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About LORLATINIB

LORLATINIB belongs to the group of medicines that inhibit an enzyme called anaplastic lymphoma kinase (ALK). It is used to treat adults with advanced stages of lung cancer called non-small cell lung cancer (NSCLC). Non-small cell lung cancer is a disease in which malignant (cancer) cells form in the lung tissues. There are several types of non-small cell lung cancer. Smoking is the major risk factor for non-small cell lung cancer.

LORLATINIB contains the active substance Lorlatinib, a medicine used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). It works by inhibiting a type of enzyme called tyrosine kinase and triggers the death of cancer cells in patients with alterations in genes for ALK. LORLATINIB is only given to patients whose disease is due to an alteration in the gene for ALK tyrosine kinase.

Always use this medicine as your doctor has told you or per the package leaflet. You must keep to your doctor's instructions to get the maximum benefit. In some cases, you may experience common side effects such as diarrhoea, constipation, joint pain, weight gain, headache, rash, and muscle pain. Most of these side effects do not require medical attention and will resolve gradually over time. However, you are advised to talk to your doctor if you experience these side effects persistently.

Consult your doctor before taking LORLATINIB if you are pregnant or breastfeeding. LORLATINIB may cause tiredness and dizziness, so drive with caution. Avoid consuming alcohol with LORLATINIB as it could lead to increased dizziness. LORLATINIB is not recommended for children below 18 years as safety and effectiveness have not been established. LORLATINIB is listed as pregnancy category D. Because LORLATINIB can cause harm to the fetus, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with LORLATINIB. Consult your doctor if you are breastfeeding; your doctor will decide whether LORLATINIB can be taken by breastfeeding mothers or not. Keep your doctor informed about your health condition and medicines to rule out any side effects. LORLATINIB may affect male fertility. Talk to your doctor about fertility preservation before taking LORLATINIB.

Uses of LORLATINIB

Treatment of advanced stages of lung cancer called non-small cell lung cancer (NSCLC)

Medicinal Benefits

LORLATINIB contains the active substance Lorlatinib, a medicine used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). LORLATINIB is only given to patients whose disease is due to an alteration in the gene for ALK tyrosine kinase. It works by inhibiting a type of enzyme called tyrosine kinase and triggers the death of cancer cells in patients with alterations in genes for ALK.

Directions for Use

Swallow it as a whole with water; do not crush, break or chew it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of LORLATINIB

  • Increase in cholesterol and triglycerides
  • Limb or skin swelling
  • Double vision
  • Pain
  • Numbness
  • Unusual sensations such as burning or pins and needles, difficulty walking, or difficulty with usual activities of daily
  • Increased level of enzymes called lipase and/or amylase
  • Anaemia
  • Diarrhoea
  • Constipation
  • Pain in your joints
  • Weight gain
  • Headache
  • Rash
  • Muscle pain

In-Depth Precautions and Warning

Drug Warnings

Consult your doctor before taking LORLATINIB if you are pregnant or breastfeeding. LORLATINIB may cause tiredness and dizziness, so drive with caution. Avoid consuming alcohol with LORLATINIB as it could lead to increased dizziness. LORLATINIB is not recommended for children below 18 years as safety and effectiveness have not been established. LORLATINIB is listed as pregnancy category D. Because LORLATINIB can cause harm to the fetus, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with LORLATINIB. Consult your doctor if you are breastfeeding; your doctor will decide whether the LORLATINIB can be taken by breastfeeding mothers or not. Keep your doctor informed about your health condition and medicines to rule out any side effects. LORLATINIB may affect male fertility. Talk to your doctor about fertility preservation before taking LORLATINIB.

Drug Interactions

Drug-Drug Interactions: LORLATINIB may interact with various medications, including medicines used to treat fungal infections (e.g. Ketoconazole, Itraconazole), medications used to treat bacterial infections/CYP3A4 inhibitors (e.g. Erythromycin), a drug used to treat irregular heartbeat and other heart problems. (e.g. Quinidine), medications used to treat severe pain (e.g. Alfentanil and Fentanyl), medicines used in organ transplantation to prevent organ rejection (e.g. Ciclosporin, Sirolimus, and Tacrolimus), medicines used to treat AIDS/HIV (e.g. Efavirenz, Cobicistat), medications used to treat migraine headaches (e.g. Dihydroergotamine, Ergotamine ), a drug used to treat depression or to help people quit smoking (e.g. Buproprion), and medication used to treat hepatitis C (e.g. Boceprevir).

Drug-Food Interactions: You must not drink grapefruit juice or eat grapefruit while on treatment with LORLATINIB as they may change the amount of LORLATINIB in your body.

Drug-Disease Interactions: LORLATINIB should be used with caution in patients with liver disorders, kidney disorders, central nervous system (CNS) and heart disorders.

Drug-Drug Interactions Checker List:

  • KETOCONAZOLE
  • ITRACONAZOLE
  • ERYTHROMYCIN
  • QUINIDINE
  • ALFENTANIL
  • FENTANYL
  • CICLOSPORIN
  • SIROLIMUS
  • TACROLIMUS
  • EFAVIRENZ
  • COBICISTAT
  • BUPRENORPHINE
  • DIHYDROERGOTAMINE
  • ERGOTAMINE
  • BUPROPION
  • BOCEPREVIR
  • Safety Advice

    • Safety Warning

      Alcohol

      caution

      It is not known if alcohol interacts with LORLATINIB. However, as a precautionary measure, you are recommended not to consume alcohol with the LORLATINIB to avoid unpleasant side effects.

    • Safety Warning

      Pregnancy

      unsafe

      LORLATINIB is listed as pregnancy category D. Because LORLATINIB can cause harm to the fetus, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with LORLATINIB.

    • Safety Warning

      Breast Feeding

      unsafe

      Do not breastfeed for seven days after the last dose while taking this medicine. This is because it is unknown if the LORLATINIB can pass into breast milk and could harm your baby.

    • Safety Warning

      Driving

      caution

      LORLATINIB moderately influences the ability to drive and use machines. Caution should be exercised when driving or operating machines, as patients may experience CNS effects.

    • Safety Warning

      Liver

      caution

      Inform your doctor before receiving the LORLATINIB if you have a history of liver diseases/conditions. Your doctor may adjust your dose depending on your current liver conditions.

    • Safety Warning

      Kidney

      caution

      Inform your doctor before receiving the LORLATINIB if you have a history of kidney diseases/conditions. Your doctor may adjust your dose depending on your current kidney conditions.

    • Safety Warning

      Children

      unsafe

      LORLATINIB is only indicated in adults, and it is not to be given to children and adolescents.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Watch out for triggers that worsen the cough, such as smoke, foods, air-conditioning, high altitude, etc.
    • Exercise moderately. Eat healthily.
    • Follow pulmonary rehabilitation program. It includes exercise, disease education, and group therapy.
    • Quit smoking and alcohol.
    • Get ample rest.
    • Include green leafy vegetables, sweet potatoes, broccoli, tomatoes, carrots, mangoes, citrus fruits, berries, and cocoa.
    • Lean proteins such as fish, meat, and poultry are the best.
    • Hydration is important. Drink plenty of water, herbal tea, and vegetable and fruit juices.
    • Avoid processed and refined foods.

    Special Advise

    You will have blood tests before you start treatment and during your treatment. These tests check the level of cholesterol, triglycerides and the enzymes amylase or lipase in your blood before you start treatment with LORLATINIB and regularly during treatment. You will have blood tests before you start treatment and during your treatment. These tests check the level of cholesterol, triglycerides and the enzymes amylase or lipase in your blood before you start treatment with LORLATINIB and regularly during treatment.

    Patients Concern

    Disease/Condition Glossary

    Non-small cell lung cancer (NSCLC): Non-small cell lung cancer (NSCLC) is a disease in which malignant (cancer) cells form in the lung tissues. There are several types of non-small cell lung cancer. Smoking is the major risk factor for non-small cell lung cancer.

    FAQs

    How does LORLATINIB work?

    LORLATINIB contains the active substance Lorlatinib, which inhibits a type of enzyme called tyrosine kinase and triggers the death of cancer cells in patients with alterations in genes for ALK. LORLATINIB is only given to patients whose disease is due to an alteration in the gene for ALK tyrosine kinase.

    What is the purpose of LORLATINIB?

    Lorlatinib belongs to the kinase inhibitor class of drugs. Lorlatinib is a drug used to treat a kind of non-small cell lung cancer (NSCLC) that has spread to other places of the body in adults. It works by preventing the malfunctioning protein from causing cancer cells to multiply.

    When should I stop the treatment with LORLATINIB?

    LORLATINIB should be stopped when a person faces a serious side effect that affects life quality. Otherwise, it would be best to keep taking LORLATINIB until your doctor asks you to stop it.

    Is it safe to smoke while taking LORLATINIB?

    Avoid smoking before starting the treatment while taking LORLATINIB as smoking might alter the effectiveness of LORLATINIB.

    I am 65 years. Is it safe to take LORLATINIB?

    In elderly patients, the risk of side effects is greater. For the elderly, dose adjustment might be required, or your doctor might prescribe any other medication safe for the elderly.

    If I start feeling well, can I skip the dose of LORLATINIB?

    You should complete the full course of LORLATINIB as your doctor prescribes. After completing the full course of LORLATINIB will work. It would help if you took LORLATINIB at the right dose, right times and for the right number of days.

    Is lung cancer curable?

    Detecting lung cancer in its early stages, when it is most treatable, is critical to survival. Early tumours have a cure rate of 85-90 per cent, but this depends on other factors.

    Available Medicines for

    LORLATINIB