Daclatasvir

IMPORTANT WARNING:

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.

IMPORTANT NOTICE:

Daclastasvir is no longer available in the United States.

WHY is this medicine prescribed?

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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

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.

What SPECIAL PRECAUTIONS should I follow?

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.

• tell your doctor if you are taking carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, Rifater), or St. John's wort. Your doctor will probably tell you not to take daclatasvir if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); certain antibiotics such as clarithromycin (Biaxin, in Prevpac), nafcillin, rifapentine (Priftin), and telithromycin (Ketek); certain antifungals such as itraconazole (Onmel, Sporanox), ketoconazole, posaconazole (Noxafil), and voriconazole (Vfend); bosentan (Tracleer); buprenorphine and naloxone (Suboxone, Zubsolv); certain cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), fluvastatin (Lescol), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Flolipid, Zocor, in Vytorin); medication containing cobicistat (Stribild); dabigatran (Pradaxa); dexamethasone; digoxin (Lanoxin); efavirenz (Sustiva, in Atripla), etravirine (Intelence); certain HIV protease inhibitors such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, Technivie, Viekira Pak), and saquinavir (Invirase); modafinil (Provigil); nefazodone; nevirapine (Viramune); and warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with daclatasvir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.