Lorbrena 25 mg tablet

Generic name:
Lorlatinib - oral

Pronunciation
(lor-LA-ti-nib)

Brand name(s)
Lorbrena

Lorlatinib is used to treat a certain type of lung cancer. It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start taking lorlatinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush, chew, or split the tablets. Do not take tablets that are broken or cracked.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the regular time.

Tiredness, constipation, nausea/vomiting, diarrhea, numbness/tingling of arms/legs, swelling ankles/feet/hands, dizziness, headache, trouble sleeping, weight gain, muscle/joint pain, or vision changes (such as blurred vision, decreased vision) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• mental/mood changes (such as depression, agitation, hallucinations, thoughts of suicide)
• slow heartbeat
• fainting
• trouble speaking

This medication may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Get medical help right away if you have any very serious side effects, including:

• seizures
• new/worsening lung disease (such as shortness of breath, cough, fever, chest pain)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking lorlatinib, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• kidney disease
• mental/mood problems (such as depression)
• seizures
• diabetes
• high blood pressure
• high cholesterol/triglycerides
• slow heartbeat

This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using lorlatinib. Lorlatinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable non-hormonal forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 1 week after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of lorlatinib from your body, which may affect how lorlatinib works. Examples include apalutamide, butalbital, enzalutamide, rifamycins (such as rifampin), secobarbital, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include daridorexant, elacestrant, certain products used to treat hepatitis C (such as asunaprevir, ombitasvir/paritaprevir/ritonavir), mavacamten, quizartinib, revumenib, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, cholesterol/triglyceride levels, heart rate, complete blood count, blood sugar, blood pressure) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is within 4 hours of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.