Daklinza

Daklinza is a prescription medication used to treat chronic hepatitis C virus (HCV) genotype 3 infection. It is given in combination with sofosbuvir for 12 weeks.

Daklinza belongs to a group of drugs called NS5A inhibitors. These help to stop the virus that causes hepatitis C from spreading inside the body.

This medication comes in tablet form and is taken once a day, with or without food.

Common side effects of Daklinza include tiredness (fatigue), headache, nausea, and diarrhea. 

This medication can make you tired. Do not drive or operate heavy machinery until you know how this medication will affect you.

Daklinza is a prescription medication used to treat chronic hepatitis C virus (HCV) genotype 3 infection. It is given in combination with sofosbuvir for 12 weeks. It is not known if Daklinza is safe and effective in children under 18 years of age.

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

• Bristol-Myers Squibb Company

Serious side effects have been reported with Daklinza. See the "Daklinza Precautions" section. 

Common side effects of Daklinza include the following:

• tiredness (fatigue)
• headache
• nausea
• diarrhea

Do not drive or operate heavy machinery until you know how this medication will affect you.

This is not a complete list of Daklinza side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. 

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and  apixaban (Eliquis), and dabigatran (Pradaxa)
• amiodarone (Cordarone, Pacerone)
• digoxin (Lanoxin)
• medications used to lower cholesterol known as "statins" such as simvastatin (Zocor) and atorvastatin (Lipitor) - (Monitor for statin-related adverse reactions such as myopathy (issues with the muscles that can lead to muscle weakness) and rhabdomyolysis (a rare but serious side effect in which the muscle tissue breaks down)
• warfarin (International normalized ratio (INR) values may rise and fall irregularly in those taking warfarin. As a result, frequent monitoring of INR values is recommended in patients taking warfarin)

This is not a complete list of Daklinza drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Daklinza including the following:

• Slow heart rate (bradycardia). Daklinza combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat certain heart problems. Get medical help right away if you take amiodarone with sofosbuvir and Daklinza and get any of the following symptoms:
  • fainting or near-fainting
  • dizziness or lightheadedness
  • not feeling well
  • weakness
  • tiredness
  • shortness of breath
  • chest pain
  • confusion
  • memory problems

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Do not take Daklinza if you:

• are allergic to Daklinza or any of its ingredients
• are taking a strong CYP3A4 inducer such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop) (see drug interactions)

Do not take Daklinza alone. Use Daklinza in combination with sofosbuvir.

Grapefruit and grapefruit juice may theoretically interact with Daklinza and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Daklinza contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), talk to your doctor before taking Daklinza.

Before taking Daklinza, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Daklinza or any of its ingredients
• if you have a history of hepatitis B infection
• have liver problems other than hepatitis C infection
• have had a liver transplant
• have heart problems
• are pregnant or plan to become pregnant. It is not known if Daklinza will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Daklinza passes into your breast milk.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No well-controlled studies have been done in humans with Daklinza. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Daklinza is excreted in human breast milk or if it will harm your nursing baby. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Daklinza, your doctor will determine the risk versus benefit of using this medication.

Take Daklinza exactly as your healthcare provider tells you to.

• Do not change your dose unless your healthcare provider tells you to.
• Do not stop taking Daklinza without first talking with your healthcare provider.
• Take Daklinza 1 time each day with or without food.
• If you miss a dose of Daklinza, take the missed dose as soon as you remember the same day. Take the next dose at your regular time. 
• If you miss a dose of Daklinza and remember the next day, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses of Daklinza at the same time to make up for the missed dose.
• If you take too much Daklinza, call your healthcare provider or go to the nearest hospital emergency room right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose and duration your doctor recommends may be based on the following:

• other medications you are taking
• how you respond to this medication
• the condition of your liver

The recommended usage of Daklinza to treat chronic hepatitis C virus is 60 mg taken orally once daily with or without food in combination with sofosbuvir. The recommended treatment duration is 12 weeks.

• Dose modification: Reduce dosage to 30 mg once daily with strong CYP3A4 inhibitors and increase dosage to 90 mg once daily with moderate CYP3A4 inducers.

If you take too much Daklinza call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Daklinza at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep this and all medications out of the reach of children. 

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C.