Zuellig Pharma
Concise Prescribing Info
Advanced renal cell carcinoma after failure of 1 prior systemic therapy.
Dosage/Direction for Use
Initially 5 mg bd approx 12 hr apart.
Should be taken on an empty stomach: Swallow whole w/ a glass of water.
Special Precautions
Periodically monitor for signs & symptoms of cardiac failure. BP should be well-controlled prior to initiating therapy. Monitor for HTN. Patients w/ HTN or history of aneurysm. Monitor thyroid functions before initiation of & periodically throughout treatment. Patients at risk or w/ history of arterial (including transient ischemic attack, CVA, MI & retinal artery occlusion) or venous (including pulmonary embolism, DVT, retinal vein occlusion/thrombosis) thromboembolic events. Discontinue treatment if reversible posterior leukoencephalopathy syndrome occurs. Monitor Hb/hematocrit before initiation of, & periodically throughout treatment. Hemorrhage; GI perforation, fistula formation, wound healing complications, reversible posterior leukoencephalopathy syndrome, proteinuria, liver function tests (prior to initiation of & periodically throughout treatment). Discontinue treatment w/ at least 24 hr prior to scheduled surgery. Moderate & severe hepatic impairment. May affect the ability to drive or operate machinery. Women of childbearing potential should be advised to avoid becoming pregnant. Potential fetal harm when used during pregnancy. Lactation. Childn.
Adverse Reactions
Hypothyroidism; decreased appetite; headache, dysgeusia; HTN, hemorrhage; dyspnea, cough, dysphonia; diarrhea, vomiting, nausea, abdominal pain, stomatitis, constipation, dyspepsia; palmar-plantar erythrodysaesthesia (hand-foot syndrome), rash, dry skin; arthralgia, pain in extremity; proteinuria; fatigue, asthenia, mucosal inflammation; decreased wt. Anemia; hyperthyroidism; dehydration, hyperkalemia, hypercalcemia; dizziness; tinnitus; cardiac failure events; venous & arterial embolic & thrombotic events; upper abdominal pain, hemorrhoids, glossodynia; erythema, pruritus, alopecia; myalgia; increased lipase, creatinine, ALT & AST, alkaline phosphatase, amylase.
Drug Interactions
Increased plasma conc w/ strong CYP3A4/5 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, voriconazole & telithromycin) & grapefruit or grapefruit juice. Reduced plasma conc w/ strong CYP3A4/5 inducers (eg, rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarb & St. John's wort; moderate (eg, bosentan, efavirenz, etravirine, modafinil & nafcillin). Increased plasma conc of CYP1A2 substrates (eg, theophylline).
ATC Classification
L01XE17 - axitinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
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