Highlights of prescribing information severe hemorrhage may. Highlights of prescribing information these highlights do not include all the information needed to use gilotrif dsafely and effectively. Afatinib gilotrif national drug monograph october 2015. Please refer to the full prescribing information for the aromatase inhibitor being used. Afatinib is an anilinequinazoline derivative that is a highly selective, potent, and irreversible inhibitor of both epidermal growth factor receptor egfr and human epidermal growth factor receptor her2 kinases. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this. Afatinib gilotrif is a tki that was approved by the fda in july 20 for firstline treatment of patients with metastatic nsclc whose tumors have egfr exon 19. Covalent adducts to proteins are the major circulating metabolites of afatinib and enzymatic metabolism of afatinib is minimal. It has shown an advantage compared with chemotherapy in the firstline setting for patients with egfrpositive nsclc however, afatinibs role as the.
Dose increase or reduction is recommended based on individual safety and tolerability. Oct 01, 2019 afatinib was present in the milk of lactating rats at concentrations 80 and 150 times higher than those found in plasma at 1 and 6 hours after administration. Prescribing information ativan lorazepam oral tablets 0. Gilotrif fda prescribing information, side effects and uses. Package insert template for anastrozole tablet brand or product name product name tablet 1mg name and strength of active substances anastrozole 1mg product description visual description of the appearance of the product eg colour, markings etc eg white, circular flat beveled edge tablets marked 1 on one side pharmacodynamics. Keep taking afatinib as you have been told by your doctor or other health care provider, even if you feel well. Follow applicable special handling and disposal procedures. Coadministration of chronic pgp inducers orally can decrease afatinib exposure. Gilotrif is a prescription medicine used to treat people with nonsmall cell lung cancer nsclc, that has certain types of abnormal epidermal growth factor receptor egfr genes. If youve been diagnosed with advanced nonsmall cell lung cancer nsclc with common egfr mutations del19 or l858r, take the time to learn more about your condition and treatment options. It has a role as a tyrosine kinase inhibitor and an. Read about giotrif afatinib dosages and prescribing information for patients with nonsmallcell lung cancer nsclc.
Zykadia is a prescription medicine that is used to treat people with nonsmall cell lung cancer nsclc that. Package insert template for anastrozole tablet brand or. Afatinib is a quinazoline compound having a 3chloro4fluoroanilino group at the 4position, a 4dimethylaminotransbut2enamido group at the 6position, and an stetrahydrofuran3yloxy group at the 7position. Patient and caregiver information gilotrif afatinib. Gilotrif is a prescription medicine used to treat people with nonsmall cell lung cancer nsclc, that has certain types of abnormal epidermal growth factor receptor egfr genes, and who have not had. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. If you get diarrhea, you will need to make sure to avoid getting dehydrated. Please refer to the full prescribing information of fulvestrant. One filmcoated tablet contains 40 mg afatinib as dimaleate. What is the role of afatinib gilotrif in the treatment. Afatinib is a convenient fdaapproved option for patients with advanced nsclc who are harboring egfr exon 19 deletions or exon 21 l858r substitution mutations. This document provides specific information to each section of the overall policy. Specialty guideline management gilotrif afatinib policy i.
Fda broadens afatinib indication to previously untreated. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may. Tarceva is not recommended for use in combination with platinumbased chemotherapy see clinical studies 14. Tagrisso osimertinib tablets, for oral use initial u. Gilotrif tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib equivalent to 59. Highlights of prescribing information these highlights do not include all the information needed to use alecensa safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use gilotrif safely and effectively. When given with ibrance, the recommended dose of fulvestrant is 500 mg administered on days 1, 15, 29, and once monthly thereafter. Treatment should continue until disease progression or unacceptable toxicity occurs. Highlights of prescribing information visual disturbance. Afatinib is a tyrosine kinase receptor inhibitor that is used in the therapy of selected forms of metastatic nonsmall cell lung cancer. Gilotrif can cause fetal harm when administered to a pregnant woman.
Highlights of prescribing information patients at risk of. Policy document for gilotrif afatinib the overall objective of this policy is to support the appropriate and cost effective use of the medication. Food and drug administration fda has approved gilotrif tm afatinib tablets for oral use, as a new firstline initial treatment for patients with metastatic nonsmall cell lung cancer nsclc with common epidermal growth factor receptor egfr mutations as detected by an fdaapproved. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use sprycel safely and effectively. Highlights of prescribing information patients at risk. If a patient cannot tolerate 20mgday, permanent discontinuation of afatinib should be. Afatinib was embryotoxic and, in animals with maternal toxicity, led to abortions at late gestational stages in rabbits at doses of 5 mgkg approximately 0. Afatinib was present in the milk of lactating rats at concentrations 80 and 150 times higher than those found in plasma at 1 and 6 hours after administration. Dec 12, 2018 erlotinib hydrochloride has the molecular formula c 22 h 23 n 3 o 4.
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. What is the role of afatinib gilotrif in the treatment of. Your healthcare provider will perform a test to make sure that gilotrif is right for you. Afatinib may then be restarted with a 10mg dose reduction 40mg 30mg. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for tarceva erlotinib. Giotrif afatinib is an irreversible erbb inhibitor approved in nonsmallcell lung cancer.
Afatinib dimaleate is a white to brownish yellow powder, water soluble and hygroscopic, with an empirical formula of c 32 h 33 clfn 5 o 11, and a molecular weight of 718. Initiate treatment with letairis in females of reproductive potential only after a negative pregnancy test. Highlights of prescribing information interstitial lung. Afatinib is associated with transient elevations in serum aminotransferase levels during therapy and has been reported to cause clinically apparent acute liver injury and rare instances of death. Oct 18, 2019 afatinib dimaleate is a white to brownish yellow powder, water soluble and hygroscopic, with an empirical formula of c 32 h 33 clfn 5 o 11, and a molecular weight of 718.
Lenvima lenvatinib capsules, for oral use initial u. Is caused by a defect in a gene called anaplastic lymphoma kinase alk and has spread to other parts of the body. Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected by. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Afatinib is a secondgeneration tyrosine kinase inhibitor. Highlights of prescribing information tafinlar with. Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor hrpositive, human epidermal growth factor receptor 2 her2negative, pik3camutated, advanced or metastatic breast cancer as detected by an fdaapproved test following progression on or after an endocrinebased regimen.
Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Coadministration of pgp inhibitors can increase afatinib exposure. Patient and caregiver information gilotrif afatinib tablets. Clinical criteria policy information specific to the clinical appropriateness for the medication. Erlotinib hydrochloride has the molecular formula c 22 h 23 n 3 o 4. Metastatic lung adenocarcinoma with nonresistant egfr. Afatinib dimaleate is a white to brownish yellow powder, water soluble and hygroscopic, with an empirical formula of c32h33clfn5o11, and a molecular weight of 718. Giotrif afatinib dose modification can be an important strategy to help manage adverse reactions. It binds to the kinase domains of egfr, her2 and her4, irreversibly inhibiting tyrosine kinase autophosphorylation, and results in reduction of tumour growth and tumour regression. Food and drug administration fda has approved gilotrif tm afatinib tablets for oral use, as a new firstline initial treatment for patients with metastatic nonsmall cell lung cancer nsclc with common epidermal growth factor receptor egfr mutations as detected by an. Giotrif, innafatinib european medicines agency europa. Gilotrif afatinib severe or worsening liver teststablets, for oral use initial u. It is not known if zykadia is safe and effective in children. Highlights of prescribing information cardiac dysfunction.
Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Fda approves afatinib for previously untreated, metastatic nsclc. The recommended daily dose of tarceva for pancreatic cancer is 100 mg taken on an empty stomach at least one hour before or two hours after the ingestion of food, in combination with gemcitabine see clinical studies 14. Alecensa alectinib capsules, for oral use initial u. Ridgefield, ct, july 12, 20 boehringer ingelheim pharmaceuticals, inc. Afatinib has activity against tumours that overexpress wildtype egfr or her2, and those having. Gilotrif afatinib dosing, indications, interactions. Gleevec imatinib mesylate tablets, for oral use initial u. Tarceva is prescribed for patients with nonsmall cell lung cancer nsclc whose cancer has spread to other parts of the body and that has certain types of epidermal growth. Gilotrif is a prescription medicine that is used to treat people with nonsmall cell lung cancer nsclc that. Substances that are inducers of cyp3a4 activity may increase metabolism and decrease. Common aes associated with giotrif afatinib are generally well managed with supportive care.
Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. It is not known whether other progestinonly contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy. Afatinib gilotrif is a tki that was approved by the fda in july 20 for firstline treatment of patients with metastatic nsclc whose tumors have egfr exon 19 deletions or exon 21 l858r. Etopophos solutions may be administered at infusion rates up to 3. Highlights of prescribing information these highlights do not include all the information needed to use tagrisso. For current full prescribing information, please visit revised. Afatinib versus cisplatin plus gemcitabine for firstline treatment of asian patients with advanced nonsmallcell lung cancer harbouring egfr mutations luxlung 6.
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