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LORBRENA® (lorlatinib) tablets Information for Patients

PATIENT INFORMATION
LORBRENA (lor-BREN-ah)
(lorlatinib)
tablets
This Patient Information has been approved by the U.S. Food and Drug Administration. November 2018

What is the most important information I should know about LORBRENA?

LORBRENA may cause serious side effects, including:

  • Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
  • Problems with brain (central nervous system [CNS]) function. Many patients experienced problems with brain function including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. In some patients, these problems are severe and your healthcare provider may need to have you stop taking LORBRENA.
  • Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most patients will have an increase in the lipid levels in your blood during treatment with LORBRENA.
    • If you have increases in the lipid levels in your blood during treatment with LORBRENA, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
    • Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORBRENA.
  • Heart problems. LORBRENA may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some patients, these problems are severe and your healthcare provider may need to have you stop taking LORBRENA or have a pacemaker placed.
  • Lung problems. LORBRENA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.
In some patients, these problems are severe and your healthcare provider may need to have you stop taking LORBRENA. See "What are possible side effects of LORBRENA?" for more information about side effects.
What is LORBRENA?
LORBRENA is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC)
  • that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene and,
  • that has spread to other parts of your body and,
  • who have taken the medicine alectinib or ceritinib or who have taken both the medicine crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • their NSCLC is no longer responding to these treatments.
It is not known if LORBRENA is safe and effective in children.
Do not take LORBRENA if you take certain other medicines called strong CYP3A inducers. Ask your healthcare provider for a list of these medicines if you are not sure.
Before taking LORBRENA, tell your healthcare provider about all of your medical conditions, including if you:
  • are taking other medications
  • have had episodes of depression or seizures
  • have high levels of cholesterol or triglycerides in your blood
  • have problems with your heart beat
  • have lung or breathing problems
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • Your healthcare provider will do a pregnancy test before you start treatment with LORBRENA.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LORBRENA.
      Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA and for at least 6 months after the final dose of LORBRENA. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with LORBRENA. Talk to your healthcare provider about birth control choices that are right for you during this time.
      Males who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA and for at least 3 months after the final dose of LORBRENA.
  • are breastfeeding or plan to breastfeed. It is not known if LORBRENA passes into your breast milk. Do not breastfeed during treatment with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
How should I take LORBRENA?
  • Take LORBRENA exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking LORBRENA unless your healthcare provider tells you to.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LORBRENA if you develop side effects.
  • Swallow LORBRENA tablets whole. Do not chew, crush, or split LORBRENA tablets. Do not take LORBRENA tablets if they are broken, cracked, or not intact.
  • Take LORBRENA at approximately the same time each day.
  • You may take LORBRENA with or without food.
  • If you miss a dose, take it as soon as you remember. However, if it is close to the time of your next dose (within 4 hours), just take your next dose at your regular time.
  • If you vomit after taking a dose of LORBRENA, do not take an extra dose. Take your next dose at your regular time.

What are the possible side effects of LORBRENA?

  • See "What is the most important information I should know about LORBRENA?"
The most common side effects of LORBRENA include:
  • swelling in your arms, legs, hands and feet (edema)
  • numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea
LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LORBRENA?
  • Store LORBRENA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep LORBRENA and all medicines out of the reach of children.
General information about the safe and effective use of LORBRENA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LORBRENA for a condition for which it was not prescribed. Do not give LORBRENA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about LORBRENA that is written for health professionals.
What are the ingredients in LORBRENA?
Active ingredient: lorlatinib
Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
Film-coating contains: hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, lactose monohydrate, macrogol/ polyethylene glycol (PEG) 3350, triacetin, titanium dioxide, ferrosoferric oxide/black iron oxide, and iron oxide red.
For more information, go to www.LORBRENA.com.

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