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Note: This document contains side effect information about daclatasvir. Some of the dosage forms listed on this page may not apply to the brand name Daklinza.
Applies to daclatasvir: oral tablet
Oral route (Tablet)
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with daclatasvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate management for HBV infection as clinically indicated.
Along with its needed effects, daclatasvir (the active ingredient contained in Daklinza) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking daclatasvir:
Incidence not known
Some side effects of daclatasvir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
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. 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.
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
Very common (10% or more): Headache (up to 31.2%)
Common (1% to 10%): Dizziness, migraine, somnolence
Erythema multiforme has been reported with this drug as part of an asunaprevir regimen.
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
Very common (10% or more): Insomnia (up to 22.4%), irritability (up to 16.1%)
Common (1% to 10%): Depression, anxiety
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
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.
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
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
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).
Very common (10% or more): Myalgia (up to 15.3%), arthralgia (up to 10.1%)
Common (1% to 10%): Back pain
Very common (10% or more): Decreased appetite (up to 11.8%)
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.
Postmarketing reports: Symptomatic bradycardia, heart block, cardiac arrhythmias
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.
Common (1% to 10%): Increased ALT, increased AST, increased total bilirubin
Postmarketing reports: Hepatitis B reactivation
Common (1% to 10%): Urinary tract infection
Common (1% to 10%): Dry eye
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