Daklinza Side Effects Center

Last updated on RxList: 11/9/2021
Daklinza Side Effects Center

What Is Daklinza?

Daklinza (daclatasvir) is a hepatitis C virus (HCV) NS5A inhibitor indicated for use with sofosbuvir for the treatment of chronic HCV genotype 3.

What Are Side Effects of Daklinza?

Common side effects of Daklinza include:

  • headache,
  • fatigue,
  • nausea,
  • diarrhea,
  • low levels of iron in the blood (anemia),
  • rash,
  • insomnia,
  • dizziness, and
  • drowsiness.

Dosage for Daklinza

The recommended dose of Daklinza is 60 mg taken orally once daily with or without food in combination with sofosbuvir for 12 weeks.

What Drugs, Substances, or Supplements Interact with Daklinza?

Daklinza may interact with:

  • anticonvulsants,
  • antimycobacterial agents,
  • azole antifungals,
  • St. John's wort,
  • other antiviral drugs,
  • antiarrhythmics (particularly amiodarone), and
  • "statin" drugs

Tell your doctor all medications and supplements you use.

Daklinza During Pregnancy and Breastfeedinjg

It is unknown how Daklinza might affect a fetus. Tell your doctor if you are pregnant or plan to become pregnant before using Daklinza. It is unknown if Daklinza passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Daklinza (daclatasvir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Hepatitis: How Do You Get Hepatitis A, B, and C? See Slideshow
Daklinza Professional Information

SIDE EFFECTS

If DAKLINZA and sofosbuvir are administered with ribavirin, refer to the prescribing information for ribavirin regarding ribavirin-associated adverse reactions.

The following serious adverse reaction is described below and elsewhere in the labeling:

  • Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Approximately 2400 subjects with chronic HCV infection have been treated with the recommended dose of DAKLINZA in combination with other anti-HCV drugs in clinical trials. Six hundred seventy-nine subjects have received a DAKLINZA and sofosbuvir-based regimen. Safety experience from three clinical trials of DAKLINZA and sofosbuvir with or without ribavirin is presented.

DAKLINZA And Sofosbuvir

In the ALLY-3 trial, 152 treatment-naive and treatment-experienced subjects with HCV genotype 3 infection were treated with DAKLINZA 60 mg once daily in combination with sofosbuvir for 12 weeks. The most common adverse reactions (frequency of 10% or greater) were headache and fatigue. All adverse reactions were mild to moderate in severity. No subjects discontinued therapy for adverse events.

In the ALLY-2 trial, 153 treatment-naive and treatment-experienced subjects with HCV/HIV-1 coinfection were treated with DAKLINZA 60 mg once daily (dose-adjusted for concomitant antiretroviral use) in combination with sofosbuvir for 12 weeks. The most common adverse reaction (frequency of 10% or greater) was fatigue. The majority of adverse reactions were mild to moderate in severity. No subjects discontinued therapy for adverse events. Adverse reactions considered at least possibly related to treatment and occurring at a frequency of 5% or greater in ALLY-3 or ALLY-2 are presented in Table 4.

Table 4: Adverse Reactions (All Severity) Reported at ≥5% Frequency, DAKLINZA + Sofosbuvir, Studies ALLY-3 and ALLY-2

Adverse Reaction ALLY-3: HCV Genotype 3
n=152
ALLY-2: HCV/HIV-1 Coinfection
n=153
Headache 14% 8%
Fatigue 14% 15%
Nausea 8% 9%
Diarrhea 5% 7%

DAKLINZA, Sofosbuvir, And Ribavirin

In the ALLY-1 trial, 113 subjects with chronic HCV infection, including 60 subjects with Child-Pugh A, B, or C cirrhosis and 53 subjects with recurrence of HCV after liver transplantation, were treated with DAKLINZA 60 mg once daily in combination with sofosbuvir and ribavirin for 12 weeks. The most common adverse reactions (frequency of 10% or greater) among the 113 subjects were headache, anemia, fatigue, and nausea. The majority of adverse reactions were mild to moderate in severity. Of the 15 (13%) subjects who discontinued study drug for adverse events, 13 (12%) subjects discontinued ribavirin only and 2 (2%) subjects discontinued all study drugs. During treatment, 4 subjects in the cirrhotic cohort underwent liver transplantation. Adverse reactions considered at least possibly related to treatment and occurring at a frequency of 5% or greater in either treatment cohort in ALLY-1 are presented in Table 5.

Table 5: Adverse Reactions (All Severity) Reported at ≥5% Frequency in Either Treatment Cohort, DAKLINZA + Sofosbuvir + Ribavirin, Study ALLY-1

Adverse Reaction Child-Pugh A, B, or C Cirrhosis
n=60
Recurrence after Liver Transplantation
n=53
Headache 12% 30%
Anemia 20% 19%
Fatigue 15% 17%
Nausea 15% 6%
Rash 8% 2%
Diarrhea 3% 6%
Insomnia 3% 6%
Dizziness 0 6%
Somnolence 5% 0

Laboratory Abnormalities

Selected Grade 3 and 4 treatment-emergent laboratory abnormalities observed in clinical trials of DAKLINZA in combination with sofosbuvir with or without ribavirin are presented in Table 6.

Table 6: Selected Grade 3 and 4 Laboratory Abnormalities in Clinical Trials of DAKLINZA + Sofosbuvir ± Ribavirin, Studies ALLY-3, ALLY2, and ALLY-1

Parameter Percent with Abnormality
ALLY-3: HCV Genotype 3 DAKLINZA + Sofosbuvir
n=152
ALLY-2: HCV/HIV-1 Coinfection DAKLINZA + Sofosbuvir
n=153
ALLY-1: Child-Pugh A, B, or C with Cirrhosis and Post-transplant DAKLINZA + Sofosbuvir + Ribavirin
n=113
Hemoglobin (≤8.9 g/dL) 0 0 6%
Alanine aminotransferase (ALT) increased (≥5.1 x ULN) 0 0 2%
Aspartate aminotransferase (AST) increased (≥5.1 x ULN) 0 0 3%
Total bilirubin increased (≥2.6 x ULN) 0 5%a 8%
Lipase increased (≥3.1 x ULN) 2% 4% 4%
a In the ALLY-2 trial, Grade 3 and 4 increases in total bilirubin were observed only in subjects receiving concomitant atazanavir.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of DAKLINZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders

Serious symptomatic bradycardia has been reported in patients taking amiodarone who initiate treatment with a sofosbuvir-containing regimen [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Read the entire FDA prescribing information for Daklinza (Daclatasvir Tablets)

QUESTION

Hepatitis C virus causes an infection of the ______________. See Answer

© Daklinza Patient Information is supplied by Cerner Multum, Inc. and Daklinza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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