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Ceritinib

About Ceritinib

Ceritinib is an oral prescription medicine used to treat ALK-positive non-small cell lung cancer (NSCLC) that has spread to other parts of the body. ALK-positive means the cancer cells have an abnormal change involving a gene called ALK that causes them to grow. This medicine blocks the abnormal ALK protein and helps slow or stop cancer growth.

Take this medicine every day exactly as prescribed by your doctor. Ceritinib is generally taken once daily with food. Taking it consistently helps maintain the amount of medicine needed to control the cancer.

Common side effects include diarrhoea, nausea, vomiting, tiredness, and reduced appetite. Consult your doctor right away if you develop serious symptoms such as yellowing of the skin or eyes, severe stomach pain, a new or worsening cough, difficulty breathing, or a fast or irregular heartbeat.

Before starting treatment, tell your doctor if you have liver problems, diabetes or high blood sugar, pancreas problems, or heart or heart rhythm problems. Do not take this medicine if you have had an allergic reaction to ceritinib or any ingredient in the medicine.

Tell your doctor about all medicines, vitamins, supplements, and herbal products you take because some can affect how ceritinib works. This medicine can harm an unborn baby. Women who can become pregnant should use effective contraception during treatment and for at least 6 months after the last dose. Men with female partners who can become pregnant should use condoms during treatment and for at least 3 months after the last dose. Tell your doctor if you are pregnant, planning a pregnancy, breastfeeding, or are an older adult.

Uses of Ceritinib

Ceritinib is used in the treatment of Non-small cell lung cancer (NSCLC). The detailed uses of Ceritinib are as follows: • Non-small cell lung cancer (NSCLC): Ceritinib is used for the treatment of ALK-positive (anaplastic lymphoma kinase-positive) metastatic NSCLC. It is especially used in patients who have either not responded to or cannot tolerate previous treatments like crizotinib. • Targeted cancer therapy: Ceritinib works by inhibiting the ALK protein, which plays a role in the growth and spread of cancer cells. By blocking this protein, it helps slow or stop tumor progression.

Medicinal Benefits

Ceritinib provides targeted treatment for ALK-positive non-small cell lung cancer by blocking a specific protein that helps the cancer grow.

  • Helps control cancer growth: This medicine blocks ALK signals that cancer cells need to grow and multiply.
  • May shrink tumours: Treatment can reduce the size of tumours in some people and help keep the cancer under control.
  • May reduce cancer-related symptoms: As the cancer responds to treatment, symptoms caused by the tumour may improve.
  • Provides an oral treatment option: Because this medicine is taken by mouth, it can usually be taken at home according to your treatment plan.

Directions for Use

  • Ceritinib should be taken with meals to reduce stomach upset and improve absorption.
  • It is usually taken once a day; however, follow your doctor's advice regarding the dosage and duration.
  • Swallow the capsule as a whole with a glass of water.
  • Do not crush, chew or break Ceritinib.

Storage

Store in a cool and dry place away from sunlight

Side Effects of Ceritinib

Common Side Effects (Usually Mild)

  • Diarrhoea
  • Nausea
  • Vomiting
  • Tiredness
  • Reduced appetite
  • Stomach pain


Serious Side Effects (Consult your doctor right away)

  • Yellowing of the skin or eyes, dark urine, or severe pain in the upper right side of the stomach
  • New or worsening cough, fever, shortness of breath, or difficulty breathing
  • Fast, slow, or irregular heartbeat, severe dizziness, or fainting
  • Severe upper stomach pain that may spread to the back
  • Severe or persistent diarrhoea or vomiting
  • Signs of high blood sugar, such as increased thirst, frequent urination, or unusual tiredness

Drug Warnings

  • Keep up with monitoring: Your doctor may regularly check your liver function, blood sugar, pancreas enzymes, and other blood tests during treatment.
  • Monitor your heart: Your doctor may perform an electrocardiogram (ECG), a test that checks your heart rhythm, and may monitor certain minerals in your blood.
  • Report breathing problems: Consult your doctor right away if you develop a new or worsening cough, fever, shortness of breath, or difficulty breathing.
  • Report severe stomach symptoms: Tell your doctor promptly about severe or persistent diarrhoea, vomiting, or stomach pain.
  • Avoid grapefruit: Grapefruit and grapefruit juice can increase ceritinib levels and raise the risk of side effects.
  • Prevent pregnancy: Women who can become pregnant should use effective contraception during treatment and for at least 6 months after the last dose.
  • Use condoms when required: Men with female partners who can become pregnant should use condoms during treatment and for at least 3 months after the last dose.
  • Discuss family planning: Tell your doctor before treatment if you or your partner are planning a pregnancy. Contact your doctor promptly if pregnancy occurs during treatment.

Drug Interactions

  • Ketoconazole, itraconazole, clarithromycin, or ritonavir: These medicines can increase ceritinib levels in your blood and may increase the risk of side effects.
  • Rifampicin, carbamazepine, phenytoin, or St John's wort: These can reduce ceritinib levels and may make the treatment less effective.
  • Medicines that affect heart rhythm: Some medicines can increase the risk of abnormal heart rhythms when taken with ceritinib. Tell your doctor about all medicines you take so this risk can be assessed.
  • Medicines that slow the heart rate: Taking certain medicines that reduce heart rate with ceritinib may increase the risk of an unusually slow heartbeat and require closer monitoring.

Drug-Drug Interactions Checker List:

  • DILTIAZEM
  • METOPROLOL
  • LITHIUM
  • AZITHROMYCIN
  • ERYTHROMYCIN
  • ESCITALOPRAM
  • AMPRENAVIR
  • ATAZANAVIR
  • EFAVIRENZ
  • FINGOLIMOD
  • HALOTHANE
  • QUINIDINE
  • KETOCONAZOLE
  • RIFAMPICIN
  • MIDAZOLAM
  • WARFARIN
  • Safety Advice

    • Safety Warning

      Alcohol

      caution

      Avoid alcohol consumption while on treatment with Ceritinib.

    • Safety Warning

      Pregnancy

      unsafe

      Ceritinib should not be used during pregnancy as it may cause embryo-fetal toxicity. So, inform your doctor if you are pregnant or suspect pregnancy. You or your partner must use a reliable form of contraception to prevent pregnancy while taking this medication.

    • Safety Warning

      Breast Feeding

      unsafe

      You should not breastfeed during the treatment with Ceritinib and for two weeks after your last dose of this medication.

    • Safety Warning

      Driving

      caution

      Ceritinib may cause tiredness and weakness (fatigue), impacting the ability to drive or use machines.

    • Safety Warning

      Liver

      caution

      Ceritinib may cause liver problems. Please consult your doctor if you have liver problems before starting Ceritinib.

    • Safety Warning

      Kidney

      consult your doctor

      It is not known how Ceritinib affects when used in kidney-impaired patients. Please consult your doctor if you have kidney problems.

    • Safety Warning

      Children

      unsafe

      Safety and effectiveness in patients below the age of 18 years have not been established. Hence, use is not recommended.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Avoid grapefruit: Do not eat grapefruit or drink grapefruit juice because it can increase the amount of ceritinib in your blood and raise the risk of side effects.
    • Stay hydrated: Drink enough fluids, particularly if you develop diarrhoea or vomiting, unless your doctor has advised you to limit fluids.
    • Eat smaller meals when needed: Smaller, more frequent meals may be easier to manage if you experience nausea or reduced appetite.
    • Maintain good nutrition: Choose a balanced diet that provides enough energy, protein, and nutrients during cancer treatment.
    • Stay active as tolerated: Gentle physical activity may help support your general wellbeing, but follow your healthcare team's advice based on how you feel.
       

    Special Advise

    • Pregnancy testing is recommended before starting treatment with Ceritinib.
    • Do not donate sperm while taking Ceritinib or within three months following completion of therapy.
    • If you vomit after taking Ceritinib, do not take an additional dose. Continue with the next scheduled dose.

    Patients Concern

    Disease/Condition Glossary

    Non-small cell lung cancer (NSCLC): Non-small cell lung cancer is a condition in which malignant (cancer) cells develop in the lung tissues. Non-small cell lung cancer is classified into numerous categories. The most important risk factor for non-small cell lung cancer is smoking. There are various forms of non-small cell lung cancer. Different types of cancer cells are found in non-small cell lung cancer. Cancer cells of different types grow and spread in different ways. The several types of non-small cell lung cancer are named after the types of cells found in the cancer and how the cells appear under a microscope.

    FAQs

    Ceritinib is used to treat a type of lung cancer called non-small cell lung cancer.

    Ceritinib contains Ceritinib, which works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

    Elevations of lipase and/or amylase and pancreatitis can occur during treatment. Your doctor monitors lipase and amylase prior to treatment and periodically thereafter, as clinically indicated. If clinically insignificant values are observed, your doctor either withholds them or reduces the Ceritinib.

    In some cases, Ceritinib can cause bradycardia. Monitoring heart rate and blood pressure regularly is recommended. If this condition persists, consult your doctor immediately.

    Ceritinib can cause hyperglycemia. Your doctor monitors fasting glucose prior to treatment and periodically after that. Your doctor may prescribe anti-hyperglycemic medications, reduce the dose, or permanently discontinue Ceritinib if required.

    ALK-positive lung cancer is a specific type of non-small cell lung cancer (NSCLC) that has a mutation in the ALK (Anaplastic lymphoma kinase) gene, resulting in uncontrolled cell replication-cancer.

    Ceritinib should be swallowed as a whole with water.

    Lab tests will help you know the body’s response to Ceritinib. Keep taking Ceritinib for the duration advised by the doctor for effective results.

    Ceritinib may cause serious side effects like stomach and gastrointestinal problems, liver injury, pneumonitis (lung inflammation), and abnormal heartbeats. Consult the doctor if you experience any unusual symptoms.

    Ceritinib may cause liver problems such as liver injury. The doctor will advise regular blood tests to check for liver health during the treatment. Consult the doctor if you experience symptoms such as tiredness, itchy skin, nausea, vomiting, yellowing of eyes, decreased appetite, dark or brown urine, bleeding or bruising easily than usual, and pain on the right side of the stomach.

    Ceritinib may cause severe or life-threatening lung inflammation (pneumonitis). Seek medical attention if you experience chest pain, fever, cough with or without mucous, shortness of breath or trouble breathing.

    Eat non-spicy food and drink enough fluids if you have diarrhoea. You can take anti-diarrhoeal medicines if advised by the doctor.

    Ceritinib may cause vision problems. Do not drive, operate machinery or do any work that requires alertness until you know how the medicine affects you. Consult the doctor if you notice any vision problems.

    Ceritinib might cause itchy skin or rash. Use moisturiser and wear loose cotton clothes if you experience this. Consult the doctor if you notice yellow skin as this could be a sign of liver problems.

    Do not take another dose to replace the one you vomited. Take your next dose at the usual scheduled time. Consult your doctor if vomiting is frequent or severe.

    There is no well-established direct interaction between ceritinib and alcohol. However, because this medicine can affect the liver and cause stomach-related side effects, ask your doctor whether alcohol is appropriate for you.

    Treatment may continue for as long as it is controlling the cancer and side effects remain manageable. Your doctor will regularly assess your response and decide whether treatment should continue or change.

    No. Ceritinib is a targeted cancer medicine called an ALK inhibitor. It blocks an abnormal ALK protein that helps certain lung cancer cells grow.

    Ceritinib may cause tiredness or other side effects that could affect your ability to drive safely. Avoid driving or operating machinery if you feel unwell, dizzy, or unable to concentrate normally.

    Women who can become pregnant should use effective contraception while taking this medicine and for at least 6 months after the last dose. Ask your doctor which method is appropriate for you.

    Men with female partners who can become pregnant should use condoms during treatment and for at least 3 months after the last dose.

    Discuss your plans with your doctor before trying to conceive. This medicine can harm an unborn baby, so the recommended contraception period must be completed after the last dose before attempting pregnancy.

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