Note: This document contains side effect information about daclatasvir. Some dosage forms listed on this page may not apply to the brand name Daklinza.

Applies to daclatasvir: oral tablet.

General

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. Headache, anemia, fatigue, and nausea were reported most often when used with sofosbuvir and ribavirin. 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 hepatitis C virus (HCV) antiviral drugs should be consulted.^[Ref]

Other

Very common (10% or more): Fatigue (up to 41.5%), asthenia (up to 24.1%), influenza-like illness (up to 22.4%), pyrexia (up to 16.1%)

Common (1% to 10%): Hot flush, pain, weight decreased^[Ref]

Nervous system

Very common (10% or more): Headache (up to 31.2%)

Common (1% to 10%): Dizziness, migraine, somnolence^[Ref]

Dermatologic

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%)

Postmarketing reports: Erythema multiforme^[Ref]

Erythema multiforme has been reported with this drug as part of an asunaprevir regimen.^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 22.4%), irritability (up to 16.1%)

Common (1% to 10%): Depression, anxiety^[Ref]

Hematologic

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.

In trials of this drug with sofosbuvir (with or without ribavirin), grade 3 decreased hemoglobin was reported in 2% of patients; all of these patients received this drug with sofosbuvir and ribavirin.^[Ref]

Very common (10% or more): Anemia (up to 20%), neutropenia (up to 14.8%)

Common (1% to 10%): Thrombocytopenia, decreased hemoglobin

Frequency not reported: Eosinophilia^[Ref]

Respiratory

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]

Gastrointestinal

Elevated lipase (at least 3.1 times the upper limit of normal [3.1 x ULN]) was reported in up to 4% of patients using this drug with sofosbuvir (with or without ribavirin).^[Ref]

Very common (10% or more): Diarrhea (up to 17.6%), nausea (up to 16.6%)

Common (1% to 10%): Upper abdominal pain, abdominal pain, constipation, flatulence, gastroesophageal reflux disease, dry mouth, vomiting, elevated lipase^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 15.3%), arthralgia (up to 10.1%)

Common (1% to 10%): Back pain^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 11.8%)^[Ref]

Cardiovascular

Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a regimen containing sofosbuvir. 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]

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased total bilirubin

Postmarketing reports: Hepatitis B reactivation^[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 8% of patients, respectively.

Grade 3/4 increased total bilirubin was reported in 5% of patients; all of these patients were coinfected with HIV and using concomitant atazanavir, had Child-Pugh A, B, or C cirrhosis, or were post-liver transplant.^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Ocular

Common (1% to 10%): Dry eye^[Ref]

Frequently asked questions

• What are the new drugs for the treatment of hepatitis C?
• How much does Daklinza cost?