Mobocertinib (moe-boe-SER-ti-nib)

Treats non-small cell lung cancer (NSCLC).

Brand Name(s):

Exkivity

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take the medicine at the same time each day.
• Swallow the capsule whole. Do not open, chew, or dissolve its contents.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If it is more than 6 hours or if you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how mobocertinib works. Tell your doctor if you are using efavirenz, itraconazole, ketoconazole, midazolam, rifampin, or medicines that may cause heart rhythm problems.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 1 month after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 1 week after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, heart disease, heart rhythm problems (including long QT syndrome), electrolyte imbalance, or other lung or breathing problems.
• This medicine may cause the following problems:
  • Heart rhythm problems (including QT prolongation, torsades de pointes), which can be life-threatening
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • Heart problems (including heart failure, cardiomyopathy)
  • Severe diarrhea
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, cold sweat, bluish-colored skin, trouble breathing
• Fast, pounding, or uneven heartbeat, fainting, dizziness, lightheadedness
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe diarrhea

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite, nausea, vomiting
• Dry skin
• Muscle or bone pain
• Redness or soreness around fingernails, loosening of the fingernails
• Sores or white patches on your lips, mouth, or throat
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088