Merck Announces Expanded Co-Pay Assistance Program for ISENTRESS® (raltegravir)
Enhanced Program Provides Assistance to People Living with HIV-1 Who are Privately Insured and Have Out-of-Pocket Co-Pays
WHITEHOUSE STATION, N.J., –- Merck today announced an enhanced co-pay assistance program for people living with HIV-1 who are taking the Company’s first-in-class HIV-1 integrase inhibitor, ISENTRESS® (raltegravir) Tablets. The program provides important savings for privately-insured patients with out-of-pocket costs for ISENTRESS, and is part of Merck’s ongoing commitment to providing access to treatment.
People who have been prescribed ISENTRESS who meet certain requirements are eligible to participate in the program, in which they can receive a Savings Coupon for up to $400 toward out-of-pocket costs on each of up to 12 eligible prescriptions of ISENTRESS, regardless of the number of tablets supplied on the prescription. The program applies to eligible patients who have private health insurance with a co-payment for the prescription. Savings are limited to co-pay amount and eligibility restrictions, terms and conditions apply.
“This effort, along with Merck’s ongoing collaboration with AIDS Drug Assistance Programs (ADAPs), further reinforces the Company’s long-standing commitment to providing access to our medicines,” said Patrick Bergstedt, senior vice president and general manager, Merck Infectious Diseases Franchise. “Given today’s economic climate, programs that help alleviate the high co-pay costs that many HIV-1 patients face are increasingly important"
The program is not available to patients who are covered under Medicaid, Medicare, a Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered), TRICARE, CHAMPUS, Government Health Insurance Plan (“Healthcare Reform”), or any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program, or to residents of Massachusetts. Participants must be residents of the United States or the Commonwealth of Puerto Rico to be eligible for the program.
Eligible patients can enroll in the Savings Coupon program and receive additional information about co-pay assistance by calling 1-877-264-2440 or at www.ISENTRESS.com. The Savings Coupon for ISENTRESS expires Sept. 30, 2012.
Important information about ISENTRESS
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The label for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 96 weeks in three double-blind controlled clinical studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class antiretroviral (ARV) [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adults and one was conducted in treatment-naïve adults.
The safety and efficacy of ISENTRESS have not been established in pediatric patients.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
The SUPPORT™ Program is designed to help patients who have been prescribed ISENTRESS or CRIXIVAN® (indinavir sulfate). The SUPPORT Program is a two-part program that consists of free reimbursement support services and a patient assistance program for eligible individuals through a single toll-free call to 1-800-850-3430. For Information about this program and others, please visit www.merckhelps.com.
ISENTRESS is the first medicine to be approved in a class of antiretroviral drugs called integrase inhibitors. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. Other HIV-1 drugs in use inhibit two other enzymes critical to the HIV-1 replication process – protease and reverse transcriptase – but ISENTRESS is the only approved drug that inhibits the integrase enzyme. ISENTRESS is now approved in more than 90 countries worldwide. Merck is continuing to move forward with filings in additional countries around the world for use of ISENTRESS in both treatment-experienced and treatment-naïve patients.
Important safety information about ISENTRESS
ISENTRESS does not cure HIV or AIDS and does not prevent passing HIV to others. Healthcare providers should know that immune reconstitution syndrome has been reported in patients treated with ARV therapy, which may necessitate further evaluation and treatment. Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported. ISENTRESS should be used with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medication known to cause these conditions.
The most commonly reported drug-related adverse event (AE) of moderate to severe intensity that occurred in greater than or equal to two percent of patients and at a higher incidence than efavarienz in treatment-naïve patients receiving ISENTRESS was (insomnia, four percent versus three percent; respectively).
The most commonly reported (greater than or equal to two percent in either treatment group) drug-related clinical AE of moderate or severe intensity in treatment-experienced patients receiving ISENTRESS and at a higher rate compared to placebo was headache (2.0 percent vs. less than 1.0 percent) for ISENTRESS plus OBT and placebo plus OBT, respectively.
In treatment-experienced patients, rash occurred more often in patients taking ISENTRESS and darunavir together than with either drug separately. Rashes were mild to moderate in severity and did not limit therapy. There were no discontinuations due to rash.
Dosing and administration
ISENTRESS is a single 400 mg tablet taken twice daily without regard to food. The dose of ISENTRESS should be increased during coadmistration with rifampin to 800 mg twice daily.
Coadmistration with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may reduce plasma concentrations of ISENTRESS. Rifampin, a strong inducer of (UGT) 1A1 reduces plasma concentrations of ISENTRESS. Based on the results of drug interaction studies and the clinical trials data, no dose adjustment of ISENTRESS is required when coadministered with other ARV agents. Also, preclinical studies show that ISENTRESS is not metabolized by cytochrome P450 enzymes.
Important information about CRIXIVAN
CRIXIVAN, a protease (PRO-tee-ase) inhibitor, in combination with other antiretroviral agents is indicated for the treatment of HIV infection. This indication is based on two clinical trials of approximately one year’s duration that demonstrated: 1) a reduction in the risk of AIDS-defining illnesses or death; 2) a prolonged suppression of HIV RNA.
CRIXIVAN is not a cure for HIV infection nor does it reduce the transmission of HIV. CRIXIVAN should only be taken in combination with other drugs for HIV.
Important safety information about CRIXIVAN
Concomitant use of CRIXIVAN with the cholesterol-lowering medicines lovastatin, simvastatin, or rosuvastatin is not recommended. Caution should be exercised if HIV protease inhibitors, including CRIXIVAN, are used concurrently with atorvastatin. The interaction of CRIXIVAN with pravastatin and fluvastatin is not known. The risk of myopathy including rhabdomyolysis may be increased when HIV protease inhibitors, including CRIXIVAN, are used in combination with these statin drugs.
In patients treated with CRIXIVAN, acute hemolytic anemia, including death in some patients, and hepatitis, including hepatic failure and death, have been reported. There have also been reports of hyperglycemia and new onset or exacerbation of preexisting diabetes mellitus in patients receiving protease inhibitors.
Nephrolithiasis/urolithiasis has occurred in clinical studies in adult patients (12.4 percent; range across individual trials, 4.7 percent to 34.4 percent) and in pediatric patients (29 percent) receiving CRIXIVAN. The cumulative frequency of nephrolithiasis events increases with increasing exposure to CRIXIVAN; however, the risk over time remains relatively constant. In some cases, nephrolithiasis/urolithiasis has been associated with renal insufficiency or acute renal failure and pyelonephritis with or without bacteremia. If signs or symptoms of nephrolithiasis/urolithiasis occur (including flank pain with or without hematuria or microscopic hematuria), temporary interruption (e.g., 1 to 3 days) or discontinuation of therapy may be considered. Adequate hydration (at least 48 ounces daily for adults) is recommended in all patients treated with CRIXIVAN.
Taking CRIXIVAN with any products containing St. John’s wort, an herbal supplement, is not recommended because it has been shown to substantially decrease concentrations of CRIXIVAN and may lead to loss of virologic response and possible resistance to CRIXIVAN or to the class of protease inhibitors.
Dosage, administration and drug interaction for CRIXIVAN
The recommended dosage of CRIXIVAN is 800 mg (usually two 400 mg capsules) orally every 8 hours. CRIXIVAN must be taken at 8 hour intervals and should be administered without food but with water one hour before or two hours after a meal. CRIXIVAN should not be coadministered with orally administered midazolam. Caution should be used with coadministration of CRIXIVAN and parenteral midazolam.
CRIXIVAN is an inhibitor of cytochrome P450 enzymes, CYP3A4. Coadministration of CRIXIVAN and drugs primarily metabolized by CYP3A4 may result in increased plasma concentrations of the other drug. Coadministration of CRIXIVAN and other drugs that inhibit CYP3A4 may result in increased plasma concentrations of CRIXIVAN.
Side effects occurring in 2 percent or more of patients taking CRIXIVAN included: fever, nausea, nephrolithiasis/urolithiasis, headache, asthenia/fatigue, and anemia.
Today’s Merck is a global healthcare leader. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
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Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2009 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
ISENTRESS® is a registered trademark of Merck & Co., Inc.
Before prescribing ISENTRESS (raltegravir) tablets or CRIXIVAN (indinavir sulfate) capsules, please read the attached full prescribing information and patient prescribing information for ISENTRESS and CRIXIVAN.
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