Important Safety Information

Abnormalities in LFTs have been observed with ERAXIS. Clinically significant hepatic abnormalities have occurred in some patients with serious underlying medical conditions who were receiving multiple medications concomitantly with ERAXIS. Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported, but a causal relationship with ERAXIS has not been established. Patients who develop abnormal LFTs during ERAXIS therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing ERAXIS therapy.

Possible histamine-mediated symptoms have been reported with ERAXIS, including rash, urticaria, flushing, pruritus, dyspnea, and hypotension. These events are infrequent when the rate of infusion does not exceed 1.1 mg/min.

In the treatment of candidemia, the most common treatment-related AEs included diarrhea (3.1%), hypokalemia (3.1%), and elevated ALT (2.3%).

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Eraxis ™ (anidulafungin) for injection

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Important Safety Information

ARTHROTEC is contraindicated in women who are pregnant or who may become pregnant. ARTHROTEC can cause miscarriage, often associated with bleeding, which may result in other serious complications.

Cardiovascular Risk

• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

ARTHROTEC is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins and in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to diclofenac sodium have been reported.

The most common adverse events in ARTHROTEC-treated patients are abdominal pain (21%), diarrhea (19%), dyspepsia (14%), nausea (11%), and flatulence (9%), which can occur more frequently than with diclofenac alone.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Administration of NSAIDs may cause a dose dependent reduction in prostaglandin formation. Elevations in ALT and/or AST, and rare cases of severe hepatic reactions have also been reported. Transaminases should be monitored within 4-8 weeks after initiating treatment with diclofenac and should be measured periodically in patients receiving long-term therapy.

NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.

Dosing regimens for OA and RA
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

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Arthrotec ^® (diclofenac sodium/misoprostol)

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Important Safety Information

Cholinesterase inhibitors have the potential to increase gastric acid secretion. Patients at risk for developing ulcers, including those receiving concurrent NSAIDs, should be monitored closely for gastrointestinal bleeding.

In clinical trials, syncopal episodes have been reported (2% for ARICEPT versus 1% for placebo).

In clinical trials, the most common adverse events seen with ARICEPT were nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, anorexia, and ecchymosis. In studies, these were usually mild and transient.

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ARICEPT^® (donepezil hydrochloride tablets)/ARICEPT ODT^® (donepezil hydrochloride)

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CADUET is a combination of two medications, Norvasc^® (amlodipine besylate) and Lipitor^® (atorvastatin calcium), and is indicated in patients for whom treatment with both Norvasc and Lipitor is appropriate.

Norvasc is indicated for the treatment of hypertension; treatment of chronic stable or vasospastic angina; and to reduce the risk of a coronary revascularization procedure and hospitalization due to angina in patients with recently angiographically documented CAD and without heart failure.

Lipitor is indicated as an adjunct to diet to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and stroke in patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adult patients with clinically evident CHD; as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

Important Safety Information

CADUET is contraindicated in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are nursing; in patients with hypersensitivity to any component of this medication.

Rare cases of rhabdomyolysis have been reported with the atorvastatin component of CADUET and with other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.

The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increased the risk of myopathy/rhabdomyolysis. Lower doses of the atorvastatin component of CADUET should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.

It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of CADUET therapy and any elevation in dose of the atorvastatin component, and periodically thereafter. If ALT or AST values >3 x ULN persist, dose reduction or withdrawal of CADUET is recommended.

Generally CCBs should be used with caution in patients with heart failure. In studies with amlodipine, there has been no evidence of worsened heart failure.

In a controlled clinical trial, the most common adverse events were edema, headache, and dizziness. These were similar to those reported previously with amlodipine and/or atorvastatin.

In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the atorvastatin 80-mg group compared with placebo (2.3% vs. 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin group.

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CADUET^® (amlodipine besylate/atorvastatin calcium)

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