Lorlatinib (lor-LA-ti-nib)

Treats non-small cell lung cancer.

Brand Name(s):

Lorbrena

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not chew, crush, or split it.
• 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 you miss a dose and it is within 4 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose. Do not take extra medicine if you vomit.
• 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.

• Do not use this medicine together with rifampin.
• Some medicines can affect how lorlatinib works. Tell your doctor if you are using acetaminophen, bupropion, fexofenadine, fluconazole, itraconazole, midazolam, modafinil, St John's wort, tolbutamide, or birth control pills.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Women should use an effective form of birth control (including condoms or spermicide along with your pills) to keep from getting pregnant during treatment with this medicine and for at least 6 months after the last dose. Men should also use an effective form of birth control during treatment with this medicine and for at least 3 months after the last dose.
• Do not breastfeed while you are using this medicine and for 7 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, heart rhythm problems, high cholesterol or fat in the blood, high blood pressure, diabetes, high blood sugar, or a history of depression or seizures.
• This medicine may cause the following problems:
  • Liver problems, when used with other medicines
  • Brain or nerve problems, including seizures
  • Changes in mood or behavior, including thoughts of suicide
  • High cholesterol or fat in the blood
  • Heart rhythm problems, including heart block
  • Interstitial lung disease or pneumonitis, which may be life-threatening
  • High blood pressure
  • High blood sugar
• This medicine could cause infertility in some men. Talk with your doctor before using this medicine if you plan to have children.
• 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.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• 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
• Blurred vision, severe headache, lightheadedness, dizziness
• Confusion, problems with thinking, memory, movement, speech, or vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth or skin, increased hunger or thirst, tiredness
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Seizures, seeing, hearing, or feeling things that are not there, trouble sleeping, mood or mental changes, thoughts of suicide
• Trouble breathing, chest pain

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

• Back, arm, or leg pain
• Constipation, diarrhea
• Joint or muscle pain
• Skin rash

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