Caprelsa package insert pdf

Hepatotoxicity see full prescribing information for complete boxed warning. The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. Sufentanil sublingual tablet 30 mcg for the management of pain following abdominal surgery. Ndesmethylvandetanib and vandetanibnoxide circulate at concentrations of approximately 717. This metabolite appears to act by inhibiting dna polymerase alpha, ribonucleotide reductase and dna primase, thus inhibiting dna synthesis. Highlights of prescribing information these highlights do. Caprelsa sgm p2017 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. When given with kisqali ribociclib tablets, the recommended dose of fulvestrant is 500 mg, administered on days 1, 15, 29, and once monthly thereafter. Discontinue aliqopa if lifethreatening aliqoparelated toxicity occurs. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for emla lidocaine prilocaine. Monitor hepatic function prior to and during treatment see warnings and precautions 5. When added to other medicines for asthma, cinqair helps prevent severe asthma attacks exacerbations and can improve your. Caprelsa will be approved based on the following criterion.

Obtain thyroidstimulating hormone tsh at baseline, at 2 4 weeks and 8 12 weeks after starting treatment with. Caprelsa vandetanib rationale for inclusion in pa program. Mar 31, 2016 ndesmethylvandetanib and vandetanibnoxide circulate at concentrations of approximately 717% and 1. Entyvio vedolizumab for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to entyvio or any of its excipients. Information for the patient caprelsa 100 mg filmcoated tablets caprelsa 300 mg filmcoated tablets vandetanib. Blinatumomab is a bispecific cd19directed cd3 tcell engager that binds to cd19 expressed on the surface of. Follicular, hurthle cell, and papillary thyroid carcinoma.

Proposed additions and deletions to the niosh hazardous drug. Protein in your urine and possible kidney problems. Full prescribing information 1 indications and usage zaltrap, in combination with. Evaluation and mitigation strategy rems program for caprelsa is required by the fda 1. Vandetanib abbreviated monograph may 2015 updated version may be found at. Indication and usage caprelsa is a prescription medicine used to treat medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body, and the tumors are growing or causing symptoms. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. Highlights of prescribing information pneumonia pcp pcp. Follicular, hurthle cell, and papillary thyroid carcinoma 2. Use of caprelsa in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment related risks of. An ongoing trial is evaluating the safetyefficacy of a lower 100 mg daily. Fludarabine may cause fetal harm when administered to a pregnant woman. Caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Highlights of prescribing information wounds have adequately. Caprelsa vandetanib monotherapy is indicated for the treatment of symptomatic or progressive. Caprelsa will be approved for uses not outlined above if supported by the national comprehensive cancer network nccn drugs and biologics compendium. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. Caprelsa vandetanib is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic. Minkowitz hs, leiman d, melson t, singla n, didonato kp, palmer pp. See full prescribing information for complete boxed warning. Vandetanib caprelsa package insert pdf pages 68 vandetanib caprelsa patient drug information uptodate. Because of the risks associated with caprelsa, your health care provider should carefully consider whether to prescribe caprelsa for you if your tumors are growing. Use caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of caprelsa. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.

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. Patients should be instructed in the use of the delivery system. Temodar temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5. Dec 31, 2019 fludarabine phosphate is rapidly dephosphorylated to 2fluoroaraa and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2fluoroaraatp. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Vandetanib is an oral tyrosine kinase inhibitor shown to have activity against the epidermal growth factor receptor family, vascular endothelial growth factor vegf receptors, ret, protein tyrosine kinase 6 brk, tyrosine kinase with immunoglobulin and egf domains2 tie2, members of the ephrin eph receptor kinase family, and members of the src family of. The 300 mg daily dose can be reduced to 200 mg two 100 mg tablets and then to 100 mg for common terminology. Please read prescribing information, including boxed warning. Zivaflibercept acts as a soluble receptor that binds to human vegfa equilibrium dissociation constant kd of 0. Caprelsa 100 mg tablet 584687820xx caprelsa 300 mg tablet 584687840xx vii. 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. Handfoot skin reactions are common with cometriq and can be severe. Dailymed fludarabine fludarabine phosphate injection, solution.

Votrient pazopanib tablets, for oral use initial u. Program prior authorization medication caprelsa vandetanib markets in scope ohio. The recommended dose is 300 mg once a day, taken with or without. Prior authorization is required to ensure the safe, clinically appropriate and costeffective use of caprelsa while maintaining optimal therapeutic outcomes. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Fludarabine phosphate was teratogenic in rats and in rabbits. Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. Stivarga regorafenib is a prescription medicine used to treat people with.

Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for zithromax azithromycin. Because of the risks associated with caprelsa, your health care provider should carefully consider whether to prescribe caprelsa for you if your. This will allow quick identification of new safety information. The recommended dose of alimtafor treatment of recurrent nonsquamous nsclcinpatients with a creatinine clearance calculated by cockcroftgault equation of 45mlmin or greateris 500mgm2 as an intravenous infusion over 10minutes on day 1 of each 21day cycle until disease progression or unacceptable toxicity. See full prescribing information for complete boxed. Your healthcare provider will do blood tests to check your liver function before you start taking stivarga and during your treatment with stivarga to check for liver problems. See the package insert for more information astrazeneca, 2011. The first medication approved by the fda to treat advanced medullary thyroid cancer amtc. Lenvima lenvatinib capsules, for oral use initial u.

The recommended dosing parameters for the treatment of medullary thyroid cancer, follicular, hurthle, and papillary. Vandetanib fda prescribing information, side effects and uses. Infusionrelated reactions and hypersensitivity reactions including anaphylaxis have occurred. Caprelsa 300 mg filmcoated tablets vandetanib medicine is subject to. Stivarga regorafenib can cause liver problems, which can be serious and sometimes lead to death. No therapy has shown a survival benefit in locally advanced or metastatic mtc. Caprelsa is not recommended for use in patients with moderate and severe hepatic impairment see use in speci. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4. Excretion within a 21day collection period after a single dose of 14 cvandetanib, approximately 69% was recovered with 44% in feces and 25% in urine.

Use of caprelsa in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment related risks of caprelsa. Nonsmall cell lung cancer with ret gene rearrangements. Oncology related including new drugs, antagonists, etc. Highlights of prescribing information these highlights do not. Erivedge vismodegib capsules, for oral use initial u. 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. If you have difficulty viewing the document below, please click here to view the full prescribing information, including the boxed warning. The benefit of vandetanib is an improvement in pfs in patients who are symptomatic with progressive mtc. Cinqair is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people aged 18 years of age and older whose asthma is not controlled with the current asthma medicines. Proposed additions and deletions to the niosh hazardous drug list 2014 established name proprietary name drug class formulations dosage fda pregnancy category drug package insert drugs recommended by niosh to be added to the 2012 hazardous drug list abacavir ziagen antiviral tablets, oral solution 600mg c pi abiraterone. Jakafi is indicated for treatment of polycythemia vera pv in adults who have had an inadequate response to or are intolerant of hydroxyurea. Aliqopa copanlisib for injection, for intravenous use. Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively.

This leaflet is offered as a guide to you and your family. Table 1 provides dosage recommendations for patients with renal or hepatic impairment and those in whom qtcf qt interval with fridericia correction prolongation or other toxicities occur. Caprelsa is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Dailymed fludarabine fludarabine phosphate injection. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and.