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Incivek (telaprevir) - Incivek@aipharma.com

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What is Incivek?
Incivek (telaprevir) is an antiviral medication that prevents certain virus cells from multiplying in your body. Incivek is used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) to treat hepatitis C in adults.

Incivek is usually given to people who have never been treated for hepatitis C, or after interferon and ribavirin have been tried without successful treatment of symptoms.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.

Incivek may also be used for purposes not listed in this medication guide.

Important information about Incivek
Do not take Incivek as your only medication to treat hepatitis C. Incivek must be used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab). Read the medication guide or patient instructions provided with each medication in your combination therapy.

Do not change your doses or medication schedule without your doctor's advice. Incivek is given together with interferon alfa and ribavirin.

Ribavirin can cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. Use at least 2 effective forms of birth control while either sexual partner is using interferon alfa and ribavirin, and for at least 6 months after treatment ends.

Incivek may cause a severe skin reaction. Call your doctor right away if you have a fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

The following drugs should not be used while you are taking Incivek: alfuzosin (Uroxatral), cisapride (Propulsid), pimozide (Orap), atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin), midazolam (Versed), triazolam (Halcion), sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension, St. John's wort, rifampin (Rifadin, Rifater, Rifamate), ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

There are many other drugs that can interact with Incivek. Tell your doctor about all medications you use.

Before taking Incivek
You should not use Incivek if you are allergic to telaprevir.

To make sure you can safely take Incivek, tell your doctor if you have any of these other conditions:
• hepatitis B or liver problems other than hepatitis C;
• kidney disease (or if you are on dialysis);
• anemia (lack of red blood cells);
• if you have had an organ transplant;
• HIV or AIDS;
• a history of gout; or
• if you have ever used medicine to treat hepatitis in the past and it did not work.


There are many other drugs that can cause serious or life threatening medical problems if you take them together with Incivek. The following drugs should not be used while you are taking Incivek:
• alfuzosin (Uroxatral);

• atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin);

• cisapride (Propulsid);

• pimozide (Orap);

• midazolam (Versed) or triazolam (Halcion);

• sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension;

• St. John's wort;

• rifampin (Rifadin, Rifater, Rifamate); or

• ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).


FDA pregnancy category X. Incivek is given together with interferon alfa and ribavirin. Although Incivek is not expected to harm an unborn baby, ribavirin is known to cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. If you are a woman, you may need to have a negative pregnancy test before using these medications and every month during your treatment.

See also: Incivek pregnancy and breastfeeding warnings (in more detail)
• Use at least 2 non-hormonal forms of birth control while either sexual partner is using Incivek with interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.
• If you are a woman, do not use Incivek with interferon alfa and ribavirin if you are pregnant.
• If you are a man, do not use Incivek with interferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
• Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking Incivek.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Incivek with interferon alfa and ribavirin.
 

It is not known whether telaprevir passes into breast milk or if it could harm a nursing baby. Do not breast-feed a baby while taking Incivek.

To learn more about Incevek, please visit:  www.incivek.com

 

 

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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FDA NEWS RELEASE
For Immediate Release: May 23, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Incivek for hepatitis C

The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.

The current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks. Less than 50 percent of patients respond to this therapy.

The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.

The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.

The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.

When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured.

Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocellular carcinoma), and decreased mortality.

“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection.”

According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C infection, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.

Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.

People can get HCV in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor or toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.

Incivek is a pill taken three times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care. Incivek is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.

The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.

On May 13, FDA approved Victrelis (boceprevir), another new treatment for chronic hepatitis C, marketed by Merck of Whitehouse Station, N.J.

Incivek is marketed by Cambridge, Mass.-based Vertex Pharmaceuticals.

For more information:

FDA: Incivek Approval Letter1

FDA: Incivek Prescribing Information2

FDA: Approved Drugs: Questions and Answers 3

FDA: What’s New at FDA in Hepatitis
4

FDA: Hepatitis C Tests
5

CDC: Hepatitis C Information for the Public
6

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



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