The active ingredient present in is daclatasvir – 60 mg.

Daklinza is a drug for the treatment of hepatitis C (HCV). Daclatasvir inhibits the HCV nonstructural protein NS5A. Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA. 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 infections.

It is advised to avoid pregnancy during combination treatment with Daklinza and sofosbuvir with ribavirin for 6 months after completion of treatment.

Dosage and direction

The recommended dosage of Daklinza is 60 mg, taken orally, once daily, with or without food.

Recommended Treatment Regimen and Duration for Daklinza

Genotype 1:

Without cirrhosis – Daklinza + sofosbuvir for 12 weeks

Compensated (Child-Pugh A) cirrhosis – Daklinza + sofosbuvir for 12 weeks

Decompensated (Child-Pugh B or C) cirrhosis – Daklinza + sofosbuvir + ribavirin for 12 weeks

Post-transplant – Daklinza + sofosbuvir + ribavirin for 12 weeks

Genotype 3:

Without cirrhosis – Daklinza + sofosbuvir for 12 weeks

Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis – Daklinza + sofosbuvir + ribavirin for 12 weeks

Post-transplant – Daklinza + sofosbuvir + ribavirin for 12 weeks

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

Precautions

The concomitant use of Daklinza and other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of Daklinza and possible development of resistance, dosage adjustments of concomitant medications or Daklinza, possible clinically significant adverse reactions from greater exposures of concomitant drugs or Daklinza.

Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza. A fatal cardiac arrest was reported in a patient receiving a sofosbuvir-containing regimen (ledipasvir/sofosbuvir). Bradycardia generally resolved after discontinuation of HCV treatment. The mechanism for this bradycardia effect is unknown.

For patients taking amiodarone who have no alternative treatment options and who will be coadministered Daklinza and sofosbuvir need cardiac monitoring for the first 48 hours of coadministration, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.

Contraindications

Drugs that are Contraindicated with Daklinza:

Anticonvulsants – phenytoin, carbamazepine

Antimycobacterial agents – rifampin

Herbal products – St. John’s wort (Hypericum perforatum)

Possible side effect

Most common side effects occurred during the trials in combination with sofosbuvir (with or without ribavirin), with peginterferon alfa/ribavirin, with asunaprevir, or with asunaprevir/peginterferon alfa/ribavirin are such: fatigue, headache, pruritus, insomnia, influenza-like illness, dry skin, nausea, decreased appetite, alopecia, rash, asthenia, irritability, myalgia, anemia, pyrexia, cough, dyspnea, neutropenia, diarrhea, arthralgia, neutropenia, anemia, thrombocytopenia, and lymphopenia.

If you take Daklinza with sofosbuvir and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart.

Drug interaction

Potential for Other Drugs to Affect Daklinza (clinically relevant increase in concentration):

HIV antiviral agents – Atazanavir with ritonavirb; Indinavir; Nelfinavir; Saquinavir

Other antiretrovirals – Cobicistat-containing antiretroviral regimens e.g. atazanavir/cobicistat,

elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate

Anticoagulants – Dabigatran etexilate mesylate

Strong inhibitors of CYP3A (eg, clarithromycin, itraconazole, ketoconazole, ritonavir) may increase the plasma levels of daclatasvir.

Potential for Daklinza to Affect Other Drugs (clinically relevant decrease in concentration):

Non-nucleoside reverse transcriptase inhibitors (NNRTI) – Efavirenzb; Etravirine; Nevirapine

Moderate CYP3A inducers (see also HIV antiviral agents) – Examples: bosentan, dexamethasone, modafinil,

nafcillin, rifapentine.

Daclatasvir is an inhibitor of P-glycoprotein transporter (P-gp), organic anion transporting polypeptide (OATP) 1B1 and 1B3, and breast cancer resistance protein (BCRP). Administration of Daklinza may increase systemic exposure to medicinal products that are substrates of P-gp, OATP 1B1 or 1B3, or BCRP, which could increase or prolong their therapeutic effect or adverse reactions.

Missed dose

Take Daklinza every day at the regularly scheduled time with or without food. It is important not to miss or skip doses and to take Daklinza for the duration that is recommended by the physician. For instructions for missed doses of other agents in the regimen, refer to the respective prescribing information.

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.

Storage

Store Daklinza tablets at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Store away from moisture and heat. Keep all drugs out of the reach children and pets.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Copegus is used together with an interferon (such as PegIntron or Intron A) to treat chronic hepatitis C which is a disease of the liver. This is a drug for the patients who have not been treated with interferon previously or who have had a return of hepatitis C following successful treatment with interferon. It helps the immune system fight the hepatitis C virus, and make it harder for the virus to reproduce within the body. Copegus belongs to the antivirals.

Dosage and direction

The usual dose of Copegus per day is 800 mg, 1,000 mg, or 1,200 mg i orally in two divided doses (morning and evening) with food for 24 or 48 weeks. The dose and duration of treatment depend on your condition, on body weight, on baseline disease characteristics, response to therapy and tolerability of the regimen. Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. It should be taken consistently. For example, it should be taken at the same time or times each day and each time.

Precautions

Copegus may decrease the number of red blood cells in your body (anemia) and it can be life-threatening in people who have heart disease or circulation problems. Careful consideration is advised if Copegus is used in patients with heart or circulation problems since the anemia may aggravate these conditions. Your blood will need to be tested often. Also your vision, liver function and thyroid function may also need to be tested. Visit your doctor regularly. Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, weakness, or trouble breathing. Copegus may cause birth defects and/or death in unborn babies that are exposed to it during pregnancy. Women and men who are taking Copegus must avoid pregnancy during treatment with this drug and for 6 months after this medication has been stopped. Consult your doctor or pharmacist for more information.

Contraindications

Before taking Copegus you should talk with your doctor if you are allergic to peginterferon alfa-2a, any other interferon, ribavirin, polyethylene glycol, or to any of the ingredients of the medication, if you are an infant, breast-feeding, pregnant or has a pregnant partner. Also in the way if you have decompensated liver disease, hemoglobinopathies (thalassemia, sickle-cell anemia), HIV-HCV (human immunodeficiency virus and hepatitis C virus) with cirrhosis and a baseline Child-Pugh score greater than or equal to 6. And you should discuss with your doctor if you have a severe psychiatric disorder, autoimmune diseases (including autoimmune hepatitis), thyroid problems not controlled by medication even in the past.

Possible side effects

The most common side effect of Copegus is a flu-like syndrome consisting of body aches and pains, fever, chills, headache and malaise. The most serious side effect is anemia. Patients with certain types of heart disease should not use Copegus. This may make your condition worse and can lead to a possibly fatal heart attack. Copegus should be avoided among patients who have severe kidney disease and have lost most of their kidneys’ function. Therapy with Copegus and interferon may aggravate psychiatric conditions or may cause a psychiatric condition such as depression, suicidal ideation, psychosis, aggressive behavior, hallucinations, or violent behavior. Patients should be closely monitored for the development of these psychiatric conditions. Therapy has caused abnormalities of the thyroid gland. If these abnormalities persist and cannot be controlled by medication, it may be necessary to finish this therapy. Other possible side effects that may occur during therapy with Copegus are fatigue, weakness, nausea, anorexia, heartburn, insomnia, irritability, difficulty breathing, rash, itching, and alterations in taste perception.

Drug interactions

If Copegus is used with other antiviral drugs with similar mechanisms of action it may cause a condition in which lactic acid accumulates in the blood (lactic acidosis). This situation can lead to serious medical problems. Also do not take Copegus with antiviral drugs that used to manage HIV infection (zidovudine (Retrovir), zalcitabine (Hivid) or stavudine (Zerit)).

Missed dose

If you miss a dose of Copegus, take the missed dose as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Overdose

Overdose symptoms may include easy bruising or bleeding, urinating less than usual or not at all, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or a general ill feeling. If you experience something from list above you need emergency medical attention.

Storage

Store Copegus in the refrigerator, protect them from light, and keep them out of the reach of children. Do not freeze, shake, or use them past the expiry date.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.