What is this medicine?

LORLATINIB (lor LA ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat non-small cell lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Lorbrena

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • high cholesterol
  • history of irregular heartbeat
  • lung or breathing disease, like asthma
  • mental illness
  • scarring or thickening of the lungs
  • seizures
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • an unusual or allergic reaction to lorlatinib, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 4 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
  • enzalutamide
  • mitotane
  • rifampin
  • St. John's Wort

This medicine may also interact with the following medications:

  • bosentan
  • certain antibiotics like clarithromycin and troleandomycin
  • certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole
  • certain medicines for hepatitis like boceprevir and telaprevir
  • certain medicines for HIV like cobicistat, indinavir, lopinavir, ritonavir, saquinavir, and tipranavir
  • conivaptan
  • female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
  • grapefruit juice
  • midazolam
  • modafinil
  • other medicines for HIV like efavirenz and etravirine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 7 days after stopping it. This may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • breathing problems
  • chest pain or tightness
  • confusion
  • cough
  • feeling faint or lightheaded, falls
  • fever
  • palpitations
  • seizures
  • signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
  • signs of infection - fever or chills, cough, sore throat, pain or trouble passing urine
  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
  • suicidal thoughts or other mood changes

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

  • dizziness
  • headache
  • irritable
  • loss of memory
  • nausea, vomiting
  • trouble sleeping
  • unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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