LIPITOR Important Safety Information and Indications

Please scroll to see the Indications below.

Important Safety Information

LIPITOR 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 LIPITOR and 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 LIPITOR with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Lower doses of LIPITOR 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 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. If ALT or AST values >3 x ULN persist, dose reduction or withdrawal is recommended.

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 LIPITOR 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 LIPITOR group.

The most commonly reported adverse reactions with LIPITOR in placebo-controlled trials were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

Indications

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.

LIPITOR, as an adjunct to diet, is also indicated 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.

*LIPITOR $4 Co-Pay Card Terms & Conditions

By using the LIPITOR $4 Co-Pay Card (the "Card"), you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

This Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma de Salud"]). The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs. To qualify for this offer, your out-of-pocket expense must be greater than $4 per prescription. If your out-of-pocket expenses for a 1-month supply (30 tablets) are $54 or less, you will pay $4 for a 1-month supply. If your out-of-pocket expenses for a 1-month supply (30 tablets) exceed $54, you qualify for up to $50 in savings for a 1-month supply. In either case, you can only qualify for up to $600 of savings per calendar year. After a maximum of $600, you will pay usual monthly out-of-pocket costs. You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf. The Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law. This Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. The Card will be accepted only at participating pharmacies. This Card is not health insurance. Offer good only in the US and Puerto Rico. The Card is limited to 1 per person during this offering period and is not transferable. Offer limited to 1 use per month. Pfizer reserves the right to rescind, revoke or amend the program without notice at any time. Card and Program expire 12/31/2012. No membership fees.

For reimbursement when using a non-participating pharmacy/mail order: Pay for LIPITOR prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: LIPITOR Co-Pay Card, 6501 Weston Parkway, Suite 370, Cary, NC 27513. Be sure to include a copy of the front of your Co-Pay Card, your name, and mailing address.

For healthcare professional customer service, call 1-800-505-4426 Monday through Friday, 8:30 AM to 5:30 PM EST or visit www.LipitorHCP.com. Pfizer Inc., 235 East 42nd Street, New York, NY 10017.

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