Daklinza is an antiviral medicine that prevents hepatitis C virus (HCV) from multiplying in your body.

Daklinza is used in combination with other medications to treat chronic hepatitis C in adults.

Daklinza treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Daklinza must be given in combination with other antiviral medications and should not be used alone. It is usually given with sofosbuvir, with or without ribavirin.

Daklinza is sometimes used in people who also have HIV. Daclatasvir is not a treatment for HIV or AIDS.

If you've ever had hepatitis B, it may become active or get worse while using or after you stop using Daklinza. You may need frequent liver function tests for several months.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Daklinza is sometimes used in combination with other medication. 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.

Before taking this medicine

You should not use Daklinza if you are allergic to daclatasvir.

When taking Daklinza with other medicine: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with daclatasvir. Your doctor may change your treatment plan if you also use:

• rifampin;

• St. John's wort; or

• seizure medicine - carbamazepine, phenytoin.

To make sure Daklinza is safe for you, tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis C;

• a liver transplant;

• diabetes;

• heart disease;

• if you have recently used a heart rhythm medicine called amiodarone; or

• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Daklinza is sometimes used in combination with ribavirin. Both men and women using ribavirin should use effective birth control to prevent pregnancy. Ribavirin can cause birth defects, miscarriage, or death to an unborn baby if the mother or father is using this medicine.

You should not take ribavirin if you are pregnant, or if you are a man and your sex partner is pregnant. Use effective birth control to prevent pregnancy. Keep using birth control for at least 6 months after your last dose of ribavirin.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Daklinza is not approved for use by anyone younger than 18 years old.

Take Daklinza exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Daklinza.

You may take Daklinza with or without food.

You will need frequent blood tests to check your liver function.

If you've ever had hepatitis B, this virus may become active or get worse while you are using this medicine or in the months after you stop. You may need liver function tests for several months after your last dose.

Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Daklinza suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Chronic Hepatitis C:

60 mg orally once a day

Recommended Regimen and Duration of Therapy:
Genotype 1:
-Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
-Compensated (Child-Pugh A) cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
-Decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks
-Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

Genotype 3:
-Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
-Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks
-Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

Comments:
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Optimal duration of therapy has not been established for HCV genotype 3-infected patients with cirrhosis or for HCV genotype 1-infected patients with Child-Pugh C cirrhosis.
-The manufacturer product information for sofosbuvir should be consulted regarding dosing. The manufacturer product information should be consulted regarding ribavirin dosing and dose adjustments (if applicable).

Use: With sofosbuvir (with or without ribavirin), for the treatment chronic HCV genotype 1 or 3 infection

You should not use Daklinza if you are allergic to daclatasvir.

When taking Daklinza with other medicine: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with daclatasvir. Your doctor may change your treatment plan if you also use:

• rifampin;

• St. John's wort; or

• seizure medicine - carbamazepine, phenytoin.

To make sure Daklinza is safe for you, tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis C;

• a liver transplant;

• diabetes;

• heart disease;

• if you have recently used a heart rhythm medicine called amiodarone; or

• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Daklinza is sometimes used in combination with ribavirin. Both men and women using ribavirin should use effective birth control to prevent pregnancy. Ribavirin can cause birth defects, miscarriage, or death to an unborn baby if the mother or father is using this medicine.

You should not take ribavirin if you are pregnant, or if you are a man and your sex partner is pregnant. Use effective birth control to prevent pregnancy. Keep using birth control for at least 6 months after your last dose of ribavirin.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Daklinza is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss a dose.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent hepatitis C transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Daklinza: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• new or worsening liver symptoms - right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well.

If you take Daklinza with sofosbuvir and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

• very slow heartbeats, chest pain, shortness of breath;

• confusion, memory problems; or

• weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common Daklinza side effects may include:

• anemia;

• headache;

• nausea; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

When you start or stop taking Daklinza, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with daclatasvir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine. Give a list of all your medicines to any healthcare provider who treats you.