Natdac 60 Tablet (Daclatasvir 60mg): Complete Product Information

Product Overview

Natdac 60 Tablet is a prescription-based antiviral medication containing Daclatasvir (60 mg) as its active pharmaceutical ingredient. It belongs to the class of hepatitis C virus (HCV) NS5A inhibitors and is used exclusively in combination with other antiviral agents for the treatment of chronic hepatitis C virus (HCV) infection .

Natdac 60 is manufactured by Natco Pharma Ltd , a prominent Indian pharmaceutical company known for producing high-quality generic antiretroviral and antiviral medications . The medication has revolutionized hepatitis C treatment by offering a more tolerable and highly effective alternative to older interferon-based regimens.

Hepatitis C is a serious viral infection that primarily affects the liver. If left untreated, chronic HCV infection can lead to progressive liver damage, including cirrhosis (liver scarring), liver failure, and hepatocellular carcinoma (liver cancer). Natdac 60, when used as part of a direct-acting antiviral (DAA) regimen, helps eliminate the virus from the body, allowing the liver to heal and preventing long-term complications .

Natdac 60 is not a cure for hepatitis C in the sense of preventing reinfection, but when used appropriately in combination therapy, it achieves sustained virologic response (SVR) —essentially a cure—in over 90% of patients. The goal of treatment is to achieve SVR at 12 weeks after completing therapy (SVR12), which indicates that the virus has been cleared from the bloodstream and is no longer detectable .

Key Specifications

Clinical Pharmacology (How Natdac 60 Works)

Mechanism of Action

Natdac 60 contains Daclatasvir, a first-in-class HCV NS5A inhibitor. To understand how this medication works, it is helpful to understand the lifecycle of the hepatitis C virus.

The HCV Lifecycle:

1. The hepatitis C virus enters liver cells (hepatocytes)

2. The virus uses its RNA (genetic material) to produce viral proteins

3. A viral protein called NS5A plays a critical role in viral RNA replication and assembly of new virus particles

4. Without functional NS5A, the virus cannot multiply or produce infectious progeny

How Daclatasvir Works:
Daclatasvir specifically targets and inhibits the NS5A protein. It binds to the NS5A protein with very high affinity, disrupting two essential viral functions :

• Inhibition of RNA Replication: By binding to NS5A, daclatasvir prevents the virus from copying its RNA genome. Without this replication step, the virus cannot produce new genetic material to package into new virus particles.

• Disruption of Virus Assembly: NS5A is also involved in the assembly of new virus particles. Daclatasvir interferes with this assembly process, preventing the formation of mature, infectious viruses.

The molecular structure of daclatasvir has twofold symmetry, which is significant because the NS5A protein functions as a dimer (two identical proteins working together). Research suggests that daclatasvir binds to this dimer interface, explaining its potent antiviral activity .

The Importance of Combination Therapy

CRITICAL: Natdac 60 must NEVER be used as monotherapy (alone). Daclatasvir is always used in combination with other direct-acting antivirals, typically:

• Sofosbuvir (400 mg) – an HCV NS5B polymerase inhibitor

• With or without Ribavirin – a broad-spectrum antiviral nucleoside analogue

The combination of daclatasvir with sofosbuvir targets the virus at two different stages of its lifecycle, making it extremely difficult for the virus to develop resistance. This dual-target approach is why modern DAA regimens achieve cure rates exceeding 95% .

Pharmacokinetics

Potency by HCV Genotype

Daclatasvir is effective against multiple HCV genotypes, with some variability in potency:

• Genotype 1b: Most sensitive to daclatasvir

• Genotype 1a: Less potently affected; resistance mutations have a greater effect than in genotype 1b 

• Genotype 3: Effective, though longer treatment duration may be required in cirrhotic patients

• Genotype 4: Effective with appropriate combination therapy

Primary Uses (Indications)

Natdac 60 Tablet is indicated for the treatment of chronic hepatitis C virus (HCV) infection in combination with other antiviral agents .

Specific Indications by Genotype

HCV Genotype 1 Infection:

• In combination with sofosbuvir, with or without ribavirin

• Effective in treatment-naïve and treatment-experienced patients

• Suitable for patients with or without cirrhosis (compensated) 

HCV Genotype 3 Infection:

• In combination with sofosbuvir

• For patients without cirrhosis: 12-week treatment course 

• For patients with cirrhosis: 24-week treatment course (with or without ribavirin) 

HCV Genotype 4 Infection:

• In combination with sofosbuvir

• May also be used with pegylated interferon and ribavirin 

Post-Liver Transplant HCV Recurrence:

• In combination with sofosbuvir and ribavirin for patients who develop HCV recurrence after liver transplantation 

Key Benefits

• High Cure Rates: Clinical studies demonstrate SVR12 rates exceeding 90-95% across multiple genotypes

• Oral Administration: No injections required (unlike older interferon-based therapy)

• Short Treatment Duration: Typically 12 to 24 weeks, compared to 48 weeks with interferon

• Fewer Side Effects: Well-tolerated compared to interferon-based regimens

• All-Oral Regimen: No need for injectable medications 

Dosage and Administration

Standard Adult Dose

The recommended dosage of Natdac 60 for most adults is one 60 mg tablet taken once daily .

Important Administration Guidelines:

Duration of Therapy by Patient Category

Genotype 1 or 4:

• Without cirrhosis: 12 weeks (daclatasvir + sofosbuvir) 

• With compensated cirrhosis (Child-Pugh A or B): 12 weeks (daclatasvir + sofosbuvir + ribavirin) OR 24 weeks (daclatasvir + sofosbuvir without ribavirin) 

• With decompensated cirrhosis (Child-Pugh C): 24 weeks (daclatasvir + sofosbuvir ± ribavirin) 

Genotype 3:

• Without cirrhosis: 12 weeks (daclatasvir + sofosbuvir) 

• With cirrhosis: 24 weeks (daclatasvir + sofosbuvir ± ribavirin) 

Post-Liver Transplant:

• Without cirrhosis: 12 weeks (daclatasvir + sofosbuvir + ribavirin) 

• With cirrhosis: 24 weeks (daclatasvir + sofosbuvir ± ribavirin) 

Missed Dose Instructions

• If you miss a dose and it has been less than 12 hours since your scheduled time: Take the missed dose immediately with food 

• If you miss a dose and it has been more than 12 hours: Skip the missed dose and take the next dose at your regular scheduled time

• Do NOT double the dose to make up for a missed dose 

Overdose

No specific overdose symptoms have been reported with daclatasvir. However, taking more than the prescribed dose will not improve treatment outcomes and may increase the risk of side effects. If you suspect an overdose, seek medical attention immediately or contact a poison control center .

Side Effect Profile

Natdac 60 is generally well-tolerated, with a favorable safety profile compared to older hepatitis C treatments like interferon-based regimens. However, as with all medications, side effects can occur .

Common Side Effects (Occurring in >5-10% of patients)

These side effects are typically mild to moderate and often resolve as the body adjusts to the medication:

Less Common Side Effects

• Abdominal pain

• Joint pain (arthralgia)

• Muscle pain (myalgia)

• Weakness (asthenia)

• Drowsiness (somnolence) 

Side Effects Requiring Immediate Medical Attention

Side Effect Management Strategies

For Headache:

• Drink adequate water to prevent dehydration

• Practice deep breathing and meditation for stress relief

• Ensure 7-8 hours of sleep

• Lie down in a quiet, dark room

• Apply cold or warm compresses

• Use over-the-counter pain relievers (acetaminophen/ibuprofen) after consulting your doctor

• Seek immediate medical attention for sudden, severe headaches 

For Nausea:

• Take medication with food

• Eat small, frequent meals rather than large meals

• Avoid strong odors and greasy/spicy foods

• Stay hydrated with clear fluids

For Fatigue:

• Plan rest periods throughout the day

• Maintain a regular sleep schedule

• Engage in light physical activity as tolerated

• Stay well-nourished and hydrated

Contraindications

Natdac 60 Tablet is contraindicated in the following situations:

1. Hypersensitivity

Known severe allergic reaction to daclatasvir, any component of the formulation, or other NS5A inhibitors 

2. Concomitant Medications (Strong CYP3A Inducers)

Natdac 60 must NOT be used with drugs that are strong inducers of CYP3A, as these medications significantly reduce daclatasvir blood levels, leading to treatment failure. These include:

3. Monotherapy (Use Without Sofosbuvir)

Daclatasvir must never be used alone. It should always be used in combination with sofosbuvir (and sometimes ribavirin). Using daclatasvir as monotherapy significantly increases the risk of viral resistance and treatment failure .

Warnings and Special Precautions

1. Hepatitis B Virus (HBV) Reactivation

CRITICAL WARNING: There have been reports of hepatitis B virus reactivation in patients co-infected with HCV and HBV who are treated with direct-acting antivirals, including daclatasvir .

Required Actions:

• All patients should be screened for HBV infection before starting Natdac 60

• Testing should include HBsAg and HBcAb

• Patients with evidence of prior HBV infection should be monitored for clinical and laboratory signs of hepatitis flare during and after treatment

• HBV reactivation can be severe and may lead to liver failure or death

2. Symptomatic Bradycardia (Slow Heart Rate)

Serious Warning: Serious symptomatic bradycardia (abnormally slow heart rate) has been reported in patients taking amiodarone (a heart medication) who are treated with sofosbuvir-containing regimens, including those containing daclatasvir .

Risk Factors:

• Patients taking beta-blockers 

• Patients with underlying cardiac disease 

• Patients with liver disease 

Symptoms to Monitor:

• Dizziness or lightheadedness

• Fainting or near-fainting

• Shortness of breath

• Chest pain

• Confusion or memory problems

• Extreme fatigue

Action: If you take amiodarone or have any heart condition, inform your doctor before starting Natdac 60. Cardiac monitoring may be required.

3. Drug-Induced Liver Injury

While rare, liver injury has been reported with daclatasvir-containing regimens. Monitor for signs of liver dysfunction (jaundice, dark urine, severe fatigue, abdominal pain).

4. Immune Reconstitution Inflammatory Syndrome (IRIS)

In patients co-infected with HIV and HCV, starting direct-acting antiviral therapy may lead to IRIS, where the recovering immune system mounts an inflammatory response against previously undiagnosed opportunistic infections.

5. Pregnancy and Contraception

• The safety of daclatasvir during pregnancy has not been fully established. There are no adequate and well-controlled studies in pregnant women .

• When used with ribavirin (Pregnancy Category X), extreme caution is required. Ribavirin is contraindicated in pregnancy and for 6 months after treatment in both female patients and female partners of male patients.

• Effective contraception must be used during treatment and for 5 weeks after the last dose of daclatasvir when used with ribavirin .

6. Breastfeeding

It is unknown whether daclatasvir is excreted in human breast milk. Because of the potential for adverse effects in nursing infants, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the treatment to the mother .

7. Pediatric Use

Natdac 60 is not recommended for use in children below 18 years of age, as the efficacy and safety have not been established .

8. Geriatric Use

Natdac 60 is generally considered safe in geriatric patients when used under medical supervision. However, age-related sensitivities may exist, and dose adjustments are generally not required based on age alone .

9. Liver Transplant Patients

Special considerations apply to patients who have undergone liver transplantation. Daclatasvir should be used with caution due to potential drug interactions with immunosuppressant medications (e.g., cyclosporine, tacrolimus) .

10. Laboratory Monitoring

Your doctor will perform regular blood tests to monitor:

• Liver function tests (ALT, AST, bilirubin)

• Hepatitis C viral load (HCV RNA)

• Complete blood count (especially when used with ribavirin)

• Hepatitis B serology (for co-infected patients)

Drug Interactions

Natdac 60 is metabolized primarily by the CYP3A4 enzyme. Drugs that induce or inhibit this enzyme can significantly affect daclatasvir blood levels. Always provide your doctor with a complete list of all medications, supplements, and herbal products you are taking.

Major Drug Interactions

Drug Interaction Management Protocol

Use in Special Populations

Clinical Efficacy Data

Study Findings

A clinical study involving 226 patients with chronic hepatitis C who received sofosbuvir-based DAA therapy (including the sofosbuvir + daclatasvir regimen) demonstrated the following outcomes :

Overall SVR12 Rate: 96% (216 out of 226 patients achieved sustained virologic response at 12 weeks post-treatment)

By Regimen:

• SOF+DCV (sofosbuvir + daclatasvir) group: 93% SVR12

• SOF+LDV (sofosbuvir + ledipasvir) group: 97% SVR12

• SOF+VEL (sofosbuvir + velpatasvir) group: 100% SVR12

Rapid Viral Decline:

• 70% of patients had undetectable HCV RNA by Week 1 of treatment

• 95% had undetectable HCV RNA by Week 4 of treatment

• 100% had undetectable HCV RNA by the end of treatment

These results demonstrate that daclatasvir, when combined with sofosbuvir, is a highly effective treatment for chronic hepatitis C, even in patients with prior treatment experience.

Genotype Distribution in Study Population

The study population included multiple HCV genotypes :

• Genotype 1b: 61.9%

• Genotype 6a: 19.9%

• Genotype 2a: 8.4%

• Genotype 3b: 5.3%

• Genotype 3a: 4.4%

Storage and Handling

Patient Education and Counseling Points

Before Starting Treatment

1. Inform your doctor about:

   • Any history of hepatitis B infection (you will be screened)

   • Any heart conditions, especially if taking amiodarone or beta-blockers

   • Any liver transplant history

   • All medications, including over-the-counter drugs, supplements, and herbal products (especially St. John’s Wort)

   • Pregnancy status or plans to become pregnant (especially important if treatment includes ribavirin)

   • Breastfeeding status

2. Confirm that you understand:

   • Natdac 60 must be taken with sofosbuvir (not alone)

   • The expected treatment duration (12 or 24 weeks)

   • The importance of adherence for achieving cure

During Treatment

1. Take medication as prescribed:

   • One tablet once daily at the same time each day

   • Can be taken with or without food

   • Swallow whole; do not crush or chew

2. Do not miss doses:

   • Set a daily reminder

   • If you miss a dose, take it within 12 hours; if more than 12 hours have passed, skip and take next dose at regular time

   • Never double the dose

3. Complete the full course:

   • Do not stop early even if you feel better

   • Premature discontinuation increases risk of viral resistance and treatment failure 

4. Attend all follow-up appointments:

   • Blood tests to monitor liver function and viral load

   • SVR12 test (12 weeks after completing treatment) to confirm cure

5. Report side effects:

   • Mild side effects (headache, fatigue, nausea) are common and usually manageable

   • Report severe or persistent side effects to your doctor

   • Seek immediate care for chest pain, severe bradycardia, confusion, or signs of allergic reaction

After Treatment

1. Confirm cure: SVR12 testing at 12 weeks post-treatment

2. Understand that cure does not provide immunity: You can be reinfected if exposed again; continue safe practices

3. Monitor for HBV reactivation: If you have a history of hepatitis B, continue monitoring as directed

Comparison with Other HCV Treatments

Frequently Asked Questions (FAQ) – 25 Questions

Q1: What is Natdac 60 used for?

Natdac 60 Tablet is used for the treatment of chronic hepatitis C virus (HCV) infection. It is always used in combination with other antiviral medications, typically sofosbuvir, and sometimes with ribavirin. It is not used alone .

Q2: How does Natdac 60 work?

Natdac 60 contains Daclatasvir, which belongs to the class of HCV NS5A inhibitors. It works by blocking the activity of the hepatitis C virus in the liver cells. This causes viral RNA termination and reduces the amount of hepatitis C virus in the body .

Q3: Can I take Natdac 60 alone without other medications?

No. Daclatasvir should never be used without sofosbuvir. These medications together reduce the amount of hepatitis C virus in your body. Using daclatasvir alone significantly increases the risk of viral resistance and treatment failure .

Q4: What is the usual dose of Natdac 60?

The recommended dose is one 60mg tablet taken orally once daily, with or without food. The tablet should be swallowed whole with a glass of water, not chewed, crushed, or broken .

Q5: How long do I need to take Natdac 60?

The usual treatment duration is 12 weeks for most patients without cirrhosis. For patients with cirrhosis (especially genotype 3), treatment may extend to 24 weeks. Your doctor will determine the appropriate duration based on your HCV genotype, cirrhosis status, and prior treatment history .

Q6: What are the common side effects of Natdac 60?

Common side effects include fatigue, headache, nausea, insomnia (difficulty sleeping), and anemia (low red blood cell count). Most side effects are mild and do not require medical attention. They typically resolve as your body adjusts to the medication .

Q7: Can I take Natdac 60 with food?

Yes, Natdac 60 can be taken with or without food. Taking it with food may help reduce nausea in some patients .

Q8: What should I do if I miss a dose of Natdac 60?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose (within 12 hours), skip the missed dose and take the next dose at your regular time. Do not double the dose .

Q9: Is Natdac 60 safe during pregnancy?

The safety of Natdac 60 during pregnancy has not been fully established. When used with ribavirin (which is Pregnancy Category X and contraindicated in pregnancy), effective contraception must be used during treatment and for 5 weeks after the last dose. Consult your doctor if you are pregnant or planning to become pregnant .

Q10: Can I breastfeed while taking Natdac 60?

It is unknown whether daclatasvir passes into breast milk. A decision should be made to discontinue breastfeeding or discontinue the medication, considering the importance of treatment to the mother. Consult your doctor .

Q11: Is Natdac 60 safe for children?

No, Natdac 60 is not recommended for use in children below 18 years of age, as the efficacy and safety have not been established .

Q12: Do I need to adjust the dose if I have kidney problems?

No, Natdac 60 is safe to use in patients with kidney disease, and no dose adjustment is recommended, including for patients on dialysis .

Q13: Do I need to adjust the dose if I have liver problems?

No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C). Natdac 60 is safe for use even in patients with decompensated cirrhosis .

Q14: Can I drink alcohol while taking Natdac 60?

It is not known whether it is safe to consume alcohol with Natdac 60. Alcohol can worsen liver disease and may interfere with treatment. It is best to avoid alcohol or consult your doctor .

Q15: Can I drive while taking Natdac 60?

Natdac 60 may cause fatigue, dizziness, and blurred vision in some patients. Do not drive or operate heavy machinery until you know how this medication affects you .

Q16: What drugs should I avoid while taking Natdac 60?

Avoid strong CYP3A inducers such as rifampicin, carbamazepine, phenytoin, dexamethasone, and St. John’s Wort, as these can reduce daclatasvir levels and cause treatment failure. Also use caution with amiodarone due to risk of severe bradycardia .

Q17: Can Natdac 60 cure hepatitis C completely?

When used appropriately in combination with sofosbuvir, Natdac 60 achieves sustained virologic response (SVR) rates exceeding 90-95%, which is considered a cure. However, it does not provide immunity against future infection; you can be reinfected if exposed again .

Q18: What is SVR12?

SVR12 stands for Sustained Virologic Response at 12 weeks after completing treatment. It means that the hepatitis C virus is undetectable in your blood 12 weeks after finishing therapy. SVR12 is considered a cure for hepatitis C .

Q19: Does Natdac 60 interact with HIV medications?

Yes, some HIV medications can interact with daclatasvir. For example, efavirenz (a CYP3A inducer) may reduce daclatasvir levels, potentially requiring a dose increase to 90 mg. Ritonavir-boosted HIV protease inhibitors may increase daclatasvir levels, potentially requiring a dose reduction to 30 mg. Always inform your doctor about all HIV medications .

Q20: Will Natdac 60 reactivate hepatitis B?

There is a risk of hepatitis B virus reactivation in patients co-infected with HCV and HBV who are treated with direct-acting antivirals like daclatasvir. All patients should be screened for HBV before starting treatment and monitored appropriately .

Q21: Can I take Natdac 60 if I have had a liver transplant?

Yes, Natdac 60 can be used in patients who have developed HCV recurrence after liver transplantation. The recommended regimen is daclatasvir + sofosbuvir + ribavirin for 12 weeks (for those without cirrhosis) or 24 weeks (for those with cirrhosis) .

Q22: How should I store Natdac 60 tablets?

Store at room temperature below 30°C, away from moisture and direct light. Keep in the original container and out of reach of children .

Q23: What should I do if I experience severe headache while taking Natdac 60?

For mild to moderate headache, rest, stay hydrated, use cold/warm compresses, and practice relaxation techniques. Over-the-counter pain relievers like acetaminophen or ibuprofen may be used after consulting your doctor. Seek immediate medical attention for sudden, severe headaches or headaches accompanied by fever, confusion, or weakness .

Q24: Is Natdac 60 the same as sofosbuvir?

No. Natdac 60 contains daclatasvir, which is an NS5A inhibitor. Sofosbuvir is a different medication (an NS5B polymerase inhibitor). The two medications work synergistically and are taken together for hepatitis C treatment. They are NOT the same and cannot be substituted for one another .

Q25: Can I stop Natdac 60 early if I feel better?

No. Do not stop taking Natdac 60 without your doctor’s advice, even if you feel better. Completing the full course of treatment is essential to achieve cure and prevent viral resistance. Premature discontinuation can lead to treatment failure and drug-resistant virus .

Summary

Natdac 60 Tablet (Daclatasvir 60mg) manufactured by Natco Pharma Ltd is a highly effective direct-acting antiviral medication for the treatment of chronic hepatitis C virus (HCV) infection. Key points include:

• Indication: Chronic hepatitis C (HCV) – genotypes 1, 3, and 4 – in combination with sofosbuvir (± ribavirin)

• Mechanism: HCV NS5A inhibitor that blocks viral RNA replication and virus assembly

• Dosage: 60 mg once daily (one tablet), with or without food, taken with sofosbuvir

• Duration: Usually 12 weeks; 24 weeks for patients with cirrhosis (especially genotype 3)

• Efficacy: SVR12 (cure) rates of 93-97% in clinical studies

• Safety: Generally well-tolerated; common side effects include headache, fatigue, nausea

• Contraindications: Strong CYP3A inducers (rifampicin, carbamazepine, phenytoin, St. John’s Wort); concomitant amiodarone (bradycardia risk)

• Special Populations: Safe in renal impairment, hepatic impairment (including decompensated cirrhosis), and HIV co-infection (with appropriate dose adjustments)

• Monitoring: HBV screening required; regular liver function tests and viral load monitoring

• Pregnancy: Use with caution; if used with ribavirin, pregnancy is contraindicated

With proper patient selection, adherence to therapy, and appropriate combination with sofosbuvir, Natdac 60 offers a highly effective, well-tolerated, all-oral treatment option that can cure hepatitis C and prevent the long-term complications of chronic liver disease.

Disclaimer: This information is for educational and medical reference purposes only. It does not constitute medical advice. Always consult a registered medical practitioner, hepatologist, or infectious disease specialist before starting, stopping, or altering any treatment regimen. Individual dosing and monitoring should be determined by a qualified healthcare provider based on patient-specific factors including HCV genotype, cirrhosis status, prior treatment history, and concomitant medications.