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JollyRX
205, Al Qaizi Building, Al Muteena Street, Deira , AE
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61adb58c16a7c5316e0f9c6f DAKLINZA 60 MG 28 TAB. https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61adb3e792e6191912c120df/webp/daklinza-60-mg-28-tab-.png

What is Daklinza and how is it used?

Daklinza is a prescription medicine used to treat the symptoms of Hepatitis C. Daklinza may be used alone or with other medications.

Daklinza belongs to a class of drugs called NS5A Inhibitors.

It is not known if Daklinza is safe and effective in children younger than 18 years of age.

What are the possible side effects of Daklinza?

Daklinza may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe dizziness,
  • rash, and
  • itching

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Daklinza include:

  • tiredness,
  • headache,
  • nausea, and
  • diarrhea

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Daklinza. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

DAKLINZA (daclatasvir) is an inhibitor of HCV nonstructural protein 5A (NS5A). The chemical name for drug substance daclatasvir dihydrochloride is carbamic acid, N,N'-[[1,1'biphenyl]-4,4'-diylbis[1H-imidazole-5,2-diyl-(2S)-2,1-pyrrolidinediyl[(1S)-1-(1-methylethyl)-2oxo-2,1-ethanediyl]]]bis-,C,C'-dimethyl ester, hydrochloride (1:2). Its molecular formula is C40H50N8O6•2HCl, and its molecular weight is 738.88 (free base). Daclatasvir dihydrochloride has the following structural formula:

DAKLINZA™ (daclatasvir) Structural Formula Illustration

Daclatasvir dihydrochloride drug substance is white to yellow. Daclatasvir is freely soluble in water ( > 700 mg/mL).

DAKLINZA 60 mg tablets contain 60 mg daclatasvir (equivalent to 66 mg daclatasvir dihydrochloride) and the inactive ingredients anhydrous lactose (116 mg), microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green.

DAKLINZA 30 mg tablets contain 30 mg daclatasvir (equivalent to 33 mg daclatasvir dihydrochloride) and the inactive ingredients anhydrous lactose (58 mg), microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green.

DAKLINZA 90 mg tablets contain 90 mg daclatasvir (equivalent to 99 mg daclatasvir dihydrochloride) and the inactive ingredients anhydrous lactose (173 mg), microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green.

Opadry green contains hypromellose, titanium dioxide, polyethylene glycol 400, FD&C blue #2/indigo carmine aluminum lake, and yellow iron oxide.

INDICATIONS

DAKLINZA is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection [see DOSAGE AND ADMINISTRATION and Clinical Studies].

Limitations Of Use

  • Sustained virologic response (SVR12) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving DAKLINZA in combination with sofosbuvir for 12 weeks [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Testing Prior To The Initiation Of Therapy

Testing For HBV Infection

Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with DAKLINZA [see WARNINGS AND PRECAUTIONS].

NS5A Resistance Testing In HCV Genotype 1a-Infected Patients With Cirrhosis

Consider screening for the presence of NS5A polymorphisms at amino acid positions M28, Q30, L31, and Y93 in patients with cirrhosis who are infected with HCV genotype 1a prior to the initiation of treatment with DAKLINZA and sofosbuvir with or without ribavirin [see Microbiology, Table 11].

Recommended Dosage

The recommended dosage of DAKLINZA is 60 mg, taken orally, once daily, with or without food [see CLINICAL PHARMACOLOGY].

Table 1 provides the recommended DAKLINZA-containing treatment regimens and duration based on HCV genotype and patient population. The optimal duration of DAKLINZA and sofosbuvir with or without ribavirin has not been established for HCV genotype 3 patients with cirrhosis or for HCV genotype 1 patients with Child-Pugh C cirrhosis [see Clinical Studies].

For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 1 [see Clinical Studies]. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

For specific dosage recommendations for sofosbuvir, refer to the prescribing information.

For HCV genotype 1 or 3 patients with Child-Pugh B or C cirrhosis or post-transplantation patients, the starting dose of ribavirin is 600 mg once daily, increasing up to 1000 mg daily as tolerated. The starting dose and on-treatment dose of ribavirin can be decreased based on hemoglobin and creatinine clearance.

For HCV genotype 3 patients with compensated cirrhosis (Child-Pugh A), the recommended dosing of ribavirin is based on weight (1000 mg for patients weighing less than 75 kg and 1200 mg for those weighing at least 75 kg administered orally in two divided doses with food).

SIDE EFFECTS

If DAKLINZA and sofosbuvir are administered with ribavirin, refer to the prescribing information for ribavirin regarding ribavirin-associated adverse reactions.

The following serious adverse reaction is described below and elsewhere in the labeling:

  • Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Approximately 2400 subjects with chronic HCV infection have been treated with the recommended dose of DAKLINZA in combination with other anti-HCV drugs in clinical trials. Six hundred seventy-nine subjects have received a DAKLINZA and sofosbuvir-based regimen. Safety experience from three clinical trials of DAKLINZA and sofosbuvir with or without ribavirin is presented.

DAKLINZA And Sofosbuvir

In the ALLY-3 trial, 152 treatment-naive and treatment-experienced subjects with HCV genotype 3 infection were treated with DAKLINZA 60 mg once daily in combination with sofosbuvir for 12 weeks. The most common adverse reactions (frequency of 10% or greater) were headache and fatigue. All adverse reactions were mild to moderate in severity. No subjects discontinued therapy for adverse events.

In the ALLY-2 trial, 153 treatment-naive and treatment-experienced subjects with HCV/HIV-1 coinfection were treated with DAKLINZA 60 mg once daily (dose-adjusted for concomitant antiretroviral use) in combination with sofosbuvir for 12 weeks. The most common adverse reaction (frequency of 10% or greater) was fatigue. The majority of adverse reactions were mild to moderate in severity. No subjects discontinued therapy for adverse events. Adverse reactions considered at least possibly related to treatment and occurring at a frequency of 5% or greater in ALLY-3 or ALLY-2 

DRUG INTERACTIONS

Potential For Other Drugs To Affect DAKLINZA

Daclatasvir is a substrate of CYP3A. Therefore, moderate or strong inducers of CYP3A may decrease the plasma levels and therapeutic effect of daclatasvir [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and Table 7]. Strong inhibitors of CYP3A (eg, clarithromycin, itraconazole, ketoconazole, ritonavir) may increase the plasma levels of daclatasvir

PRECAUTIONS

Risk Of Hepatitis B Virus Reactivation In Patients Coinfected With HCV And HBV

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients.

HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.

Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with DAKLINZA. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with DAKLINZA and during post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

OVERDOSE

There is no known antidote for overdose of DAKLINZA. Treatment of overdose with DAKLINZA should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Because daclatasvir is highly protein bound (>99%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

CONTRAINDICATIONS

  • When DAKLINZA is used in combination with other agents, the contraindications applicable to those agents are applicable to the combination regimen. Refer to the respective prescribing information for a list of contraindications.
  • DAKLINZA is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of DAKLINZA. Contraindicated drugs include, but are not limited to those listed in Table 3 [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Table 3: Drugs that are Contraindicated with DAKLINZA

Drug Class Drugs Within Class that are Contraindicated with DAKLINZAa Clinical Comments
Anticonvulsants phenytoin, carbamazepine May lead to loss of virologic
Antimycobacterial agents rifampin response to DAKLINZA
Herbal products St. John’s wort (Hypericum perforatum)
a This table is not a comprehensive list of all drugs that strongly induce CYP3A.

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DAKLINZA 60 MG 28 TAB.

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Description of product

What is Daklinza and how is it used?

Daklinza is a prescription medicine used to treat the symptoms of Hepatitis C. Daklinza may be used alone or with other medications.

Daklinza belongs to a class of drugs called NS5A Inhibitors.

It is not known if Daklinza is safe and effective in children younger than 18 years of age.

What are the possible side effects of Daklinza?

Daklinza may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe dizziness,
  • rash, and
  • itching

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Daklinza include:

  • tiredness,
  • headache,
  • nausea, and
  • diarrhea

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Daklinza. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

DAKLINZA (daclatasvir) is an inhibitor of HCV nonstructural protein 5A (NS5A). The chemical name for drug substance daclatasvir dihydrochloride is carbamic acid, N,N'-[[1,1'biphenyl]-4,4'-diylbis[1H-imidazole-5,2-diyl-(2S)-2,1-pyrrolidinediyl[(1S)-1-(1-methylethyl)-2oxo-2,1-ethanediyl]]]bis-,C,C'-dimethyl ester, hydrochloride (1:2). Its molecular formula is C40H50N8O6•2HCl, and its molecular weight is 738.88 (free base). Daclatasvir dihydrochloride has the following structural formula:

DAKLINZA™ (daclatasvir) Structural Formula Illustration

Daclatasvir dihydrochloride drug substance is white to yellow. Daclatasvir is freely soluble in water ( > 700 mg/mL).

DAKLINZA 60 mg tablets contain 60 mg daclatasvir (equivalent to 66 mg daclatasvir dihydrochloride) and the inactive ingredients anhydrous lactose (116 mg), microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green.

DAKLINZA 30 mg tablets contain 30 mg daclatasvir (equivalent to 33 mg daclatasvir dihydrochloride) and the inactive ingredients anhydrous lactose (58 mg), microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green.

DAKLINZA 90 mg tablets contain 90 mg daclatasvir (equivalent to 99 mg daclatasvir dihydrochloride) and the inactive ingredients anhydrous lactose (173 mg), microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green.

Opadry green contains hypromellose, titanium dioxide, polyethylene glycol 400, FD&C blue #2/indigo carmine aluminum lake, and yellow iron oxide.

INDICATIONS

DAKLINZA is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection [see DOSAGE AND ADMINISTRATION and Clinical Studies].

Limitations Of Use

  • Sustained virologic response (SVR12) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving DAKLINZA in combination with sofosbuvir for 12 weeks [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Testing Prior To The Initiation Of Therapy

Testing For HBV Infection

Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with DAKLINZA [see WARNINGS AND PRECAUTIONS].

NS5A Resistance Testing In HCV Genotype 1a-Infected Patients With Cirrhosis

Consider screening for the presence of NS5A polymorphisms at amino acid positions M28, Q30, L31, and Y93 in patients with cirrhosis who are infected with HCV genotype 1a prior to the initiation of treatment with DAKLINZA and sofosbuvir with or without ribavirin [see Microbiology, Table 11].

Recommended Dosage

The recommended dosage of DAKLINZA is 60 mg, taken orally, once daily, with or without food [see CLINICAL PHARMACOLOGY].

Table 1 provides the recommended DAKLINZA-containing treatment regimens and duration based on HCV genotype and patient population. The optimal duration of DAKLINZA and sofosbuvir with or without ribavirin has not been established for HCV genotype 3 patients with cirrhosis or for HCV genotype 1 patients with Child-Pugh C cirrhosis [see Clinical Studies].

For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 1 [see Clinical Studies]. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

For specific dosage recommendations for sofosbuvir, refer to the prescribing information.

For HCV genotype 1 or 3 patients with Child-Pugh B or C cirrhosis or post-transplantation patients, the starting dose of ribavirin is 600 mg once daily, increasing up to 1000 mg daily as tolerated. The starting dose and on-treatment dose of ribavirin can be decreased based on hemoglobin and creatinine clearance.

For HCV genotype 3 patients with compensated cirrhosis (Child-Pugh A), the recommended dosing of ribavirin is based on weight (1000 mg for patients weighing less than 75 kg and 1200 mg for those weighing at least 75 kg administered orally in two divided doses with food).

SIDE EFFECTS

If DAKLINZA and sofosbuvir are administered with ribavirin, refer to the prescribing information for ribavirin regarding ribavirin-associated adverse reactions.

The following serious adverse reaction is described below and elsewhere in the labeling:

  • Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Approximately 2400 subjects with chronic HCV infection have been treated with the recommended dose of DAKLINZA in combination with other anti-HCV drugs in clinical trials. Six hundred seventy-nine subjects have received a DAKLINZA and sofosbuvir-based regimen. Safety experience from three clinical trials of DAKLINZA and sofosbuvir with or without ribavirin is presented.

DAKLINZA And Sofosbuvir

In the ALLY-3 trial, 152 treatment-naive and treatment-experienced subjects with HCV genotype 3 infection were treated with DAKLINZA 60 mg once daily in combination with sofosbuvir for 12 weeks. The most common adverse reactions (frequency of 10% or greater) were headache and fatigue. All adverse reactions were mild to moderate in severity. No subjects discontinued therapy for adverse events.

In the ALLY-2 trial, 153 treatment-naive and treatment-experienced subjects with HCV/HIV-1 coinfection were treated with DAKLINZA 60 mg once daily (dose-adjusted for concomitant antiretroviral use) in combination with sofosbuvir for 12 weeks. The most common adverse reaction (frequency of 10% or greater) was fatigue. The majority of adverse reactions were mild to moderate in severity. No subjects discontinued therapy for adverse events. Adverse reactions considered at least possibly related to treatment and occurring at a frequency of 5% or greater in ALLY-3 or ALLY-2 

DRUG INTERACTIONS

Potential For Other Drugs To Affect DAKLINZA

Daclatasvir is a substrate of CYP3A. Therefore, moderate or strong inducers of CYP3A may decrease the plasma levels and therapeutic effect of daclatasvir [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and Table 7]. Strong inhibitors of CYP3A (eg, clarithromycin, itraconazole, ketoconazole, ritonavir) may increase the plasma levels of daclatasvir

PRECAUTIONS

Risk Of Hepatitis B Virus Reactivation In Patients Coinfected With HCV And HBV

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients.

HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.

Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with DAKLINZA. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with DAKLINZA and during post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

OVERDOSE

There is no known antidote for overdose of DAKLINZA. Treatment of overdose with DAKLINZA should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Because daclatasvir is highly protein bound (>99%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

CONTRAINDICATIONS

  • When DAKLINZA is used in combination with other agents, the contraindications applicable to those agents are applicable to the combination regimen. Refer to the respective prescribing information for a list of contraindications.
  • DAKLINZA is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of DAKLINZA. Contraindicated drugs include, but are not limited to those listed in Table 3 [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Table 3: Drugs that are Contraindicated with DAKLINZA

Drug Class Drugs Within Class that are Contraindicated with DAKLINZAa Clinical Comments
Anticonvulsants phenytoin, carbamazepine May lead to loss of virologic
Antimycobacterial agents rifampin response to DAKLINZA
Herbal products St. John’s wort (Hypericum perforatum)
a This table is not a comprehensive list of all drugs that strongly induce CYP3A.

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