Brand Names: Daklinza

Generic Name: daclatasvir

What is daclatasvir (Daklinza)?
What are the possible side effects of daclatasvir (Daklinza)?
What is the most important information I should know about daclatasvir (Daklinza)?
What should I discuss with my healthcare provider before taking daclatasvir (Daklinza)?
How should I take daclatasvir (Daklinza)?
What happens if I miss a dose (Daklinza)?
What happens if I overdose (Daklinza)?
What should I avoid while taking daclatasvir (Daklinza)?
What other drugs will affect daclatasvir (Daklinza)?
Where can I get more information (Daklinza)?

What is daclatasvir (Daklinza)?

Daclatasvir is an antiviral medicine that is used in combination with other medications to treat chronic hepatitis C in adults.

Daclatasvir 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.

Daclatasvir 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.

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

Daclatasvir may also be used for purposes not listed in this medication guide.

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What are the possible side effects of daclatasvir (Daklinza)?

Get emergency medical help if you have signs of an allergic reaction: 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 daclatasvir 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 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.

What is the most important information I should know about daclatasvir (Daklinza)?

If you've ever had hepatitis B, it may become active or get worse while using or after you stop using daclatasvir. 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.

Daclatasvir 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.

What should I discuss with my healthcare provider before taking daclatasvir (Daklinza)?

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

When taking daclatasvir 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.

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.

Daclatasvir 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.

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

How should I take daclatasvir (Daklinza)?

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

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 daclatasvir 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 daclatasvir suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store at room temperature away from moisture and heat.

SLIDESHOW

Hepatitis: How Do You Get Hepatitis A, B, and C? See Slideshow

What happens if I miss a dose (Daklinza)?

Call your doctor for instructions if you miss a dose.

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

What happens if I overdose (Daklinza)?

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

What should I avoid while taking daclatasvir (Daklinza)?

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.

What other drugs will affect daclatasvir (Daklinza)?

When you start or stop taking daclatasvir, 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 daclatasvir. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information (Daklinza)?

Your pharmacist can provide more information about daclatasvir.

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

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.