Names and pronunciation
(be-lim′ue-mab) Benlysta
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Drug reference
(be-lim′ue-mab) Benlysta
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Func. class.: Immunosuppressant, monoclonal antibody
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Chem. class.: Disease-modifying antirheumatic drugs (DMARDs)
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ACTION: Inhibits B-lymphocyte stim- ulator (BLyS), needed for B-cell survival
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USES: Active, autoantibody-positive, systemic lupus erythematosus (SLE) in combination with standard therapy
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CONTRAINDICATIONS: Hyper- sensitivity Precautions: Pregnancy, breastfeeding, children/infants, geriatric patients, patients of African descent, depression, immunosuppression, infection, suicidal ideation, vaccination, secondary malig- nancy, cardiac disease; requires experi- enced clinician
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SIDE EFFECTS CNS: Headache, dizziness, depression, fever, insomnia, migraine, suicidal ide- ation, progressive multifocal leukoen cephalopathy GU: UTI CV: Bradycardia GI: Nausea, diarrhea MISC: Rash, allergic reactions, myalgia SYST: Anaphylaxis, angioedema, anti- body formation, secondary malignancy, infection, influenza, infusion reactions
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INTERACTIONS • Don’t use with cyclophosphamide (IV) • Don’t use with live virus vaccines within 30 days of belimumab; response to vaccine will be decreased Drug/Herb • Decrease belimumab effect—echinacea Drug/Lab Test Decrease: leukocytes
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DOSAGE AND ROUTES • Adult: IV 10 mg/kg over 1 hr q2wk for the first 3 doses, then q4wk; SUBCUT 200 mg weekly • Child/adolescent 5-17 yr: IV 10 mg/kg/dose over 1 hr q2wk × 3 doses, then q4wk
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Available forms: Powder for IV injec- tion 120, 400 mg; SUBCUT autoinjector 200 mg/mL, prefilled syringe
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Administer: • Only health care providers prepared to manage anaphylaxis should administer this product; may give premedication for pro- phylaxis against infusion and hypersensitiv- ity reactions (antihistamine, antipyretic) Intermittent IV INFUSION route • Visually inspect for particulate matter and discoloration whenever solution and container permit • Give as IV infusion only; do not give IV bolus or push; give over 1 hr and slow or stop if infusion reactions occur • Do not give with any other agents in the same IV line • Allow to stand at room temperature for 10-15 min before using • Reconstitute with the appropriate amount of sterile water for injection (80 mg/ mL); add 1.5 mL of sterile water (120 mg/ vial) or 4.8 mL of sterile water (400 mg/vial) • Direct the stream of sterile water toward the side of the vial; gently swirl for 60 sec, allow to sit during reconstitution, gently swirl for 60 sec until powder is dissolved; do not shake • Solution should be opalescent and col- orless to pale yellow and without parti- cles; small air bubbles are expected; protect from sunlight • Dilution: dilute only in normal saline for injection, 0.45% NaCl, lactated Ringer’s; di- lute reconstituted solution with enough compatible solution to 250 mL; from a 250- mL infusion bag or bottle of compatible so- lution, withdraw and discard a volume equal to the volume of the reconstituted so- lution required for dose; add the required volume of the reconstituted solution to the infusion bag/bottle; gently invert to mix • Discard any unused solution • Store in refrigerator or at room tem- perature; total time from reconstitution to completion of infusion max 8 hr SUBCUT route • Allow 30 min to reach room tempera- ture • Inspect for particulate matter and discoloration; product should be clear to opalescent and colorless to pale yel- low. It is normal to see air bubbles • Do not use the autoinjector or pre- filled syringe if dropped on a hard sur- face • Protect from light and store refriger- ated at 36°F-46°F (2°C-8°C) until time of use. Do not freeze. Do not shake. Avoid exposure to heat • Do not administer where skin is ten- der, bruised, erythematous, or hard • Rotate injection site with each dose • Missed dose: if a dose is missed, ad- minister as soon as possible. Do not give 2 doses on same day
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Assess: • SLE improvement: monitor for de- creasing fever, malaise, fatigue, joint pain, myalgias • Progressive multifocal leuko- encephalopathy: apathy, confusion, ataxia, cognitive problems; if diagnosed, discontinue • Suicidal ideation: more common in those with preexisting depression • Infection: determine if a chronic or acute infection is present, may be fatal; do not begin therapy if any products are being used for a chronic infection; leu- kopenia may occur and susceptibility to infections is increased • Anaphylaxis (angioedema, rash, pruri- tus, wheezing), infusion site reactions: if these occur, stop infusion • African descent patients: use cautiously in these patients; may not re- spond to this product • Pregnancy/breastfeeding: determine if pregnant or if pregnancy is planned or suspected; if pregnant, enroll in registry (877-681-6296); do not breastfeed; con- traception is required during and for 4 mo after conclusion of therapy B
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Evaluate: • Positive response: decreasing symptoms of SLE; decreasing fatigue, fever, malaise
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To seek treatment immediately for se- rious hypersensitive reactions • Not to receive live vaccinations during treatment; bring up to date before treat- ment • That compliance is required • Infection: To report fever, shortness of breath, diarrhea, urinary frequency/ burning, sweating, chills; to avoid others with known infections • To report history of cancer in patient or family • SUBCUT injection technique, must give at same time of day every week • To take as prescribed, not to double or skip doses; if dose is missed, then take as soon as remembered, then re- sume correct schedule, provide “Med- ication Guide” and go over with patient HIGH ALERT
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PHARMACOKINETICS Half-life 19.4 days, SUBCUT 18.3 days. Onset, peak duration unknown
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• Child/adolescent 5-17 yr: IV 10 mg/kg/dose over 1 hr q2wk × 3 doses, then q4wk
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