Elimination

            At steady-state, the near elimination (≥99%) of isatuximab from plasma after last dose is predicted to occur in ~2 months

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            Administration

            IV Incompatibilities

            Do not administer concomitantly in the same IV line with other agents

            IV Compatibilities

            0.9% NaCl

            Dextrose 5% (D5W)

            IV Preparation

            Calculate dose required based on actual body weight

            Visual inspect parenteral drug products for particulate matter and discoloration before administration

            Remove the same volume of diluent from 0.9% NaCl or D5W diluent bag as the required volume of isatuximab

            Withdraw the necessary volume of isatuximab and add to the 0.9% NaCl or D5W infusion bag

            Infusion bag must be made of polyolefins (PO), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with di-(2-ethylhexyl) phthalate (DEHP), or ethyl vinyl acetate (EVA)

            Gently invert bag to mix; do not shake

            IV Administration

            Administer by IV infusion using an IV tubing infusion set (in PE, PVC with or without DEHP, polybutadiene [PBD], or polyurethane [PU]) with a 0.22-micron in-line filter (polyethersulfone [PES], polysulfone, or nylon)

            Premedications

            • Administer 15-60 min before infusion
            • Dexamethasone 40 mg PO/IV (or 20 mg PO/IV for patients aged ≥75 years)
            • Acetaminophen 650-1000 mg PO (or equivalent)
            • H2-antagonist
            • Diphenhydramine 25-50 mg PO/IV (or equivalent); IV route is preferred for at least the first 4 infusions
            • Dexamethasone dose is the total dose to be administered only once before infusion as part of the premedication and of the treatment, before isatuximab and pomalidomide administration

            Infusion rate

            • Consider incremental escalation of the infusion rate only in the absence of infusion-related reactions
            • First IV infusion: Start 25 mL/hr; if no reaction after 60 min, increase by 25 mL/hr q30min, not to exceed 150 mL/hr
            • Second IV infusion: Infuse at 50 mL/hr; if no reaction after 30 min, increase by 50 mL/hr for 30 min then increase by 100 mL/hr q30min; not to exceed 200 mL/hr
            • Subsequent IV infusions: Infuse at 200 mL/hr; not to exceed 200 mL/hr

            Missed dose

            • If planned dose is missed, administer dose as soon as possible
            • Adjust treatment schedule accordingly, maintain treatment interval

            Storage

            Unused vials: Refrigerate at 2-8ºC (36-46ºF); do not shake and protect from light

            Diluted solutions: Refrigerate at 2-8ºC for up to 48 hr, followed by 8 hr (including infusion time) at room temperature

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.