Generic Name: Daclatasvir Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Daclatasvir used for?

Daclatasvir  is used with another antiviral medication (sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Daclatasvir should never be used without sofosbuvir. Daclatasvir and sofosbuvir may also be used with another antiviral medication (ribavirin). These medications together reduce the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.

It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice “safer sex” (including the use of latex condoms) to lower the risk of passing the virus to others.

How should I take Daclatasvir?

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Continue to take daclatasvir and your other antiviral medication(s) for the full length of time prescribed, even if your symptoms disappear after a short time. Stopping any of the drugs too early may result in a return of the infection.

How do I store Daclatasvir?

Daclatasvir is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Daclatasvir in the bathroom or the freezer. There may be different brands of Daclatasvir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Daclatasvir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Daclatasvir?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, other liver problems (such as hepatitis B).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, daclatasvir should be used only when clearly needed. Discuss the risks and benefits with your doctor. Daclatasvir, in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for six months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.

It is unknown if daclatasvir passes into breast milk. Consult your doctor before breast-feeding. Breast-feeding is not recommended if daclatasvir is used in combination with ribavirin.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Daclatasvir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Daclatasvir. Daclatasvir is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Daclatasvir?

Tiredness, headache, nausea, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Daclatasvir?

Amiodarone may interact with sofosbuvir. Tell your doctor and pharmacist if you are taking amiodarone.

Other medications can affect the removal of daclatasvir from your body, which may affect how daclatasvir works. Examples include mitotane, rifampin, St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Daclatasvir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Daclatasvir?

Daclatasvir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Daclatasvir?

Daclatasvir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Daclatasvir.

What is the dose of Daclatasvir for an adult?

Usual Adult Dose for Chronic Hepatitis C

60 mg orally once a day

Recommended Regimen and Duration of Therapy:

Genotype 1:

-Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks

-Compensated (Child-Pugh A) cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks

-Decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

-Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

Genotype 3:

-Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks

-Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

-Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

Comments:

-Dose recommendations also apply to HCV/HIV-1-coinfected patients.

-Optimal duration of therapy has not been established for HCV genotype 3-infected patients with cirrhosis or for HCV genotype 1-infected patients with Child-Pugh C cirrhosis.

-The manufacturer product information for sofosbuvir should be consulted regarding dosing. The manufacturer product information should be consulted regarding ribavirin dosing and dose adjustments (if applicable).

Use: With sofosbuvir (with or without ribavirin), for the treatment chronic HCV genotype 1 or 3 infection

Renal Dose Adjustments

No adjustment recommended.

Comments:

-The manufacturer product information for sofosbuvir and ribavirin should be consulted regarding use in patients with renal dysfunction.

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Comments:

-Based on liver dysfunction study in non-HCV-infected subjects

Dose Adjustments

Coadministration with strong CYP450 3A inhibitors and certain HIV antiviral agents: 30 mg orally once a day

Coadministration with moderate CYP450 3A inducers and nevirapine: 90 mg orally once a day

Coadministration with strong CYP450 3A inducers: Contraindicated

The dose of this drug should not be reduced for side effects.

Other Comments

Administration advice:

-Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).

-Use in combination with sofosbuvir (with or without ribavirin); do not use alone.

-Before starting this drug and sofosbuvir (with or without ribavirin), consider screening HCV genotype 1a-infected patients with cirrhosis for nonstructural protein 5A (NS5A) polymorphisms at amino acid positions M28, Q30, L31, and Y93.

-May administer without regard to food

-Consult the manufacturer product information regarding missed doses.

General:

-Limitations of use: Sustained virologic response (SVR12) rates were reduced in HCV genotype 3-infected patients with cirrhosis using this drug with sofosbuvir for 12 weeks.

-Before starting therapy, the manufacturer product information for coadministered HCV antiviral drugs should be consulted for additional information.

Patient advice:

-Read the US FDA-approved patient labeling (Patient Information).

-Avoid missing doses and complete the entire course of therapy.

What is the dose of Daclatasvir for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Daclatasvir available?

Daclatasvir is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Daclatasvir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 16, 2018 | Last Modified: August 16, 2018

Want to live your best life?
Get the Hello Doktor Daily newsletter for health tips, wellness updates and more.