anifrolumab (Rx)

Brand and Other Names:Saphnelo, anifrolumab-fnia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 300mg/2mL (single-dose vial)

Systemic Lupus Erythematosus

Indicated for moderate-to-severe systemic lupus erythematosus (SLE) in adults who are receiving standard therapy

300 mg IV q4Weeks

Dosage Modifications

Renal impairment

  • Mild-to-moderate (30-89 mL/min/1.73 m2): Based on population pharmacokinetic analyses, drug clearance decreases in eGFR
  • Severe (<30 mL/min/1.73 m2) or end-stage renal disease: No patients in analyses
  • Anifrolumab is not cleared renally

Hepatic impairment

  • Not studied
  • IgG1 monoclonal antibodies predominantly eliminated via catabolism and are not expected to undergo hepatic metabolism; changes in hepatic function are not expected to influence clearance
  • Based on population pharmacokinetic analyses, baseline hepatic function biomarkers (ALT and AST ≤2x ULN, and total bilirubin) had no clinically relevant effect on clearance

Dosing Considerations

Limitation of use

  • Not evaluated in patients with severe active lupus nephritis or severe active CNS lupus; use not recommended in these situations

Safety and efficacy not established

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Interactions

Interaction Checker

and anifrolumab

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Upper respiratory tract infection (34%)

            Bronchitis (11%)

            1-10%

            Infusion-related reactions (9.4%)

            Herpes zoster (6.1%)

            Cough (5%)

            Respiratory tract infection (3.3%)

            Hypersensitivity (2.8%)

            Malignant neoplasm (including nonmelanoma skin cancers) (1.3%)

            <1%

            Malignancies (excluding nonmelanoma skin cancers (0.7%)

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            Warnings

            Contraindications

            History of anaphylaxis associated with anifrolumab

            Cautions

            Update immunizations, according to current immunization guidelines, before initiating therapy

            Serious infections

            • Serious and sometimes fatal infectious occurred
            • May increase risk of respiratory tract infections and herpes zoster
            • Avoid initiating during active infection until infection resolves or is adequately treated
            • If signs or systems of infection occur, instruct patients to seek medical advice
            • Consider the benefit-risk if using in patients with severe or chronic infections
            • If an infection develops, or is not responding to standard anti-infective therapy, closely monitor patient and consider interrupting therapy until infection resolves

            Hypersensitivity reactions

            • Hypersensitivity reactions, including anaphylaxis and angioedema, reported
            • Other hypersensitivity reactions and infusion-related reactions occurred following administration
            • Consider premedication before infusion for patients with history of these reactions
            • Prepare to manage hypersensitivity reactions and infusion-related reactions
            • If such reactions occur, immediately interrupt administration and initiate appropriate therapy

            Malignancy

            • Use of immunosuppressants may increase risk of malignancies
            • Unknown if anifrolumab may also increases such risk
            • Consider the benefit-risk in patients with known risk factors for developing or recurring malignancies before prescribing therapy
            • In patients who develop malignancies, consider the benefit-risk of continued treatment

            Other biologic therapies

            • Not recommended
            • Not studied in combination with other biologic therapies, including B-cell–targeted therapies

            Drug interaction overview

            Live or live attenuated immunizations
            • Avoid use
            • Update immunizations, according to current immunization guidelines, before initiating
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            Pregnancy & Lactation

            Pregnancy

            Limited human data with use in pregnant females are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome

            Pregnancy exposure registry

            • Monitor pregnancy outcomes in females exposed to anifrolumab during pregnancy
            • For more information, contact AstraZeneca at 1-877-693- 9268

            Clinical considerations

            • Monoclonal antibodies are known to cross the placenta as pregnancy progresses; therefore, anifrolumab exposure to fetus may be greater during third trimester of pregnancy
            • Pregnant females with SLE are at increased risk of adverse pregnancy outcomes (eg, worsening of underlying disease, premature birth, miscarriage, intrauterine growth restriction)
            • Maternal lupus nephritis may increase risk of hypertension and preeclampsia/eclampsia
            • Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus a congenital heart block

            Lactation

            No data are available regarding presence of drug in human milk, effects on breastfed children, or effects on milk production

            Detected in milk of treated female cynomolgus monkeys

            Maternal IgG is known to be present in human milk

            If drug is transferred into human milk, effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to therapy are unknown

            Consider benefits of breastfeeding along with mother’s clinical need and any potential adverse effects on the breastfed child from therapy or from underlying maternal condition

            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

            IgG1 monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor; binding inhibits type 1 IFN signaling, thereby blocking biologic activity of type 1 IFNs

            Also, induces internalization of type 1 IFN receptor, which reduces levels of cell surface available for receptor assembly

            Blockade of receptor-mediated type 1 IFN signaling inhibits IFN-responsive gene expression as well as downstream inflammatory and immunological processes

            Inhibition of type 1 IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets

            Absorption

            Steady-state was reached by Day 85

            Accumulation ratio: 1.36 (Cmax); 2.49 (Ctrough)

            Distribution

            Vd: 6.23 L

            Metabolism

            IgG1 monoclonal antibodies not expected to undergo hepatic metabolism

            Elimination

            Estimated systemic clearance (CL): 0.193 L/day

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            Administration

            IV Incompatibilities

            Do not coadminister other medicinal products through same infusion line

            IV Compatibilities

            0.9% NaCl

            IV Preparation

            Visually inspect vial for particulate matter and discoloration; solution is clear to opalescent, colorless to slightly yellow; discard if solution is cloudy, discolored, or visible particles observed

            Do NOT shake

            Withdraw 2 mL from 100-mL 0.9% NaCl infusion bag and discard solution

            Withdraw 2 mL of drug from vial and add to infusion bag; gently invert bag to mix; do NOT shake

            Each vial is intended for single dose only; discard any unused portion remaining in vial

            Administer solution immediately after preparation

            IV Administration

            If diluted solution was refrigerated, allow it to reach room temperature before administration

            Infuse over 30 min through an infusion line containing a sterile, low-protein–binding 0.2- or 0.22-micron inline filter

            Flush infusion set with 25 mL of 0.9% NaCl to ensure all the drug has been administered

            Dispose of any unused medicinal product or waste material in accordance with local requirements

            Missed dose: Administer as soon as possible; maintain a minimum interval of 14 days between infusions

            Storage

            Protect from light

            Unopened vials

            • Refrigerate at 2-8ºC (36-46ºF) in original carton; do NOT freeze

            Diluted solution

            • If not administered immediately, store at room temperature (15-25ºC [59-77ºF]) for up to 4 hr OR
            • Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr; do NOT freeze
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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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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.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each 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.