Sovaldi (Sofosbuvir)

BEFORE you use SOVALDI talk to your doctor, nurse, or pharmacist if you:

• have liver problems other than hepatitis C infection
• have hepatitis B or HIV
• have severe kidney disease
• have any other medical condition
• are pregnant or planning to become pregnant
• are breastfeeding. It is not known if SOVALDI passes into your breast milk. You are recommended NOT to breastfeed while taking SOVALDI.

SOVALDI should not be taken with any other medicine containing sofosbuvir (e.g. HARVONI).

Pregnancy:

SOVALDI must be used with ribavirin or peginterferon and ribavirin. Ribavirin may cause birth defects and death of the fetus. Extreme care must be taken to avoid becoming pregnant. This means:

• You or your partner must not become pregnant while taking SOVALDI combination treatment or become pregnant within 6 months after you have stopped taking ribavirin.
• If you or your partner become pregnant during this period, you must contact your doctor.
• Read the package insert for ribavirin for information regarding pregnancy.

Contraception:

Male and female partners must use 2 effective methods of birth control during the entire treatment and for 6 months after you stop taking SOVALDI combination treatment.

The most common side effects of SOVALDI in combination with ribavirin include:

• tiredness
• low red blood cells
• headache
• difficulty sleeping
• nausea
• depression
• irritability

The most common side effects of SOVALDI in combination with peginterferon alfa and ribavirin include:

• tiredness
• low red blood cells
• low white blood cells
• headache
• difficulty sleeping
• nausea
• depression
• rash
• irritability

Drugs that may interact with SOVALDI include:

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Other medicines may affect how SOVALDI works.

Especially tell your healthcare provider if you take:

• amiodarone (Cordarone)
• carbamazepine (Tegretol)
• oxcarbazepine (Trileptal)
• phenytoin (Dilantin)
• phenobarbital
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rifater, Rofact)
• St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Usual adult dose:

SOVALDI should not be used alone. Your healthcare provider will tell you what other medicines you should take with SOVALDI.

Take 1 tablet (400 mg) only once daily with or without food.

SOVALDI is taken for either 12 or 24 weeks. Your healthcare provider will tell you exactly how long you need to take SOVALDI.

Do not stop taking SOVALDI without first talking with your healthcare provider.

SOVALDI only works when it is used along with other antiviral medicines. You might not need to take interferon or you might be able to shorten your time on interferon. Your doctor will decide which other medicines you need to use along with SOVALDI.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

It is important not to miss a dose of SOVALDI.

• If you do miss a dose of SOVALDI, you must take the tablet as soon as possible. Then take the next dose as usual.
• If it is nearly 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).

If you are sick (vomit) less than 2 hours after taking SOVALDI, take another tablet. If you vomit more than 2 hours after taking SOVALDIyou should not take another tablet until your next regularly scheduled tablet.

Do not take a double dose to make up for a missed dose.