Incivek

Incivek is a prescription medication used to treat chronic hepatitis C. Incivek is used in combination with other medications.

Incivek belongs to a group of drugs called protease inhibitors, which stop the hepatitis C virus from reproducing.

This medication comes in tablet form and is taken three times a day, with food.

Common side effects include nausea, vomiting, diarrhea and itching.

Incivek is a prescription medication used to treat chronic hepatitis C genotype 1 infection in adults with stable liver problems. It is used in combination with other hepatitis C medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Vertex Pharmaceuticals Incorporated

Incivek may cause serious side effects including:

• See "Drug Precautions"

Common side effects of Incivek in combination with peginterferon alfa and ribavirin 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
• tiredness

Tell your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects of Incivek. For more information, ask your healthcare provider or pharmacist.

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. This can cause you to have too much or not enough Incivek or your other medicines in your body, and cause side effects that can be serious or life-threatening. Your healthcare provider may need to change the amount of medicine you take.

Do not take Incivek if you take a medicine that contains:

• alfuzosin hydrochloride (Uroxatral)
• ergot, 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 
• 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
• triazolam (Halcion)

Tell your healthcare provider if you are taking or starting to take medicines that contain:

• atorvastatin (Lipitor)
• budesonide (Pulmicort, Rhinocort, Symbicort)
• colchicine (Colcrys)
• darunavir (Prezista) and ritonavir (Norvir)
• fluticasone (Advair, Flonase, Flovent, Veramyst)
• fosamprenavir (Lexiva) and ritonavir (Norvir)
• lopinavir and ritonavir (Kaletra)
• methylprednisolone (Medrol)
• prednisone
• rifabutin (Mycobutin)
• salmeterol (Advair, Serevent)

Your healthcare provider may need to monitor your therapy more closely if you take Incivek with the following medicines. Talk to your healthcare provider if you are taking or starting to take medicines that contain:

• alprazolam (Xanax)
• amiodarone (Cordarone, Pacerone)
• amlodipine (Norvasc)
• atazanavir and ritonavir (Reyataz, Norvir)
• bepridil hydrochloride (Vascor, Bepadin)
• bosentan (Tracleer)
• carbamazepine (Carbatrol, Equetro, Tegretol)
• clarithromycin (Biaxin, Prevpac)
• colchicine (Colcrys)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• desipramine (Norpramin)
• dexamethasone
• digoxin (Lanoxin)
• diltiazem (Cardizem, Dilacor XR, Tiazac)
• efavirenz (Sustiva, Atripla)
• erythromycin (E.E.S., Eryc, Ery-Tab, Erythrocin, Erythrocin Stearate)
• escitalopram (Lexapro)
• ethinyl estradiol containing birth control methods (Lo Loestrin FE, Norinyl, Ortho Tri-Cyclen Lo)
• felodipine (Plendil)
• flecainide (Tambocor)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• methadone (Dolophine, Methadose)
• nicardipine (Cardene)
• nifedipine (Adalat, Procardia)
• nisoldipine (Sular)
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• posaconazole (Noxafil)
• propafenone (Rythmol)
• quinidine (Nuedexta)
• sildenafil for the treatment of erectile dysfunction (Viagra)
• sirolimus (Rapamune)
• tacrolimus (Prograf)
• tadalafil for the treatment of erectile dysfunction (Cialis)
• telithromycin (Ketek)
• tenofovir disoproxil fumarate (Atripla, Complera, Truvada, Viread)
• trazodone (Desyrel, Trialodine, Oleptro)
• vardenafil for the treatment of erectile dysfunction (Levitra, Staxyn)
• verapamil (Calan, Covera-HS, Isoptin, Tarka)
• voriconazole (Vfend)
• warfarin (Coumadin)
• zolpidem (Ambien)

Know the medicines you take. Keep a list of them with you and show it to your healthcare provider and pharmacist each time you get a new medicine.

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
  • blisters or skin lesions
  • fever
  • swelling of your face
  • mouth sores or ulcers
  • red or inflammed eyes, like "pink eye" or 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.
• See "Side Effects" for more information about side effects.

Low red blood cell count (anemia), which can be severe. Tell your healthcare provider if you have any of these symptoms of anemia:

• dizziness
• tiredness
• shortness of breath
• 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 Incivek is stopped for this reason, do not start taking it again.

Birth defects or death of your unborn baby. Incivek in combination with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual 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 you are a female whose male partner takes these medicines:

• You must have a negative pregnancy test before starting treatment, each month during treatment, and for 6 months after your treatment ends.
• You must use 2 forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control including birth control pills, vaginal rings, implants, or injections may not work during treatment with Incivek. You could become pregnant. Talk to your healthcare provider about other forms of birth control that may be used during this time. If your healthcare provider tells you to stop taking Incivek, peginterferon alfa and ribavirin, you must still use 2 forms of birth control for the 6 months after treatment with these medicines. You may use a hormonal form of birth control as one of your 2 forms of birth control after 2 weeks of stopping Incivek.
• If you or your female sexual partner becomes pregnant while taking Incivek , peginterferon alfa, and ribavirin or within 6 months after you stop taking these medicines, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.

Do not take Incivek alone to treat chronic hepatitis C infection. Incivek must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Incivek there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take 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 infection
• have Human Immunodeficiency Virus (HIV) infection or any other problems with your immune system
• 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. It is not known if this medication passes into your breast milk. You and your healthcare provider should decide if you will take telaprevir or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Incivek in combination with peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Incivek falls into category X. It has been shown that women taking Incivek during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

See "Drug Precautions" section.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Incivek passes into your breast milk. You and your healthcare provider should decide if you will take Incivek or breastfeed. You should not do both.

• Take Incivek exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Incivek to take and when to take it.
• Take Incivek 3 times a day. Each dose should be taken 7 to 9 hours apart. Eat a meal or snack that contains about 20 grams of fat, within 30 minutes before you take each dose of Incivek . Talk to your healthcare provider about examples of foods that you can eat that contain about 20 grams of fat. Always take Incivek with food.
• 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 dosing schedule.
• Do not stop taking Incivek unless your healthcare provider tells you to. If you think there is a reason to stop taking Incivek, talk to your healthcare provider before doing so.Incivek 
• If your healthcare provider tells you to stop taking Incivek, you should not start taking it again even if the reason for stopping goes away.
• If you take too much Incivek or overdose, call your healthcare provider or local Poison Control Center, or go to the nearest hospital emergency room right away.

Take Incivek exactly as prescribed. Follow the directions on your prescription label carefully.

Incivek/Peginterferon Alfa/Ribavirin Combination Treatment

The recommended dose of Incivek tablets is 750 mg (two 375-mg tablets) taken orally 3 times a day (7-9 hours apart) with food (not low fat).

Duration of Treatment

If you take too much Incivek or overdose, call your healthcare provider or local Poison Control Center, or go to the nearest hospital emergency room right away.

• Store Incivek tablets at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep Incivek and all medicines out of the reach of children.

WARNING:

SERIOUS SKIN REACTIONS

Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with Incivek combination treatment. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment after a serious skin reaction was identified. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, Incivek, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.