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FOR US PATIENTS ONLY

Understanding
Side Effects

Here’s what you might experience

EXKIVITY may cause side effects. Not every person will experience the same side effects, and for some people, some side effects may be more severe than others. You and your healthcare team should monitor for side effects and work together to manage them early so you can get the most out of treatment.
Possible serious side effects you should be aware of:
Changes in the electrical activity of your heart
In some people, EXKIVITY can affect the electrical activity of the heart, causing irregular heartbeats. This can be life-threatening and can 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 you start EXKIVITY and during treatment. Tell your healthcare provider right away if you feel dizzy, lightheaded, faint or have an irregular heartbeat.
Lung problems
EXKIVITY may cause severe lung problems that may lead to death. It may be hard to tell lung problems from your lung cancer symptoms, so tell your healthcare team 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, including heart failure. Your healthcare provider should check your heart function before you start EXKIVITY and during treatment. 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 with EXKIVITY and may sometimes be severe. Diarrhea can cause you to lose too much body fluid (dehydration) and kidney problems. Tell your healthcare provider right away if you have any loose stools or have stools more often than is normal for you.
How to manage diarrhea if it occurs
ANTICIPATE
  • Diarrhea should be treated right away
  • It typically occurs within 5 days but can occur as soon as 24 hours after starting EXKIVITY. It can continue to occur at any point during therapy
  • It is most often mild to moderate
  • It is recommended that you have an antidiarrheal medicine (such as loperamide) at home so you can treat diarrhea promptly when it happens
  • Talk to your healthcare team before taking any medication
In general, the sooner your diarrhea is addressed, the more likely it will be controlled and tolerable
ADDRESS
  • Your healthcare team is likely to instruct you to take an antidiarrheal medicine at first sign of loose or poorly formed stool
  • Tell your healthcare team immediately if you have any loose stools or if your bowel movements become more frequent than normal
  • Stay hydrated: drink enough liquids (about 8 to 10 cups) every day to replace lost fluids and electrolytes
  • Eat simply: eat smaller, more frequent meals of plain foods such as bananas, rice, applesauce, and toast. Avoid fatty and high-fiber foods
How to manage skin reactions if they occur
Some people taking EXKIVITY experienced skin reactions, but they were mostly mild or moderate. They included rash, dry skin, and nail inflammation. Common symptoms of rash were itchy, dry, or swollen red skin, and red, inflamed, scaly skin.
If you experience any of these skin reactions, be sure to talk to your healthcare team right away. Your team may refer you to a dermatologist. If your rash is severe, they may reduce, withhold, or permanently discontinue your dose of EXKIVITY.
Limit sun exposure
Sunburn can make rash symptoms worse. Avoid too much time in the sun, use sunscreen, and protect your skin with a hat and long sleeves.
Keep skin soft
Use an alcohol- and perfume-free skin cream often. Avoid hot showers and products that dry your skin.
Talk to your healthcare team
Speak up if rash makes it hard for you to carry out normal daily activities.
The importance of speaking up
Sometimes people worry about mentioning side effects to their doctors or nurses—they don’t want to bother them, or they’re scared of being taken off their medication.
If you have any side effect that interferes with daily life or that does not go away, tell your healthcare team right away. Addressing side effects as soon as possible may keep them from getting worse.
Take notes on how you are feeling and share them with your healthcare team.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects directly to Takeda Oncology at 1-844-817-6468 or GlobalOncologyMedinfo@Takeda.com.
Download the Treatment Guide

IMPORTANT SAFETY INFORMATION

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.

What is EXKIVITY?

EXKIVITY is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC):

  • that has spread to other parts of the body (metastatic) and cannot be removed by surgery, and
  • has a certain abnormal epidermal growth factor receptor (EGFR) gene, and
  • whose disease has worsened while on or after chemotherapy that contains platinum

Your healthcare provider will perform a test to make sure that EXKIVITY is right for you.

It is not known if EXKIVITY is safe and effective in children.

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 FDA at 1-800-FDA-1088.

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

  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • have lung or breathing problems other than lung cancer
  • are pregnant or plan to become pregnant. EXKIVITY can harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with EXKIVITY. You should use an effective form of non-hormonal birth control during treatment and for 1 month after your last dose of EXKIVITY. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not work as well during treatment with EXKIVITY. Talk to your healthcare provider about birth control methods that might be right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with EXKIVITY.

    Males who have female partners who are able to become pregnant:

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

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?

  • Take EXKIVITY exactly as your healthcare provider tells you to take it.
  • Take your prescribed dose of EXKIVITY 1 time each day.
  • Take EXKIVITY with or without food.
  • Swallow EXKIVITY capsules whole. Do not open, chew, or dissolve the contents of the capsules.
  • Do not change your dose or stop taking EXKIVITY unless your healthcare provider tells you to.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with EXKIVITY if you develop certain side effects.
  • If you miss a dose of EXKIVITY, and it has been more than 6 hours, skip the dose and take your next dose at your regularly scheduled time the next day.
  • If you vomit a dose of EXKIVITY, do not take an extra dose. Take your next dose at your regularly scheduled time the next day.

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.