satralizumab (Rx)

Brand and Other Names:Enspryng, satralizumab-mwge
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for SC injection

  • 120mg/mL single-dose prefilled syringe

Neuromyelitis Optica Spectrum Disorder

Indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are antiaquaporin-4 (AQP4) antibody positive

Loading: 120 mg SC at Weeks 0, 2, and 4

Maintenance: 120 mg SC q4Weeks

Dosage Modifications

Renal impairment

  • No formal pharmacokinetic studies conducted

Hepatic impairment

  • No formal pharmacokinetic studies conducted
  • Caution when initiating if AST/ALT levels >1.5x ULN

ALT/AST >5x ULN during therapy

  • If associated with any bilirubin elevation, discontinue and do not reinitiate
  • If not associated with any bilirubin elevation above ULN, discontinue and reinitiate when ALT or AT returned to normal range following benefit-risk assessment
  • Restart after liver transaminase elevation
    • <12 weeks: 120 mg SC q4Weeks
    • ≥12 weeks: 120 mg SC q4Weeks at Weeks 0, 2, and 4, followed by 120 mg q4Weeks; Week 0 refers to first administration after missed dose
    • If treatment restarted, closely monitor liver parameters; discontinue if any subsequent increased ALT/AST and/or bilirubin above the ULN observed and do not reinitiate

Neutrophil count

  • <1 x 109/L: Interrupt dosing until >1 x 109/L

Dosing Considerations

Before every dose: Assess for active infection, including localized infections; in case of active infection, delay use until the infection is resolved

Before initiating

  • Evaluate for active tuberculosis (TB) and test for latent TB infection; consult infectious disease expert if positive
  • Perform hepatitis B virus (HBV) screening; consult liver disease expert for patients who are negative for HBsAg and positive for HB core antibody (HBcAb+) or are HBV carriers (HBsAg+)
  • Complete scheduled vaccinations

Liver transaminases

  • Before initiating: Assess liver transaminases and serum bilirubin; caution if AST/ALT levels >1.5x ULN
  • During treatment: Measure ALT/AST q4Weeks x 3 months, then q3Months x 1 year, and thereafter as clinically needed

Neutrophil counts

  • Monitor neutrophils 4-8 weeks after initiation and thereafter at regular clinically determined intervals

Safety and efficacy not established

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Interactions

Interaction Checker

and satralizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            ALT >ULN (43%)

            Platelets

            Nasopharyngitis (31%)

            Headache (27%)

            Triglycerides >300 mg/dL (12-17%)

            AST >ULN (25%)

            Upper respiratory tract infection (19%)

            Rash (17%)

            Arthralgia (12-17%)

            Pain in extremity (15%)

            Fatigue (15%)

            Nausea (15%)

            Gastritis (15%)

            Neutrophils <1 x 109/L (10-15%)

            Nasopharyngitis (12%)

            1-10%

            Pruritus (10%)

            Depression (10%)

            Cellulitis (10%)

            Neutropenia (10%)

            Blood CPK increased (10%)

            Fall (10%)

            ALT/AST 3x ULN (3%)

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            Warnings

            Contraindications

            Hypersensitivity

            Active hepatitis B infection

            Active or untreated latent TB

            Cautions

            Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other interleukin 6 (IL-6) antagonists

            Increased risk of infections, including serious and potentially fatal infections, observed with IL-6 antagonists, including satralizumab; risk of hepatitis B virus reactivation or TB infection

            Mild and moderate liver enzyme elevations observed; monitor before and during treatment

            Regularly monitor neutrophil count during treatment

            Drug interaction overview

            • Vaccines
              • Vaccination with live-attenuated or live vaccines not recommended during treatment
              • Administer all vaccines according to immunization guidelines at least 4 weeks before initiating satralizumab when possible (or at least 2 weeks before initiation of nonlive vaccines)
            • CYP450 substrates
              • Clinical significance unknown
              • IL-6 signaling suppression is expected to have minor impact on exposure of concomitant medications metabolized by CYP450 enzymes
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            Pregnancy & Lactation

            Pregnancy

            Data are not available regarding developmental risk associated with the use in pregnant females

            Clinical considerations

            • Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
            • Consider risks and benefits before administering live or live-attenuated vaccines to infants exposed to satralizumab in utero

            Animal studies

            • No adverse effects on maternal animals or fetal development observed in pregnant monkeys and their offspring, with satralizumab at doses up to 50 mg/kg/week

            Lactation

            No information available on excretion in human milk, effects on breastfed infants, or effects on milk production

            Human IgG excreted in human milk; potential for absorption in infant is unknown

            Animal studies

            • Excreted in milk of lactating monkeys administered satralizumab throughout pregnancy

            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

            Humanized monoclonal antibody that targets the interleukin 6 (IL-6) receptor

            Cytokine IL-6 is thought to be a key cause of NMOSD, triggering the inflammation cascade and leading to damage and disability

            Absorption

            Bioavailability: 85%

            Steady-state after 8-week loading dose

            • Peak plasma concentration: 31.5 mcg/mL
            • Minimum plasma concentration: 19.7 mcg/mL
            • AUC 737 mcgmL/day

            Distribution

            Vd

            • Biphasic distribution
            • Central volume: 3.46 L
            • Peripheral volume: 2.07 L
            • Intercompartmental clearance: 0.336 L/day

            Metabolism

            Not studied; antibodies cleared principally by catabolism

            Elimination

            Half-life: ~30 days

            Total clearance: 0.0601 L/day

            Excretion: Monoclonal antibodies are not eliminated via renal or hepatic pathways

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            Administration

            SC Preparation

            Remove syringe from refrigerator and let sit at room temperature for 30 minutes

            Solution is colorless to slightly yellow

            Do not use if expiration date has passed, syringe is damaged, or liquid is cloudy

            SC Administration

            SC use only; intended for patient self-administration after proper training

            Inject full amount in syringe (ie, 120 mg/mL) SC in lower abdomen or front and middle of thighs; rotate injection sites

            Do not inject into the 2-inch are around naval; do not inject into moles, scars, or skin that is tender, bruised, red, hard, or not intact

            Delayed or missed doses

            • Recommendations for any reason other than increased liver enzymes
            • <8 weeks during maintenance or missed loading dose
              • Administer 120 mg SC as soon as possible, and do not wait until the next planned dose
              • Maintenance period: After delayed/missed dose administered, reset dose schedule to q4Weeks
              • Second loading dose delayed/missed: Administer dose as soon as possible, then administer third (final) loading dose 2 weeks later
              • Third loading dose delayed/missed: Administer dose as soon as possible, then first maintenance dose 4 weeks later
            • 8 to <12 weeks
              • 120 mg SC at 0 and 2 weeks, followed by 120 mg q4Weeks
            • ≥12 weeks
              • 120 mg SC at 0, 2, and 4 weeks followed by 120 mg q4Weeks

            Storage

            Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light

            If unopened before administration, can be removed from and returned to refrigerator, if necessary; do not exceed 8 days combined time out of refrigerator at room temperature <30ºC (86ºF)

            Do not freeze

            Do not shake

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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
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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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.