Updated May 30, 2026, 4:23 PM
Antineoplastic, biologic response modifier, signal transduction inhibitor (STI)US FDA Database Verified

axitinib

Brand: Inlyta

(none listed)

Pregnancy Category: D

Pharmacological Action

Inhibits receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)- 1, VEGFR- 2, and VEGFR- 3; inhibits tumor growth and phosphorylation of VEGFR- 2 and VEGF- mediated endothelial cell proliferation

Therapeutic outcome: Decreased spread of malignancy

Uses

Treatment of advanced renal cell cancer after failure of one prior systemic therapy

Contraindications

Pregnancy (D), breastfeeding

Precautions: Risk for or history of thromboembolic disease, recent bleeding, untreated brain metastasis, recent GI bleeding, GI perforation, fistula, surgery, moderate hepatic disease, uncontrolled hypertension, hyper/hypothyroidism, proteinuria, infertility, end- stage renal disease (CrCl < 15 ml/min ); not intended for use in adolescents, children, infants, neonates

Dosage & Routes

Adult: PO 5 mg bid (at 12 hr intervals), may increase to 7 mg bid and then to 10 mg bid in those not receiving antihypertensives who tolerate the lower dosage for at least 2 consecutive wk with no more than grade 2 adverse reactions. Reduce to 3 mg bid if a dose reduction is needed; if further reduction is necessary, reduce to 2 mg bid Adult receiving a strong CYP 3 A4/5 inhibitor: Reduce dose by 1/2, adjust as needed

Available forms: Tab 1, 5 mg

Implementation Give with or without food; swallow tablet whole with a glass of water If patient vomits or misses a dose, an additional dose should not be taken; the next dose should be taken at the usual time Store at room temperature

Adverse Effects

CNS: Dizziness, headache, reversible posterior leukoencephalopathy syndrome (RPLS), fatigue

CV: Hypertension, arterial thromboembolic events (ATE), venous thromboembolic events (VTE)

ENDO: Hypothyroidism, hyperthyroidism

GI: Lower GI bleeding/perforation/fistula. abdominal pain, constipation, diarrhea, dysgeusia, dyspepsia, dysphonia, hemorrhoids, nausea, mucosal inflammation, stomatitis, vomiting, increased ALT/AST

GU: Proteinuria

HEMA: Bleeding intracranial bleeding, anemia, polycythemia, decreased/increased hemoglobin, lymphopenia thrombocytopenia, neutropenia

INTEG: Palmar-plantar erythrodysesthesia (hand and foot syndrome) rash, dry skin, pruritus, alopecia, erythema

MISC: Weight loss dehydration metabolic and electrolyte laboratory abnormalities included

MS: Asthenia, arthralgia, musculoskeletal pain, myalgia

RESP: Cough, dyspnea

Pharmacokinetics

Absorption: Unknown

Distribution: Protein binding &gt; 99%

Metabolism: Liver

Excretion: Unknown

Half-life: 2.5-6.1 hr

Pharmacodynamics

Onset: Unknown

Peak: Unknown

Duration: Unknown

Interactions

Individual drugs CYP3 A4/5 inhibitor, strong, moderate (ketoconazole, boceprevir, chloramphenicol, conivaptan, delavirdine, fosamprenavir, imatinib, indinavir, isoniazid, itraconazole, dalfopristin; quinupristin, posaconazole, ritonavir, telithromycin, tipranavir [boosted with ritonavir], darunavir [boosted with ritonavir], aldesleukin, IL- 2, amiodarone, aprepitant, fosaprepitant atazanavir, bromocriptine, clarithromycin, crizotinib, danazol, diltiazem, dronedarone, erythromycin, fluvoxaMINE, lanreotide, lapatinib, miconazole, mifepristone, nefazodone, nelfinavir, niCARdipine, octreotide, pantoprazole, saquinavir, tamoxifen, verapamil, voriconazole, grapefruit juice): increased axitinib effect CYP3 A4/5 inducers, strong/moderate (rifampin, carBAMazepine, dexamethasone, phenytoin, PHENobarbital, rifabutin, rifapentine, St. John's wort, ethanol, bexarotene, bosentan, efavirenz, etravirine, griseofulvin, metyrapone, modafinil, nafcillin, nevirapine, OXcarbazepine, vemurafenib, pioglitazone, topiramate): decreased effect of axitinib CYP3 A4/5 inhibitor and inducers (quiNINE): increased or decreased axitinib effect

Drug/lab test

Increase: creatinine, lipase, amylase, sodium, potassium, glucose

Decrease: bicarbonate, calcium, albumin, glucose, phosphate, sodium Increase or decrease: sodium, glucose

Drug/herb St. John's wort: decreased effect of axitinib

Nursing Considerations

Assessment

Bleeding: monitor for GI bleeding or perforation; temporarily discontinue therapy at a patient develops any bleeding that requires treatment

Surgery: discontinue \geq 24 hr before surgery, may be resumed after adequate wound healing Hepatic/renal disease: dosage should be reduced in patients with moderate (Child-Pugh Class B) hepatic disease, monitor liver function tests (ALT, AST, bilirubin) before and periodically during therapy; monitor Cr before and during treatment

Hypertension: B/P should be well controlled before starting treatment; monitor patients for hypertension and administer antihypertensive therapy as needed before and during therapy; dose should be reduced for persistent hypertension; therapy should be discontinued if B/P remains elevated after a dosage reduction or if there is evidence of hypertensive crisis; after discontinuation monitor B/P for hypotension in those receiving antihypertensives

Hyper/hypothyroidism: monitor thyroid function tests before and periodically during therapy; thyroid disease should be treated with thyroid medications Monitor for proteinuria before and periodically during therapy; product may need to be decreased or discontinued if moderate to severe proteinuria occurs

Pregnancy/breastfeeding: pregnancy category D; determine if the patient is pregnant or breastfeeding before using this product; may also cause infertility

Patient/family education Instruct patient to use contraception during treatment (pregnancy category D) or to avoid use of this product; to notify prescriber if pregnancy is planned or suspected, not to breastfeed Instruct patient to notify prescriber of bleeding that is severe or that requires treatment Teach patient that product will be discontinued \geq 24 hr before surgery; may be resumed after adequate wound healing Teach patient that laboratory testing will be required before and periodically during product use Teach patient how to monitor B/P and that B/P products should be continued as directed by prescriber

Evaluation

Positive therapeutic outcome: Decreased spread of malignancy

Reference

Mosby's Drug Guide; Davis Drug Guide

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