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The alarm centermost is accessible Monday through Friday 8 AM to 10 PM EST, Saturday 8 AM to 5 PM EST, and bankrupt on Sundays.Please see the abounding account of frequently asked questions for answers to any added questions.
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About Tasigna
Tasigna (nilotinib) capsules is adumbrated for the analysis of abiding appearance and accelerated appearance Philadelphia chromosome-positive (Ph+) abiding myelogenous leukemia (CML) in developed patients aggressive or antipathetic to above-mentioned analysis that included imatinib. Tasigna has been accustomed in added than 50 countries. The capability of Tasigna is based on hematologic and cytogenetic acknowledgment rates. There are no controlled trials demonstrating a analytic benefit, such as advance in disease-related affection or added survival. Please see Important Safety Information below.
Tasigna important assurance advice
WARNING: QT PROLONGATION AND SUDDEN DEATHS
TASIGNA prolongs the QT interval. Sudden deaths accept been appear in patients accepting nilotinib. TASIGNA should not be acclimated in patients with hypokalemia, hypomagnesemia, or continued QT syndrome. Hypokalemia or hypomagnesemia have to be adapted above-mentioned to TASIGNA administering and should be periodically monitored. Drugs accepted to prolong the QT breach and able CYP3A4 inhibitors should be avoided. Patients should abstain aliment 2 hours afore and 1 hour afterwards demography dose. Use with attention in patientswith hepatic impairment. ECGs should be acquired to adviser the QTc at baseline, seven canicule afterwards initiation, and periodically thereafter, as able-bodied as afterward any dosage adjustments.
Myelosuppression
Treatment with Tasigna is associated with Grade 3/4 neutropenia, thrombocytopenia, and anemia. Complete claret counts should be performed every 2 weeks for the aboriginal 2 months, again account thereafter as clinically indicated. Myelosuppression with Tasigna was about capricious and usually managed by denial Tasigna briefly or dosage reduction.
QT assiduity
Tasigna prolongs the QT interval. Correct hypokalemia or hypomagnesemia above-mentioned to administering and adviser periodically. Avoid drugs accepted to prolong the QT breach and able CYP3A4 inhibitors. Use attention in patients with hepatic impairment. Obtain ECGs at baseline, seven canicule afterwards initiation, and periodically thereafter, as able-bodied as afterward any dosage adjustments.
Sudden deaths
There were abrupt deaths appear in the assurance citizenry and the broadcast acceptance program. Ventricular repolarization abnormalities may accept contributed to their occurrence.
Elevated serum lipase
Caution is recommended in patients with history of pancreatitis. Check serum lipase periodically.
Liver action aberancy
Serum bilirubin and hepatic transaminases
The use of Tasigna may aftereffect in elevations in bilirubin, AST/ALT, and acrid phosphatase. Check hepatic action tests periodically.
Electrolyte abnormalities
Tasigna can could cause hypophosphatemia, hypokalemia, hyperkalemia, hyponatremia and hypocalcemia. Correct electrolyte abnormalities above-mentioned to initiating Tasigna and adviser periodically during therapy.
Hepatic crime
Metabolism of Tasigna is mainly hepatic. Tasigna has not been advised in patients with hepatic impairment. Caution is recommended in these patients and QT breach should be monitored closely.
Drug interactions
The accessory use of QT assiduity drugs and able inhibitors or inducers of CYP3A4 should be abhorred as they may affect serum absorption of Tasigna.
Concomitant able CYP3A4 inhibitors
The accessory use of able CYP3A4 inhibitors should be abhorred (including, but not bound to, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Should analysis with any of these agents be required, it is recommended that analysis with Tasigna be interrupted. If abeyance of analysis with Tasigna is not possible, patients who crave analysis with a biologic that prolongs QT or acerb inhibits CYP3A4 should be carefully monitored for assiduity of the QT interval, and a dosage abridgement to ½ the circadian dosage is recommended (400 mg already daily). If the able inhibitor is discontinued, a accident aeon should be accustomed afore Tasigna is adapted advancement to the adumbrated dose. Close ecology for assiduity of the QT breach is adumbrated for patients who cannot abstain able CYP3A4 inhibitors. Grapefruit articles and added foods that are accepted to arrest CYP3A4 should aswell be avoided.
Concomitant able CYP3A4 inducers
The accessory use of able CYP3A4 inducers should be abhorred (including, but not bound to, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital). Patients should aswell burden from demography St John's Wort. If patients have to be co-administered a able CYP3A4 inducer, the dosage of Tasigna may charge to be increased, depending on accommodating tolerability. If the able inducer is discontinued, the Tasigna dosage should be bargain to the adumbrated dose. Tasigna is a aggressive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6, and UGT1A1. Since warfarin is metabolized by CYP2C9 and CYP3A4, it should be abhorred if possible. Tasigna inhibits animal P-glycoprotein. If Tasigna is administered with drugs that are substrates of Pgp, added concentrations of the substrate are acceptable and attention should be exercised. Tasigna may aswell abet CYP2B6, CYP2C8, and CYP2C9. Therefore, Tasigna may adapt serum absorption of added drugs.
Food accoutrement
Food increases claret levels of Tasigna. Patients should abstain aliment 2 hours afore and 1 hour afterwards demography dose.
Lactose
Since the capsules accommodate lactose, Tasigna is not recommended for patients with attenuate ancestral problems of galactose intolerance, astringent lactase deficiency, or of glucose-galactose malabsorption.
Pregnancy
Fetal abuse can action if Tasigna is administered to a abundant woman. Women should be audacious not to become abundant if demography Tasigna.
Adverse reactions
In abiding appearance patients, the a lot of frequently appear adverse reactions (>10%) were adventurous (33%), pruritus (29%), abhorrence (31%), fatigue (28%), cephalalgia (31%), ache (21%), diarrhea (22%), and airsickness (21%). The a lot of accepted (>10%) Grade 3/4 adverse reactions were thrombocytopenia (28%), neutropenia (28%), animated lipase (15%), and hyperglycemia (11%). In accelerated appearance patients, the a lot of frequently appear adverse reactions (>10%) were adventurous (28%), pruritus (20%), and ache (18%). The a lot of accepted (>10%) Grade 3/4 adverse reactions were thrombocytopenia (37%), neutropenia (37%), anemia (23%), and animated lipase (17%). Other austere adverse reactions included pneumonia, delirious neutropenia, leukopenia, intracranial hemorrhage, and agitation (Grade 3/4: 2%).
Dose adjustments or modifications
Tasigna may charge to be briefly withheld and/or dosage bargain for QT prolongation, hematological toxicities that are not accompanying to basal leukemia, clinically cogent abstinent or astringent nonhematologic toxicities, class abnormalities, or accessory use of able CYP3A4 inhibitors. With accessory use of able CYP3A4 inducers, the dosage of Tasigna may charge to be increased, depending on accommodating tolerability.
Other patients in whom Tasigna should be acclimated with attention
Tasigna should not be acclimated during pregnancy. Sexually breath changeable patients should use able contraception during treatment. Women should not breast augment while demography Tasigna. There are no abstracts to abutment the use of Tasigna in pediatric patients. Use with attention in patients with hepatic impairment.
About Gleevec
Gleevec (imatinib mesylate) tablets are adumbrated for the analysis of anew diagnosed developed patients with Philadelphia chromosome-positive abiding myeloid leukemia (Ph+ CML) in the abiding phase. Follow-up is bound to 5 years. Gleevec is aswell adumbrated for patients with Ph+ CML in bang crisis (BC), accelerated appearance (AP), or in the abiding appearance (CP) afterwards abortion of interferon-alpha therapy.
Gleevec important assurance advice (1)
Fetal abuse can action if administered to a abundant woman; therefore, women of bearing abeyant should be audacious to not become abundant while demography Gleevec tablets and to abstain breast-feeding while demography Gleevec tablets because of the abeyant for austere adverse reactions in nursing infants. Sexually breath changeable patients demography Gleevec should use able contraception. If the accommodating does become abundant while demography Gleevec, the accommodating should be audacious of the abeyant hazard to the fetus.
Severe (NCI Grades 3/4) lab abnormalities - including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (<1%-33%), and hepatotoxicity (approx 5%)--and astringent adverse adventures (NCI Grades 3/4), including astringent aqueous assimilation (e.g., pleural effusion, pulmonary edema, and ascites) and apparent edema (1.3%-11%), drain (1.8%-19%), and musculoskeletal affliction (2%-9%) were appear a allotment of patients accepting Gleevec*. Severe aqueous assimilation appears to be dose-related, was added accepted in the beat appearance studies (where the dosage was 600 mg/day), and is added accepted in the elderly.
Severe congestive affection abortion and larboard ventricular dysfunction accept occasionally been reported. Most of the patients with appear cardiac contest accept had added co-morbidities and accident factors, including beat age and antecedent medical history of cardiac disease. Patients with cardiac ache or accident factors for cardiac abortion should be monitored carefully, and any accommodating with signs or affection connected with cardiac abortion should be evaluated and treated.
Dose adjustments may be all-important due to hepatotoxicity, added nonhematologic adverse reactions, or hematologic adverse reactions. Therapy with Gleevec was discontinued for drug-related adverse reactions in 2.4% to 5% of patients. Complete claret counts should be performed account for the aboriginal month, annual for the additional month, and periodically thereafter as clinically adumbrated (for example, every 2-3 months).
A 25% abatement in the recommended dosage should be acclimated for patients with astringent hepatic impairment. Patients with abstinent renal crime (CrCL = 20-39 mL/min) should accept a 50% abatement in the recommended starting dosage and added as tolerated. Doses greater than 600 mg are not recommended in patients with balmy renal crime (CrCL = 40-59 mL/min). For patients with abstinent renal crime doses greater than 400 mg are not recommended. Gleevec should be acclimated with attention in patients with astringent renal impairment.
Patients should be advised and monitored consistently for signs and affection of edema, which can be austere or life-threatening. There accept aswell been reports, including fatalities, of cardiac tamponade, bookish edema, adroit respiratory failure, and GI perforation.
Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) accept aswell been reported. In some cases, the acknowledgment recurred aloft re-challenge. Several column business letters call patients able to abide the reintroduction of Gleevec at a lower dosage with or after accessory corticosteroids or antihistamines afterward resolution or advance of the bullous reaction.
Consider abeyant toxicities--specifically liver, kidney, and cardiac toxicity, and immunosuppression from abiding use.
Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6, and CYP2C9. Dosage of Gleevec should access by at atomic 50%, and analytic acknowledgment should be anxiously monitored, in patients accepting Gleevec with a almighty CYP3A4 inducer such as rifampin or phenytoin. Examples of frequently acclimated drugs that may decidedly collaborate with Gleevec cover ketoconazole, acetaminophen, warfarin, erythromycin, and phenytoin. (Please see abounding Prescribing Information for added abeyant biologic interactions.)
For circadian dosing of 800 mg and above, dosing should be able application the 400 mg book to abate acknowledgment to iron.
Common ancillary accoutrement of Gleevec tablets
The majority of developed Ph+ CML patients who accustomed Gleevec in analytic studies accomplished adverse reactions at some time, but a lot of were balmy to abstinent in severity. The a lot of frequently appear adverse reactions (all Grades) were apparent edema (60%-74%), abhorrence (50%-73%), beef cramps (28%-62%), airsickness (23%-58%), diarrhea (43%-57%), musculoskeletal affliction (38%-49%), and adventurous and accompanying agreement (36%-47%)*†.
Supportive affliction may advice administration of some mild-to-moderate adverse reactions so that the assigned dosage can be maintained whenever possible. However, in some cases, either a dosage abridgement or abeyance of analysis with Gleevec may be necessary.
Gleevec tablets should be taken with aliment and a ample bottle of baptize to abbreviate GI irritation. Gleevec tablets should not be taken with grapefruit abstract and added foods accepted to arrest CYP3A4.
Patients should be abreast to crop Gleevec absolutely as prescribed, not to change their dosage or stop demography Gleevec unless they are told to do so by their doctor. If patients absence a dose, they should be audacious to crop their dosage as anon as accessible unless it is about time for their next dose, in which case the absent dosage should not be taken. A bifold dosage should not be taken to accomplish up for any absent dose.
*Numbers announce the ambit of percentages in 4 studies a allotment of developed patients, with anew diagnosed Ph+ CML, patients in bang crisis, accelerated phase, and in the abiding appearance afterwards abortion of interferon-alpha therapy.
†For added abundant abstraction advice amuse see abounding Prescribing Information.
Disclaimer
The above absolution contains advanced statements that can be articular by analogue such as "suggesting," "may," "commitment," or agnate expressions, or by accurate or adumbrated discussions apropos abeyant new break or labeling for Tasigna, the abiding appulse of a patient's use of Tasigna or apropos abeyant approaching revenues from Tasigna. You should not abode disproportionate assurance on these statements. Such advanced statements reflect the accepted angle of administration apropos approaching events, and absorb accepted and alien risks, uncertainties and added factors that may could cause absolute after-effects with Tasigna to be materially altered from any approaching results, achievement or achievements bidding or adumbrated by such statements. There can be no agreement that Tasigna will be accustomed for any added break or labeling in any market. Nor can there be any agreement apropos the abiding appulse of a patient's use of Tasigna. Neither can there be any agreement that Tasigna will accomplish any accurate levels of acquirement in the future. In particular, management's expectations apropos Tasigna could be afflicted by, a allotment of added things, abrupt authoritative accomplishments or delays or government adjustment generally; abrupt analytic balloon results, including abrupt new analytic abstracts and abrupt added appraisal of absolute analytic data; the company's adeptness to access or advance apparent or added proprietary bookish acreage protection; antagonism in general; government, industry and accepted accessible appraisement pressures; the appulse that the above factors could accept on the ethics attributed to the Novartis Group's assets and liabilities as recorded in the Group's circumscribed antithesis sheet, and added risks and factors referred to in Novartis AG's accepted Form 20-F on book with the US Securities and Exchange Commission. Should one or added of these risks or uncertainties materialize, or should basal assumptions prove incorrect, absolute after-effects may alter materially from those anticipated, believed, estimated or expected. Novartis is accouterment the advice in this columnist absolution as of this date and does not undertake any obligation to amend any advanced statements absolute in this columnist absolution as a aftereffect of new information, approaching contest or otherwise.
About Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, articles and markets arch avant-garde decree drugs acclimated to amusement a amount of diseases and conditions, including those in the cardiovascular, metabolic, cancer, agency transplantation, axial afraid system, dermatological, GI and respiratory areas. The Company's mission is to advance people's lives by beat atypical healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an accessory of Novartis AG, which provides healthcare solutions that abode the evolving needs of patients and societies. Focused alone on healthcare, Novartis offers a adapted portfolio to best accommodated these needs: avant-garde medicines, cost-saving all-encompassing pharmaceuticals, antitoxin vaccines, analytic accoutrement and chump bloom products. Novartis is the alone aggregation with arch positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) accomplished net sales of USD 38.1 billion and net assets of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies apply about 97,000 full-time assembly and accomplish in over 140 countries about the world. For added information, amuse appointment http://www.novartis.com.
For added information
Additional advice apropos Gleevec, Tasigna and Novartis Oncology can be begin on the websites www.novartisoncologyvpo.com, www.gleevec.com, www.us.tasigna.com and www.novartisoncology.us.
Reference
1. Gleevec (imatinib mesylate) tablets prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; Nov 2007.
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