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Daklinza

Generic Name: daclatasvir (dak LAT as vir)
Brand Names: Daklinza

Medically reviewed on February 6, 2018

What is Daklinza?

Daklinza (daclatasvir) 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. Daclatasvir 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.

Important Information

If you have ever had hepatitis B, Daklinza can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Daklinza 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. If you take daclatasvir with sofosbuvir: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

If you take daclatasvir with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

Some medicines can interact with daclatasvir and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

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

Daklinza is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.

  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Daklinza with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of 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 is not known whether daclatasvir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

How should I take Daklinza?

Daklinza must be given in combination with sofosbuvir and it should not be used alone.

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

Daklinza is usually taken with other antiviral medicines once per day for 12 weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

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

If you have ever had hepatitis B, Daklinza can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication 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 this medicine suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store at room temperature away from moisture and heat.

Daklinza dosing information

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

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Use Daklinza regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

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

What should I avoid while taking Daklinza?

Taking daclatasvir will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Daklinza side effects

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 - loss of appetite, upper stomach pain; dark urine, clay-colored stools; jaundice (yellowing of the skin or eyes).

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:

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.

See also: Side effects (in more detail)

What other drugs will affect Daklinza?

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. Give a list of all your medicines to any healthcare provider who treats you.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Daklinza only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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