Daclatasvir (dak-LAT-as-vir)

Treats hepatitis C infection. Used with sofosbuvir and ribavirin.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with carbamazepine, phenytoin, rifampin, or St John's wort.
• Amiodarone can cause bradycardia (slow heartbeat) if used together with sofosbuvir and another antiviral drug, or if you have used it recently.
• Some medicines can affect how daclatasvir works. Tell your doctor if you are using any of the following:
  • Atazanavir/ritonavir, bosentan, ciprofloxacin, clarithromycin, darunavir/ritonavir, dabigatran, dexamethasone, digoxin, diltiazem, efavirenz, erythromycin, etravirine, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, modafinil, nafcillin, nefazodone, nelfinavir, posaconazole, rifapentine, saquinavir, telithromycin, verapamil, voriconazole
  • Beta-blocker medicine
  • Cancer medicine
  • Medicine to lower cholesterol
  • Steroid medicine

Warnings While Using This Medicine:

• Ribavirin may cause birth defects if either partner is using it during conception or pregnancy. Avoid pregnancy during combination treatment with daclatasvir, sofosbuvir, and ribavirin for 6 months of stopping treatment. Tell your doctor right away if you or your partner becomes pregnant. Follow all directions about birth control.
• Tell your doctor if you are breastfeeding, or if you have other liver problems (including hepatitis B) or heart disease. Tell your doctor if you had a liver transplant.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or discomfort
• Lightheadedness, dizziness, or fainting
• Slow or uneven heartbeat

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088