Inlyta

Inlyta

axitinib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Axitinib
Indications/Uses
Advanced renal cell carcinoma (RCC) after failure of 1 prior systemic therapy.
Dosage/Direction for Use
Administration
May be taken with or without food.
Special Precautions
Monitor for signs & symptoms of cardiac failure; thyroid function; Hb or hematocrit; proteinuria; LFTs prior to initiation, of & periodically throughout treatment; GI perforation periodically during therapy. Control BP prior to initiation of 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. Patients who have evidence of untreated brain metastasis or recent active GI bleeding. Temporarily interrupt or permanently discontinue treatment in patients w/ signs/symptoms of reversible posterior leukoencephalopathy syndrome (RPLS). Discontinue treatment at least 24 hr prior to scheduled surgery. May affect ability to drive & use machines. Moderate (Child-Pugh class B) & severe (Child-Pugh class C) hepatic impairment. Women of childbearing potential. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Hypothyroidism; decreased appetite; headache, dysgeusia; HTN, haemorrhage; dyspnoea, cough, dysphonia; diarrhoea, vomiting, nausea, abdominal pain, stomatitis, constipation, dyspepsia; palmar-plantar erythrodysaesthesia (hand-foot syndrome), rash, dry skin; arthralgia, pain in extremity; proteinuria; fatigue, asthaenia, mucosal inflammation; decreased wt. Anaemia; hyperthyroidism; dehydration, hyperkalaemia, hypercalcemia; dizziness; tinnitus; cardiac failure events; venous & arterial embolic & thrombotic events; upper abdominal pain, haemorrhoids, glossodynia; erythema, pruritus, alopecia; myalgia; haematuria; 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 & telithromycin) & grapefruit. Decreased plasma conc w/ strong CYP3A4/5 inducers (eg, rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarb & St. John's wort). May increase plasma conc of CYP1A2 substrates (eg, theophylline).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EK01 - axitinib ; Belongs to the class of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Inlyta FC tab 1 mg
Packing/Price
1 × 14's
Form
Inlyta FC tab 5 mg
Packing/Price
1 × 14's
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