belimumab (Rx)

Brand and Other Names:Benlysta
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Dosing & Uses

AdultPediatric

Dosing Form & Strengths

IV solution

  • 120mg/vial
  • 400mg/vial

SC solution

  • 200mg/mL single-dose, prefilled syringe or autoinjector

Systemic Lupus Erythematosus

Indicated for active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs

Also see Administration

IV

  • Must be administered by healthcare professional in clinic/hospital setting
  • Initial: 10 mg/kg IV q2Weeks x3 doses, THEN  
  • Maintenance: 10 mg/kg IV q4Weeks

SC

  • After training from their health care provider, patients may self-administer SC dose
  • 200 mg SC once weekly
  • If transitioning from IV to SC, administer the first SC dose 1-4 weeks after the last IV dose

Dosage Modifications

Renal or hepatic impairment: No dosage adjustment recommended for any degree of impairment

Dosing Considerations

Limitations of use

  • Efficacy has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or IV cyclophosphamide; not recommended in these situations

Safety and efficacy not established

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Interactions

Interaction Checker

and belimumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Infusion related reactions, common (17%) (ie, nausea, headache, skin reactions)

            Nausea (15%)

            Hypersensitivity reactions (13%)

            Diarrhea (12%)

            Pyrexia (10%)

            1-10%

            Nasopharyngitis (9%)

            Bronchitis (9%)

            Insomnia (7%)

            Local injection site reaction, SC (6.1%)

            Serious infections (6%)

            Pain in extremity (5%)

            Depression (5%)

            Migraine (5%)

            Pharyngitis (5%)

            <1%

            Anaphylaxis (0.6%)

            Serious infusion reactions (0.5%) (ie, bradycardia, myalgia, headache, rash, urticaria, hypotension)

            Postmarketing Reports

            Fatal anaphylaxis

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents; during clinical studies, more deaths and serious infections (eg, pneumonia, UTI, cellulitis, bronchitis) were reported with belimumab compared with placebo

            Hypersensitivity reactions, including anaphylaxis and death, have been reported; delayed onset of acute hypersensitivity reactions has been observed; limited data suggest that patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk

            Impact on development of malignancies is not known; as with other immunomodulating agents, the mechanism of action of belimumab could increase the risk for developing malignancies

            Cases of progressive multifocal leukoencephalopathy (PML) resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including belimumab

            Depression and suicidality have been reported; monitor for new or worsening depression

            May decrease response to immunizations; do not administer live vaccines 30 days before or concurrently with belimumab

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            Pregnancy & Lactation

            Pregnancy

            Healthcare professionals are encouraged to register patients by calling the pregnancy registry: at 1- (877) 681-6296

            Data are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage

            There are risks to the mother and fetus associated with SLE, including worsening of the underlying disease, premature birth, spontaneous abortion, and intrauterine growth restriction

            Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia

            Passage of maternal antiphospholipid antibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block

            Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant

            Use during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus

            Contraception

            • Following an assessment of benefit versus risk, if prevention of pregnancy is warranted, females of reproductive potential should use effective contraception during treatment and for at least 4 months after the final treatment

            Lactation

            Unknown whether distributed in breast milk

            Because maternal antibodies are excreted in human breast milk, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of breastfeeding to the infant and the importance of the drug to the mother

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Inhibits the biological activity of B-lymphocyte stimulator (BLyS); BLyS is a naturally occurring protein required for survival and development of B-lymphocyte cells into mature plasma B cells that produce antibodies

            In autoimmune diseases, elevated BLyS levels are thought to contribute to production of autoantibodies

            Belimumab specifically recognizes and binds to BLyS, inhibits BLyS’s stimulation of B-cell development, and finally, restores the potential for autoantibody-producing B cells to undergo the normal process of apoptosis (programmed cell death)

            Absorption

            Peak Plasma Concentration: 313 mcg/mL

            AUC: 3,083 days•mcg/mL

            Distribution

            Vd: 5.29 L

            Elimination

            Half-Life: 1.75 days (distribution); 19.4 days (terminal)

            Clearance: 215 mL/day

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            Administration

            IV Compatibilities

            0.9% NaCl (normal saline)

            IV Incompatibilities

            Dextrose solutions

            IV Preparation

            Lyophilized powder in a single-use vial for intravenous infusion only and should be reconstituted and diluted using aseptic technique

            Remove vial from refrigerator; let stand for 10-15 minutes to reach room temperature

            Reconstitution

            • Reconstitute powder with sterile water for injection to final concentration of 80 mg/mL
            • 120 mg vial: Reconstitute with 1.5 mL sterile water for injection
            • 400 mg vial: Reconstitute with 4.8 mL sterile water for injection
            • Direct stream of sterile water toward side of vial to minimize foaming
            • DO NOT SHAKE; gently swirl vial for 60 seconds every 5 minutes until powder is dissolved
            • Reconstitution is typically complete within 10-15 minutes, but may take up to 30 minutes
            • Note: If mechanical reconstitution device is used, it should not exceed 500 rpm and the vial swirled for no longer than 30 minutes
            • Once reconstituted, the solution should be opalescent and colorless to pale yellow, and without particles; small air bubbles are expected and acceptable

            Dilution

            • Dilute reconstituted solution in 0.9% NaCl 250 mL
            • From 250 mL bag/bottle of 0.9% NaCl, withdraw and discard volume equal to volume of the reconstituted solution required for the patient’s dose
            • Add required volume of reconstituted solution to infusion bag/bottle
            • Gently invert bag/bottle to mix the solution
            • Vial is for single use; discard any unused portion
            • Total time from reconstitution to completion of infusion should not exceed 8 hours

            IV Administration

            Administer diluted solution IV over 1 hour

            Administer by health care providers prepared to manage anaphylaxis

            Do not infuse concomitantly in same IV line with other drugs

            Consider administering premedication (ie, antihistamines, corticosteroids) for prophylaxis against infusion reactions and hypersensitivity

            SC Preparation

            Instruct patient to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to the SC injection; do not warm drug in any other way

            Visually inspect the window of the autoinjector or the prefilled syringe for particulate matter or discoloration; solution should be clear to opalescent and colorless to pale yellow

            Do not use if the product exhibits discoloration or particulate matter

            Instruct the patient not to use autoinjector or prefilled syringe if dropped on a hard surface

            SC Administration

            Administer SC once weekly, preferably on the same day each week

            Administer SC in abdomen or thigh

            When injecting in the same body region, advise the patient to use a different injection site each week; never give injections into areas where the skin is tender, bruised, red, or hard

            Missed dose

            • Administer missed dose as soon as the patient remembers
            • Thereafter, the patient can resume dosing on their usual day of administration or start a new weekly schedule from the day that the missed dose was administered
            • Not recommended to administer 2 doses on the same day

            Storage

            Unopened IV vials

            • Store refrigerated 2-8°C (36-46°F); do not freeze
            • Store vials in original carton and protect from light until use
            • Avoid exposure to heat

            Reconstituted IV vials

            • If not used immediately, may be stored refrigerated 2-8°C (36-46°F)
            • For single use only; discard any unused portion

            Diluted IV solution

            • May be stored refrigerated 2-8°C (36-46°F) or at room temperature
            • Total time from reconstitution to completion of infusion should not exceed 8 hours

            SC prefilled syringes or autoinjector

            • Refrigerated
              • Refrigerate prefilled syringe or autoinjectors at 2-8°C (36-46°F)
              • Keep product in the original carton to protect from light until the time of use
              • Do not freeze, shake, or expose to heat
            • Nonrefrigerated
              • May be stored outside of the refrigerator up to 86°F (30°C) for up to 12 hr in the original container
              • Do not use and do not place back in refrigerator if left out for >12 hr
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • 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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