Daclaxen 60 MG (Daclatasvir)
Product Name : Daclaxen
Generic Name : Daclatasvir
Formulation : Tablet
Available Pack Size : 28’s
Available Strengths : 60 mg
Registrations : Export Only
Product Information
Daclaxen (Daclatasvir) 60mg is an oral HCV NS5A inhibitor used in combination with sofosbuvir for the treatment of chronic Hepatitis C Virus (HCV) genotype 1 or genotype 3 infection. It works through dual modes of antiviral activity, binding the N-terminus of the NS5A protein to inhibit both viral RNA replication and virion assembly, complementing sofosbuvir’s action at a different stage of the HCV life cycle. Daclaxen is not used alone but always as part of a combination regimen. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Daclaxen (Daclatasvir) 60mg
| Brand Name | Daclaxen (Daclatasvir) |
| Generic Name | Daclatasvir (as Daclatasvir Dihydrochloride) INN |
| Drug Class | HCV NS5A Inhibitor (Direct-Acting Antiviral) |
| Available Strength | 60mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 28 Tablets per Pack |
| Primary Indication | Chronic Hepatitis C Virus (HCV) Genotype 1 or Genotype 3 Infection, With Sofosbuvir |
| Regulatory Approvals | USFDA Approved (Combination Therapy for HCV Genotype 1 and 3). EMA Approved. Carries an FDA Boxed Warning for HBV reactivation risk. |
| Originator Brand | Daklinza by Bristol Myers Squibb |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration Status | Export Only – Manufactured for International Markets |
| Storage Conditions | Store below 30 degrees Celsius. Keep in a dry place away from light and moisture. Keep out of the reach of children. |
How Daclaxen (Daclatasvir) Works
Daclaxen contains Daclatasvir, an inhibitor of the HCV NS5A protein, a multifunctional protein that is an essential component of the HCV replication complex. Daclatasvir binds to the N-terminus (domain I) of NS5A, and this binding produces dual modes of antiviral activity: it inhibits viral RNA replication and also disrupts virion assembly, the process by which new infectious virus particles are formed.
Because Daclatasvir targets a different stage of the HCV life cycle than sofosbuvir (an NS5B polymerase inhibitor), Daclaxen is always used together with sofosbuvir, with or without ribavirin, to provide effective, complementary suppression of the virus while minimising the chance of resistance developing. In the pivotal ALLY-3 study, Daclatasvir plus sofosbuvir given for 12 weeks achieved high sustained virologic response rates in patients with genotype 3 infection, one of the historically more difficult-to-treat HCV genotypes.
Daclaxen is taken as a once-daily oral tablet, with or without food, forming part of a fully oral, interferon-free HCV treatment regimen.
Indications for Daclaxen (Daclatasvir)
Daclaxen (Daclatasvir), in combination with sofosbuvir, is indicated for the following:
|
Genotype 3 Chronic HCV For adult patients with chronic HCV genotype 3 infection, including those with compensated cirrhosis, in combination with sofosbuvir. |
Genotype 1 Chronic HCV For adult patients with chronic HCV genotype 1 infection, in combination with sofosbuvir, with or without ribavirin. |
|
Challenging-to-Treat Patient Populations Also studied and used, in combination with sofosbuvir, in patients with HCV/HIV-1 co-infection, advanced (decompensated) cirrhosis, or recurrence of HCV following liver transplantation. |
|
Benefits of Daclaxen (Daclatasvir) 60mg
|
First All-Oral Option for Genotype 3 Daclatasvir plus sofosbuvir was the first 12-week, once-daily, all-oral treatment option for genotype 3 HCV, historically one of the hardest genotypes to treat effectively. |
Dual Antiviral Mechanism By inhibiting both viral RNA replication and virion assembly, Daclatasvir provides broader suppression of HCV than a single-mechanism antiviral. |
Interferon-Free Regimen Daclaxen combined with sofosbuvir avoids the need for interferon injections, reducing the burden and side effects associated with older HCV treatment regimens. |
|
Affordable Alternative to Daklinza Daclaxen contains the same active ingredient as Daklinza by Bristol Myers Squibb, at a significantly lower cost, making combination HCV therapy more financially accessible worldwide. |
Suited to Complex Patient Groups Daclaxen plus sofosbuvir has been used in challenging-to-treat populations, including HIV-coinfected patients and those with advanced cirrhosis or post-transplant HCV recurrence. |
cGMP Certified Manufacturing Produced by Everest Pharmaceuticals Ltd. under cGMP-compliant manufacturing standards, helping ensure consistent quality, purity, and potency in every batch of Daclaxen tablets. |
How to Take Daclaxen (Daclatasvir)
Route: Oral, with or without food. The tablet should be swallowed whole.
Standard dose: One 60mg tablet, taken orally, once daily, in combination with sofosbuvir, with or without ribavirin as directed, for 12 weeks. Treatment duration in patients with cirrhosis is individualised by the prescribing physician.
Missed dose: If a dose is missed and remembered within 20 hours of the usual time, take it as soon as possible; if more than 20 hours have passed, skip the missed dose and resume the normal schedule the next day.
Dose adjustment for CYP3A4 interactions: Reduce the dose to 30mg once daily when co-administered with strong CYP3A4 inhibitors. Increase the dose to 90mg once daily when co-administered with moderate CYP3A4 inducers. Strong CYP3A4 inducers should not be used with Daclaxen, as they substantially reduce Daclatasvir exposure and may result in loss of therapeutic effect.
Hepatic impairment: No dose adjustment is required for hepatic impairment.
Renal impairment: No dose adjustment is required for renal impairment.
Dose reduction for adverse reactions: Dose reduction of Daclaxen for adverse reactions is not recommended; if a serious adverse reaction occurs, treatment interruption or discontinuation should be discussed with the prescribing physician.
Combination therapy: Daclaxen is not intended to be used as a standalone treatment for HCV. Refer also to the prescribing information for sofosbuvir, and ribavirin if prescribed, as these carry their own dosing requirements and precautions.
Monitoring and Dosage Adjustments
Before starting Daclaxen, all patients must be tested for current or prior Hepatitis B virus infection. Your physician will review your full medication list for CYP3A4 or P-glycoprotein-affecting drugs that may require a dose adjustment. Monitoring during treatment largely follows the requirements of the companion antiviral agent(s); if ribavirin is included in your regimen, haemoglobin monitoring is required. If Daclaxen and sofosbuvir are combined with amiodarone, close cardiac monitoring is required due to a risk of serious bradycardia. Report any yellowing of the skin or eyes, unusual fatigue, dizziness, fainting, or a very slow or irregular heartbeat to your doctor immediately.
Drug Interactions and Important Information
Daclatasvir is a substrate of CYP3A4 and both a substrate and inducer of P-glycoprotein (P-gp), giving it meaningful potential for drug interactions. Strong CYP3A4 inducers, such as rifampin, carbamazepine, phenytoin, and St. John’s Wort, are not recommended with Daclaxen due to substantially reduced drug exposure. Dose adjustment is required with strong CYP3A4 inhibitors (dose reduction) and moderate CYP3A4 inducers (dose increase), including certain antiretroviral medications used in HIV treatment.
Daclaxen (with sofosbuvir) should not be used with amiodarone unless no alternative treatment is available, due to a risk of serious symptomatic bradycardia associated with sofosbuvir-containing regimens combined with amiodarone. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Daclaxen, particularly any antiretroviral therapy if you are HIV-coinfected.
Side Effects and Precautions
|
Common Side Effects Fatigue Headache Nausea Diarrhoea |
Serious Warnings and Precautions Hepatitis B virus reactivation in HCV/HBV coinfected patients, potentially fatal. Requires baseline HBV testing. Serious symptomatic bradycardia when the combination is used with amiodarone, in rare cases fatal. Reduced treatment response in genotype 3 patients with cirrhosis; treatment duration and expected response should be discussed with your physician. |
Who Should Use Daclaxen (Daclatasvir)?
Daclaxen is suitable for adult patients with chronic Hepatitis C virus genotype 1 or genotype 3 infection, being treated with a physician-prescribed combination of Daclaxen and sofosbuvir (with or without ribavirin), including patients with compensated cirrhosis, HIV-1 co-infection, or post-liver transplant HCV recurrence. It is prescribed by hepatologists, gastroenterologists, and infectious disease specialists experienced in managing combination HCV therapy. A thorough medical assessment including HCV genotype testing, HBV testing, and a review of concomitant medications is required before initiating treatment.
Manufacturer: Everest Pharmaceuticals Ltd.
Everest Pharmaceuticals Ltd. is a vertically integrated pharmaceutical company based in Dhaka, Bangladesh, focused on complex, technology-driven specialty medicines across oncology, nephrology, and virology. Operating under Bangladesh’s TRIPS/Doha Declaration exemption for least-developed countries, Everest manufactures advanced generics such as Daclaxen under cGMP-compliant standards, with the stated mission of making high-cost, life-saving medicines accessible and affordable to patients around the world. Daclaxen is one of Everest’s specialty virology products, offering a bioequivalent alternative to Daklinza by Bristol Myers Squibb at a fraction of the cost.
Global Supplier: Mediaid Pharmacy with Worldwide Shipping
Mediaid Pharmacy is a trusted global supplier of specialty medications. We ensure Daclaxen (Daclatasvir) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.
Why Choose Daclaxen (Daclatasvir) from Mediaid Pharmacy?
Daclaxen represents a proven, effective option for patients with genotype 1 or genotype 3 chronic HCV, including some of the more challenging-to-treat patient populations. As the generic equivalent of Daklinza by Bristol Myers Squibb, it delivers the same active ingredient, Daclatasvir, with the same proven dual-mechanism NS5A inhibition at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under cGMP-compliant standards and distributed globally by Mediaid Pharmacy, Daclaxen gives patients worldwide access to essential combination HCV therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Daclatasvir option with worldwide delivery, Daclaxen from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Daclaxen (Daclatasvir)
What is Daclaxen used for?
Daclaxen (Daclatasvir) is used, always in combination with sofosbuvir, to treat chronic Hepatitis C virus genotype 1 or genotype 3 infection in adults, including patients with compensated cirrhosis, HIV co-infection, or post-transplant HCV recurrence. It works by blocking a key viral protein needed for HCV replication and the assembly of new virus particles.
How should I take Daclaxen?
Daclaxen is taken as one 60mg tablet, once daily, with or without food, always alongside sofosbuvir (with or without ribavirin, as prescribed). Treatment typically lasts 12 weeks. Never take Daclaxen alone, and complete the full prescribed course even if you feel well.
What strength is Daclaxen available in?
Daclaxen is available in a 60mg film-coated tablet, supplied in a pack of 28 tablets, enough for a standard 4-week supply at the once-daily dose. A lower dose may be needed if you are taking certain other medications, as directed by your physician.
Is Daclaxen the same as Daklinza (Daclatasvir by Bristol Myers Squibb)?
Yes. Daclaxen is the generic equivalent of Daklinza. Both contain the same active ingredient, Daclatasvir, and work through the same NS5A inhibition mechanism. Daclaxen is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and delivers the same clinical mechanism as Daklinza at a significantly lower cost.
What are the side effects of Daclaxen?
Common side effects include fatigue, headache, nausea, and diarrhoea, generally mild to moderate in severity. The most important risks are Hepatitis B virus reactivation in patients also infected with HBV, and serious slow heart rate if the regimen is combined with amiodarone. Always consult your physician for a complete assessment of your individual risks and benefits before starting treatment.
Can Daclaxen be used with other medications?
Daclaxen has meaningful interactions with medications that affect CYP3A4, including many antiretroviral drugs, and may require dose adjustment. Strong CYP3A4 inducers such as rifampin should not be used with Daclaxen. Always inform your physician of all medications, supplements, and herbal products you are taking before starting Daclaxen, particularly if you are also being treated for HIV.
Is Daclaxen safe during pregnancy or breastfeeding?
Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding. This is especially important if ribavirin is part of your regimen, as ribavirin carries significant pregnancy-related restrictions for both patients and their partners.
Can I order Daclaxen online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Daclaxen (Daclatasvir) globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.
Order Daclaxen (Daclatasvir) 60mg with Worldwide Shipping
Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com
