Use with caution in patients with severe renal impairment. Jan 30, 2020 the current safety database for axitinib is too small to detect rare and very rare adverse reactions. In the event that this is not possible, the manufacturer recommends the dose of axitinib be reduced by one half. Identification of the substancemixture and of the companyundertaking product name. At steady state, axitinib exhibits approximately linear pharmacokinetics within the 1mg to 20mg dose range. It has been shown to significantly inhibit growth of breast cancer in animal. Tabulated list of adverse reactions table 1 presents adverse reactions reported in a pooled dataset axitinjb patients who received axitinib in clinical studies for. Dosing of axitinib at 5 mg twice daily resulted in approximately 1. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Treatment with axitinib should be inesrt at imsert 24 hours prior to scheduled surgery.
Axitinib is usually given after other treatments have failed. Ambisome package insert pdf name of the medicinal product. Based on the short halflife of axitinib, steady state is expected within 2 to 3 days of the initial dose. Based on the plasma halflife, steady state is expected within 2 to 3 days of dosing. Abstract background the combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renalcell carcinoma. The incidence and severity of hypertension were proportional to drug dosage.
Recommended dose modifications of bavencio for adverse reactions are provided. Highlights of prescribing information inlytasafely and. Prescribing information for axitinib prior to initiation. In the pnet study, 183 patients 1% receiving sutent had grade 3 epistaxis, and no patients had other grade 3 or 4 bleeding events. Tabulated list of adverse reactions table 1 presents adverse reactions reported in a pooled dataset axitinjb patients who received axitinib in clinical studies for the treatment of patients with rcc see section 5. Swallow the tablet whole and do not crush, chew, or break it. Information for the patient inlyta 1 mg filmcoated. Feb 03, 2020 what other drugs will affect axitinib inlyta. See full prescribing information for complete boxed warning. Although inlyta dose adjustment has not been studied in patients receiving strong cyp3a45 inhibitors, if a strong cyp3a45 inhibitor must be coadministered, a dose decrease of inlyta by approximately half is recommended, as this dose reduction is predicted to adjust the axitinib area under the plasma concentration vs time curve auc to the. For current full prescribing information, please visit.
Read all of this leaflet carefully before you start taking this medicine because it contains important. Medlineplus information on axitinib a lay language summary of important information about this drug that may include the following. Axitinib is an inhibitor of the efflux transporter pglycoprotein pgp in vitro. Further on in the same package label, in the full prescribing information, the drug. Dose increase or reduction is recommended based on individual safety and tolerability. Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving antihypertension medication. Please see full prescribing information for inlyta.
Inlyta axitinib fdaapproved patient labeling pfizer. This patient information has been approved by the u. Inlyta axitinib side effects, images, uses, dosage. See full prescribing information, including boxed warning. Axitinib interferes with the growth of some cancer cells. It has been shown to significantly inhibit growth of breast cancer in animal models and has shown partial responses in clinical trials with renal cell carcinoma rcc and several other tumour types. Hepatotoxicity has been observed in clinical trials and postmarketing experience. Axitinib may also be used for purposes not listed in this. Axitinib should be taken at evenly spaced intervals, usually once every 12 hours. Azilect package insert pdf easy to read fda package insert, drug facts, dosage and administration, and adverse effects for azilect rasagiline. Inlyta axitinib dosing, indications, interactions, adverse. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Warning and precautions, special populations and dosage and.
Axitinib inlyta axitinib inlyta is a chemotherapy regimen for renal cell carcinoma kidney cancer. This is one of the first examples of a new indication for an existing drug being discovered by screening. Axitinib has a higher potency of inhibition in comparison to first generation tyrosine kinase inhibitors or pazopanib which may contribute to its better therapeutic window and decreased incidence of adverse effects. Hepatotoxicity may be severe, and in some cases fatal. These highlights do not include all the information needed to use. Alecensa alectinib capsules, for oral use initial u. Inlyta axitinib fdaapproved patient labeling pfizer medical.
Axitinib is designed to slow the growth of cancer cells by inhibiting several mechanisms that the cell uses to grow and survive. No dosage adjustment is required on the basis of patient age or race see sections 4. Listing a study does not mean it has been evaluated by the u. Targeted agents have revolutionized the management of metastatic renal cell carcinoma rcc. Inlyta axitinib tablets fact sheet product description inlyta, a kinase inhibitor, is an oral therapy that selectively inhibits vascular endothelial growth factor vegf receptors 1, 2 and 3, which are receptors that can influence tumour growth. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Votrient pazopanib tablets, for oral use initial u. See full prescribing information for afinitorafinitor disperz.
In vitro studies in human hepatocytes indicated that axitinib does not induce cyp1a1, cyp1a2, or cyp3a45. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Axitinib is also being studied in the treatment of other types of cancer. Inlyta 1 mg filmcoated tablets each filmcoated tablet contains 1 mg of axitinib. Hepatotoxicity see full prescribing information for complete boxed warning. The drug substance is an aptamer, meaning it is the secondary structure i. Argatroban package insert pdf store in original package until time of use. Adjuvant axitinib therapy of renal cell cancer in high risk patients atlas the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Full prescribing information 1 indications and usage inlyta is indicated for the treatment of advanced renal cell carcinoma rccafter failure of one prior systemic therapy. Food and drug administration approves pfizers inlyta. Firstline treatment, in combination with axitinib of patients with advanced. No dosage adjustments required for mild to moderate impairment.
Aug 14, 2018 axitinib should be taken at evenly spaced intervals, usually once every 12 hours. Inlyta may cause fertility problems in males and females, which may affect your ability to have a child. Read all of this leaflet carefully before you start taking this medicine because it contains. Axitinib therapy is commonly associated with transient elevations in serum aminotransferase that are generally mild and asymptomatic. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and.
Highlights of prescribing information patients at risk. Highlights of prescribing information these highlights do not include all the information needed to use afinitorafinitor disperz safely and effectively. Inlyta axitinib is indicated for the treatment of advanced renal cell carcinoma rcc after failure of one prior systemic therapy. Prescribing information pdf, search, whats new, other resources, therapeutic. Learn about inlyta axitinib tablets indicated for the treatment of advanced rcc after failure of one prior systemic therapy. Mar 28, 2020 axitinib package insert pdf inlyta axitinib tablet, film coated. Inlyta axitinib tablets 2ndline mrcc treatment safety info. Eligible, privately insured patients may save on a qualifying prescription with the savings coupon for. The current safety database for axitinib is too small to detect rare and very rare adverse reactions.
There is no specific treatment for axitinib overdose. Highlights of prescribing information patients at risk of. Inlyta axitinib tablets 2ndline mrcc treatment safety. Axitinib therapy is commonly associated with transient elevations in serum aminotransferase that are. Dificid package insert pdf view the savings offer for dificid fidaxomicin. Adjuvant axitinib therapy of renal cell cancer in high risk. Food and drug administration fda has approved inlyta axitinib, a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma rcc after failure of one prior systemic therapy. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended see warnings and precautions 5. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. Axitinib, an inhibitor of vascular endothelial growth factor receptor vegfr, has been an important addition to currently available therapies for advanced rcc. Definition from the nci drug dictionary detailed scientific definition and other names for this drug.
In vitro studies indicated that axitinib does not inhibit cyp2a6, cyp2c9, cyp2c19, cyp2d6, cyp2e1, cyp3a45, or ugt1a1 at therapeutic plasma concentrations. Axitinib is an oral tyrosine kinase inhibitor selective for vascular endothelial growth factor vegf receptors 1, 2 and 3 that is used in the therapy of advanced renal cell carcinoma. Jun 21, 2019 axitinib package insert pdf inlyta axitinib tablet, film coated. Pembrolizumab plus axitinib versus sunitinib for advanced. Talk to your healthcare provider if this is a concern for you. Highlights of prescribing information these highlights do not include all the information needed to use tarceva safely and effectively. The same dosing reduction by one half is suggested in the package insert as a starting dose for patients with baseline moderate hepatic impairment childpugh class b.
Axitinib is used to treat late stage kidney cancer in patients who have received at least one cancer treatment that did not work well. Before taking inlyta, tell your healthcare provider about all of your medical. Inlyta is a prescription medicine used to treat advanced kidney cancer advanced renal cell carcinoma or rcc when 1 prior drug treatment regimen for your rcc has not worked. Afinitor everolimus tablets, for oral use afinitor disperz everolimus tablets for oral suspension. Jun 29, 2019 axitinib package insert pdf inlyta axitinib tablet, film coated. Linear pharmacokinetics were observed in the dose range. Axitinib is a second generation tyrosine kinase inhibitor with greater selective inhibition of vegf1, vegf2, and vegf3 only. If you vomit shortly after taking axitinib, do not take another dose. Bicitra package insert pdf medscape nephrolithiasis prevention dosing for albrights solution, bicitra sodium medscape prescription drug monographs are based on fdaapproved. Highlights of prescribing information these highlights do not.
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