Buy Daklinza
Daklinza

14
A direct-acting antiviral used in combination with other drugs to treat chronic Hepatitis C.


Ingredient
Category
Availability
In Stock
Delivery
Airmail (14-21 days) | EMS trackable (5-9 days)
Product is shipped in a fully discreet envelope with no content disclosure, including all required documentation inside

Product Sheet

Alternative/Local Brand
Daklinza
Active Ingredient(s)
Daclatasvir
Primary Category
Antiviral, Liver Health
Therapeutic Class
Antivirals for systemic use, Direct-acting antivirals, NS5A inhibitors
Pharmacological Class
Hepatitis C virus NS5A inhibitor
Indications
Chronic Hepatitis C infection
Contraindications
Strong inducers of CYP3A4, Hypersensitivity to daclatasvir
Minor Side Effects
Headache, Fatigue
Moderate Side Effects
Nausea, Diarrhoea, Insomnia
Serious Side Effects
Severe bradycardia (when used with amiodarone), Hepatitis B reactivation
Dosage Forms
Tablet
Administration Route
Oral
Mechanism of Action
It targets the NS5A protein, which the Hepatitis C virus needs to replicate and assemble. By blocking this protein, the virus can no longer multiply and the level of infection decreases.
Prescription Status
Rx
Manufacturer
Bristol-Myers Squibb
Patient Summary
A direct-acting antiviral used in combination with other drugs to treat chronic Hepatitis C.
Onset Time
Steady state in 4 days
Duration
24 hours
Storage Instructions
Store at room temperature.
Drug Interactions
Amiodarone, St. John's Wort, Rifampicin, Carbamazepine
Age Restrictions
Adults only.
Pregnancy Use
Not recommended, especially in combination with Ribavirin.
Alternative Drugs
Sovaldi, Harvoni, Epclusa

What is Daklinza?

Daklinza is a brand-name medication that contains daclatasvir as its active ingredient. Daclatasvir is an antiviral agent classified as an NS5A inhibitor and is used in the treatment of chronic hepatitis C virus (HCV) infection. The medication is supplied as a 60 mg pill for oral administration. In Hong Kong, Daklinza is a prescription-only product regulated by the Department of Health’s Drug Office.

How Daklinza Works in the Body

Daclatasvir targets the non-structural protein 5A (NS5A) of HCV. NS5A is essential for viral RNA replication and the assembly of new virus particles. By binding to NS5A, daclatasvir disrupts these processes, leading to a rapid decline in viral load. The drug is absorbed well after oral intake, attaining peak plasma concentrations within 2-4 hours. It is extensively metabolized by the liver enzyme CYP3A4 and excreted primarily in the feces.

Conditions Treated by Daklinza

Daklinza is approved for use in combination with other direct-acting antivirals (such as sofosbuvir, ribavirin, or simeprevir) to treat chronic HCV infection. Approved indications in Hong Kong include:

  • HCV genotype 1 infection (with or without cirrhosis) when used with sofosbuvir ± ribavirin.
  • HCV genotype 3 infection (with or without cirrhosis) when used with sofosbuvir ± ribavirin.
  • HCV genotype 4 infection (with or without cirrhosis) when used with sofosbuvir ± ribavirin.

The regimen is intended for adult patients; pediatric use has not been established.

Patient Suitability and Contraindications

Who Should Use Daklinza?

  • Adults with chronic HCV infection who are eligible for antiviral therapy.
  • Patients whose liver function permits the use of the recommended combination regimen.

Absolute Contraindications

  • Known hypersensitivity to daclatasvir or any of the tablet’s excipients.
  • Co-administration with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, St. John’s wort) because efficacy may be markedly reduced.

Relative Contraindications

  • Moderate to severe hepatic impairment (Child-Pugh B or C) - dose adjustment and close monitoring are required.
  • Pregnancy or breastfeeding: Daclatasvir is classified as Pregnancy Category C; safety data are insufficient, so use is generally avoided unless the benefit clearly outweighs the risk.

Special Populations

  • Renal impairment: No dose adjustment is needed for mild to moderate renal dysfunction, but patients on hemodialysis should be managed by a specialist.
  • Elderly: No specific dose change, but clinicians should monitor for drug interactions and liver function.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Fatigue (commonly reported)
  • Headache
  • Nausea
  • Diarrhea

These effects are usually mild and transient. Patients should stay hydrated and report persistent symptoms to their healthcare provider.

Serious Adverse Events

  • Hepatocellular injury (rare; monitor liver enzymes).
  • Severe allergic reactions, including rash or angioedema (prompt medical attention required).

Drug Interactions

Major Interactions

  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John’s wort) - may lower daclatasvir concentrations, reducing antiviral efficacy.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, atazanavir) - can increase daclatasvir exposure, potentially heightening side-effect risk. Dose adjustment or alternative therapy may be necessary.

Moderate Interactions

  • Co-administration with certain antiretrovirals (e.g., efavirenz) may require monitoring of plasma levels.
  • Drugs affecting P-gp transport may modestly alter daclatasvir absorption.

Patients should provide a complete medication list, including over-the-counter products and herbal supplements, to their prescriber before starting Daklinza.

Food and Lifestyle Interactions

  • Daklinza can be taken with or without food; however, a consistent routine (e.g., same timing each day) helps maintain stable drug levels.
  • Alcohol consumption should be limited, as excessive intake can worsen liver disease.
  • No known effect on driving or the operation of machinery, but severe fatigue may impair performance in some individuals.

How to Take Daklinza

  • Standard dosing: One 60 mg tablet once daily, taken as part of the prescribed combination regimen.
  • Administration: Swallow the pill whole with water; do not crush or split unless instructed by a pharmacist.
  • Missed dose: Take the missed tablet as soon as remembered on the same day; do not double the next dose.
  • Overdose: Signs may include severe nausea, vomiting, dizziness, or liver enzyme abnormalities. Seek emergency medical care; supportive treatment is the mainstay.
  • Discontinuation: Abrupt stopping is not recommended without medical guidance, as insufficient antiviral exposure can lead to viral resistance.

Monitoring and Follow-Up

  • Baseline: Hepatic panel (ALT, AST, bilirubin), HCV RNA level, and assessment of cirrhosis status before initiating therapy.
  • During treatment: Periodic HCV RNA testing (typically at weeks 4 and 12) to confirm viral suppression; liver function tests every 4-8 weeks.
  • Post-treatment: A sustained virologic response (SVR) is evaluated 12 weeks after completion of therapy to determine cure.

Patients should maintain scheduled appointments with their hepatology or infectious disease specialist throughout the treatment course.

Storage and Handling

  • Store tablets at room temperature (20-25 °C), away from excess moisture and direct sunlight.
  • Keep the container tightly closed and out of reach of children.
  • Do not use the medication after the printed expiration date.

If a tablet becomes discolored or broken, discard it according to local pharmaceutical waste guidelines and obtain a replacement.

Medication-Specific Glossary

NS5A Inhibitor
A class of antivirals that block the NS5A protein of hepatitis C virus, preventing RNA replication and virus assembly.
Sustained Virologic Response (SVR)
Undetectable HCV RNA in the blood 12 weeks after completing therapy, indicating a functional cure.
CYP3A4
A liver enzyme that metabolizes many drugs, including daclatasvir; its activity can be increased or decreased by other medications.

Medical Disclaimer

This article provides educational information about Daklinza and is not a substitute for professional medical advice. Treatment decisions, including use for unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Daklinza FAQ

What should I know about the timing of Daklinza doses?

Daclatasvir is typically taken once daily at approximately the same time each day to maintain consistent blood levels. Whether you take it with food or on an empty stomach does not significantly affect absorption, but maintaining a regular schedule helps optimize treatment efficacy.

Can Daklinza be used alone to treat hepatitis C?

No. Daklinza is approved only as part of a combination regimen with other direct-acting antivirals such as sofosbuvir. Using it alone does not achieve sufficient viral suppression and may foster resistance.

How does Daklinza differ from other HCV agents like ledipasvir?

Both daclatasvir and ledipasvir target the NS5A protein, but they have distinct chemical structures and dosing strengths. Choice of agent depends on HCV genotype, presence of cirrhosis, and the specific combination partner prescribed by the clinician.

Is there a risk of drug resistance if I miss several doses of Daklinza?

Missing doses can lead to sub-therapeutic drug levels, allowing the virus to replicate and potentially develop resistance mutations. Adherence to the daily regimen is crucial for achieving a cure.

What are the visible characteristics of a Daklinza pill?

Daklinza tablets are round, white, and imprinted with “60 MG” on one side. The appearance may vary slightly between manufacturers, but the dosage strength remains 60 mg per tablet.

Can I travel internationally with Daklinza, and will customs inspect it?

You may travel with a prescription-filled container of Daklinza for personal use. Carry the original prescription label and be prepared to present it to customs officials if requested. Regulations differ by country, so verify local requirements before travel.

Are there any special considerations for athletes using Daklinza?

Daklinza is not listed on major anti-doping prohibited substance tables, but athletes should disclose all medications to their team physician and check sport-specific regulations, especially if combined with other agents that may affect liver function.

How long does a typical Daklinza treatment course last?

The duration depends on the HCV genotype, presence of cirrhosis, and the accompanying antiviral(s). Commonly, treatment spans 12 weeks, but some regimens may extend to 24 weeks based on clinical assessment.

What should I do if I experience severe fatigue while on Daklinza?

Mild fatigue is a common side effect. If fatigue becomes severe or interferes with daily activities, contact your healthcare provider for evaluation; they may adjust the regimen or investigate other causes.

Is there a generic version of daclatasvir available in Hong Kong?

As of the latest regulatory updates, daclatasvir is marketed primarily under the brand name Daklinza in Hong Kong. Generic formulations may become available pending approval from the Department of Health, but patients should consult their pharmacist for current options.

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