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Daklinza

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Daklinza (daclatasvir) is an antiviral medication indicated for the treatment of chronic hepatitis C infection. It target specific viral proteins to stop the multiplication of the virus within the body. This medication helps reduce the viral load and is used in conjunction with other therapies to manage liver health in adults.


Ingredient
Category
Availability
In Stock
Delivery Time
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

Active Ingredient(s)
Daclatasvir
Reference Brand
Daklinza
Manufacturer
Bristol-Myers Squibb
Product Form
Tablet
Regulatory Classification
Rx
Primary Category
Antiviral, Liver Health
Product Category
Antivirals for systemic use, Direct-acting antivirals, NS5A inhibitors
Pharmacological Class
Hepatitis C virus NS5A inhibitor
Clinical Indications
Manufacturer Description
A direct-acting antiviral used in combination with other drugs to treat chronic Hepatitis C.
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.
Route of Administration
Oral
Onset Time
Steady state in 4 days
Duration
24 hours
Contraindications
Strong inducers of CYP3A4, Hypersensitivity to daclatasvir
Severe Adverse Events
Severe bradycardia (when used with amiodarone), Hepatitis B reactivation
Common Side Effects
Headache, Fatigue
Uncommon Side Effects
Nausea, Diarrhoea, Insomnia
Drug Interactions
Amiodarone, St. John's Wort, Rifampicin, Carbamazepine
Pregnancy Safety Warnings
Not recommended, especially in combination with Ribavirin.
Age Restrictions
Adults only.
Storage Guidelines
Store at room temperature.
Related Products
Sovaldi, Harvoni, Epclusa

Daklinza FAQ

Can I travel internationally with Daklinza tablets?

Yes, Daklinza can be taken while traveling, but you should keep the medication in its original packaging with the prescription label visible. Carry a copy of the prescription or a letter from your clinician, as some countries may request proof of medical necessity for antiviral drugs.

Does taking Daklinza affect routine blood tests?

Daklinza does not typically interfere with standard laboratory assays. However, liver function tests (ALT, AST) are routinely monitored during treatment to assess the medication’s impact on the liver.

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; they may evaluate for anemia, underlying liver disease progression, or consider adjusting concomitant medications.

Are there any known differences between Daklinza tablets manufactured in the UK versus abroad?

All Daklinza tablets marketed in the UK must meet MHRA quality standards, regardless of the manufacturing site. The appearance, strength (60 mg), and excipients are consistent across authorised batches.

How does Daklinza compare to other HCV antivirals like Harvoni?

Both Daklinza and Harvoni target hepatitis C but use different mechanisms-Daklinza is an NS5A inhibitor, while Harvoni combines an NS5A inhibitor (ledipasvir) with a polymerase inhibitor (sofosbuvir). Choice of regimen depends on viral genotype, liver disease stage, and prior treatment history, as guided by specialist assessment.

Can I take Daklinza if I have a mild kidney problem?

Daclatasvir is eliminated primarily via the bile and does not require dose adjustment for mild to moderate renal impairment. Nevertheless, your clinician will review kidney function as part of overall treatment planning.

Is alcohol consumption prohibited during Daklinza therapy?

While modest alcohol intake does not directly affect the drug’s efficacy, alcohol can worsen liver inflammation and accelerate disease progression. Patients are generally advised to limit or avoid alcohol while treating HCV.

What imprint or visual features identify genuine Daklinza tablets?

Daklinza 60 mg tablets are typically round, white, and bear the imprint “60 MG DACLATA.” Always verify the appearance against the pharmacy label and consult a pharmacist if you have doubts about authenticity.

Will my health insurance in the UK cover Daklinza?

In the UK, Daklinza is prescribed through the NHS for eligible patients with chronic HCV. Coverage decisions are made by NHS prescribing guidelines and local formularies rather than private insurance.

How long after completing Daklinza treatment can I conceive?

Women are advised to use effective contraception during treatment and for at least three months after the final dose, as safety data on early pregnancy are lacking. Men should also consider contraception during treatment and for a short period thereafter.

What is Daklinza?

Daklinza is a brand-name medication that contains the active ingredient daclatasvir. It belongs to the antiviral class of drugs and is formulated as a 60 mg oral pill. Daclatasvir is a direct-acting antiviral (DAA) that targets the hepatitis C virus (HCV). The product is authorised for use in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) and is prescribed by specialist liver-or-infectious-disease clinicians.

How Daklinza Works in the Body

Daclatasvir is an NS5A inhibitor. NS5A is a non-structural protein that the hepatitis C virus uses to organise its replication complex and to assemble new viral particles. By binding to NS5A, Daklinza:

  • Disrupts the formation of the replication complex
  • Hinders viral RNA synthesis
  • Reduces the production of infectious virus particles

These actions lead to a rapid decline in viral load. When combined with other DAAs that target different steps of the HCV life-cycle (for example, sofosbuvir, a polymerase inhibitor), the overall antiviral effect is synergistic, allowing many patients to achieve a sustained virologic response (SVR)-the clinical term for a cure of HCV infection.

Conditions Treated by Daklinza

In the UK, Daklinza is approved for the treatment of chronic hepatitis C infection in adult patients with the following genotypes:

  • Genotype 1 (including subtypes 1a and 1b)
  • Genotype 2 (in combination with sofosbuvir)
  • Genotype 3 (in combination with sofosbuvir)
  • Genotype 4 (in combination with sofosbuvir)

The medication is typically used together with other DAAs as part of a fixed-duration regimen (often 12 weeks). NICE guidance recommends Daklinza-based regimens for patients with compensated liver disease (Child-Pugh A) and for those who have not responded to previous HCV therapy. Treatment decisions are based on genotype, presence of cirrhosis, and prior treatment history.

Evaluating Daklinza for Your Health Profile

Ideal candidates are adults with a confirmed chronic HCV infection who have adequate liver function (Child-Pugh A) and no contraindicating conditions. Prior to starting therapy, clinicians will:

  • Confirm HCV genotype and baseline viral load
  • Assess liver disease severity (e.g., elastography, ultrasound)
  • Review concomitant medications for potential interactions

Absolute Contraindications

  • Known hypersensitivity to daclatasvir or any pill excipients
  • Co-administration with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, St John’s wort) because they markedly reduce daclatasvir exposure

Relative Contraindications

  • Severe hepatic impairment (Child-Pugh B or C); dosing adjustments are required and efficacy data are limited
  • Pregnancy and breastfeeding: daclatasvir is not recommended because safety data are insufficient; effective contraception should be used during treatment and for at least three months after the last dose

Special Populations

  • Renal impairment: No dose adjustment is required for mild to moderate renal dysfunction; data in end-stage renal disease are limited.
  • Elderly patients: No specific dose change, but careful monitoring for drug interactions and liver function is advised.

If any of the above conditions apply, a clinician will evaluate the risk-benefit balance before prescribing Daklinza.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Fatigue - reported by many patients but usually mild
  • Headache - transient and often resolves without treatment
  • Nausea - occasional; taking the pill with food may help

Serious Adverse Events

  • Elevated liver enzymes (ALT/AST) - may indicate liver irritation; requires monitoring
  • Severe hypersensitivity reactions - rare but can include rash, swelling, or anaphylaxis; seek immediate medical attention

Drug Interactions

Daklinza is primarily metabolised by the cytochrome P450 3A4 (CYP3A4) pathway and is also a substrate of the transporter P-glycoprotein (P-gp). Interactions of clinical relevance include:

  • Strong CYP3A4 inducers (rifampicin, carbamazepine, St John’s wort) → ↓ daclatasvir levels, loss of efficacy
  • CYP3A4 inhibitors (ketoconazole, clarithromycin) → ↑ daclatasvir exposure; dose adjustment (usually reduction to 30 mg) may be required under specialist guidance
  • P-gp inhibitors (verapamil, amiodarone) → modest increase in daclatasvir levels; monitor for toxicity

Because many patients with HCV take additional medications (e.g., antiretrovirals, anticoagulants), a full medication review is essential before initiating Daklinza.

Food and Lifestyle Interactions

  • Food: Daclatasvir can be taken with or without meals; however, a high-fat meal does not significantly alter exposure.
  • Alcohol: While moderate consumption does not directly affect daclatasvir pharmacokinetics, alcohol can worsen liver disease and should be limited or avoided.
  • Driving: No specific impairment has been reported, but patients experiencing fatigue or dizziness should assess their ability to operate machinery safely.

How to Take Daklinza

  • Standard dosing: One 60 mg tablet taken once daily, preferably at the same time each day.
  • With or without food: The pill may be swallowed whole with water; crushing or splitting is not recommended.
  • Combination therapy: When prescribed with another DAA (e.g., sofosbuvir), follow the dosing schedule for each agent as directed by the prescriber.
  • Special adjustments:
  • Severe hepatic impairment (Child-Pugh B/C): Reduce the dose to 30 mg once daily, if the prescriber deems it appropriate.
  • CYP3A4 inhibitor co-administration: Consider dose reduction to 30 mg; the prescriber will decide based on the specific inhibitor.

Missed Dose

If a dose is missed, take it as soon as remembered provided it is at least 8 hours before the next scheduled dose. Do not double the dose.

Overdose

Symptoms may include nausea, vomiting, or abdominal discomfort. In the event of suspected overdose, seek urgent medical care; supportive treatment is the mainstay, as no specific antidote exists.

Discontinuation

Daklinza does not require tapering. Therapy is usually completed after the prescribed treatment duration (commonly 12 weeks). If therapy is stopped early, the patient should be evaluated for virologic relapse and may need an alternative regimen.

Monitoring and Follow-Up

Effective HCV treatment with Daklinza involves regular clinical monitoring:

  • Baseline labs: HCV RNA level, liver function tests (ALT, AST, bilirubin), complete blood count, renal function.
  • On-treatment labs: HCV RNA at week 4 and at the end of treatment to assess viral clearance; liver enzymes may be repeated if clinically indicated.
  • Post-treatment: A final HCV RNA test 12 weeks after completing therapy determines whether a sustained virologic response (SVR) has been achieved, which is considered a cure.

Patients should report any new symptoms, especially signs of liver decompensation (jaundice, abdominal swelling) or severe allergic reactions.

Storage and Handling

  • Store Daklinza tablets at room temperature (15 °C - 30 °C), away from excess moisture and heat.
  • Keep the medication in the original container with the lid tightly closed.
  • Do not use the pills after the expiry date printed on the package.
  • Dispose of unused tablets in accordance with local pharmacy take-back schemes or follow the MHRA guidelines for safe disposal of medicines.

Medication-Specific Glossary

NS5A inhibitor
A class of antivirals that block the hepatitis C virus non-structural protein 5A, disrupting viral replication and assembly.
Sustained virologic response (SVR)
The absence of detectable HCV RNA in the blood 12 weeks (or more) after completing treatment, indicating a cure.
Child-Pugh classification
A scoring system used to assess the severity of chronic liver disease, categorising patients as class A (mild), B (moderate), or C (severe).
CYP3A4
A liver enzyme that metabolises many drugs; substances that induce or inhibit CYP3A4 can alter the levels of medications processed by this pathway.

Medical Disclaimer

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

Information for Daklinza is sourced from established medical standards and updated frequently. It is provided for general guidance and should be confirmed with a healthcare professional before use.
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