Do not take ZOKINVY if you are taking:

• a strong CYP3A inhibitor
• a strong or moderate CYP3A inducer
• midazolam
• lovastatin, simvastatin, or atorvastatin

ZOKINVY can cause a change in the electrical activity of your heart called QT prolongation, which can cause irregular heartbeats and may lead to death. Your health care provider should perform an imaging test called an electrocardiogram (ECG) before starting ZOKINVY and during treatment as needed. Tests to check the levels of your blood potassium, calcium, and magnesium should also be performed before starting treatment and regularly while on Zokinvy. Tell your healthcare provider right away if you feel dizzy, lightheaded, faint, or have a change in your heartbeat (a fast or irregular heartbeat).

Before taking ZOKINVY, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems.
• have eye problems.
• are pregnant or plan to become pregnant. ZOKINVY can harm your unborn baby. Women who are able to become pregnant should use effective birth control (contraception) during treatment with ZOKINVY.
• are breastfeeding or plan to breastfeed. It is not known if ZOKINVY can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ZOKINVY.

Do not give ZOKINVY to children under the age of 12 months because it has not been studied in this age group.

How should I take ZOKINVY?

• Take ZOKINVY exactly as your healthcare provider tells you to.
• Do not stop taking ZOKINVY without talking to your healthcare provider.
• Your healthcare provider may change your dose of ZOKINVY if needed.
• Your healthcare provider will provide you with the dose you should be taking. The dose is based on body size (height and weight).
• Take ZOKINVY 2 times a day with food.
• Swallow ZOKINVY capsules whole with an adequate amount of water. Do not chew ZOKINVY capsules.
• If you cannot swallow the ZOKINVY capsule whole, see the detailed Instructions for Use that comes with ZOKINVY for information about how to prepare and give or take a dose of ZOKINVY by mixing the contents of a ZOKINVY capsule with either Ora-Blend SF, Ora-Plus, orange juice, or applesauce.
• Each dose of ZOKINVY mixture must be prepared fresh and taken within about 10 minutes of mixing.
• Do not take ZOKINVY with any juice that contains grapefruit or Seville oranges. Seville oranges may also be called bitter or sour oranges.
• If you miss a dose of ZOKINVY, take it as soon as possible up to 8 hours before your next scheduled dose with food. If it is less than 8 hours before your next dose of ZOKINVY, skip the missed dose and take ZOKINVY at your next regularly scheduled dose.

What are the possible side effects of ZOKINVY?

ZOKINVY may cause serious side effects, including:

Severe kidney problems. ZOKINVY may cause severe kidney problems. Your healthcare provider will monitor your kidney function regularly during treatment with ZOKINVY.

The most common side effects of ZOKINVY include:

Call your healthcare provider if you continue to have nausea, vomiting, or diarrhea that leads to loss of appetite and weight loss during your treatment with ZOKINVY. ZOKINVY may cause an increase in your blood pressure (hypertension). Your healthcare provider will check your blood pressure during treatment with ZOKINVY. Call your healthcare provider right away if you develop any symptoms of high blood pressure including headaches, shortness of breath, nosebleeds, flushing, tiredness, dizziness, vision problems, irregular heartbeat, or chest pain.

ZOKINVY may cause fertility problems in women and men, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of ZOKINVY.