Names and pronunciation
(eye-broo′ti-nib) Imbruvica
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Drug reference
(eye-broo′ti-nib) Imbruvica
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Func. class.: Antineoplastic-biologic response modifier
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Chem. class.: Signal transduction inhibitor (STIs)—kinase inhibitor
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ACTION: Irreversible inhibitor of Bruton’s tyrosine kinases in B cells responsible for tumor growth
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USES: Recurrent mantle cell lym- phoma in patients who have received at least 1 prior treatment, Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL) including those with 17 p deletion; dependent or steroid refrac- tory chronic graft-versus-host disease (cGVD)
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CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity, hepatic disease Precautions: Children, geriatric patients, active infections, anticoagulant therapy (3 × 140-mg caps once daily until disease progression), bleeding, hepatic/renal dis- ease, neutropenia, surgery
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SIDE EFFECTS CNS: Fatigue, fever, headache, insomnia CV: Hypertension, atrial fibrillation, peripheral edema EENT: Sinusitis GI: Nausea, vomiting, dyspepsia, ano rexia, abdominal pain, constipation, stomatitis, diarrhea, GI bleeding GU: Increased serum creatinine, UTI, renal failure HEMA: Neutropenia, thrombocytopenia, anemia, bleeding, epistaxis, transient lymphocytosis, febrile neutropenia INTEG: Rash, skin infections, bruising MS: Pain, arthralgia, muscle cramps RESP: Cough, dyspnea SYST: Secondary malignancy, infection
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INTERACTIONS Increase: ibrutinib effect—avoid use with moderate or strong CYP3A4 inhibitors (clarithromycin, indinavir, itraconazole, ketoconazole, nelfinavir, posaconazole, ritonavir, saquinavir, voriconazole) Decrease: ibrutinib effect—avoid use with moderate or strong CYP3A4 inducers (carBAMazepine, phenytoin, rifAMPin) Drug/Herb Decrease: SUNItinib concentration—St. John’s wort Drug/Food Test Increase: plasma concentrations— grapefruit juice; avoid use Drug/Lab Test Increase: lymphocytes, uric acid, creatinine
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DOSAGE AND ROUTES CLL, WM, cGVHD • Adult: PO 420 mg/day MCL • Adult: PO 560 mg (4 × 140-mg caps) daily Dosage adjustment for $ grade 3 nonhematologic toxicities, $ grade 3 neutropenia with infection or fever, or grade 4 hematologic toxicities: Interrupt therapy; resume upon recov ery to grade 1 or baseline as indicated below: • First occurrence: Resume dosing at original dose (daily dose = 560 mg/ day) • Second occurrence: Reduce dose by 1 capsule (daily dose = 420 mg/day) • Third occurrence: Reduce dose by 2 capsules (daily dose = 280 mg/day) • Fourth occurrence: Discontinue
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Available forms: Caps 140 mg
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Administer: • At same time of day with water; without regard to food; if dose is missed, take as soon as possible on same day, do not double • Do not open, break, chew cap, swallow whole • Use safe handling procedures • Store at room temperature, avoid moisture
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Assess: • Bleeding: bruising; grade 3 or higher bleeding events may occur, may be fatal; CBC • Hypersensitivity: trouble breathing, fever, itching, wheezing; swelling of face, lips, tongue; stop product immediately, provide supportive treatment • Renal failure: monitor (BUN, creati nine), maintain hydration, monitor for hy peruricemia • Infection: fever, sore throat, malaise; infections may be fatal • Cardiac changes/hypertension: moni tor B/P and for cardiac changes • Secondary malignancies: monitor for new malignancies • Hepatic/renal function; signs and symptoms of infections • Surgery: may interrupt treatment a few days before surgery • Pregnancy/breastfeeding: identify whether pregnancy is planned or sus pected or if breastfeeding
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Evaluate: • Therapeutic response: decrease in progression of disease
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About reason for treatment, expected result • That many adverse reactions may oc- cur: high B/P, bleeding, mouth swelling, shortness of breath, report immediately • To avoid persons with known upper respiratory infections; that immunosup- pression is common • To avoid grapefruit juice or medica- tions, herbs; there are many interactions • To report if pregnancy is planned or suspected, or if breastfeeding • To report bleeding, severe infections, renal toxicity (maintain hydration), devel opment of second malignancies, diarrhea (contact physician if it persists) • To take with water at same time each I day; do not open, break, or chew (eye-byoo-proe′fen) Addaprin, Advil Junior Strength, Advil Liqui-Gels minis, Advil Migraine, Advil, Childrens Advil, Childrens Ibuprofen, Childrens Motrin, Dyspel, Genpri, GoodSense Ibuprofen Childrens, GoodSense Ibuprofen, IBU, IBU-200, Ibupak, Ibuprofen Childrens, Infants Advil, KS Ibuprofen, Motrin Childrens, Motrin IB, Motrin Infants Drop
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PHARMACOKINETICS Protein binding 97.3%; metabolized by CYP3A4/CYP2D6; primarily excreted in feces, small amount in urine; peak 1-2 hr, half-life 4-8 hr
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• Adult: PO 420 mg/day MCL
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• Adult: PO 560 mg (4 × 140-mg caps) daily Dosage adjustment for $ grade 3 nonhematologic toxicities, $ grade 3 neutropenia with infection or fever, or grade 4 hematologic toxicities: Interrupt therapy; resume upon recov ery to grade 1 or baseline as indicated below:
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