Sovaldi

Yes, you need a prescription from your doctor or health care professional for this drug.

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There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C. 

Antiviral;1 nucleotide analog HCV NS5B polymerase inhibitor.1

Sofosbuvir is used in combination with ribavirin (Copegus®, Rebetol®) with or without injectable peginterferon alfa (Pegasys®, Pegintron®) to treat chronic hepatitis C infection.

This medicine is available only with your doctor's prescription.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet. Read and follow the information carefully. Ask your doctor if you have any questions.

To help clear up your infection completely, sofosbuvir must be taken together with peginterferon alfa and ribavirin for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, sofosbuvir must be used on a regular schedule.

You may take this medicine with or without food. However, you should take it the same way each time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For hepatitis C virus infection, in combination with peginterferon alfa and ribavirin:
    • Adults—400 milligrams (mg) once a day.
    • Children 12 years of age and older or weighing at least 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 400 milligrams (mg) once a day.
    • Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

• If you have an allergy to sofosbuvir or any other part of Sovaldi.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have liver problems other than hepatitis C.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with Sovaldi.
• If you are taking St. John's wort. Do not take St. John's wort with this medicine. This medicine may not work as well.
• If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with Sovaldi.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

For all patients taking Sovaldi:

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine is used with ribavirin, with or without peginterferon alfa. Talk with the doctor about the risks and side effects that may happen with those drugs.
• It is not known if Sovaldi stops the spread of diseases like hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• Slow heartbeat and the need to get a pacemaker have happened when amiodarone was given with sofosbuvir and certain other hepatitis C drugs. Sometimes, this has been deadly. Slow heartbeat has happened up to 2 weeks after starting hepatitis C treatment. You will need to be watched closely if you will be taking amiodarone with hepatitis C treatment. Follow what your doctor has told you to do. Call your doctor right away if you have signs of slow heartbeat like chest pain, confusion, dizziness, passing out or near-passing out, memory problems, shortness of breath, tiredness, or weakness.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Children:

• If giving to your child, the dose of Sovaldi may need to be changed as your child's weight changes. Have your child's weight checked often. Talk with the doctor before changing your child's dose.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Sovaldi must be given in combination with other antiviral medications and it should not be used alone. Your disease may become resistant if you do not take all the medicines your doctor has prescribed.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Sovaldi.

Sovaldi is usually taken once per day for 12 to 24 weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Sovaldi with or without food. Take the medicine at the same time each day.

You will need frequent blood tests to check your liver function.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Sovaldi suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, Sovaldi can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Store this medicine in the original container at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.