Names and pronunciation
(dar′a-toom-ue-mab) Darzalex Faspro
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Drug reference
(dar′a-toom-ue-mab) Darzalex Faspro
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Func. class.: Antineoplastic
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Chem. class.: Monoclonal antibody
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ACTION: Binds to CD38, thereby inducing apoptosis in tumor cells
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USES: For the treatment of multiple myeloma in patients who have received at least 3 prior therapies including a proteasome inhibitor (PI) and an immu- nomodulatory agent or who are double refractory to a PI and an immunomodula- tory agent
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CONTRAINDICATIONS: Hyper- sensitivity
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SIDE EFFECTS CNS: Fever, headache, fatigue, chills GI: Nausea, vomiting, diarrhea, constipa- tion, anorexia CV: Hypertension RESP: Cough, dyspnea, URI, pneumonia HEMA: Thrombocytopenia, neutropenia, lymphopenia, anemia EENT: Nasal congestion MS: Arthralgia, back pain MISC: Infusion site reactions, herpes zoster reactivation
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INTERACTIONS None known Drug/Lab Test Decrease: platelets, RBCs, neutrophils, lymphocytes
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DOSAGE AND ROUTES • Adult: IV 16 mg/kg (actual body weight) weekly on wk 1 to 8 (8 doses), 16 mg/kg every other week on wk 9 to 24 (8 doses), and then 16 mg/kg q4wk starting on wk 25 until disease progres- sion; premedicate 1-3 hr prior to infu- sion with corticosteroid, oral antipyretic, oral or IV antihistamine
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Available forms: Injection 100 mg/ 5 mL, 400 mg/mL in single-dose vials Administer • Visually inspect for particulate matter and discoloration prior to use, solution in single-dose vials is colorless to pale yellow • Premedication 1-3 hr prior to each infusion with acetaminophen 650-1000 mg PO, diphenhydramine 25-50 mg IV/ PO, dexamethasone 20 mg • If a dose is missed, give as soon as possible and adjust the dosing schedule to maintain the treatment interval • Initial dilution volume and/or infusion rate differ for first, second, and subse- quent infusions; the maximum infusion rate is 200 mL/hr • Withdraw the needed amount (mL) from the 20-mg/mL vials for the calcu- lated dose (use actual body weight); discard any unused portion left in the vial • For the first infusion (week 1), dilute the calculated amount in 0.9% NaCl in- jection to a total infusion bag volume of 1000 mL for a single-dose infusion (16 mg/kg) or 500 mL for split-dose infu- sions (8 mg/kg). For subsequent infu- sions, dilute the calculated amount in 0.9% NaCl injection to a total infusion bag volume of 500 mL. Following a sin- gle-dose infusion (16 mg/kg), reduce the total infusion bag volume to 500 mL only if there were no grade 1 or higher infusion reactions during the previous week • Gently invert the bag to mix, do not shake • Infusion bags/containers must be made of polyvinylchloride (PVC), polypropyl- ene (PP), polyethylene (PE), or polyole- D fin blend • Storage of admixture: Store at room temperature 59°F to 77°F (15°C to 25°C) for up to 15 hr (includes infusion time) or for up to 24 hr refrigerated 36°F to 46°F (2°C to 8°C), protect from light; al- low refrigerated admixtures to warm to room temperature prior to use • Administer using an infusion-set fitted with a flow regulator and with an inline, sterile, nonpyrogenic, low-protein-bind- ing polyethersulfone filter (pore size of 0.2 or 0.22 micrometer); polyurethane, polybutadiene (PBD), PVC, PP, or PE ad- ministration sets must be used • Do not infuse other drugs concomi- tantly in the same IV line • Administer the diluted infusion intrave- nously at the appropriate infusion rate as follows: Week 1 infusion(s): start at 50 mL/hr, increase by 50 mL/hr hourly to a max 200 mL/hr; Week 2 infusion (follow- ing a single 16-mg/kg dose infusion only): start at 50 mL/hr, increase by 50 mL/ hr hourly to max 200 mL/hr; Subsequent infusions: start at 100 mL/hr, increase by 50 mL/hr hourly to max 200 mL/hr if there were no grade 1 or higher infusion reactions during the previous week • Discard unused product
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Assess: • Hypersensitivity/bronchospasm: pre- medicate prior to infusion to prevent hyper- sensitivity and bronchospasm, have emer- gency equipment nearby, reactions may occur for up to 4 hr after conclusion of infusion • Thrombocytopenia, neutropenia, lymphopenia: monitor CBC, platelets peri- odically; type and cross for blood transfu- sions prior to infusion, type and cross-match may not be accurate after using product • Pregnancy/breastfeeding: not to use during pregnancy, response is unknown, use contraception during and for 3 mo after last dose; secretion in breast milk is unknown • Herpes zoster reactivation: use anti- virals 1 wk prior to infusion and continue for 3 mo after conclusion of therapy
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Evaluate: • Therapeutic response: Slowly, preven- tion of growth in multiple myeloma
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That bloodwork and continuing labs will be needed • To report immediately change in breathing, tight chest, wheezing, itching, chills, nausea, vomiting • To report to all providers the use of this product • Pregnancy/breastfeeding: To report if pregnancy is planned or suspected or if breastfeeding
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PHARMACOKINETICS Onset, peak, duration unknown, half-life 9-27 days
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• Adult: IV 16 mg/kg (actual body weight) weekly on wk 1 to 8 (8 doses), 16 mg/kg every other week on wk 9 to 24 (8 doses), and then 16 mg/kg q4wk starting on wk 25 until disease progres- sion; premedicate 1-3 hr prior to infu- sion with corticosteroid, oral antipyretic, oral or IV antihistamine
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