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Generic Name: lorlatinib

Trade Name: Lorbrena®

For which conditions is Lorbrena approved for? Lorbrena is approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is caused by a defect in a gene called ALK (anaplastic lymphoma kinase) and whose cancer is verified as ALK-positive by an FDA-approved test.

What is the mechanism of action? Lorbrena is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. Specifically, Lorbrena targets ALK.

How is Lorbrena typically given (administered)? Lorbrena is given orally (tablet) once daily at the same time each day, with or without food. Do not chew, crush or split Lorbrena tablets. If you vomit after taking Lorbrena, do not take an extra dose but take your next dose at your regular time. Do not take two doses of Lobrena at the same time to make up for a missed dose.

How are patients typically monitored? Lorbrena can cause complications involving the liver, central nervous system, lipid levels, heart, lungs, blood pressure and blood sugar. Your healthcare provider will monitor your blood sugar levels, lipid levels, blood pressure and your heart rhythm during treatment. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the common side effects of treatment with Lorbrena?

  • Swelling in your arms, legs, hands or feet
  • Numbness and tingling in your joints, arms or legs
  • Weight gain
  • Problems with thinking (forgetfulness or confusion)
  • Tiredness
  • Difficulty breathing
  • Joint pain
  • Diarrhea
  • Mood changes (depression or irritability)
  • High cholesterol and triglyceride blood levels
  • Cough

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all of your medical conditions and about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements. Lorbrena can cause liver problems due to interactions with other medications.
  • Take Lorbrena exactly as your healthcare provider tells you. Do not change your dose or stop taking it unless your healthcare provider tells you to.
  • Take Lorbrena one time each day and swallow whole.
  • Take Lorbrena with or without food.
  • If you miss a dose of Lorbrena, do not take the missed dose. Take your next dose at your regular time.

Are there any special precautions patients should be aware of before starting treatment?

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  • Tell your healthcare provider if you have any of the following: Kidney problems Depression episodes or seizures High levels of cholesterol or triglycerides Heart beat problems Lung or breath problems High blood pressure Diabetes or high blood sugar
  • Tell your doctor if you are pregnant or plan to become pregnant. Lorbrena may harm your unborn baby. Women who are able to become pregnant should use an effective method of birth control during treatment with Lorbrena and for at least six months after stopping Lorbrena. Talk to your healthcare provider about birth control methods that may be right for you; hormonal forms of birth control may not be effective while you are being treated with Lorbrena. Men should also use effective birth control while on treatment with Lorbrena and for at least 3 months after completing treatment.
  • Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Lorbrena or for 7 days after your last dose of Lorbrena.

When should patients notify their physician? Tell your doctor if you have signs of lung problems including trouble breathing, shortness of breath, any cough, chest pain or fever. Also tell your doctor if you have any signs of high blood pressure such as headaches, blurred vision, chest pain or shortness of breath. Any signs of heart problems should also be reported to you doctor right away including feeling dizzy, lightheaded or faint. In addition, let your doctor know right away if you experience central nervous system side effects including problems with thinking, changes in mood, psychotic effects, seizures, or changes in speech or sleep.

In addition, tell your doctor if you have signs of high blood sugar. These include:

  • Feeling very thirsty
  • Needing to urinate more than usual
  • Feeling very hungry
  • Feeling sick to your stomach
  • Feeling weak or tired
  • Feeling confused

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 3/19/21.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.