What is the most important information I should know about EXKIVITY?
EXKIVITY may cause serious side effects, including changes in the electrical activity of your heart called QTc prolongation and Torsades de Pointes. QTc prolongation can cause irregular heartbeats that can be life-threatening and may lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and do blood tests to check your electrolytes before starting treatment and during treatment with EXKIVITY. Tell your healthcare provider right away if you feel dizzy, lightheaded, faint or have an irregular heartbeat.
EXKIVITY may cause serious side effects, including:
- Lung problems. EXKIVITY may cause severe lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you develop any new or worsening symptoms, including trouble breathing or shortness of breath, cough, chest pain, or fever.
- Heart problems, including heart failure. EXKIVITY may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start and during treatment with EXKIVITY. Tell your healthcare provider right away if you have any signs or symptoms of a heart problem, including feeling like your heart is pounding or racing, shortness of breath, chest pain, swelling of your ankles and feet, or feeling faint.
- Diarrhea. Diarrhea is common during treatment with EXKIVITY and may sometimes be severe. Diarrhea can cause you to lose too much body fluid (dehydration) and kidney problems. Your healthcare provider may tell you to start drinking more fluids and electrolytes to replace body salts or start taking your antidiarrheal medicines. Tell your healthcare provider right away if you have any loose stools or have stools more often than is normal for you.
The most common side effects of EXKIVITY include diarrhea, rash, nausea, mouth sores, vomiting, decreased appetite, infection of skin around nails, tiredness, dry skin, muscle or bone pain. EXKIVITY may affect fertility in females and males, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of EXKIVITY. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking EXKIVITY, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider if you take medicines for heart problems. EXKIVITY and other medicines may affect each other causing serious side effects.
How should I take EXKIVITY?
What should I avoid while taking EXKIVITY?
- Avoid eating grapefruit or drinking grapefruit juice during treatment with EXKIVITY. Grapefruit may increase the amount of EXKIVITY in your blood.
Please see Patient Information in the EXKIVITY (mobocertinib) full Prescribing Information.