other. This can cause you to have too much or not enough SOVALDI or other medicines in your body.
This may affect the way SOVALDI or your other medicines work, or may cause side effects.
Keep a list of your medicines to show your healthcare provider and pharmacist.
• You can ask your healthcare provider or pharmacist for a list of medicines that interact with
SOVALDI.
• Do not start taking a new medicine without telling your healthcare provider. Your
healthcare provider can tell you if it is safe to take SOVALDI with other medicines.
How should I take SOVALDI?
• Take SOVALDI exactly as your healthcare provider tells you to take it. Do not change your
dose unless your healthcare provider tells you to.
• Do not stop taking SOVALDI without first talking with your healthcare provider.
• Take SOVALDI tablets or oral pellets by mouth, with or without food.
• For adults the usual dose of SOVALDI is one 400 mg tablet each day.
• For children 3 years of age and older, your healthcare provider will prescribe the right dose of
SOVALDI tablets or oral pellets based on your child’s body weight.
o Tell your healthcare provider if your child has problems with swallowing tablets.
o If your healthcare provider prescribes SOVALDI pellets for your child, see “How
should I give SOVALDI oral pellets to my child.”
• Do not miss a dose of SOVALDI. Missing a dose lowers the amount of medicine in your blood.
Refill your SOVALDI prescription before you run out of medicine.
• If you take too much SOVALDI, call your healthcare provider or go to the nearest hospital
emergency room right away.
How should I give SOVALDI oral pellets to my child?
See the detailed Instructions for Use for information about how to give or take a dose of
SOVALDI oral pellets.
• Administer SOVALDI oral pellets exactly as instructed by your healthcare provider.
• Do not open the packet until ready to use.
• Hold the SOVALDI pellets packet with the cut line on top.
• Shake the SOVALDI pellets packet gently to settle the pellets.
• Tear or cut the SOVALDI packet along the cut line.
• SOVALDI pellets can be taken right in the mouth without chewing, or with food.
• If SOVALDI pellets are taken with food, sprinkle the pellets on one or more spoonfuls of non-
acidic soft food at or below room temperature. Examples of non-acidic foods include pudding,
chocolate syrup, mashed potato, and ice cream. Take SOVALDI pellets within 30 minutes of
gently mixing with food and swallow the entire contents without chewing to avoid a bitter taste.
• Do not store any leftover SOVALDI mixture (oral pellets mixed with food) for use at a later time.
Throw away any unused portion.
What are the possible side effects of SOVALDI?
SOVALDI can cause serious side effects, including:
• Hepatitis B virus reactivation. See “What is the most important information I should know
about SOVALDI?”
• Slow heart rate (bradycardia). SOVALDI treatment may result in slowing of the heart rate
along with other symptoms when taken with amiodarone (Cordarone
®
, Nexterone
®
,
Pacerone
®
), a medicine used to treat certain heart problems. In some cases bradycardia has
led to death or the need for a heart pacemaker when amiodarone is taken with SOVALDI. Get
medical help right away if you take amiodarone with SOVALDI and get any of the following
symptoms:
• fainting or near-fainting
• dizziness or
lightheadedness
• not feeling well
• weakness
• extreme tiredness
• shortness of breath
• chest pain
• confusion
• memory problems
The most common side effects of SOVALDI when used in combination with ribavirin include: