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LORBRENA®Medication Guide (lorlatinib)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers

Inform patients of the potential risk of hepatoxicity with the concomitant use of strong CYP3A inducers.

Advise patients to inform their healthcare providers of all medications they are taking, including prescription medicines, over-the-counter drugs, vitamins, and herbal products (e.g., St. John's wort) [see Warnings and Precautions (5.1)].

Central Nervous System (CNS) Effects

Advise patients to notify their healthcare provider if they experience new or worsening CNS symptoms [see Warnings and Precautions (5.2)].

Hyperlipidemia

Inform patients that serum cholesterol and triglycerides will be monitored during treatment. Advise patients that initiation or an increase in the dose of lipid-lowering agents may be required [see Warnings and Precautions (5.3)].

Atrioventricular (AV) Block

Inform patients of the risks of AV block. Advise patients to contact their healthcare provider immediately to report new or worsening cardiac symptoms [see Warnings and Precautions (5.4)].

Interstitial Lung Disease (ILD)/Pneumonitis

Inform patients of the risks of severe ILD/pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.5)].

Hypertension

Advise patients of the risks of hypertension and to promptly report signs or symptoms of hypertension to their healthcare provider. Advise patients with hypertension that antihypertension medications may need to be initiated or adjusted during treatment with LORBRENA [see Warnings and Precautions (5.6)].

Hyperglycemia

Inform patients of the risks of new or worsening hyperglycemia and the need to periodically monitor glucose levels. Advise patients with newly occurring hyperglycemia during treatment with LORBRENA that antihyperglycemic medications may need to be initiated. Inform patients with diabetes mellitus or glucose intolerance that antihyperglycemic medications may need to be adjusted during treatment with LORBRENA [see Warnings and Precautions (5.7)].

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective non-hormonal contraception during treatment with LORBRENA and for at least 6 months after the final dose [see Use in Specific Populations (8.3)].

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LORBRENA and for at least 3 months after the final dose [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

Lactation

Advise women not to breastfeed during treatment with LORBRENA and for 7 days after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise males of reproductive potential that LORBRENA may transiently impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].


PATIENT INFORMATION
LORBRENA (lor-BREN-ah)
(lorlatinib)
tablets
This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: March 2021

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.
  • Central nervous system (CNS) effects. LORBRENA may cause CNS effects, including:
    • problems with thinking, such as forgetfulness or confusion
    • changes in mood, such as depression and thoughts about suicide or dying
    • psychotic effects, such as seeing or hearing things that are not real (hallucinations)
    • seizures
    • changes in speech
    • changes in sleep
    Tell your healthcare provider if you experience new or worsening symptoms of these CNS effects during treatment with LORBRENA.
  • Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will have an increase in the lipid levels in their 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 or 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 people, 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.
  • High blood pressure (hypertension). Your healthcare provider should check your blood pressure before starting treatment, 2 weeks after starting treatment, and then at least every month during treatment with LORBRENA. Your healthcare provider may need to start or change your blood pressure medicine if you have high blood pressure during treatment with LORBRENA. Tell your healthcare provider right away if you get signs or symptoms of high blood pressure, including: headaches, dizziness, blurred vision, chest pain or shortness of breath.
  • High blood sugar (hyperglycemia). LORBRENA may increase your blood sugar levels. Your healthcare provider should do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of high blood sugar, including:
  • feeling very thirsty
  • needing to urinate more than usual
  • feeling very hungry
  • feeling sick to your stomach
  • feeling weak or tired
  • feeling confused
If you have serious side effects during treatment with LORBRENA, your healthcare provider may change your dose, stop your treatment for a period of time, or completely stop treatment with LORBRENA.
See "What are possible side effects of LORBRENA?" for more information about side effects.
What is LORBRENA?
LORBRENA is a prescription medicine used to treat adults 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.
Your healthcare provider will perform a test to make sure that LORBRENA is right for you.
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:
  • have kidney problems
  • 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
  • have high blood pressure
  • have diabetes or high blood sugar
  • 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. LORBRENA may affect the way other medicines work and other medicines may affect the way LORBRENA works causing side effects.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
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.
  • 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 1 time a day, at 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. Do not take 2 doses of LORBRENA at the same time to make up for the missed dose.
  • 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)
  • weight gain
  • problems with thinking, such as forgetfulness or confusion
  • tiredness (fatigue)
  • difficulty breathing
  • pain in your joints
  • diarrhea
  • changes in mood, such as depression and irritability
  • high cholesterol and triglyceride levels in the blood
  • cough
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 doctor 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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