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Daclatasvir (United States: Not available): Drug information

Daclatasvir (United States: Not available): Drug information
(For additional information see "Daclatasvir (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Hepatitis B virus reactivation:

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 hepatitis C virus (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.

Brand Names: US
  • Daklinza [DSC]
Brand Names: Canada
  • Daklinza [DSC]
Pharmacologic Category
  • Antihepaciviral, NS5A Inhibitor;
  • NS5A Inhibitor
Dosing: Adult

Note: Discontinue daclatasvir if other antihepaciviral therapy is permanently discontinued. Not indicated as monotherapy. The American Association for the Study of Liver Diseases/Infectious Diseases Society of America guidelines for testing, managing, and treating hepatitis C no longer include daclatasvir as a component of recommended treatment regimens for hepatitis C virus infection (AASLD/IDSA 2020).

Chronic hepatitis C, genotype 1

Chronic hepatitis C, genotype 1: Oral:

Patients without cirrhosis or with compensated cirrhosis (Child-Pugh class A): 60 mg once daily with concomitant sofosbuvir for 12 weeks.

Patients with decompensated (Child-Pugh class B or C) cirrhosis or post–liver transplant: 60 mg once daily with concomitant sofosbuvir and ribavirin for 12 weeks.

Chronic hepatitis C, genotype 3

Chronic hepatitis C, genotype 3:

Patients without cirrhosis: 60 mg once daily with concomitant sofosbuvir for 12 weeks.

Patients with compensated (Child-Pugh class A) or decompensated cirrhosis (Child-Pugh class B or C) or post–liver transplant: 60 mg once daily with concomitant sofosbuvir and ribavirin for 12 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Child-Pugh class A, B, or C: No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Daklinza: 30 mg [DSC], 60 mg [DSC], 90 mg [DSC] [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Daklinza: 30 mg [DSC], 60 mg [DSC] [contains fd&c blue #2 (indigo carm) aluminum lake]

Product Availability

The manufacturer of Daklinza, Bristol Myers Squibb, plans to cease distribution of the 90 mg tablets as of December 2018 and the 30 mg and 60 mg tablets as of June 2019.

Administration: Adult

Oral: Administer with or without food.

Use: Labeled Indications

Chronic hepatitis C: Treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in combination with sofosbuvir, with or without ribavirin. Note: The American Association for the Study of Liver Diseases/Infectious Diseases Society of America guidelines for testing, managing, and treating hepatitis C no longer include daclatasvir as a component of recommended treatment regimens for HCV infection (AASLD/IDSA 2021).

Limitations of use: Sustained virologic response rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving daclatasvir in combination with sofosbuvir for 12 weeks.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. All adverse drug reactions are from combination therapy trials with sofosbuvir.

>10%:

Central nervous system: Fatigue (14% to 15%), headache (12% to 14%)

Gastrointestinal: Nausea (8% to 15%)

Hematologic & Oncologic: Anemia (20%)

1% to 10%:

Central nervous system: Drowsiness (5%), insomnia (3%)

Dermatologic: Skin rash (8%)

Gastrointestinal: Diarrhea (3% to 5%), increased serum lipase (>3x ULN, transient)

<1%, postmarketing, and/or case reports: Reactivation of HBV (FDA Safety Alert Dec. 8, 2016)

Contraindications

Concurrent use of strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampin, St John's wort). When used in combination with other agents (eg, ribavirin), the contraindications to those agents also apply (refer to respective labeling information).

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to daclatasvir or any component of the formulation; concurrent use with strong inducers of CYP3A4 and P-glycoprotein (P-gp)

Warnings/Precautions

Concerns related to adverse effects:

• Bradycardia: When used in combination with sofosbuvir and amiodarone, symptomatic bradycardia (eg, near-fainting, dizziness, lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion, memory problems) has been reported; pacemaker intervention may be required. Bradycardia generally occurs within hours or days but has been observed up to 2 weeks after treatment initiation. Risk factors include concomitant beta blocker use, underlying cardiac morbidities, and/or advanced hepatic disease. Patients receiving amiodarone (with no alternate treatment options) and initiating daclatasvir and sofosbuvir treatment, and patients on daclatasvir and sofosbuvir treatment who are initiating amiodarone therapy should have inpatient cardiac monitoring for the first 48 hours of amiodarone coadministration and daily outpatient self-monitoring through at least the first 2 weeks of treatment. Patients discontinuing amiodarone just prior to starting daclatasvir and sofosbuvir treatment should also undergo similar cardiac monitoring procedures. Bradycardia usually resolves after HCV treatment discontinuation.

Disease-related concerns:

• Cardiovascular disease: Patients with underlying cardiac morbidities and also taking concomitant amiodarone are at increased risk for symptomatic bradycardia; use with caution and monitor for bradycardia.

• Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral (DAA) therapy for hepatitis C may lead to improvement in glucose metabolism in patients with diabetes, potentially resulting in symptomatic hypoglycemia if antidiabetic agents are continued at the same dose. Monitor for changes in glucose tolerance and inform patients of the risk of hypoglycemia during DAA therapy, particularly within the first 3 months. Modification of antidiabetic therapy may be necessary (Ciancio 2018; Dawood 2017; Hum 2017).

• Hepatic disease: Patients with advanced hepatic disease and also taking concomitant amiodarone are at increased risk for symptomatic bradycardia; use with caution. Sustained virologic response rates are reduced in HCV genotype 3-infected patients with cirrhosis. Optimal duration of treatment for HCV genotype 3-infected patients with cirrhosis or HCV genotype 1 patients with Child-Pugh class C cirrhosis has not been established.

• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV) reactivation has been reported in hepatitis C virus (HCV)/HBV coinfected patients who were receiving 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. Test all patients for evidence of current or prior HBV infection prior to initiation of daclatasvir; monitor HCV/HBV co-infected patients for hepatitis flare or HBV reactivation during treatment and post-treatment follow-up. Initiate treatment for HBV infection as clinically indicated. HBV reactivation has been reported in HBsAg positive patients and in patients with serologic evidence of resolved HBV infection (ie, HBsAg negative and anti-HBc positive) and is characterized by an abrupt increase in HBV replication manifested as a rapid increase in serum HBV DNA level; reappearance of HBsAg may occur in patients with resolved HBV infection. Risk of HBV reactivation may be increased in patients receiving certain immunosuppressants or chemotherapeutic agents.

Other warnings/precautions:

• Appropriate use: Do not use as monotherapy; use only in combination with other antihepatitis C virus drugs.

Metabolism/Transport Effects

Substrate of CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits BCRP/ABCG2, OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Afatinib. Management: If combined, administer the P-gp inhibitor simultaneously with, or after, the dose of afatinib. Monitor closely for signs and symptoms of afatinib toxicity and if the combination is not tolerated, reduce the afatinib dose by 10 mg. Risk D: Consider therapy modification

Aliskiren: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Aliskiren. Risk C: Monitor therapy

Alpelisib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Alpelisib. Management: Avoid coadministration of BCRP/ABCG2 inhibitors and alpelisib due to the potential for increased alpelisib concentrations and toxicities. If coadministration cannot be avoided, closely monitor for increased alpelisib adverse reactions. Risk D: Consider therapy modification

Amiodarone: Daclatasvir may enhance the bradycardic effect of Amiodarone. Risk X: Avoid combination

Antidiabetic Agents: Direct Acting Antiviral Agents (HCV) may enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Asunaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Asunaprevir. Risk X: Avoid combination

Atogepant: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Atogepant. Management: The recommended dose of atogepant when coadministered with OATP1B1/1B3 inhibitors is 10 mg once daily or 30 mg once daily. Risk D: Consider therapy modification

Atorvastatin: Daclatasvir may increase the serum concentration of Atorvastatin. Risk C: Monitor therapy

Berotralstat: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Berotralstat. Management: Decrease the berotralstat dose to 110 mg daily when combined with P-glycoprotein (P-gp) inhibitors. Risk D: Consider therapy modification

Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Bilastine. Risk X: Avoid combination

Brincidofovir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Brincidofovir. Management: Consider alternatives to OATP1B/1B3 inhibitors in patients treated with brincidofovir. If coadministration is required, administer OATP1B1/1B3 inhibitors at least 3 hours after brincidofovir and increase monitoring for brincidofovir adverse reactions. Risk D: Consider therapy modification

Buprenorphine: Daclatasvir may increase the serum concentration of Buprenorphine. Risk C: Monitor therapy

Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Celiprolol. Risk C: Monitor therapy

Cladribine: BCRP/ABCG2 Inhibitors may increase the serum concentration of Cladribine. Management: Avoid concomitant use of BCRP inhibitors during the 4 to 5 day oral cladribine treatment cycles whenever possible. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Risk D: Consider therapy modification

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a P-gp inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. See interaction monograph for details. Risk D: Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily if used with a moderate CYP3A4 inducer. Risk D: Consider therapy modification

CYP3A4 Inducers (Strong): May decrease the serum concentration of Daclatasvir. Risk X: Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Daclatasvir. Management: Decrease the daclatasvir dose to 30 mg once daily if combined with a strong CYP3A4 inhibitor. Risk D: Consider therapy modification

Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Risk C: Monitor therapy

Digoxin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Digoxin. Management: Measure digoxin serum concentrations before initiating treatment with these P-glycoprotein (P-gp) inhibitors. Reduce digoxin concentrations by either reducing the digoxin dose by 15% to 30% or by modifying the dosing frequency. Risk D: Consider therapy modification

DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Conventional). Risk X: Avoid combination

DOXOrubicin (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Liposomal). Risk C: Monitor therapy

Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Edoxaban. Risk C: Monitor therapy

Elagolix: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Elagolix. Risk X: Avoid combination

Elagolix, Estradiol, and Norethindrone: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Elagolix, Estradiol, and Norethindrone. Specifically, concentrations of elagolix may be increased. Risk X: Avoid combination

Elbasvir and Grazoprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Elbasvir and Grazoprevir. Risk X: Avoid combination

Eluxadoline: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Eluxadoline. Management: Decrease the eluxadoline dose to 75 mg twice daily if combined with OATP1B1/1B3 inhibitors and monitor patients for increased eluxadoline effects/toxicities. Risk D: Consider therapy modification

Etoposide: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Etoposide. Risk C: Monitor therapy

Etoposide Phosphate: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Etoposide Phosphate. Risk C: Monitor therapy

Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Everolimus. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Glecaprevir and Pibrentasvir: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Glecaprevir and Pibrentasvir. Risk C: Monitor therapy

HMG-CoA Reductase Inhibitors (Statins): Daclatasvir may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Lapatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Lapatinib. Risk C: Monitor therapy

Larotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Larotrectinib. Risk C: Monitor therapy

Lefamulin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin tablets with P-glycoprotein/ABCB1 inhibitors. If concomitant use is required, monitor for lefamulin adverse effects. Risk D: Consider therapy modification

Morphine (Systemic): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Morphine (Systemic). Risk C: Monitor therapy

Nadolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Nadolol. Risk C: Monitor therapy

Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naldemedine. Risk C: Monitor therapy

Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naloxegol. Risk C: Monitor therapy

Nevirapine: May decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily if used with nevirapine. Risk D: Consider therapy modification

PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination

PAZOPanib: BCRP/ABCG2 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination

Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ranolazine. Risk C: Monitor therapy

Relugolix: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Relugolix. Management: Avoid coadministration of relugolix with oral P-gp inhibitors whenever possible. If combined, take relugolix at least 6 hours prior to the P-gp inhibitor and monitor patients more frequently for adverse reactions. Risk D: Consider therapy modification

Relugolix, Estradiol, and Norethindrone: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Relugolix, Estradiol, and Norethindrone. Management: Avoid use of relugolix/estradiol/norethindrone with P-glycoprotein (P-gp) inhibitors. If concomitant use is unavoidable, relugolix/estradiol/norethindrone should be administered at least 6 hours before the P-gp inhibitor. Risk D: Consider therapy modification

Revefenacin: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentrations of the active metabolite(s) of Revefenacin. Risk X: Avoid combination

Rifapentine: May decrease the serum concentration of Daclatasvir. Management: US labeling recommends increasing the daclatasvir dose to 90 mg once daily if used with rifapentine. Canadian labeling states that the combination of daclatasvir and rifapentine is contraindicated. Risk D: Consider therapy modification

RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RifAXIMin. Risk C: Monitor therapy

Rimegepant: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Rimegepant. Management: Avoid administration of another dose of rimegepant within 48 hours if given concomitantly with a P-glycoprotein (P-gp) inhibitor. Risk D: Consider therapy modification

RisperiDONE: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RisperiDONE. Risk C: Monitor therapy

RomiDEPsin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RomiDEPsin. Risk C: Monitor therapy

Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Silodosin. Risk C: Monitor therapy

Sirolimus (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Sirolimus (Conventional). Management: Avoid concurrent use of sirolimus with P-glycoprotein (P-gp) inhibitors when possible and alternative agents with lesser interaction potential with sirolimus should be considered. Monitor for increased sirolimus concentrations/toxicity if combined. Risk D: Consider therapy modification

Sirolimus (Protein Bound): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Sirolimus (Protein Bound). Risk X: Avoid combination

St John's Wort: May decrease the serum concentration of Daclatasvir. Risk X: Avoid combination

Tacrolimus (Systemic): Direct Acting Antiviral Agents (HCV) may decrease the serum concentration of Tacrolimus (Systemic). Direct Acting Antiviral Agents (HCV) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Talazoparib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Talazoparib. Risk C: Monitor therapy

Talazoparib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Talazoparib. Risk C: Monitor therapy

Taurursodiol: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Taurursodiol. Risk X: Avoid combination

Tegaserod: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Tegaserod. Risk C: Monitor therapy

Teniposide: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Teniposide. Risk C: Monitor therapy

Tenofovir Disoproxil Fumarate: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy

Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination

Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination

Ubrogepant: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor. Risk D: Consider therapy modification

Venetoclax: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring concomitant treatment with P-glycoprotein (P-gp) inhibitors. Resume the previous venetoclax dose 2 to 3 days after discontinuation of a P-gp inhibitor. Risk D: Consider therapy modification

VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of VinCRIStine (Liposomal). Risk X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Direct Acting Antiviral Agents (HCV) may diminish the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Voxilaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Voxilaprevir. Risk X: Avoid combination

Reproductive Considerations

Patients with hepatitis C virus (HCV) infection should be treated before considering pregnancy to optimize maternal health and reduce the risk of HCV transmission (AASLD/IDSA 2021).

If used in combination with ribavirin, all warnings related to the use of ribavirin and contraception should be followed.

Pregnancy Considerations

Based on a placental perfusion study, daclatasvir is expected to cross the placenta (Frerikesen 2020).

Daclatasvir must not be used as monotherapy. If used in combination with ribavirin, use is contraindicated in pregnant patients and males whose partners are pregnant. All warnings related to the use of ribavirin and pregnancy should be followed.

Outcome data following maternal use of daclatasvir and other direct-acting antiviral (DAA) medications during pregnancy are limited. Use of a DAA is not currently recommended for the purpose of reducing mother to child transmission of hepatitis C virus due to a lack of safety and efficacy data. The decision to continue treatment in a patient who becomes pregnant while taking a DAA should be individualized after considering the potential benefits and risks of therapy. DAA medications should not be initiated during pregnancy outside of clinical trials until safety and efficacy data are available (AASLD/IDSA 2021; AbdAllah 2021; SMFM [Dotters-Katz 2021]).

Breastfeeding Considerations

It is not known if daclatasvir is present in breast milk.

Breastfeeding is not linked to the spread of hepatitis C virus; however, if nipples are cracked or bleeding, breastfeeding is not recommended (milk should be expressed and discarded) (AASLD/IDSA 2021; SMFM [Dotters-Katz 2021]). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Baseline (obtain any time prior to treatment initiation) hepatitis C virus (HCV) genotype and subtype (if a non–pan-genotypic direct-acting antiviral (DAA) will be prescribed), quantitative HCV viral load. Baseline (within 6 months prior to treatment initiation) CBC, INR, hepatic function (albumin, total and direct bilirubin, ALT, AST, alkaline phosphatase), calculated GFR. Before initiating DAA therapy, serum pregnancy test (women of childbearing age) and assessment for HIV coinfection. During treatment, monitor CBC, serum creatinine, calculated GFR, hepatic function panel as clinically indicated. Quantitative HCV viral load testing at ≥12 weeks after completion of therapy. Hepatitis B virus (HBV) surface antigen, HBV core antibody, and HBV surface antibody prior to initiation (AASLD/IDSA 2020). Prior to treatment initiation in genotype 1a patients with cirrhosis, consider screening for the presence of NS5A polymorphisms at amino acid positions M28, Q30, L31, and Y93 in patients with cirrhosis. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during treatment and during post-treatment follow-up. If used in combination with amiodarone or in patients who discontinued amiodarone just prior to initiating sofosbuvir in combination with daclatasvir, inpatient cardiac monitoring for the first 48 hours of coadministration, then outpatient self-monitoring of heart rate daily through at least the first 2 weeks of treatment.

In patients with diabetes, monitor blood glucose and for signs/symptoms of hypoglycemia (AASLD/IDSA 2020; Ciancio 2018; Dawood 2017; Hum 2017); in patients taking warfarin, monitor INR during and post-therapy (AASLD/IDSA 2020).

Mechanism of Action

Daclatasvir binds to the N-terminus within Domain 1 of HCV nonstructural protein 5A (NS5A) and inhibits viral RNA replication and virion assembly.

Pharmacokinetics

Distribution: Vdss: 47 L

Protein binding: ~99%

Metabolism: Primarily via CYP3A4

Bioavailability: 67%

Half-life elimination: ~12 to 15 hours

Time to peak, plasma: ≤2 hours

Excretion: Feces (88%, 53% unchanged); urine (6.6%, primarily unchanged)

Pricing: US

Tablets (Daklinza Oral)

30 mg (per each): $900.00

60 mg (per each): $900.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Augidacla (EG);
  • Daclacef (BD);
  • Daclavir (BD, EG);
  • Daklinza (AR, AT, AU, BB, BE, BH, BR, CH, CN, CR, CZ, DO, EE, ES, FI, FR, GB, GR, GT, HK, HN, HU, IE, IL, IS, JP, KR, KW, LB, LT, LU, MT, MX, NI, NL, NO, NZ, PA, PL, PT, RO, RU, SA, SE, SG, SK, SV, TH);
  • Javidacla (EG);
  • Mydekla (PH);
  • Virodacla (BD);
  • Zetaciver (EG)


For country code abbreviations (show table)
  1. AbdAllah M, Alboraie M, Abdel-Razek W, et al. Pregnancy outcome of anti-HCV direct-acting antivirals: real-life data from an Egyptian cohort. Liver Int. 2021;41(7):1494-1497. doi:10.1111/liv.14913 [PubMed 33905164]
  2. American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA). HCV guidance: recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org. Updated October 5, 2021. Accessed March 24, 2022.
  3. American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA). HCV guidance: recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org. Updated August 27, 2020. Accessed October 19, 2020.
  4. Ciancio A, Bosio R, Bo S, et al. Significant improvement of glycemic control in diabetic patients with HCV infection responding to direct-acting antiviral agents. J Med Virol. 2018;90(2):320-327. doi:10.1002/jmv.24954. [PubMed 28960353]
  5. Daklinza (daclatasvir) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; October 2019.
  6. Daklinza (daclatasvir) [product monograph]. Montreal, Canada: Bristol-Myers Squibb Canada; July 2019.
  7. Dawood AA, Nooh MZ, Elgamal AA. Factors associated with improved glycemic control by direct-acting antiviral agent treatment in Egyptian type 2 diabetes mellitus patients with chronic hepatitis C genotype 4. Diabetes Metab J. 2017;41(4):316-321. doi: 10.4093/dmj.2017.41.4.316. [PubMed 28868829]
  8. Dotters-Katz SK, Kuller JA, Hughes BL. Society for Maternal-Fetal Medicine Consult Series #56: hepatitis C in pregnancy-updated guidelines: replaces Consult Number 43, November 2017. Am J Obstet Gynecol. 2021;225(3):B8-B18. doi:10.1016/j.ajog.2021.06.008 [PubMed 34116035]
  9. FDA Safety Alert. MedWatch. Direct-Acting Antiviral for Hepatitis C: Drug Safety Communication-Risk of Hepatitis B reactivating. Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm. Accessed December 8, 2016.
  10. Freriksen JJM, Meijerhof M, van Drongelen J, et al. Transfer of daclatasvir and sofosbuvir's main metabolite, GS-331007, across the human placenta ex vivo. Am J Obstet Gynecol. 2020;223(6):941-943. doi:10.1016/j.ajog.2020.08.107 [PubMed 32877661]
  11. Hum J, Jou JH, Green PK, et al. Improvement in Glycemic Control of Type 2 Diabetes After Successful Treatment of Hepatitis C Virus. Diabetes Care. 2017;40(9):1173-1180. doi: 10.2337/dc17-0485. [PubMed 28659309]
  12. Nelson DR, Cooper JN, Lalezari JP, et al; ALLY-3 Study Tea. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61(4):1127-1135. [PubMed 25614962]
  13. Sunvepra (asunaprevir) [product monograph]. Montreal, Canada: Bristol-Myers Squibb Canada; January 2017.
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