S4 INLYTA® 1 mg (Film-coated tablets). Reg. No. 48/26/0605. Each film-coated tablet contains 1 mg axitinib. Each INLYTA film-coated tablet contains 33,60 mg lactose monohydrate. INLYTA® 3 mg (Film-coated tablets). Reg. No. 48/26/0606. Each INLYTA film-coated tablet contains 3 mg axitinib. Each INLYTA 3 mg film-coated tablet contains 35,28 mg lactose monohydrate. INLYTA® 5 mg (Film-coated tablets). Reg. No. 48/26/0607. Each INLYTA film-coated tablet contains 5 mg axitinib. Each INLYTA 5 mg film-coated tablet contains 58,8 mg lactose monohydrate. INLYTA® 7 mg (Film-coated tablets). Reg. No. 48/26/0608. Each film-coated tablet contains 7 mg axitinib. Each INLYTA 7 mg film-coated tablet contains 82,32 mg lactose monohydrate. The tablets contain the following inactive ingredients: Tablet core - microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate. Tablet film-coating - Hypromellose, titanium dioxide, Lactose monohydrate, triacetin, red iron oxide. Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors. ATC code: L01XE17. INDICATIONS: INLYTA is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) with a clear cell component or advanced papillary cell renal carcinoma, after failure of previous systemic therapy and total nephrectomy of the involved kidney. CONTRA-INDICATIONS: *Hypersensitivity to axitinib or any of the ingredients contained in INLYTA. *Pregnancy and lactation, and women of childbearing potential.*Children < 18 years of age.*Patients with evidence of untreated brain metastasis or recent gastrointestinal bleeding.*Severe hepatic impairment.*History of recent (within the previous 12 months) arterial thromboembolism (myocardial infarction, stroke, transient ischaemic attack) when other appropriate treatment options are available. *History of recent (within the previous 6 months) venous thromboembolism (deep vein thrombosis, pulmonary embolism) when other appropriate treatment options are available. *Uncontrolled hypertension. *Uncontrolled cardiac failure. *Uncontrolled hypothyroidism. *A history of previous posterior reversible encephalopathy syndrome (PRES).*A tendency to bleeding.*A recent history of a gastrointestinal perforation and/or fi stula when other treatment options are available.*Unhealed surgery of trauma wounds. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Cardiac failure event: Cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported in 1,8 % receiving INLYTA. Grade 3/4 cardiac failure events were reported in 1,0 % and fatal cardiac failure events were reported in 0,3 % receiving INLYTA. Monitor for signs or symptoms of cardiac failure periodically throughout treatment with INLYTA. Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of INLYTA therapy. Hypertension: Hypertension was reported in 51 % receiving INLYTA. Grade 3 hypertension was reported in 22 % receiving INLYTA. Grade 4 hypertension was reported in 1 % receiving INLYTA. Hypertensive crisis was reported in < 1 % receiving INLYTA. Discontinuation of INLYTA treatment due to hypertension may be necessary. Thyroid dysfunction: Hypothyroidism was reported in 25 % receiving INLYTA. Hyperthyroidism was reported in 2 % receiving INLYTA. In patients who had thyroid stimulating hormone (TSH) < 5 μU/mL before treatment, elevations of TSH to ≥ 10 μU/mL occurred in 79/245 patients (32 %) receiving INLYTA. Monitor thyroid function before initiation of, and periodically throughout, treatment with INLYTA. Arterial thromboembolic events: Arterial thromboembolic events were reported in 3 % receiving INLYTA. Grade 3/4 arterial thromboembolic events were reported in 2 %. Fatal arterial thromboembolic events were reported in 2 patients (< 1 %) receiving INLYTA. INLYTA should be used with caution in patients who are at risk for, or who have a history of, these events. Venous thromboembolic events: Venous thromboembolic events were reported in 3 % receiving INLYTA. Grade 3/4 venous thromboembolic events were reported in 2% of patients. Fatal venous thromboembolic events were reported in < 1 % receiving INLYTA. INLYTA should be used with caution in patients who are at risk for, or who have a history of, these events. Elevation of haemoglobin or haematocrit: Increases in haemoglobin or haematocrit, refl ective of increases in red blood cell mass, may occur during treatment with INLYTA. An increase in red blood cell mass may increase the risk of thromboembolic events. Elevated haemoglobin above the upper limit of normal in 10 % of patients receiving INLYTA. Monitor haemoglobin or haematocrit before initiation of, and periodically throughout, treatment with INLYTA. Haemorrhage: Haemorrhagic events were reported in 26 % receiving INLYTA. Grade 3/4 haemorrhagic events were reported in 4 %. Fatal haemorrhagic events were reported in < 1 % receiving INLYTA. Most common haemorrhagic events in patients treated with INLYTA were epistaxis, haematuria, haemoptysis, and rectal haemorrhage. If any bleeding requires medical intervention, temporarily interrupt the INLYTA dose. Gastrointestinal perforation and fi stula formation: Gastrointestinal perforation and fi stula were reported in 2 % receiving INLYTA. A case of fatal gastrointestinal perforation has been reported in a monotherapy study. Monitor for symptoms of gastrointestinal perforation periodically throughout treatment with INLYTA. Wound healing complications: Treatment with INLYTA should be stopped at least 24 hours prior to scheduled surgery. Reversible posterior leukoencephalopathy syndrome: Reversible posterior leukoencephalopathy syndrome (RPLS) was reported in < 1 % receiving INLYTA. In patients with signs/symptoms of RPLS, temporarily interrupt or permanently discontinue INLYTA. Proteinuria: Proteinuria was reported in 11 % receiving INLYTA. Grade 3/4 proteinuria was reported in <6 % receiving INLYTA. Monitoring for proteinuria before initiation of, and periodically throughout, treatment with INLYTA is recommended. Elevation of liver enzymes: No concurrent elevations of ALT (> 3 times the ULN) and bilirubin (> 2 times the ULN) were observed for patients receiving INLYTA. Monitor liver function tests before initiation of, and periodically throughout, treatment with INLYTA. Hepatic impairment:. A dose decrease is recommended when administering INLYTA to patients with moderate hepatic impairment. Lactose intolerance: INLYTA contains lactose. Patients with rare hereditary conditions of galactose intolerance should not take INLYTA. FERTILITY, PREGNANCY AND LACTATION: Women of childbearing potential: Women of childbearing potential should be advised to avoid becoming pregnant while receiving INLYTA. They should use adequate contraception. Breastfeeding: Women taking INLYTA should not breastfeed their infants. Fertility: Based on non-clinical fi ndings, INLYTA has the potential to impair reproductive function and fertility in men and women. Conservation of sperm or ova should be considered before initiation of treatment with INLYTA. Effects on ability to drive and use machines: Patients should be advised that they may experience events such as dizziness and/or fatigue during tr eatment with INLYTA. Such symptoms may impair their ability to drive or to use machines. DOSAGE AND DIRECTIONS FOR USE: Posology: The recommended starting oral dose of INLYTA is 5 mg twice daily. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. Dose adjustments: Dose increase or reduction is recommended based on individual safety and tolerability. Method of administration: INLYTA is for oral use. INLYTA may be taken with or without food. The fi lmcoated tablets should be swallowed whole with a glass of water. SIDE EFFECTS: Summary of the safety profile: The most common (≥ 20 %) adverse reactions observed following treatment with INLYTA were diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, palmar-plantar erythrodysaesthesia (handfoot) syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough, and constipation. Post-marketing experience. The following adverse reactions have been identifi ed during post-approval use of INLYTA: cardiac failure event and glossodynia. Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefi t/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the "6.04 Adverse Drug Reactions Reporting Form", found online under SAHPRA's publications: https://www.sahpra.org.za/ Publications/ Index/8. HOLDER OF CERTIFICATE OF REGISTRATION: Pfizer Laboratories (Pty) Ltd. Reg. No.: 1954/000781/07. 85 Bute Lane, Sandton, 2196. Tel. 0860 PFIZER (0860 734937). (PI Ref: 19/05/2020). Please refer to detailed professional information leafl et for complete prescribing information. PP-INL-ZAF-0001

Pfizer Laboratories (Pty) Ltd. Reg. No.: 1954/000781/07. 85 Bute Lane, Sandton 2196. Tel. No. 0860 PFIZER (734937).
Please refer to detailed package insert for complete prescribing information.
PP-INL-ZAF-0034