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FDA Approves Daklinza
Daklinza in combination with sofosbuvir is the first 12-week, once-daily, all-oral treatment regimen for patients with chronic hepatitis C virus (HCV) genotype 3.
The U.S. Food and Drug Administration (FDA) has approved Daklinza (daclatasvir), an NS5A replication complex inhibitor indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
Daklinza is used in combination with the antiviral medicine sofosbuvir (Sovaldi).
You should not take Daklinza alone to treat chronic hepatitis C infection.
You should also read the Patient Information for sofosbuvir (Sovaldi).
What is Daklinza?
- Daklinza is a prescription medicine used with sofosbuvir to treat chronic (lasting a long time) hepatitis C genotype 3 infection in adults.
- Daklinza should not be taken alone.
It is not known if this medicine is safe and effective in children under 18 years of age.
Before taking Daklinza
Before taking Daklinza, tell your healthcare provider about all of your medical conditions, including if you:
- 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 this medicine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Daklinza may affect the way other medicines work, and vice versa, which may cause side effects.
Keep a list of your medicines to show your healthcare provider and pharmacist.
- You can ask your healthcare provider or pharmacist for a list of medicines that interact with Daklinza.
- Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Daklinza with other medicines.
How should I take Daklinza?
- 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 treatment without first talking with your healthcare provider.
- Take Daklinza one time each day with or without food.
- If you miss a dose, 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 and remember the next day, skip the missed dose. Take the next dose at your regular time.
- Do not take two doses at the same time to make up for the missed dose.
- If you exceed your prescribed dose, call your healthcare provider or go to the nearest hospital emergency room right away.
Daklinza side effects
Daklinza in combination with sofosbuvir and amiodarone may cause serious side effects, including:
- 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
- chest pain
- dizziness or lightheadedness
- not feeling well
- shortness of breath
- memory problems
The most common side effects of Daklinza when used in combination with sofosbuvir include:
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
How should I store Daklinza?
- Store Daklinza at room temperature between 68°F and 77°F (20°C and 25°C).
Keep all medicines out of the reach of children.
General information about the safe and effective use of Daklinza
It is not known if treatment with Daklinza will prevent you from infecting another person with the hepatitis C virus during treatment. Talk with your healthcare provider about ways to prevent spreading the hepatitis C virus.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it 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 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
Not all side effects for Daklinza may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to daclatasvir: oral tablet
In clinical trials, this drug was used in combination with sofosbuvir (with or without ribavirin), with peginterferon alfa/ribavirin, with asunaprevir, or with asunaprevir/peginterferon alfa/ribavirin. Fatigue, headache, and nausea were reported most often when used with sofosbuvir. Fatigue, headache, pruritus, insomnia, influenza-like illness, dry skin, nausea, decreased appetite, alopecia, rash, asthenia, irritability, myalgia, anemia, pyrexia, cough, dyspnea, neutropenia, diarrhea, and arthralgia were reported most often when used with peginterferon alfa/ribavirin; the most common side effects of at least grade 3 severity were neutropenia, anemia, thrombocytopenia, and lymphopenia. The side effects and laboratory abnormalities reported with this drug in combination with peginterferon alfa/ribavirin was similar to those reported with peginterferon alfa/ribavirin alone, including in patients with cirrhosis. Headache, fatigue, diarrhea, nasopharyngitis, and nausea were reported most often when used with asunaprevir. Fatigue, headache, pruritus, asthenia, influenza-like illness, insomnia, rash, anemia, cough, dry skin, diarrhea, nausea, alopecia, irritability, pyrexia, and myalgia were reported most often when used with asunaprevir/peginterferon alfa/ribavirin.
The manufacturer product information for coadministered drugs should be consulted.[Ref]
Very common (10% or more): Fatigue (up to 41.5%), asthenia (up to 22.4%), influenza-like illness (up to 22.4%), pyrexia (up to 16.1%)
Common (1% to 10%): Hot flush, pain, weight decreased[Ref]
Very common (10% or more): Headache (up to 31.2%)
Common (1% to 10%): Dizziness, migraine[Ref]
Very common (10% or more): Pruritus (up to 26.1%), rash (up to 20.6%), dry skin (up to 17.8%), alopecia (up to 16.1%)[Ref]
Very common (10% or more): Insomnia (up to 22.4%), irritability (up to 16.1%)
Common (1% to 10%): Depression, anxiety[Ref]
Very common (10% or more): Anemia (up to 19.3%), neutropenia (up to 14.8%)
Common (1% to 10%): Thrombocytopenia
Frequency not reported: Decreased hemoglobin, eosinophilia[Ref]
Of the patients reporting anemia, 43% received ribavirin in addition to this drug and sofosbuvir. During the study, anemia was not reported in the ribavirin-free treatment groups.
Grade 3 decreased hemoglobin was reported in 1 patient in a ribavirin treatment group.[Ref]
Very common (10% or more): Cough (up to 18.3%), nasopharyngitis (up to 13.7%), dyspnea (up to 12.3%)
Common (1% to 10%): Exertional dyspnea, nasal congestion, upper respiratory tract infection[Ref]
Very common (10% or more): Diarrhea (up to 17.6%), nausea (up to 16.6%)
Common (1% to 10%): Upper abdominal pain, constipation, flatulence, gastroesophageal reflux disease, dry mouth, vomiting, elevated lipase[Ref]
Transient, asymptomatic elevated lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in 2% of patients using this drug with sofosbuvir.[Ref]
Very common (10% or more): Myalgia (up to 15.3%), arthralgia (up to 10.1%)
Common (1% to 10%): Back pain[Ref]
Very common (10% or more): Decreased appetite (up to 11.8%)[Ref]
Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with sofosbuvir in combination with another hepatitis C virus direct-acting antiviral (including this drug). Cases of severe bradycardia and heart block have been reported with this drug in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate.[Ref]
Postmarketing reports: Symptomatic bradycardia, heart block, cardiac arrhythmias[Ref]
Increased ALT (at least 5.1 x ULN), AST (at least 5.1 x ULN), and total bilirubin (at least 2.6 x ULN) were reported in up to 4%, up to 3%, and up to 1% of patients, respectively.[Ref]
Common (1% to 10%): Increased ALT, increased AST
Uncommon (0.1% to 1%): Increased total bilirubin[Ref]
Common (1% to 10%): Urinary tract infection
Common (1% to 10%): Dry eye[Ref]