Names and pronunciation
(bren-tuk′see-mab) Adcetris
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Drug reference
(bren-tuk′see-mab) Adcetris
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Func. class.: Antineoplastic
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Chem. class.: Monoclonal antibody Controlled Substance Schedule IV
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ACTION: The anticancer activity is due to the binding of tubulin and disrupts the microtubule network within the cell, inducing cell cycle arrest and apoptotic death of the cells
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USES: Hodgkin’s disease after failure of autologous stem cell transplant (ASCT) or after failure of at least 2 prior multiagent chemotherapy regimens in patients who are not ASCT candidates; non-Hodgkin’s lymphoma (NHL); sys- temic anaplastic large cell lymphoma (sALCL) after failure of at least 1 prior multiagent chemotherapy regimen, pre- viously untreated systemic ALCL or other CD30-expressing peripheral T-cell lym- phoma (PTCL)
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CONTRAINDICATIONS: Hyper- sensitivity, pregnancy Precautions: Breastfeeding, children, infants, neonates, neutropenia, peripheral neuropathy, tumor lysis syndrome (TLS)
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Black Box Warning: Progressive multifo- cal leukoencephalopathy Black Box Warning: Peripheral neurop- athy, progressive multifocal leukoen- cephalopathy: assess for weakness or paralysis, vision loss, impaired speech, and cognitive deterioration; often fatal • Monitor CBC and differential, LFTs, se- rum bilirubin (direct and indirect), elec- trolytes, uric acid, neurologic function • Bone marrow suppression: monitor CBC before each dose • GI toxicity: monitor for changes in bowel habits, bowel obstruction, consti- pation, pancreatitis • Anaphylaxis: monitor for symptoms; high risk during administration • Stevens-Johnson syndrome: monitor and report skin reactions or rash; discon- tinue if toxic epidermal necrolysis or Ste- vens-Johnson syndrome occurs • Pregnancy: determine if pregnancy is planned or suspected; do not use in pregnancy/breastfeeding; reliable contra- ception should be used
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SIDE EFFECTS CNS: Headache, dizziness, fever, periph- eral neuropathy, anxiety, chills, fatigue, insomnia, night sweats, progressive multi- focal leukoencephalopathy CV: Peripheral edema GI: Abdominal pain, nausea, vomiting, constipation, diarrhea, weight loss, GI hemorrhage/perforation/obstruction INTEG: Rash, pruritus, alopecia, xerosis RESP: Pneumothorax, pneumonitis dys- pnea, cough SYST: Anaphylaxis, tumor lysis syndrome, Stevens-Johnson syndrome, infusion reactions, toxic epidermal necrolysis HEMA: Anemia, neutropenia, thrombocy- topenia, lymphadenopathy
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INTERACTIONS Increase: brentuximab action—CYP3A4 inhibitors, P-gp inhibitors, ketoconazole, boceprevir, delavirdine, isoniazid, indina- vir, itraconazole, dalfopristin, quinupris- tin, telithromycin, tipranavir, rifAMPin, ritonavir Increase: toxicity live virus vaccines Increase: pulmonary toxicity—bleomy- cin; do not use together Decrease: brentuximab action—CYP3A4 inducers Drug/Herb Increase: brentuximab component action—St. John’s wort Drug/Lab Increase: ALT/AST, bilirubin Decrease: WBC, platelets, RBCs
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DOSAGE AND ROUTES • Adult: IV 1.8 mg/kg q3wk until disease progression or unacceptable toxicity Renal dose • Adult: IV CCr <30 mL/min, avoid use Hepatic dose • Adult: IV (Child-Pugh A) 1.2 mg/kg q3wk, max 120 mg; (Child-Pugh B or C avoid use)
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Available forms: Powder for injec- tion 50 mg/vial
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Administer: B Intermittent IV INFUSION route • Visually inspect for particulate matter and discoloration whenever solution and container permit • Only as an IV infusion, do not give as an IV push or bolus • Use cytotoxic handling procedures • Do not mix, or administer as an infu- sion, with other IV products • Calculate the dose (mg) and the num- ber of vials required. For patients weigh- ing >100 kg, use 100 kg to calculate the dose; reconstitute each 50-mg vial per 10.5 mL of sterile water for injection (5 mg/mL) • Direct the stream of sterile water toward the wall of the vial and not di- rectly at the cake or powder; gently swirl the vial, do not shake • Discard any unused portion left in the vial • After reconstitution, dilute immedi- ately with ≥100 mL of 0.9% sodium chloride, 5% dextrose, or lactated Ring- er’s solution to a final concentration (0.4 mg/mL-1.8 mg/mL) • Infuse over 30 min • Use the diluted solution immediately or store in refrigerator for ≤24 hr after reconstitution; do not freeze
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Assess: • Pulmonary toxicity: cough, trouble breathing, report immediately • Infection: report immediately, fever, chills • Tumor lysis syndrome (TLS): assess for hyperkalemia, hypophosphatemia, hy- pocalcemia; may develop renal failure; may use allopurinol or rasburicase to pre- vent TLS; monitor serum BUN/creatinine
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Evaluate: • Decreasing symptoms of Hodgkin’s dis- ease (decreased lymph nodes, night sweats, weight loss, splenomegaly, hepatomegaly)
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report immediately weakness, change in vision, impaired speech, pe- ripheral neuropathy, neutropenia if se- vere, rash, change in bowel habits • Hepatotoxicity: AST/ALT, bilirubin base- line and periodically; if elevated, product may need to be discontinued or decreased • Pulmonary toxicity: dyspnea, cough; if these occur, product may need to be discontinued • Infusion site reactions: check site fre- quently, if reaction occurs (redness, swelling at site), stop infusion, give antihistamines • To use reliable contraception; not to breastfeed
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PHARMACOKINETICS Onset rapid, peak 1-3 days, duration unknown, protein binding is 68%-82%, only a small amount is metabolized; potent inhibitors or inducers of CYP3A4 may alter action; half-life is 4-6 days
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• Adult: IV 1.8 mg/kg q3wk until disease progression or unacceptable toxicity Renal dose
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• Adult: IV CCr <30 mL/min, avoid use Hepatic dose
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• Adult: IV (Child-Pugh A) 1.2 mg/kg q3wk, max 120 mg; (Child-Pugh B or C avoid use)
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