Names and pronunciation
Ruxience
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Drug reference
Ruxience
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Func. class.: Antineoplastic—miscel- laneous; DMARDs
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Chem. class.: Murine/human mono- clonal antibody
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ACTION: Directed against the CD20 antigen that is found on malignant B lymphocytes; CD20 regulates a portion of cell-cycle initiation/differentiation
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USES: Non-Hodgkin’s lymphoma (CD20+, B-cell), bulky disease (tumors >10 cm), rheumatoid arthritis, Wegener’s granulomatosis, microscopic polyangiitis Unlabeled uses: Antibody-mediated rejection in cardiac transplantation auto- immune hemolytic anemia, Burkitt lym- phoma, graft-versus-host disease, Hodg- kin lymphoma, lupus nephritis
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CONTRAINDICATIONS: Hyper sensitivity, murine proteins Precautions: Pregnancy, breastfeeding, children, geriatric patients, pulmonary/ cardiac/renal conditions
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Black Box Warning: Exfoliative derma- titis, infusion-related reactions, progres- sive multifocal leukoencephalopathy, hepatitis B exacerbation Black Box Warning: Fatal infusion re- action: hypoxia, pulmonary infiltrates, ARDS, MI, ventricular fibrillation, cardio- genic shock; most fatal reactions occur with 1st infusion; potentially fatal Black Box Warning: Severe mucocu- taneous reactions: Stevens-Johnson syndrome, lichenoid dermatitis, toxic epi- dermal lysis; occur 1-13 wk after product given, discontinue treatment immediately Black Box Warning: Tumor lysis syn- drome: acute renal failure requiring he- modialysis, hyperkalemia, hypocalcemia, hyperuricemia, hyperphosphatemia; al- lopurinol and adequate hydration may be needed Black Box Warning: Multifocal leu- koencephalopathy: confusion, dizzi- ness, lethargy, hemiparesis; monitor periodically • Bone marrow suppression: CBC, dif- ferential, platelet count weekly; withhold product if WBC is <3500/mm3 or platelet count <100,000/mm3; notify prescriber of results; product should be discontinued • Labs: CBC with differential, hepatitis B serology, pregnancy test if applicable, ECG, serum creatinine/BUN, electrolytes, uric acid; correct electrolyte imbalances before use; hyperkalemia, hypocalcemia, hyperphosphatemia often occur • GI symptoms: frequency of stools, abdominal pain, perforation/obstruction may occur • Infection: fever, increased tempera- ture, flulike symptoms in those with We- gener’s granulomatosis and microscopic polyangiitis in those using DMARDs Black Box Warning: Hepatitis B exac- erbation: fulminant hepatitis, hepatic failure, death may occur during or fol- lowing treatment; screen all patients for HBV infection (HBV/HBsAg and anti-HBc titers) before use; monitor those with cur- rent or prior HBV for signs of hepatitis or for HBV reactivation for several months after therapy; if reactivation occurs, dis- continue product • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; contracep- tion should be used during and for 12 mo after last dose; enroll pregnant women in the Mother To Baby Autoimmune Diseases in Pregnancy Study, 1-877-311-8972 (pa- tients with RA); do not breastfeed, excre- tion unknown
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SIDE EFFECTS CNS: Life-threatening brain infection (pro- gressive multifocal leukoencephalopathy) CV: Cardiac dysrhythmias, heart failure, hypertension, MI, supraventricular tachy- cardia, angina GI: Nausea, vomiting, anorexia, GI obstruction/perforation GU: Renal failure HEMA: Leukopenia, neutropenia, throm- bocytopenia, anemia INTEG: Irritation at site, rash, fatal mucocutaneous infections (rare) MISC: Fever, chills, asthenia, headache, angioedema, hypotension, myalgia, bronchospasm, ARDs SYST: Toxic epidermal necrolysis, tumor lysis syndrome, Stevens-Johnson syn- drome, exfoliative dermatitis META: Hyperkalemia, hypocalcemia, hyperphosphatemia
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INTERACTIONS Increase: hypotension—antihyperten- sives, separate by 12 hr Increase: nephrotoxicity—CISplatin, avoid concurrent use; if used, monitor renal status Increase: bleeding—anticoagulant • Avoid with vaccines, toxoids
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DOSAGE AND ROUTES non-Hodgkin’s lymphoma (NHL) • Adult: IV 375 mg/m2/wk × 4 doses, may re-treat with 4 more doses of 375 mg/m2/wk CLL • Adult: IV 375 mg/m2 on cycle 1; cy- cle 2 through 6 500 mg/m2, treatment cycles are q28days; given with cyclo- phosphamide and fludarabine GPA/MPA • Adult: IV 375 mg/m2 weekly × 4 wk give methylPREDNISolone 100 mg/day 1-3 days, then predniSONE Rheumatoid arthritis • Adult: IV infusion 1000 mg days 1, 15; then q24wk give methylPREDNISolone 100 mg or similar product 30 min before infusion to decrease reactions
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Available forms: Inj 10 mg/mL (100 mg/10 mL, 500 mg/50 mL)
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Administer: Intermittent IV INFUSION route • Hold antihypertensives 12 hr before administration • After diluting to final concentration of 1-4 mg/mL; use 0.9% NaCl, D5W, gently invert bag to mix; do not mix with other products; give 50 mg/hr initially; if no reaction, increase rate by 50 mg/hr to max 400 mg/hr • Monitor closely during infusion, severe reactions usually occur within 30-120 min • Store vials at 36°F-40°F; protect vials from direct sunlight; infusion sol is stable at 36°F-46°F × 24 hr and at room tem- perature for another 12 hr
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Assess:
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Evaluate: • Therapeutic response: prevention of increasing cancer progression
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That scheduled appointment must be kept, as relapse may occur • To avoid use with vaccines, toxoids • To use contraception during and for 12 mo after therapy, not to breastfeed • To report to prescriber possible infec- tion (cough, fever, chills, sore throat), re- nal issues (painful urination, back/side pain), bleeding (gums, stools, urine, bruis- ing, emesis, fatigue) • To avoid OTC products, alcohol • To avoid crowds, those with known infections • To maintain fluid intake HIGH ALERT
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PHARMACOKINETICS Half-life varies, binds to CD20 sites or lymphoma cells
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• Adult: IV 375 mg/m2/wk × 4 doses, may re-treat with 4 more doses of 375 mg/m2/wk CLL
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• Adult: IV 375 mg/m2 on cycle 1; cy- cle 2 through 6 500 mg/m2, treatment cycles are q28days; given with cyclo- phosphamide and fludarabine GPA/MPA
PDF page 1170
• Adult: IV 375 mg/m2 weekly × 4 wk give methylPREDNISolone 100 mg/day 1-3 days, then predniSONE Rheumatoid arthritis
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• Adult: IV infusion 1000 mg days 1, 15; then q24wk give methylPREDNISolone 100 mg or similar product 30 min before infusion to decrease reactions
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