INLYTA (axitinib) tablet, film coated. NDC Code(s): , ; Packager: Pfizer Laboratories Div Pfizer Inc. Package Photo. This Patient Information has been approved by the U.S. Food and Drug ( axitinib) tablets. What is INLYTA? INLYTA is a prescription medicine used to treat . prescribed for purposes other than those listed in a Patient Information leaflet. Package leaflet: Information for the patient. Inlyta® 1 mg film-coated tablets. Inlyta ® 3 mg film-coated tablets. Inlyta® 5 mg film-coated tablets. Inlyta® 7 mg.
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Inlyta is indicated for the treatment of adult patients with advanced psckage cell carcinoma RCC after failure of prior treatment with sunitinib or a cytokine. Treatment with Inlyta should pacmage conducted by a physician experienced in the use of anticancer therapies.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs that cannot be managed by concomitant medicinal products or dose adjustments. If the patient vomits or misses a dose, an additional dose should not axitiinb taken. The next prescribed dose should be taken at the usual time. Subsequently, using the same criteria, patients who tolerate an axitinib dose of 7 mg twice daily may have their dose increased to a maximum of 10 mg twice daily. When dose reduction is necessary, the axitinib dose may be reduced to 3 mg twice daily and further to 2 mg twice daily.
Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy see section 4.
Inlyta 1 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
If the dose of axitinib is increased, the patient should be monitored carefully for toxicity. No dose adjustment is required see section 5. No dose adjustment is required when administering axitinib to patients with mild pwckage impairment Child-Pugh class A.
A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment Child-Pugh class B e. Axitinib has not been studied in patients with severe hepatic impairment Child-Pugh class C and should not be used in this population see sections 4.
No data are available. Axitinib padkage for oral use. The tablets should be taken orally twice daily approximately 12 hours apart with or without food see section 5. They should be swallowed whole with a glass of water. Specific safety events should be monitored before initiation of, and periodically throughout, treatment with axitinib as described below. In clinical studies with axitinib for the treatment of patients with RCC, cardiac failure events including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure were reported see section 4.
Signs or symptoms of cardiac failure should periodically be monitored throughout treatment with axitinib. In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported see section 4.
Blood pressure should be well-controlled prior to initiating axitinib. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. In the case insery persistent hypertension, despite use of antihypertensive medicinal products, the axitinib dose should be reduced.
For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive. If axitinib is interrupted, patients receiving antihypertensive medicinal products should be monitored for hypotension see section 4. In case of severe or persistent arterial hypertension and symptoms suggestive of posterior reversible encephalopathy syndrome PRES see belowa diagnostic brain magnetic resonance image MRI should be considered.
In clinical studies with axitinib for the treatment of patients packags RCC, events of hypothyroidism and, to a lesser extent, hyperthyroidism, were reported see section 4. Thyroid function should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Hypothyroidism or hyperthyroidism should be treated according to standard medical practice to maintain euthyroid state. In clinical studies with axitinib, arterial embolic and thrombotic events including transient ischemic attack, myocardial infarction, cerebrovascular accident and retinal artery occlusion were reported see section 4. Axitinib should be used with caution in patients who are at risk for, or who have a history of, these events. Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months.
Axitinib has not been studied in patients who had a venous embolic or thrombotic event within the previous 6 months. Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib see section 4. An increase in red blood cell mass may increase the risk of embolic and thrombotic events.
Haemoglobin or haematocrit should be monitored before initiation of, and periodically throughout, treatment with axitinib. If haemoglobin or haematocrit becomes elevated above the normal level, patients should be treated according to standard medical practice to decrease haemoglobin or haematocrit to an acceptable level.
Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients. If any bleeding requires medical intervention, temporarily interrupt the axitinib dose. Cases of ruptured aneurysms including pre-existing aneurysms have been reported, some with fatal outcome.
Before initiating axitinib therapy in patients with pre-existing aneurysms, this risk should be carefully considered. In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported see section 4. Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib.
Treatment with axitinib axitinlb be stopped at least 24 hours prior to scheduled surgery. The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing. PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present. Magnetic resonance imaging is necessary to confirm the diagnosis of PRES.
In patients with signs or symptoms of PRES, temporarily interrupt or permanently discontinue axitinib treatment. The safety of reinitiating axitinib therapy in patients previously experiencing PRES is not known. In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported see section 4.
Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended. For patients who develop moderate to severe proteinuria, reduce the dose or temporarily interrupt axitinib treatment see section 4. Axitinib should be discontinued if the patient develops nephrotic syndrome. In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.
The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase ALTaspartate aminotransferase ASTand blood bilirubin see section packaage.
Liver function tests padkage be monitored before initiation of, and periodically throughout, treatment with axitinib. In clinical studies with axitinib, the systemic exposure to axitijib was approximately two-fold axirinib in subjects with moderate hepatic impairment Child-Pugh class B compared to subjects with normal hepatic function.
A dose decrease is recommended inseft administering axitinib to patients with moderate hepatic impairment Child-Pugh class B see section 4. Axitinib has not been studied in patients with severe hepatic impairment Child-Pugh class C and should not be used in this population. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Grapefruit may also increase axitinib plasma concentrations.
The effect of strong inhibitors of these isozymes on axitinib pharmacokinetics has not been studied. Caution should be exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes. John’s wort] may decrease axitinib plasma concentrations. In vitro studies indicated that axitinib has a potential to inhibit CYP1A2.
In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8. However, co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.
In vitro studies indicated that axitinib inhibits P-glycoprotein. However, axitinib is not expected to inhibit P-glycoprotein at therapeutic plasma concentrations.
Therefore, co-administration of axitinib is not expected to increase the plasma concentration of digoxin, or other P-glycoprotein substrates, in vivo. There are no data regarding the use of axitinib in pregnant women.
Inlyta 1 mg film-coated tablets
Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity including malformations see section 5.
Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with this medicinal product. Women of childbearing potential must use effective contraception during and inxert to 1 week after treatment. It is unknown whether axitinib is excreted in human milk. A risk to the suckling child cannot be excluded. Axitinib should not be used during breast-feeding.
Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans see section 5. Axitinib has minor influence on the ability to drive and use machines. The following risks, including appropriate action to be taken, are discussed in greater detail in section 4. Table 1 presents adverse reactions reported in a pooled dataset of patients who received axitinib in clinical studies for the treatment of patients with RCC see section 5. Post-marketing adverse reactions identified in clinical studies are axifinib included.
The adverse reactions are listed by system organ class, frequency category and grade of severity. Frequency categories are defined as: The current safety database for axitinib is aixtinib small to detect rare and very rare adverse reactions. Categories have been assigned based on absolute frequencies in the pooled clinical studies data.
Within each system paclage class, adverse reactions with the same frequency are presented in order of decreasing seriousness. Thyroid stimulating hormone increased. Grade 4 cardiac failure adverse reactions were reported in 0.
Fatal cardiac failure was reported in 0. In a controlled clinical study with axitinib axitini the treatment of patients with RCC, hypothyroidism was reported in Thyroid stimulating hormone TSH increased was reported as an adverse reaction in 5. Hyperthyroidism was reported in 1.
In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3. Fatal pulmonary embolism was reported in one patient 0.