For adults with chronic hepatitis C genotype 1 infection with stable liver problems
www.aa.org
A fellowship of men and women who share their journey to sobriety with one another, Alcoholics Anonymous was formed in 1935 to help individuals recover from alcoholism. Information concerning local meetings and the AA publication, AA Grapevine, can be found on the website. Available in Spanish.
www.aasld.org/patients
AASLD is comprised of scientists and healthcare professionals committed to preventing and curing liver disease. In addition to information for professionals, a section is devoted to patients with helpful information and resources.
www.liverfoundation.org
The American Liver Foundation's mission is to facilitate, advocate, and promote education, support, and research for the prevention, treatment, and cure of liver disease. Their website features a database directory of hepatitis clinical trials, facts sheets, and links to additional resources.
www.cdc.gov/ncidod/diseases/hepatitis
The CDC website provides general information about hepatitis C in English and Spanish.
www.hepc-connection.org
The mission of Hep C Connection is to educate the general public about hepatitis C and to provide resources and support for those affected by the virus.
www.hcvadvocate.org
HCSP's mission is to provide unbiased information, support, and advocacy to all communities affected by HCV and HIV/HCV coinfection, including medical providers.
www.hepeducation.org
The Hepatitis Education Project is committed to providing support, education, and advocacy for people affected by hepatitis and to helping raise hepatitis awareness among patients, medical providers, and the general public.
www.hepfi.org
The HFI website features a support group page, where more than 350 hepatitis support groups can be accessed. Additionally, the Patient Advocacy Support Telecommunications System (PATS) is a service that will provide the name and phone number of hepatitis patients (with written permission) to other hepatitis patients in their area.
www.mayoclinic.com
The Mayo Clinic website provides useful and up-to-date information, giving you access to the experience and knowledge of the more than 3,700 physicians, scientists, and researchers of Mayo Clinic.
digestive.niddk.nih.gov
The NDDIC offers information and publications about specific diseases, including hepatitis C, in varying reading levels.
www.ssa.gov/disability
Patients with chronic hepatitis who are unable to work can apply for Social Security Disability Income (SSDI) or Supplemental Security Income (SSI) benefits. Eligibility is determined by several criteria, including the patient's current working status, severity of disease, ability to continue with previous work, or perform a different type of work. Available in Spanish.
www.hepatitis.va.gov
The Department of Veterans Affairs (VA) is the largest single provider of medical care to people with hepatitis C in the United States. The VA hepatitis C website offers comprehensive information and resources for veterans with hepatitis C as well as the general public.
What is INCIVEK?
INCIVEK® (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.It is not known if INCIVEK is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
Serious Side Effects
INCIVEK combination treatment may cause serious side effects, including:-
Skin rash and serious skin reactions. Skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become serious, require treatment in a hospital, and may lead to death
Call your healthcare provider right away if you develop any skin changes during treatment with INCIVEK. Your healthcare provider will decide if your skin changes or any of the following symptoms may be a sign of a serious skin reaction: skin rash with or without itching, fever, swelling of your face, blisters or skin lesions, mouth sores or ulcers, or red or inflamed eyes, like "pink eye" (conjunctivitis). Your healthcare provider will decide if you need treatment for your skin rash or if you need to stop taking INCIVEK or any of your other medicines. Never stop taking INCIVEK combination treatment without talking with your healthcare provider first. -
Low red blood cell count (anemia) that can be severe. Tell your healthcare provider if you have any of these symptoms of anemia: dizziness, shortness of breath, tiredness, or weakness.
Your healthcare provider will do blood tests regularly to check your red blood cell count during treatment. If your anemia is severe, your healthcare provider may tell you to stop taking INCIVEK. If this happens, do not start taking it again. -
Birth defects or death of an unborn baby. INCIVEK combined with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you or your sexual partner is pregnant or plan to become pregnant, do not take these medicines. You or your partner should not become pregnant while taking INCIVEK with peginterferon alfa and ribavirin and for 6 months after treatment is over.
If you are a female who can become pregnant, or if you are a female whose male partner takes these medicines:- You must have a negative pregnancy test before starting treatment, every month during treatment, and for 6 months after your treatment ends.
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You must use 2 effective methods of birth control during treatment and for 6 months after all treatment has ended. These 2 forms of birth control should not contain hormones, as these may not work during treatment with INCIVEK. Talk to your healthcare provider about the forms of birth control you should use during this time.
Two weeks after stopping INCIVEK, you can use a hormonal form of birth control as one of your two forms of birth control. - If you or your partner becomes pregnant during treatment or within 6 months after stopping these medicines, tell your healthcare provider right away. Contact the Ribavirin Pregnancy Registry right away by calling 1-800-593-2214. The Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while pregnant.
Who should not take INCIVEK?
- Do not take INCIVEK if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
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Do not take INCIVEK if you are taking certain medicines as there could be serious side effects. If these drugs are taken together, this can cause you to have too much or not enough INCIVEK or your other medicines in your body. It can also cause side effects that can be serious or life-threatening.
- These medicines include: alfuzosin hydrochloride (Uroxatral®), cisapride (Propulsid®), ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, Migranal®), ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes), methylergonovine maleate (Ergotrate®, Methergine®), lovastatin (Advicor®, Altoprev®, Mevacor®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®), sildenafil citrate (Revatio®) or tadalafil (Adcirca®) for the lung problem pulmonary artery hypertension (PAH), simvastatin (Zocor®, Vytorin®, Simcor®), St. John's wort (Hypericum perforatum) or products containing St. John’s wort, or triazolam (Halcion®)
- Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. INCIVEK and other medicines can affect each other. Your healthcare provider may need to change the amount of medicines you take.
What should I tell my healthcare provider before taking INCIVEK?
Tell your healthcare provider if you:- have certain blood problems such as low red blood cell count (anemia)
- have liver problems other than hepatitis C infection
- have hepatitis B, HIV infection, or any problems with your immune system
- have a history of gout or high uric acid levels in your blood
- have had an organ transplant
- plan to have surgery
- have any other medical condition
- are breastfeeding
How should I take INCIVEK?
Do not take INCIVEK alone to treat chronic hepatitis C infection. It must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
Take INCIVEK exactly as your healthcare provider tells you. Take 2 INCIVEK pills 3 times a day, 7 to 9 hours apart, with food. Eat a meal or snack containing about 20 grams of fat within 30 minutes before you take each dose. Talk to your healthcare provider about examples of foods you can eat.
If you miss a dose within 4 hours of when you usually take it, take your dose with food as soon as possible. If you miss a dose and it is more than 4 hours after the time you usually take it, skip that dose only and take the next dose at your normal time. Do not stop taking INCIVEK unless your healthcare provider tells you to. If your healthcare provider tells you to stop, you should not start taking it again, even if the reason for stopping goes away. If you take too much INCIVEK, call your healthcare provider or local Poison Control Center, or go to the nearest emergency room right away.Common Side Effects of INCIVEK Combination Treatment
The most common side effects include itching, nausea, diarrhea, vomiting, anal or rectal problems (including hemorrhoids, discomfort or burning around or near the anus, itching around or near the anus), taste changes, and tiredness. Tell your healthcare provider about any side effect that bothers you or doesn't go away.
These are not all the possible side effects of INCIVEK. For more information, ask your healthcare provider or pharmacist.Please see the full Prescribing Information for INCIVEK, including Boxed Warning, and read the Medication Guide.
Please see the full Prescribing Information and read the Medication Guides for peginterferon alfa and ribavirin.
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