Daclatasvir (Oral)

Daclatasvir is used along with sofosbuvir and with or without ribavirin to treat chronic hepatitis C infection.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests will be needed to check for unwanted effects.

Using this medicine together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Avoid pregnancy during combination treatment with daclatasvir, sofosbuvir, and ribavirin for 6 months after stopping treatment. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

Do not use this medicine together with certain other medicines, including carbamazepine (Tegretol®), phenytoin (Dilantin®), rifampin (Rifadin®), or St. John's wort. Using these medicines together may cause unwanted effects.

Do not use this medicine together with sofosbuvir and amiodarone. Using these medicines together may increase your risk of bradycardia. Symptoms of bradycardia include chest pain or discomfort, lightheadedness, dizziness or fainting, shortness of breath, slow or irregular heartbeat, or unusual tiredness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. When using non-prescription products, read the label or package ingredients closely.

Pediatric

There have not been enough studies done to determine how age affects the use of daclatasvir in children. Its safety and effectiveness in this age group have not been confirmed.

Geriatric

Studies conducted so far have not found any specific problems in older adults that would limit the effectiveness of daclatasvir.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In cases of potential interaction, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are highlighted for their potential importance but do not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or change some of your other medicines.

• Carbamazepine
• Enzalutamide
• Fosphenytoin
• Mitotane
• Phenytoin
• Rifampin
• St John's Wort

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or the frequency of use for one or both medicines.

• Abametapir
• Amiodarone
• Boceprevir
• Bosentan
• Clarithromycin
• Cobicistat
• Conivaptan
• Dexamethasone
• Digoxin
• Efavirenz
• Etravirine
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Mavacamten
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Omaveloxolone
• Oxcarbazepine
• Phenobarbital
• Posaconazole
• Prednisone
• Primidone
• Rifabutin
• Ritonavir
• Saquinavir
• Simeprevir
• Telaprevir
• Telithromycin
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with certain foods because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are highlighted for their potential significance but do not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some scenarios. If these are used together, your doctor may adjust the dose or how often you take this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Other medical issues may impact the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Heart disease or
• Liver disease—Use with caution. May increase the risk for bradycardia (slow heartbeat) when used with sofosbuvir and amiodarone.

• Hepatitis B, or a history of—Use with caution. May cause this condition to become active again.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Chest pain or discomfort
• Lightheadedness, dizziness, or fainting
• Slow or irregular heartbeat
• Unusual tiredness

Some side effects may happen that usually do not require medical attention. These side effects may go away as your body adjusts to the medicine. Additionally, your health care professional may have ways to help prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

More common

• Headache
• Nausea

Less common

• Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Daklinza

Pharmacologic Class: Hepatitis C Virus NS5A Inhibitor

To help clear up your infection completely, take daclatasvir together with sofosbuvir for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, daclatsvir must be used on a regular schedule.

This medicine should come with patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For chronic hepatitis C, with sofosbuvir: Adults—60 milligrams (mg) once a day for 12 weeks. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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