Important Safety Information

VITRAKVI may cause serious side effects, including:

• Central Nervous System (CNS) problems: VITRAKVI may cause dizziness, confusion, problems with concentration, attention, and memory, changes in your mood, and sleep problems. Tell your healthcare provider if you develop any of these symptoms or if they get worse.
• Bone Fractures: Bone fractures can happen with VITRAKVI. Tell your healthcare provider if you develop pain, changes in your ability to move around, or bone abnormalities
• Liver problems: Abnormal liver blood tests may occur with VITRAKVI and can sometimes become serious. Your healthcare provider will do blood tests to check your liver function before starting and during treatment with VITRAKVI as needed. Tell your healthcare provider right away if you develop new or worsening symptoms of liver problems including:

Your healthcare provider may decrease your dose, temporarily stop or permanently stop your treatment with VITRAKVI if you develop serious side effects.

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

• have liver problems
• have nervous system (neurological) problems

• are pregnant or plan to become pregnant. VITRAKVI can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with VITRAKVI or think you may be pregnant.

  Females who are able to become pregnant:

  • Your healthcare provider may do a pregnancy test before you start treatment with VITRAKVI.
  • You should use effective birth control (contraception) during treatment and for 1 week after the last dose of VITRAKVI. Talk to your healthcare provider about birth control methods that may be right for you.

  Males with female partners who are able to become pregnant:

  • You should use effective birth control during treatment with VITRAKVI and for 1 week after the last dose of VITRAKVI.
• are breastfeeding or plan to breastfeed. It is not known if VITRAKVI passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of VITRAKVI.

While on VITRAKVI, you should avoid:

• VITRAKVI can make you feel dizzy. Do not drive or operate machinery until you know how VITRAKVI affects you.
• Avoid taking St. John’s wort, eating grapefruit, or drinking grapefruit juice during treatment with VITRAKVI.