See full prescribing information for complete boxed warning. Alecensa alectinib capsules, for oral use initial u. Dosing of axitinib at 5 mg twice daily resulted in approximately 1. Jan 30, 2020 axitinib package insert pdf inlyta axitinib tablet, film coated. Dailymed dacarbazine injection, powder, for solution. Find information on the resources available to patients prescribed a pfizer oncology medication. In the pnet study, 183 patients 1% receiving sutent had grade 3 epistaxis, and no patients had other grade 3 or 4 bleeding events.
Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections. Each vial also contains anhydrous citric acid and mannitol. The subsequent doses can be increased or decreased based on. Inlyta 1 mg filmcoated tablets each filmcoated tablet contains 1 mg of axitinib. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient.
It is not known whether other progestinonly contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy. See full prescribing information for afinitorafinitor disperz. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. In vitro studies indicated that axitinib does not inhibit cyp2a6, cyp2c9, cyp2c19, cyp2d6, cyp2e1, cyp3a45, or ugt1a1 at therapeutic plasma concentrations. If a dose of axitinib is missed or vomited, take the next dose at the regularly scheduled time. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Inlyta may cause fertility problems in males and females, which may affect your ability to have a child. 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. If previously receiving 60 mg daily dose, resume treatment at 40 mg daily. If a serious infection develops, interrupt xeljanzxeljanz xr until the infection is controlled. Refer to the pembrolizumab prescribing information for recommended pembrolizumab dosing information. Aug 03, 2019 the safety of reinitiating axitinib therapy in patients previously experiencing pres is not known. Highlights of prescribing information palmarplantar.
Caprelsa vandetanib tablets for oral use initial u. 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. Find helpful tips for taking inlyta axitinib tablets. It is not known if inlyta is safe and effective in children.
Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. The subsequent doses can be increased or decreased based on individual safety and tolerability. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Pfizer oncology field reimbursement managers frms are trained to help address specific access issuesin person or over the phone. Afinitor everolimus tablets, for oral use afinitor disperz everolimus tablets for oral suspension. In the overall patient population and the two main subgroups prior sunitinib treatment and prior cytokine treatmentthere was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of pfs see table 2 and figures 1, 2 and 3. Inlyta axitinib tablets how to take inlyta safety info. Inlyta axitinib is indicated for the treatment of advanced renal cell carcinoma rcc after failure of one prior systemic therapy. Hepatotoxicity see full prescribing information for complete boxed warning. 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. 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. They can help educate your staff on our access and.
Inlyta axitinib indications and usage pfizer medical. In vitro studies in human hepatocytes indicated that axitinib does not induce cyp1a1, cyp1a2, or cyp3a45. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer. Inlyta axitinib dosing, indications, interactions, adverse. Highlights of prescribing information these highlights do not. Table 2 lists the recommended dosage reductions of.
Jun 21, 2019 axitinib package insert pdf inlyta axitinib tablet, film coated. Prescribers are advised to consult the package insert. Importance of swallowing axitinib tablets whole with a glass of. Highlights of prescribing information inlytasafely. Gilotrif is indicated for the firstline treatment of patients with. Inlyta axitinib fdaapproved patient labeling pfizer. Highlights of prescribing information these highlights do. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Axitinib is a nextgeneration, selective tyrosine kinase inhibitor targeting the vascular endothelial growth factor receptors. If coadministration of the strong inhibitor is discontinued, the inlyta. Please see full prescribing information for inlyta. Pfizer rxpathways connects eligible patients, regardless of their insurance status, to a range of assistance programs that offer insurance support, copay help, and medicines for free or at a savings. Axitinib is an inhibitor of the efflux transporter pglycoprotein pgp in vitro. Highlights of prescribing information these highlights do not include all the information needed to use alecensa safely and effectively.
New patients who have been prescribed ibrance can start a free 1month 21day trial with this voucher, regardless of insurance coverage. Mar 28, 2020 no dose adjustment is required see section 5. Highlights of prescribing information urothelial carcinoma. 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. The current safety database for axitinib is too small to detect rare and very rare adverse reactions. The safety of reinitiating axitinib therapy in patients previously experiencing pres is not known. Based on the plasma halflife, steady state is expected within 2 to 3 days of dosing. Inlyta axitinib tablets 2ndline mrcc treatment safety. Highlights of prescribing information these highlights do not include all the information needed to use afinitorafinitor disperz safely and effectively. Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives. Axitinib is also being studied in the treatment of other types of cancer.
Axitinib is designed to slow the growth of cancer cells by inhibiting several mechanisms that the cell uses to grow and survive. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. It is approved for the treatment of metastatic renal cell carcinoma mrcc based on a demonstrated progressionfree survival advantage over sorafenib in the secondline treatment setting.
Inlyta axitinib inlyta fep clinical rationale prior approval is required to ensure the safe, clinically appropriate and cost effective use of inlyta while maintaining optimal therapeutic outcomes. At steady state, axitinib exhibits approximately linear pharmacokinetics within the 1mg to 20mg dose range. It is approved for the treatment of metastatic renal cell. Indication and usage is recognized in nccn drugs and biologics compendium as a category 1 or 2a recommendation approval duration. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. In the overall patient population and the two main subgroups prior sunitinib treatment and prior. Jan 30, 2020 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. See risks and benefits on the official inlyta site. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the. 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. Importance of swallowing axitinib tablets whole with a glass of water. Jun 29, 2019 axitinib package insert pdf inlyta axitinib tablet, film coated. Highlights of prescribing information interstitial lung. Axitinib inlyta axitinib inlyta is a chemotherapy regimen for renal cell carcinoma kidney cancer. Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median t max ranging from 2. They can help educate your staff on our access and reimbursement resources and help address challenging or urgent pfizer oncology patient cases you have sent to pfizer oncology together. Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib. Jun 23, 2019 axitinib package insert pdf inlyta axitinib tablet, film coated. Talk to your healthcare provider if this is a concern for you. Axitinib package insert pdf inlyta axitinib tablet, film coated. Reduce the daily cometriq dose by 40 mg for example, from 140.
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