ASH Clinical News November 2015 | Page 30

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Providers are also encouraged to apply for
hardship exceptions if they need to switch
EHR vendors or have other technology
difficulties with their EHR vendor.
“This new framework will be based on
the landmark bipartisan legislation – the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) – that requires
the establishment of a Merit-based
Incentive Payment System (MIPS) and

consolidates certain aspects of a number
of quality measurement and federal incentive programs for Medicare physicians and
other providers into one, more efficient
framework,” said Patrick Conway, MD,
MSc, deputy administrator for innovation
and quality and chief medical officer at
CMS, in a press release.
Critics of the recent health-care overhaul are noting that the requirements are

Elevated total cholesterol (all grades) occurred in 28% (Tasigna 300 mg bid) and
4% (imatinib). Elevated triglycerides (all grades) occurred in 12% and 8% of
patients in the Tasigna and imatinib arms, respectively. Hyperglycemia (all
grades) occurred in 50% and 31% of patients in the Tasigna and imatinib arms,
respectively.
Most common biochemistry laboratory abnormalities (all grades) were alanine
aminotransferase increased (72%), blood bilirubin increased (59%), aspartate
aminotransferase increased (47%), lipase increased (28%), blood glucose
increased (50%), blood cholesterol increased (28%), and blood triglyceride
increased (12%).
6.2 Additional Data from Clinical Trials
The following adverse drug reactions were reported in patients in the
Tasigna clinical studies at the recommended doses. These adverse drug
reactions are ranked under a heading of frequency, the most frequent first
using the following convention: common (≥1% and <10%), uncommon
(≥0.1% and <1%), and unknown frequency (single events). For laboratory
abnormalities, very common events (≥10%), which were not included in
Tables 5 and 6, are also reported. These adverse reactions are included
based on clinical relevance and ranked in order of decreasing seriousness
within each category, obtained from 2 clinical studies:
1. Newly diagnosed Ph+ CML-CP 60 month analysis and,
2. Resistant or intolerant Ph+ CML-CP and CMP-AP 24 months’ analysis.
Infections and Infestations: Common: folliculitis. Uncommon: pneumonia,
bronchitis, urinary tract infection, candidiasis (including oral candidiasis).
Unknown frequency: sepsis, subcutaneous abscess, anal abscess, furuncle,
tinea pedis.
Neoplasms Benign, Malignant, and Unspecified: Common: skin papilloma.
Unknown frequency: oral papilloma, paraproteinemia.
Blood and Lymphatic System Disorders: Common: leukopenia,
eosinophilia, febrile neutropenia, pancytopenia, lymphopenia. Unknown
frequency: thrombocythemia, leukocytosis.
Immune System Disorders: Unknown frequency: hypersensitivity.
Endocrine Disorders: Uncommon: hyperthyroidism, hypothyroidism.
Unknown frequency: hyperparathyroidism secondary, thyroiditis.
Metabolism and Nutrition Disorders: Very Common: hypophosphatemia.
Common: electrolyte imbalance (including hypomagnesemia, hyperkalemia,
hypokalemia, hyponatremia, hypocalcemia, hypercalcemia, hyperphosphatemia), diabetes mellitus, hyperglycemia, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia. Uncommon: gout, dehydration, increased
appetite. Unknown frequency: hyperuricemia, hypoglycemia.
Psychiatric Disorders: Common: depression, anxiety. Unknown frequency:
disorientation, confusional state, amnesia, dysphoria.
Nervo us System Disorders: Common: peripheral neuropathy, hypoesthesia,
paresthesia. Uncommon: intracranial hemorrhage, ischemic stroke, transient
ischemic attack, cerebral infarction, migraine, loss of consciousness
(including syncope), tremor, disturbance in attention, hyperesthesia.
Unknown frequency: basilar artery stenosis, brain edema, optic neuritis,
lethargy, dysesthesia, restless legs syndrome.
Eye Disorders: Common: eye hemorrhage, eye pruritus, conjunctivitis, dry
eye (including xerophthalmia). Uncommon: vision impairment, vision
blurred, visual acuity reduced, photopsia, hyperemia (scleral, conjunctival,
ocular), eye irritation, conjunctival hemorrhage. Unknown frequency: papilloedema, diplopia, photophobia, eye swelling, blepharitis, eye pain, chorioretinopathy, conjunctivitis allergic, ocular surface disease.
Ear and Labyrinth Disorders: Common: vertigo. Unknown frequency: hearing impaired, ear pain, tinnitus.
Cardiac Disorders: Common: angina pectoris, arrhythmia (including atrioventricular block, cardiac flutter, extrasystoles, atrial fibrillation, tachycardia,
bradycardia), palpitations, electrocardiogram QT prolonged. Uncommon:
cardiac failure, myocardial infarction, coronary artery disease, cardiac murmur, coronary artery stenosis, myocardial ischemia, pericardial effusion,
cyanosis. Unknown frequency: ventricular dysfunction, pericarditis, ejection
fraction decrease.
Vascular Disorders: Common: flushing. Uncommon: hypertensive crisis,
peripheral arterial occlusive disease, intermittent claudication, arterial
stenosis limb, hematoma, arteriosclerosis. Unknown frequency: shock
hemorrhagic, hypotension, thrombosis, peripheral artery stenosis.

too large of an undertaking to meet the
current deadlines, and many call for the
final stage requirements to be pushed until 2017. Opponents have also asked for a
period of assessment of the achievements
and failures of phase 2 of the program
before enacting these new rules.
Medical organizations appear to have
mixed feelings toward the program: the
American Medical Association is on

Respiratory, Thoracic and Mediastinal Disorders: Common: dyspnea exertional, epistaxis, dysphonia. Uncommon: pulmonary edema, pleural effusion,
interstitial lung disease, pleuritic pain, pleurisy, pharyngolaryngeal pain,
throat irritation. Unknown frequency: pulmonary hypertension, wheezing.
Gastrointestinal Disorders: Common: pancreatitis, abdominal discomfort,
abdominal distension, dysgeusia, flatulence. Uncommon: gastrointestinal
hemorrhage, melena, mouth ulceration, gastroesophageal reflux, stomatitis,
esophageal pain, dry mouth, gastritis, sensitivity of teeth. Unknown frequency: gastrointestinal ulcer perforation, retroperitoneal hemorrhage,
hematemesis, gastric ulcer, esophagitis ulcerative, subileus, enterocolitis,
hemorrhoids, hiatus hernia, rectal hemorrhage, gingivitis.
Hepatobiliary Disorders: Very Common: hyperbilirubinemia. Common:
hepatic function abnormal. Uncommon: hepatotoxicity, toxic hepatitis, jaundice. Unknown frequency: cholestasis, hepatomegaly.
Skin and Subcutaneous Tissue Disorders: Common: eczema, urticaria, erythema, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform). Uncommon: exfoliative rash, drug eruption, pain of
skin, ecchymosis. Unknown frequency: psoriasis, erythema multiforme, erythema nodosum, skin ulcer, palmar-plantar erythrodysesthesia syndrome,
petechiae, photosensitivity, blister, dermal cyst, sebaceous hyperplasia, skin
atrophy, skin discoloration, skin exfoliation, skin hyperpigmentation, skin
hypertrophy, hyperkeratosis.
Musculoskeletal and Connective Tissue Disorders: Common: bone pain,
musculoskeletal chest pain, musculoskeletal pain, back pain, neck pain,
flank pain, muscular weakness. Uncommon: musculoskeletal stiffness, joint
swelling. Unknown frequency: arthritis.
Renal and Urinary Disorders: Common: pollakiuria. Uncommon: dysuria,
micturition urgency, nocturia. Unknown frequency: renal failure, hematuria,
urinary incontinence, chromaturia.
Reproductive System and Breast Disorders: Uncommon: breast pain,
gynecomastia, erectile dysfunction. Unknown frequency: breast induration,
menorrhagia, nipple swelling.
General Disorders and Administration Site Conditions: Common: pyrexia,
chest pain (including non-cardiac chest pain), pain, chest discomfort,
malaise. Uncommon: gravitational edema, influenza-like illness, chills, feeling body temperature change (including feeling hot, feeling cold). Unknown
frequency: localized edema.
Investigations: Very Common: alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, lipoprotein cholesterol
(including very low density and high density) increased, total cholesterol
increased, blood triglycerides increased. Common: hemoglobin decreased,
blood amylase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, blood alkaline phosphatase increased,
weight decreased, weight increased, globulins decreased. Uncommon:
blood lactate dehydrogenase increased, blood urea increased. Unknown frequency: troponin increased, blood bilirubin unconjugated increased, insulin
C-peptide decreased, blood parathyroid hormone increased.
10 OVERDOSAGE
Overdose with nilotinib has been reported, where an unspecified number of
Tasigna capsules were ingested in combination with alcohol and other
drugs. Events included neutropenia, vomiting, and drowsiness. In the event
of overdose, the patient should be observed and appropriate supportive
treatment given.
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
© Novartis
T2015-21
January 2015

board with the hardship exemption for
providers, while the American Hospital
Association called the phase 3 ruling “too
much too soon.”
Despite the pushback, CMS stresses
that improving the functionality of
EHRs will make data more accessible to
consumers and prevent providers and
vendors from engaging in informationblocking.
CMS is allowing for public comment on the final rule through early
December.
Sources: HHS press release, October 6, 2015; CMS press release,
October 6, 2015.

American College of
Physicians Develops
Best Practice Recommendations for the
Evaluation of Suspected Pulmonary
Embolism
A new best practice statement from the
American College of Physicians (ACP)
recommends that, in the diagnosis of
pulmonary embolism (PE), computed
tomography (CT) scans and D-dimer
testing should be limited to patients
who have a high pretest likelihood of
having this condition. The recommendations, recently published in Annals of
Internal Medicine, seeks to avoid inappropriate use of these tests.
PE, the authors of the guideline
noted, can be difficult to diagnose due
to its nonspecific signs and symptoms,
which has also led to an increase in testing of patients with suspected PE. “The
use of CT for the evaluation of patients
with suspected PE is increasing despite
no evidence that this increased use
has led to improved patient outcomes,
while exposing patients to unnecessary
risks and expense,” said Wayne J. Riley,
MD, president of ACP, in a press release
that accompanied the journal article.
“ACP’s advice is designed to help physicians identify patients for whom a PE
is so unlikely that they need no further
testing, for whom plasma D-dimer
testing can provide additional risk
stratification, and for whom imaging is
indicated because of their high risk and
clinical presentation.”
The ACP’s guideline was developed
through a literature review of 1,752 articles published between 1966 and 2014,
including clinical trials and meta-analyses
related to diagnostic strategies, decision
rules, laboratory tests, and imaging studies for the diagnosis of PE. The guideline

November 2015