Daclatasvir

Daclastasvir is no longer available in the United States.

You may already be infected with hepatitis B (a virus that infects the liver and may cause severe liver damage) but not have any symptoms of the disease. In this case, taking daclatasvir may increase the risk that your infection will become more serious or life-threatening and you will develop symptoms. Tell your doctor if you have or ever had a hepatitis B virus infection. Your doctor will order a blood test to see if you have or have ever had hepatitis B infection. Your doctor will also monitor you for signs of hepatitis B infection during and for several months after your treatment. If necessary, your doctor may give you medication to treat this infection before and during your treatment with daclatasvir. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, pale stools, stomach pain, or dark urine.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before, during, and after your treatment to check your body's response to daclatasvir.

Talk to your doctor about the risk(s) of taking daclatasvir.

Daclatasvir is used along with another medication (sofosbuvir [Solvadi]) to treat a certain type of chronic hepatitis C (an ongoing viral infection that damages the liver). Daclatasvir is in a class of antiviral medications called hepatitis C virus (HCV) NS5A inhibitors. It works by stopping the virus that causes hepatitis C from spreading inside the body. It is not known if daclatasvir prevents the spread of hepatitis C to other people.

Daclatasvir comes as a tablet to take by mouth. It is usually taken with or without food once a day. Daclatasvir must be taken in combination with sofosbuvir, usually for 12 weeks. Take daclatasvir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take daclatasvir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take daclatasvir even if you feel well. Do not stop taking daclatasvir or sofosbuvir without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before taking daclatasvir,

• tell your doctor and pharmacist if you are allergic to daclatasvir, any other medications, or any of the ingredients in daclatasvir tablets. Ask your pharmacist for a list of the ingredients.
• some medications should not be taken with daclatasvir. Other medications may cause dosing changes or extra monitoring when taken with daclatasvir. Make sure you have discussed any medications you are currently taking or plan to take before starting daclatasvir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking daclatasvir, please get the advice of your doctor or pharmacist.
• the following herbal product may interact with daclatasvir: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking daclatasvir. Do not start this medication while taking daclatasvir without discussing with your healthcare provider.
• tell your doctor if you have had a liver transplant, any type of liver disease other than hepatitis C, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking daclatasvir, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you remember the missed dose on the day that you were supposed to take it, take the missed dose as soon as you remember it on that day. However, if you do not remember the missed dose until the next day, skip the missed dose and continue your regular dosing schedule. Do not take two doses on the same day.

Daclatasvir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea

Some side effects can be serious. If you are also taking amiodarone and you experience any of these symptoms or those in the IMPORTANT WARNING section, call your doctor immediately:

• near fainting or fainting
• dizziness or lightheadedness
• weakness or not feeling well
• shortness of breath
• chest pain
• memory problems
• confusion

Daclatasvir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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