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DAKLINZA- daclatasvir tablet


  1. Patient Information
  2. Important:
  3. What Is Daklinza?
  4. Hepatitis B Virus Reactivation:
  5. Daklinza Can Cause Serious Side Effects, Including:
  6. What Are The Ingredients In Daklinza?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV

Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of HBV infection [seeWarnings and Precautions (5.1)].

Drug Interactions

Inform patients of the potential for drug interactions with DAKLINZA, and that some drugs should not be taken with DAKLINZA [seeContraindications (4),Drug Interactions (7), andClinical Pharmacology (12.3)].

Symptomatic Bradycardia When Used in Combination with Sofosbuvir and Amiodarone

Advise patients to seek medical evaluation immediately for symptoms of bradycardia, such as near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion or memory problems [seeWarnings and Precautions (5.3),Adverse Reactions (6.2), andDrug Interactions (7.3)].

DAKLINZA Combination Therapy with Sofosbuvir

Inform patients that DAKLINZA should not be used alone. DAKLINZA should be used in combination with sofosbuvir with or without ribavirin for the treatment of HCV genotype 1 or HCV genotype 3 infection [seeIndications and Usage (1)].

Missed Doses

Advise patients to take DAKLINZA every day at the regularly scheduled time with or without food. Inform patients that it is important not to miss or skip doses and to take DAKLINZA for the duration that is recommended by the physician. For instructions for missed doses of other agents in the regimen, refer to the respective prescribing information.

Pregnancy

Advise patients to avoid pregnancy during combination treatment with DAKLINZA and sofosbuvir with ribavirin for 6 months after completion of treatment. Inform patients to notify their healthcare provider immediately in the event of a pregnancy [seeUse in Specific Populations (8.1)].


Manufactured for:
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA


DAKLINZA is a trademark of Bristol-Myers Squibb Company. Other brands listed are the trademarks of their respective owners.

Important: 

DAKLINZA is used in combination with other antiviral medicines. When taking DAKLINZA in combination with sofosbuvir, you should read the Patient Information leaflet for sofosbuvir.When taking DAKLINZA in combination with sofosbuvir and ribavirin, you should also read the Medication Guide for ribavirin.

What Is Daklinza? 

DAKLINZA is a prescription medicine used to treat chronic (lasting a long time) hepatitis C genotype 1 or genotype 3 infection in adults.
Take DAKLINZA with sofosbuvir or with sofosbuvir and ribavirin.You should not take DAKLINZA by itself.

It is not known if DAKLINZA is safe and effective in children under 18 years of age.

Hepatitis B Virus Reactivation: 

Before starting treatment with DAKLINZA, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with DAKLINZA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking DAKLINZA.

For more information about side effects,

Take DAKLINZA exactly how you are told to by your healthcare provider.
Do not change your dose unless you are told to by your healthcare provider.
Do not stop taking DAKLINZA without first talking with your healthcare provider.
Take DAKLINZA one time each day with or without food.
If you miss a dose, call your healthcare provider or pharmacist. It is important that you do not miss or skip doses of DAKLINZA during treatment.
If you take too much DAKLINZA, call your healthcare provider or go to the nearest hospital emergency room right away.

Daklinza Can Cause Serious Side Effects, Including: 

Hepatitis B virus reactivation.

Store DAKLINZA at room temperature between 68 F and 77 F (20 C and 25 C).

Keep DAKLINZA and all medicines out of the reach of children.

General information about the safe and effective use of DAKLINZA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DAKLINZA for a condition for which it was not prescribed. Do not give DAKLINZA to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about DAKLINZA that is written for health professionals.

What Are The Ingredients In Daklinza? 

Active ingredient: daclatasvir

Inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green. Opadry green contains hypromellose, titanium dioxide, polyethylene glycol 400, FD&C blue #2/indigo carmine aluminum lake, and yellow iron oxide.

Manufactured for: Bristol-Myers Squibb Company, Princeton, NJ 08543, USA

DAKLINZA is a trademark of Bristol-Myers Squibb Company. For more information, go to www.patientsupportconnect.com or call 1-844-442-6663.

This Patient Information has been approved by the U.S. Food and Drug Administration.


Revised October 2019



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