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

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (20)

              • adenovirus types 4 and 7 live, oral

                anifrolumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • BCG vaccine live

                anifrolumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • cholera vaccine

                anifrolumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • dengue vaccine

                anifrolumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • Ebola Zaire vaccine

                anifrolumab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • influenza virus vaccine quadrivalent, intranasal

                anifrolumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • measles (rubeola) vaccine

                anifrolumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • measles mumps and rubella vaccine, live

                anifrolumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • measles, mumps, rubella and varicella vaccine, live

                anifrolumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • poliovirus vaccine live oral trivalent

                anifrolumab decreases effects of poliovirus vaccine live oral trivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • rotavirus oral vaccine, live

                anifrolumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • rubella vaccine

                anifrolumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating

                anifrolumab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • smallpox (vaccinia) vaccine, attenuated

                anifrolumab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • smallpox (vaccinia) vaccine, live

                anifrolumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • typhoid polysaccharide vaccine

                anifrolumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • typhoid vaccine live

                anifrolumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • varicella virus vaccine live

                anifrolumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • yellow fever vaccine

                anifrolumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • zoster vaccine live

                anifrolumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              Monitor Closely (0)

                Minor (0)

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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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                  Images

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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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                  • Access your plan list on any device – mobile or desktop.

                  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.