

Dasicast 60mg Tablet (Daclatasvir)
Manufactured By
Aprazer Healthcare Pvt Ltd
Pack Of
28
Salt Composition
Daclatasvir
Storage
Keep in cold place
ALL SUBSTITUTES
Overview
Dasicast 60mg Tablet is a prescription antiviral medicine containing daclatasvir, a direct-acting antiviral (DAA) that inhibits the hepatitis C virus (HCV) NS5A protein. Daclatasvir 60mg tablet must be used as part of an appropriate combination antiviral regimen; it is not HCV monotherapy. Historically, daclatasvir tablet was authorized in combination with other medicines for chronic HCV infection across selected genotypes and patient populations. The exact partner medicine, treatment duration and role of ribavirin depended on HCV genotype, cirrhosis, prior treatment and other clinical factors.
An important publication point for Madicine: the European marketing authorization for originator Daklinza expired in August 2019 for commercial reasons. Daclatasvir 60mg remains used or available in some jurisdictions, but its place in current therapy varies. The page should therefore avoid presenting an old regimen as universally current first-line treatment.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | dasicast |
| Generic / Active Ingredient | Daclatasvir |
| Strength | 60 |
| Dosage Form | Tablet |
| Manufacturer / Marketer | Aprazer Healthcare Pvt Ltd |
| Pack Size | 28 |
| Prescription Required | Yes |
| Therapeutic Categories | Hepatitis Medicines |
| Uses | Hepatitis C |
Uses and Indications
Dasicast 60mg tablet should be used only for an appropriate specialist-directed indication. The exact treatment setting, combination regimen and duration depend on the diagnosis and current clinical guidance.
Chronic hepatitis C infection: Daclatasvir tablet is an HCV direct-acting antiviral used with other antiviral medicines. The precise regimen must be selected according to the patient's HCV genotype, cirrhosis status, previous treatment, renal/hepatic status and current local guidance.
Combination with sofosbuvir: Daclatasvir 60mg tablet plus sofosbuvir became an important interferon-free regimen in multiple HCV populations. Treatment duration and whether ribavirin was added varied by genotype and disease characteristics.
Special populations: Historically, daclatasvir 60mg-based regimens were studied in patients with advanced liver disease and post-transplant HCV, but current regimen selection should follow contemporary local HCV guidelines.
How Dasicast 60mg Tablet Works
Daclatasvir tablet acts on the hepatitis C virus NS5A protein. This protein is essential for the multiplication of viral genome and production of new viruses. The medicine inhibits this protein, resulting in rapid reduction in the replication of the virus. In order to prevent resistance, daclatasvir 60mg is recommended only as part of combination therapy.
Clinical Evidence for Dasicast 60mg Tablet
Clinical evidence for daclatasvir 60mg tablet comes from combination-regimen studies rather than daclatasvir monotherapy. Studies of Dasicast 60mg tablet plus sofosbuvir demonstrated high sustained virologic response rates in several HCV populations, including difficult-to-treat groups.
Historical regulatory product information described genotype- and disease-specific regimens and emphasized use with other antivirals. Modern DAA options have evolved, so treatment selection should be based on current national/international HCV guidance rather than copying an older regimen unchanged.
Side Effects of Dasicast 60mg Tablet
Common or clinically relevant adverse effects can include:
- Headache
- Fatigue
- Nausea
- When combined with ribavirin: anemia may occur
- Adverse effects also depend strongly on the partner antiviral regimen
Serious adverse reactions can include:
- Hepatitis B reactivation during or after DAA therapy
- Clinically important drug interactions through CYP3A
- Serious bradycardia reported with sofosbuvir-containing regimens and amiodarone in relevant DAA labeling/history
- Decompensation risk in patients with advanced liver disease depends on regimen and baseline status
Patients should receive medicine-specific instructions about symptoms that require urgent medical attention.
Common or Clinically Frequent Side Effects
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Critical Safety Warning
- Dasicast tablet is a prescription medicine that requiring appropriate specialist supervision.
- Patients should be tested for current or previous hepatitis B infection before DAA treatment because HBV reactivation has been reported during or after HCV DAA therapy.
- The medicine exposure is strongly affected by CYP3A modulators. Strong CYP3A inducers can make therapy ineffective; moderate/strong inhibitors can require dose adjustment according to historical labeling.
- However, Daclatasvir 60mg must not be used alone. The partner regimen and duration should follow current specialist guidance and local availability.
- Because HCV treatment standards evolve quickly, a current hepatology/infectious-disease review is essential before publishing a specific regimen as preferred.
Dasicast 60mg Tablet Dosage and How To Take It
There is no safe basis for choosing a dose simply from the 60mg pack strength. The prescribed regimen depends on the approved indication and patient factors.
These are molecule-level examples/principles from regulatory labeling and are not instructions for self-dosing. The treating specialist determines the actual dose, duration, dose modifications and supportive treatment.
| Clinical situation | Dose |
|---|---|
| Standard historical adult dose | Take 60mg orally once daily, with or without food. |
| With strong CYP3A inhibitors | In historical labeling, the dose was reduced to 30 mg once daily when used with certain strong CYP3A inhibitors. |
| With moderate CYP3A inducers | Historical labeling increased daclatasvir 60mg to 90mg once daily with specified moderate CYP3A inducers. |
| Strong CYP3A inducers | The use of such medications is not recommended since they may significantly lower the concentration of daclatasvir tablet in the body. |
| Treatment duration | The course of the therapy will vary depending on different variables, including HCV genotype, cirrhosis, previous therapy, and others. Local HCV therapy recommendations must be adhered to. |
Dasicast 60mg Tablet Missed Dose
Historical product information advised taking a missed dose as soon as possible if remembered within 20 hours of the scheduled time; if more than 20 hours late, skip it and take the next dose at the usual time. Do not double the dose. The current Dasicast 60mg tablet insert should be checked before publication.
Safety Advice for Dasicast 60mg Tablet
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | High Caution | Pregnancy guidance should be provided based on the overall treatment regimen. Regimens that include ribavirin have specific limitations in pregnant women. |
| Breastfeeding | High Caution | Breastfeeding guidance should be provided to the treating physician based on all the medications in the treatment regimen. |
| Hepatitis B | Monitor | Testing for hepatitis B infection is required prior to the initiation of the therapy. Monitoring for HBV reactivation is needed in patients who are at risk for HBV reactivation. |
| Liver disease | High Caution | The choice and duration of treatment are guided by the presence of cirrhosis or advanced liver disease. |
| Drug interactions | High Caution | Medication review is essential because daclatasvir tablet undergoes metabolism through the CYP3A enzyme system and might interfere with other medications. |
| Adherence | Monitor | Proper daily intake of the medication is crucial for obtaining the intended antiviral effect and preventing resistance development. |
Monitoring During Dasicast 60mg Tablet Treatment
Monitoring is individualized according to the disease, regimen and patient risk factors. It may include:
- Baseline HCV RNA and genotype/regimen assessment where relevant
- Liver function and cirrhosis status
- HBV screening before DAA therapy
- Drug-interaction review
- HCV RNA response according to current treatment protocol
- Adherence and adverse effects
Dasicast 60mg Tablet Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Dasicast |
| Molecule | Daclatasvir |
| Strength | 60mg |
| Dosage form | Tablet |
| Therapy type | Hepatitis C virus NS5A inhibitor |
| Route | Oral |
| Prescription required | Yes |
| Dose principle | Indication/protocol-specific; do not infer patient dose from pack strength |
| Medical supervision | Required |
Dasicast 60mg Tablet Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| OTC medicines, supplements and herbal products | They may influence the safety, efficacy, or dosage of Daclatasvir 60 mg tablet. | Check the list of medications and supplements before treatment. |
| Strong CYP3A inducers — rifampicin, carbamazepine, phenytoin, St John's wort | May significantly lower exposure to the Daclatasvir 60 mg tablets. | Do not take concurrently unless explicitly recommended by the treating specialist. |
| Strong CYP3A inhibitors | Increases exposure to daclatasvir, and dose adjustment may be required based on the regimen. | Check the particular combination and adhere to prescribing instructions. |
| Amiodarone with certain sofosbuvir-containing DAA regimens | Severe bradycardia has been reported with this combination. | For use in conjunction with expert assessment and cardiac monitoring. |
| P-gp/OATP/BCRP substrates or interacting medicines | Transporter-mediated interactions could affect drug disposition. | Evaluate the entire protocol for clinically significant interactions involving transporters. |
FAQs About Dasicast 60mg Tablet
What are the uses of Dasicast 60mg Tablet?
Dasicast 60mg Tablet is used in combination with other antiviral drugs for the treatment of chronic hepatitis C in appropriate cases.
Is daclatasvir 60mg administered in isolation?
No, Dasicast 60mg Tablet is supposed to be used in combination with other antiviral drugs used in the treatment of hepatitis C.
What is meant by the term NS5A inhibitor?
NS5A inhibitor refers to an agent that blocks a certain protein which is essential for reproduction of the hepatitis C virus.
Is 60mg the normal daclatasvir tablet dose?
Traditionally, 60mg once per day was the usual dose for adult patients. This could be modified to 30mg or 90mg depending on drug interactions.
Can Dasicast 60 mg Tablet be used with sofosbuvir?
There has been a combination treatment between daclatasvir tablet and sofosbuvir that has already become a well-established antiviral combination therapy. The current usage should be done following the latest local guidelines for hepatitis C infection treatment.
Why is hepatitis B testing required prior to starting the Dasicast 60mg treatment?
There is a chance of reactivation of hepatitis B virus in patients undergoing direct-acting antivirals treatment for hepatitis C.
Is rifampicin compatible with daclatasvir 60mg tablet?
CYP3A enzyme inducers like rifampicin cause a dramatic decrease in plasma concentration of daclatasvir 60mg. However, combination is contraindicated based on labeling history.
How can it be verified that HCV treatment was successful?
Physicians examine HCV RNA concentrations and evaluate whether sustained virologic response was achieved as a result of treatment, depending on its regimen.
Does Dasicast 60mg Tablet require review by specialist at present?
Yes. Guidelines for HCV therapy vary in time. Therefore, the choice of medications and the course length should be up-to-date.
References
1. European Medicines Agency. Daklinza (daclatasvir) EPAR and product information; EU authorization expired August 2019 for commercial reasons. https://www.ema.europa.eu/en/medicines/human/EPAR/daklinza
2. Historical daclatasvir regulatory product information and HCV combination-regimen clinical evidence https://pmc.ncbi.nlm.nih.gov/articles/PMC5097339/
3. Current local HCV treatment guidelines and current India-specific Dasicast package insert before publication https://www.ncbi.nlm.nih.gov/books/NBK559965/
4. Brand-specific Dasicast prescribing information/package insert should remain the primary source for manufacturer, exact presentation, storage, pack configuration and India-specific approved labeling before publication.
Marketer Details
Aprazer Healthcare Pvt Ltd
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