Lorlatinib tablets

What is this medication?

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 care team before I take this medication?

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

• diabetes (high blood sugar)
• high blood pressure
• high cholesterol
• irregular heartbeat or rhythm
• kidney disease
• lung disease
• mental health disease
• 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 medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Avoid grapefruit juice while taking this medicine.

Talk to your health care provider about 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 medication?

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

• apalutamide
• certain medicines for seizures like carbamazepine, fosphenytoin, mephobarbital, phenobarbital, phenytoin, primidone
• enzalutamide
• lumacaftor; ivacaftor
• mitotane
• ranolazine
• rifampin
• rifapentine
• 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 fluconazole, 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 medication?

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women must use a non-hormonal form of birth control while taking this medicine. Women will also need to take it for 6 months after stopping the medicine. There is potential for serious harm to an unborn child. Tell your health care provider right away if you think you might be pregnant. Do not breast-feed an infant while taking this medicine or for 7 days after stopping it.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a woman pregnant, there is potential for serious harm to an unborn child. You will need to continue wearing a condom for 3 months after stopping the medicine. Tell your health care provider right away if you think your partner might be pregnant.

This medicine may make it more difficult to father a child. It is usually temporary. Talk to your health care provider if you are concerned about your fertility.

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

Be careful brushing or 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.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medicine can increase cholesterol and triglyceride levels and decrease HDL (the good cholesterol) levels. Your health care provider may check your cholesterol. It may be necessary to change your diet or take new prescription medicines to help lower cholesterol. Alcohol can increase the risk of high cholesterol. Avoid alcoholic drinks while you are taking this medicine.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your health care provider right away.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• chest pain or tightness
• confusion
• cough
• edema (sudden weight gain; swelling of the ankles, feet, hands or other unusual swelling; trouble breathing)
• high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• seizures
• suicidal thoughts, mood changes
• unusual bruising or bleeding

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

• blurred vision OR changes in vision
• decreased need for sleep
• depressed mood
• elevated mood
• increase in blood pressure
• increase in cholesterol levels
• irritable
• loss of memory
• nausea, vomiting
• trouble sleeping

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 medication?

Keep out of the reach of children and pets.

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

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.