Inlyta

Inlyta

axitinib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Axitinib
Indications/Uses
Advanced renal cell carcinoma (RCC) after failure of prior treatment w/ sunitinib or cytokine.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if posterior reversible encephalopathy syndrome occurs; nephrotic syndrome develops. Not to be used in patients w/ evidence of untreated brain metastasis or recent active GI bleeding. HTN; history of aneurysm, arterial & venous embolic & thrombotic events. Periodically monitor signs & symptoms of cardiac failure, GI perforation or fistula; thyroid function; Hb & haematocrit elevations; proteinuria & liver function tests prior to & periodically thereafter. Discontinue use at least 24 hr prior to scheduled surgery. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Moderate hepatic impairment (Child-Pugh class B). Women of childbearing potential must use effective contraception during & up to 1 wk after last dose.
Adverse Reactions
Hypothyroidism; decreased appetite; headache, dysgeusia; HTN, haemorrhage; dyspnoea, cough, dysphonia; diarrhoea, vomiting, nausea, abdominal pain, constipation, stomatitis, dyspepsia; palmar-plantar erythrodysaesthesia, rash, dry skin; arthralgia, pain in extremity; proteinuria; fatigue, asthenia, mucosal inflammation; decreased wt. Anaemia, thrombocytopenia, polycythaemia; hyperthyroidism; dehydration, hyperkalaemia, hypercalcaemia; dizziness, tinnitus; cardiac failure events, venous & arterial embolic & thrombotic events; oropharyngeal pain, upper abdominal pain, flatulence, haemorrhoids, glossodynia, GI perforation & fistula; hyperbilirubinaemia, cholecystitis; pruritus, erythema, alopecia; myalgia; renal failure; increased lipase, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine & thyroid-stimulating hormone.
Drug Interactions
Increased plasma conc w/ CYP3A4/5 inhibitors eg, ketoconazole, itraconazole, clarithromycin, erythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin; grapefruit; strong CYP1A2 & CYP2C19 inhibitors. Reduced plasma conc w/ CYP3A4/5 inducers eg, rifampicin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarb, St. John's wort.
ATC Classification
L01XE17 - axitinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Inlyta FC tab 5 mg
Packing/Price
56's
Form
Inlyta FC tab 1 mg
Packing/Price
56's
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