Patient Medication Information: uses, side effects, how to take - Sovaldi
What is Sovaldi used for?
- Sovaldi treats chronic (lasting longer than 6 months) hepatitis C genotype 1, 2, 3 or 4 infection in adults.
- Sovaldi is used in combination with ribavirin or pegylated interferon and ribavirin. Read the ribavirin and/or pegylated interferon patient medication information if your doctor says you should also take ribavirin or pegylated interferon and ribavirin.
How does Sovaldi work?
- Sovaldi blocks the virus from making more copies of itself in the body.
- Sovaldi, used with other medicines, cures chronic hepatitis C in most patients. Cure means hepatitis C virus is cleared from your blood 3 months after finishing the medicine.
What are the ingredients in Sovaldi?
Each tablet has the following medicines: sofosbuvir.
Each tablet has the following ingredients that are not medicines: colloidal silicon dioxide, cellulose, croscarmellose sodium, mannitol, and microcrystalline cellulose.
Each tablet is covered with the following ingredients that are not medicines: polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, and yellow iron oxide.
Sovaldi comes in the following dosage forms:
Sovaldi comes in yellow tablets. Each tablet has 400 mg of sofosbuvir.
Do not use Sovaldi if:
- you are pregnant or may become pregnant (or if your partner is pregnant or may become pregnant). Ribavirin may cause birth defects or the death of your unborn baby.
- you are allergic to sofosbuvir or any of the other ingredients in this product. (Read also “What are the ingredients in Sovaldi?” above.)
Serious Warnings and Precautions
- Hepatitis B activity (eg, inflamed liver) may increase when taking antiviral drugs like Sovaldi, sometimes leading to liver failure and death. (See the “To help avoid side effects…” section, Hepatitis B Reactivation)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sovaldi. Talk about any health conditions or problems you may have, including if you:
- have liver problems other than hepatitis C infection.
- have HIV.
- have severe kidney disease.
- have any other medical condition.
- are pregnant or plan to become pregnant (see “Pregnancy and Birth Control” below).
- are breastfeeding or plan to breastfeed. Do NOT breastfeed while taking Sovaldi.
- are taking anything listed in the section “The following may interact with Sovaldi”.
Your doctor may monitor your blood test results during Sovaldi treatment if you have some conditions, for example, to check:
- how well your blood can clot if you take warfarin (Coumadin®) or other similar medicines called vitamin K antagonists, to thin the blood.
- blood sugar levels if you have diabetes.
- immunosuppressant drug levels if you receive immunosuppressive therapy.
Other warnings you should know about:
Hepatitis B Reactivation:
Taking antiviral drugs such as Sovaldi may increase hepatitis B activity. This can lead to liver problems such as liver failure and death. Contact your doctor if:
- you have never been tested for hepatitis B.
- you know you have a current hepatitis B infection.
- you have had a previous hepatitis B infection.
Your healthcare professional may do blood tests:
- before hepatitis C treatment.
- to see the hepatitis B levels in your blood.
- and may order hepatitis B treatment.
Ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and Birth Control:
If you are pregnant or plan to become pregnant, ask your doctor for advice before taking this medicine. It is NOT known if Sovaldi will harm your unborn baby.
Sovaldi must be used with ribavirin or pegylated interferon and ribavirin. Ribavirin may cause birth defects and death of your unborn baby. Extreme care must be taken to avoid becoming pregnant.
- Females must have a negative pregnancy test before starting Sovaldi and ribavirin, every month while on the medicine, and for 6 months after stopping them.
- You or your partner should not become pregnant while taking Sovaldi with ribavirin and for 6 months after you have stopped taking them.
- You and your partner must use 2 kinds of birth control while taking Sovaldi and ribavirin and for 6 months after you have stopped taking them.
- Talk to your doctor about the kind of birth control you can use.
- If you or your partner becomes pregnant while taking Sovaldi and ribavirin or within 6 months after you stop taking them, tell your doctor right away.
Products containing sofosbuvir:
Do not take Sovaldi with any other medicines containing sofosbuvir (eg, Harvoni®, Epclusa®, Vosevi®).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Sovaldi:
- amiodarone (Cordarone®), a drug used to treat irregular heartbeats.
- carbamazepine (Tegretol®), a drug used to treat seizures, nerve pain and bipolar disorder.
- phenobarbital, a drug used to treat anxiety and to control seizures.
- phenytoin (Dilantin®), a drug used to control seizures.
- rifampin (Rifadin®, Rifater®, Rofact®), a drug used to treat tuberculosis.
- rifapentine, a drug used to treat tuberculosis.
- St. John’s wort (Hypericum perforatum), an herbal product used for anxiety or depression.
How to take Sovaldi:
- Do not take this medicine alone. It must be used with other medicines. You might not need to take pegylated interferon or you might be able to shorten your time on pegylated interferon. Your doctor will tell you what other medicines you should take with Sovaldi.
Take this medicine with or without food.
- Your doctor will tell you how long you need to take this medicine. It can be for 12 or 24 weeks.
- Do NOT stop taking Sovaldi without first talking with your doctor.
Usual dose:
- Take one tablet once each day.
Overdose:
| If you think you, or a person you are caring for, have taken too much Sovaldi, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
It is important to take Sovaldi each day.
- If you miss a dose of Sovaldi, take a tablet as soon as you can. Then take the next dose at your usual time.
- If you miss a dose of Sovaldi and it is almost time for your next dose, wait and take the next dose at your usual time. Do NOT take a double dose (two doses close together).
What to do if you vomit (throw up):
- If you vomit less than 2 hours after taking Sovaldi, take another tablet.
- If you vomit more than 2 hours after taking Sovaldi, wait. Do NOT take another tablet until you are scheduled to take the next tablet.
What are possible side effects from using Sovaldi?
These are not all the possible side effects you may have when taking Sovaldi. If you experience any side effects not listed here, tell your healthcare professional.
Common side effects when Sovaldi is used with ribavirin:
- feeling tired.
- headache.
- trouble sleeping.
- feeling sad or annoyed.
- nausea.
- low red blood cells (in a blood test).
Common side effects when Sovaldi is used with ribavirin and pegylated interferon:
- feeling tired.
- headache.
- trouble sleeping.
- feeling sad or annoyed.
- rash.
- nausea.
- low red blood cells or white blood cells (in a blood test).
When Sovaldi is used with other hepatitis C medicines (eg, daclatasvir* [Daklinza®], simeprevir* [Galexos®], or ledipasvir) and amiodarone (a heart drug), side effects may be:
- slow heartbeat leading to a need for a pacemaker or death.
*Drug not marketed in Canada.
Contact your doctor immediately if you have symptoms of a slow heartbeat such as:
- fainting or near-fainting.
- dizziness or lightheadedness.
- not feeling well.
- feeling weak or very tired.
- shortness of breath.
- chest pains.
- confusion or memory problems.
When Sovaldi is used with pegylated interferon and ribavirin, the following serious side effects have occurred:
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON* | |||
Low red blood cells (anemia) with symptoms such as:
| ✓ | ||
Low white blood cells (neutropenia) with symptoms such as:
| ✓ | ||
Low blood platelets (thrombocytopenia), with symptoms such as:
| ✓ | ||
| FREQUENCY UNKNOWN | |||
| Stevens-Johnson Syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
*These side effects are commonly associated with peginterferon alfa and ribavirin therapy.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store Sovaldi at 15 to 30°C (59 to 86°F).
- Keep Sovaldi in its original container.
- Do NOT use Sovaldi if the seal over the bottle opening is broken or missing.
- Keep out of reach and sight of children.
If you want more information about Sovaldi:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.gilead.ca), or by calling 1-800-207-4267.
Last Revised: June 21, 2021
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
ATRIPLA®, COMPLERA®, EPCLUSA®, HARVONI®, SOVALDI®, STRIBILD®, VOSEVI®, TRUVADA®, and VIREAD® are trademarks of Gilead Sciences, Inc. or its related companies.
All other marks referenced herein are the property of their respective owners.
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