WHITEHOUSE STATION, N.J., Oct. 7 /PRNewswire/ -- Merck & Co., Inc. today announced that researchers will conduct a clinical trial to evaluate the use of raltegravir tablets at a once-daily investigational dose in an investigational population, previously untreated (treatment-naive) HIV patients. The once-a-day dose will be compared to a twice-daily regimen, and both will be studied in combination with Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), in treatment-naive HIV patients. The trial, called QDMRK, is a double-blind, randomized, active comparator-controlled clinical trial that aims to enroll 750 patients at 94 centers in 21 countries.
The study will measure the proportion of patients achieving HIV RNA <50 copies/mL at weeks 48 and 96 to determine the antiretroviral activity of raltegravir once daily (raltegravir given 800 mg QD) compared to twice daily (raltegravir 400 mg BID). The study will also evaluate the proportion of patients achieving HIV RNA <400 copies/mL and the change from baseline in
CD4 cell counts.
Patients interested in taking part in the QDMRK clinical trial are encouraged to speak with their physician. For more information, please visit http://www.benchmrk.com/ and click on QDMRK.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. For more information, visit http://www.merck.com/.
Forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
Full prescribing information and patient product information for raltegravir is attached.
Patient Information
ISENTRESS(TM) (eye sen tris)
(raltegravir)
Tablets
Read the patient information that comes with ISENTRESS(1) before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is ISENTRESS?
-- ISENTRESS is an anti-HIV (antiretroviral) medicine that helps to
control HIV infection. The term HIV stands for Human Immunodeficiency
Virus. It is the virus that causes AIDS (Acquired Immune Deficiency
Syndrome). ISENTRESS is used along with other anti-HIV medicines in
patients who are already taking or have taken anti-HIV medicines and
the medicines are not controlling their HIV infection. ISENTRESS will
NOT cure HIV infection.
-- People taking ISENTRESS may still develop infections, including
opportunistic infections or other conditions that happen with HIV
infection.
-- Stay under the care of your doctor during treatment with ISENTRESS.
-- The long-term effects of ISENTRESS are not known at this time.
-- The safety and effectiveness of ISENTRESS in children less than 16
years of age has not been studied.
ISENTRESS must be used with other anti-HIV medicines.
How does ISENTRESS work?
-- ISENTRESS blocks an enzyme which the virus (HIV) needs in order to
make more virus. The enzyme that ISENTRESS blocks is called HIV
integrase.
-- When used with other anti-HIV medicines, ISENTRESS may do two things:
-- It may reduce the amount of HIV in your blood. This is called your
"viral load".
-- It may also increase the number of white blood cells called CD4 (T)
cells that help fight off other infections.
-- ISENTRESS may not have these effects in all patients.
Does ISENTRESS lower the chance of passing HIV to other people?
No. ISENTRESS does not reduce the chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood.
-- Continue to practice safer sex.
-- Use latex or polyurethane condoms or other barrier methods to lower
the chance of sexual contact with any body fluids. This includes semen
from a man, vaginal secretions from a woman, or blood.
-- Never re-use or share needles.
-- Ask your doctor if you have any questions about safer sex or how to
prevent passing HIV to other people.
1. What should I tell my doctor before and
during treatment with ISENTRESS?
Tell your doctor about all of your medical conditions. Include any of the following that applies to you:
-- You have any allergies.
-- You are pregnant or plan to become pregnant.
-- ISENTRESS is not recommended for use during pregnancy. ISENTRESS has
not been studied in pregnant women. If you take ISENTRESS while you
are pregnant, talk to your doctor about how you can be included in the
Antiretroviral Pregnancy Registry.
-- You are breast-feeding or plan to breast-feed.
-- It is recommended that HIV-infected women should not breast-feed their
infants. This is because their babies could be infected with HIV
through their breast milk.
-- Talk with your doctor about the best way to feed your baby.
Tell your doctor about all the medicines you take. Include the following:
-- prescription medicines
-- non-prescription medicines
-- vitamins
-- herbal supplements
Know the medicines you take.
-- Keep a list of your medicines. Show the list to your doctor and
pharmacist when you get a new medicine.
How should I take ISENTRESS?
Take ISENTRESS exactly as your doctor has prescribed. The recommended dose is as follows:
-- Take only one 400 mg tablet at a time.
-- Take it twice a day.
-- Take it by mouth.
-- Take it with or without food.
Do not change your dose or stop taking ISENTRESS or your other anti-HIV medicines without first talking with your doctor.
IMPORTANT: Take ISENTRESS exactly as your doctor prescribed and at the right times of day because if you don't:
-- The amount of virus (HIV) in your blood may increase if the medicine
is stopped for even a short period of time.
-- The virus may develop resistance to ISENTRESS and become harder to
treat.
-- Your medicines may stop working to fight HIV.
-- The activity of ISENTRESS may be reduced (due to resistance).
If you fail to take ISENTRESS the way you should, here's what to do:
-- If you miss a dose, take it as soon as you remember. If you do not
remember until it is time for your next dose, skip the missed dose and
go back to your regular schedule. Do NOT take two tablets of ISENTRESS
at the same time. In other words, do NOT take a double dose.
-- If you take too much ISENTRESS, call your doctor or local Poison
Control Center.
Be sure to keep a supply of your anti-HIV medicines.
-- When your ISENTRESS supply starts to run low, get more from your
doctor or pharmacy.
-- Do not wait until your medicine runs out to get more.
1. What are the possible side effects of ISENTRESS?
When ISENTRESS has been given with other anti-HIV drugs, the most common side effects included:
-- diarrhea
-- nausea
-- headache
Other side effects include rash and severe skin reactions.
A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when combination antiretroviral treatment is started. Signs and symptoms of inflammation from opportunistic infections that a person has or had may occur as the medicines work to control the HIV infection and strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS with other anti-HIV medicines.
Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the side effects of ISENTRESS. For more information, ask your doctor or pharmacist.
How should I store ISENTRESS?
-- Store ISENTRESS at room temperature (68 to 77°F).
-- Keep ISENTRESS and all medicines out of the reach of children.
General information about the use of ISENTRESS
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
-- Do not use ISENTRESS for a condition for which it was not prescribed.
-- Do not give ISENTRESS to other people, even if they have the same
symptoms you have. It may harm them.
This leaflet gives you the most important information about ISENTRESS.
-- If you would like to know more, talk with your doctor.
-- You can ask your doctor or pharmacist for additional information about
ISENTRESS that is written for health professionals.
-- For more information go to http://www.isentress.com/ or call 1-800-622-4477.
What are the ingredients in ISENTRESS?
Active ingredient: Each film-coated tablet contains 400 mg of raltegravir.
Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.
Manufactured and Distributed by:
MERCK & CO., Inc.
Whitehouse Station, NJ 08889, USA
Revised May 2008
9795101
U.S. Patent Nos. US 7,169,780
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS.
ISENTRESS (raltegravir) Tablets
Initial U.S. Approval: 2007
INDICATIONS AND USAGE
ISENTRESS(TM) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated:
-- In combination with other antiretroviral agents for the treatment of
HIV-1 infection in treatment-experienced adult patients who have
evidence of viral replication and HIV-1 strains resistant to multiple
antiretroviral agents (1).
The safety and efficacy of ISENTRESS have not been established in treatment-naive adult patients or pediatric patients (1).
DOSAGE AND ADMINISTRATION
-- 400 mg administered orally, twice daily with or without food (2.1).
DOSAGE FORMS AND STRENGTHS
Tablets: 400 mg (3).
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Monitor for Immune Reconstitution Syndrome (5.1)
Drug Interactions
-- Caution should be used when coadministering ISENTRESS with strong
inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1
(e.g., rifampin) due to reduced plasma concentrations of raltegravir
(5.2).
ADVERSE REACTIONS
-- The most common adverse reactions (>10%) of all intensities, reported
in subjects in either the ISENTRESS or the placebo treatment group,
regardless of causality were: nausea, headache, diarrhea and pyrexia
(6.1).
-- Creatine kinase elevations were observed in subjects who received
ISENTRESS. Myopathy and rhabdomyolysis have been reported; however,
the relationship of ISENTRESS to these events is not known. Use with
caution in patients at increased risk of myopathy or rhabdomyolysis,
such as patients receiving concomitant medications known to cause
these conditions (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy:
-- ISENTRESS should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus. Physicians are
encouraged to register pregnant women exposed to ISENTRESS by calling
1-800-258-4263 so that Merck can monitor maternal and fetal outcomes
(8.1).
Nursing Mothers:
-- Breast-feeding is not recommended while taking ISENTRESS
(8.3).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 05/2008
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Immune Reconstitution Syndrome
5.2 Drug Interactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Effect of Raltegravir on the Pharmacokinetics of Other Agents
7.2 Effect of Other Agents on the Pharmacokinetics of Raltegravir
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Use in Patients with Hepatic Impairment
8.7 Use in Patients with Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are not listed.
full prescribing information
1 INDICATIONS AND USAGE
ISENTRESS(2) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
This indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of ISENTRESS. These studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (1