Lorlatinib

(lor-LA-tih-nib)

Trade Name(s): Lorbrena®

Lorlatinib is the generic name for the trade name drug Lorbrena®. In some cases, health care professionals may use the trade name Lorbrena® when referring to the generic drug name Lorlatinib.

Drug Type: Lorlatinib is a targeted therapy (for more detail, see "How Lorlatinib Works" section below).

What Lorlatinib is Used For

• For the treatment of metastatic non-small cell lung cancer (NSCLC) that is caused by a defect in a gene called ALK (anaplastic lymphoma kinase) who have progressed on other similar therapies, including (1) crizotinib and at least one other ALK inhibitor for metastatic disease, (2) alectinib as the first ALK inhibitor used for metastatic disease, or (3) certinib as the first ALK inhibitor used for metastatic disease. The cancer must be ALK-positive as indicated by an FDA-approved test.

Note: If a drug has been approve for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Lorlatinib Is Given

• Lorlatinib is a tablet, taken by mouth.
• Take this medication with or without food.
• Swallow lorlatinib tablets whole. Do not open, crush or split the tablets. Do not take tablets that are broken or cracked.
• Do not change your dose or stop lorlatinib unless your health care provider tells you to.
• Take lorlatinib at the same time each day.
• If you miss a dose, take it as soon as you remember. If it is too close to your next dose (within 4 hours), just take your next dose at your regular time. Do not take an extra dose to make up for a missed dose.
• If you take too much lorlatinib, call your health care provider right away and go to the emergency room.
• Do not repeat a vomited dose.
• Let your doctor know if you are starting any new medication as some medications may interact with lorlatinib.

The amount of lorlatinib that you will receive depends on many factors, your general health or other problems, and the type of side effects that you may have. Your doctor will determine your exact dosage.

Side Effects

Important things to remember about the side effects of lorlatinib:

• Most people will not experience all of the lorlatinib side effects listed.
• Side effects are often predictable in terms of their onset, duration and severity.
• There are many options to minimize or prevent the side effects of lorlatinib
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking lorlatinib:

• Anemia (low red blood cell count)
• High blood sugar or hyperglycemia
• High cholesterol or hypercholesterolemia
• High trigylcerides or hypertriglyceridemia
• Increased liver function tests: AST, ALT, bilirubin (liver problem)
• Low albumin (hypoalbuminemia
• Numbness or tingling in extremities
• Swelling (edema)

These are less common side effects (occurring in 10-29%) for patients receiving lorlatinib:

• Back and limb pain
• Constipation
• Cough
• Decline in memory, concentration, or attention
• Diarrhea
• Dizziness
• Fatigue
• Fever
• Headache
• High potassium
• Increased blood amylase
• Increased blood lipase
• Joint pain or arthralgias
• Low blood counts
• Low magnesium
• Low phosphate
• Mood disorder
• Muscle pain or myalgias
• Nausea
• Rash
• Sleep disorder
• Speech disturbance
• Shortness of breath
• Upper respiratory tract infection
• Visual disturbance
• Vomiting
• Weight gain

Not all side effects are listed above. Side effects that are very rare - occurring in less than about 10 percent of patients - are not listed here. You should always inform your healthcare provider if you experience any unusual symptoms.

When to Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
• New or worsening cardiac symptoms (slow or abnormal heart beats, dizziness, or fainting)
• New or worsening respiratory symptoms (trouble breathing, shortness of breath, or cough)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24-hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Constipation unrelieved by laxative use
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools
• Blood in the urine
• Changes in vision
• Hallucinations
• Extreme fatigue (unable to carry on self-care activities)
• Yellowing of the skin or eyes
• Tingling or burning, redness, swelling of the palms of the hands or soles of the feet
• Swelling of the feet or ankles. Sudden weight gain
• Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness

Always inform your health care provider if you experience any unusual symptoms.

Precautions

• Before starting lorlatinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking lorlatinib.
• Inform your health care provider if you are pregnant or may be pregnant prior to starting this treatment. This drug must not be given to a pregnant woman or a woman who intends to become pregnant.
• For both men and women: Use non-hormonal contraceptives (birth control pills may not be effective), and do not conceive a child (get pregnant) while taking lorlatinib. Barrier methods of contraception, such as condoms, are recommended for up to 6 months for women and 3 months for men after the last dose of lorlatinib.
• Do not breast feed while taking lorlatinib and for at least 7 days after the last dose of lorlatinib.

Self-Care Tips

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Follow regimen of anti-diarrhea medications as prescribed by your health care provider.
• Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).
• Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Lorlatinib

You will be checked regularly by your doctor while you are taking lorlatinib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your liver) will also be ordered by your doctor.

How Lorlatinib Works

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and normal cells. This information is used to create targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Lorlatinib is a reversible tyrosine kinase inhibitor (TKI). Tyrosine kinases are proteins that may signal cancer cells to grow. TKI's block these cells' signals to stop the growth of the cancer cells. Lorlatinib blocks the abnormal ALK (anaplastic lymphoma kinase) protein.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.