Sovaldi

Generic Name: sofosbuvir (Oral route)

soe-FOS-bue-vir

Commonly used brand name(s)

In the U.S.

  • Sovaldi

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiviral

Uses For Sovaldi

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

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

Before Using Sovaldi

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sofosbuvir in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sofosbuvir in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Fosphenytoin
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • St John's Wort
  • Tipranavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Liver cirrhosis, decompensated or
  • Liver transplant, history of or
  • Kidney disease, severe—It is not known if this medicine will work in patients with these conditions.

Proper Use of Sovaldi

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.

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.

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

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—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.

Precautions While Using Sovaldi

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

To make sure you are not pregnant, your doctor may ask you to have a pregnancy test before you start using this medicine. You must have a negative pregnancy test before you will be allowed to use this medicine with ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You should test for pregnancy every month while you are using this medicine, and for 6 months after your treatment ends.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Sovaldi Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • chills
  • fever
  • lower back or side pain
  • pale skin
  • ulcers, sores, or white spots in the mouth
  • unusual tiredness or weakness
Rare
  • Changes in behavior
  • discouragement
  • feeling sad or empty
  • loss of interest or pleasure
  • thoughts of killing oneself
  • trouble concentrating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Decreased appetite
  • diarrhea
  • difficulty with moving
  • fatigue
  • headache
  • irritability
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • rash or itching skin
  • trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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