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Spexib Capsule
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Spexib Capsule

Manufactured byNOVARTIS INDIA LTD
ContainsCeritinib
Description
Spexib Capsule is used in the treatment of Non-small cell lung cancer (NSCLC), which is a type of cancer that affects the lungs. This medicine is not recommended for use in patients below 18 years of age.
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Side effectsConcernsUsage

Side effects

Major & minor side effects for Spexib Capsule

  • Nausea and vomiting
  • Diarrhea
  • Loss of appetite
  • Abdominal pain
  • Skin Rash
  • Weight loss
  • Fever
  • Unusual tiredness and weakness
  • Blurred vision

Uses of Spexib Capsule

What is it prescribed for?

  • Non-Small Cell Lung Cancer
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Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    The peak effect of this medicine can be observed within 4-6 hours of administration of the dose.
  • How long do the effects of this medicine last?
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Is it safe to consume alcohol while taking this medicine?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is this a habit forming medicine?
    No habit-forming tendencies were reported.
  • Can this medicine be taken during pregnancy?
    This medicine is not recommended for use in pregnant women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.
  • Can this medicine be taken while breast-feeding?
    This medicine is not recommended for use in breastfeeding women. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition

Allergy

This medicine is not recommended for use in patients with a known allergy to Ceritinib or any other inactive ingredients present along with it.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition
General warnings

Liver Disease

Use of this medicine should be done with caution in patients with liver diseases due to the increased risk of liver toxicity. Close monitoring of liver function is recommended for patients on treatment with this medicine. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Lung toxicity

Use of this medicine should be done with caution since it may increase the risk of Interstitial Lung Disease (ILD) with lung infiltration, pneumonitis, acute respiratory distress syndrome, allergic alveolitis, etc especially in patients with lung disorders. Management of lung toxicities may include symptomatic therapies, temporary treatment discontinuation and/or dose modification, or in severe or persistent cases, permanent discontinuation of the treatment. Report any symptoms such as difficulty in breathing, cough, fever, etc to the doctor immediately. An alternative treatment option should be considered in some cases based on the clinical condition.

Heart rhythm disorders

Use of this medicine may cause cardiac rhythm dysfunctions. Close monitoring of cardiac function, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition. Discontinuation of the medicine is recommended in case of development of severe cardiac adverse effects.

Increased blood glucose level

Use of this medicine is associated with an increased risk of elevated blood glucose levels. Close monitoring of blood sugar levels, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Pancreatitis

Use of this medicine may increase the risk of pancreatitis in some patients. Close monitoring, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Gastrointestinal adverse reactions

Use of this medicine should be done with caution in patients with gastrointestinal disorders due to the increased risk of severe gastrointestinal toxicity. Close monitoring, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Use in Children

This medicine is not recommended for use in children below 18 years of age since the safety and efficacy of use are not clinically established.

Driving or Operating machinery

Use of this medicine may cause blurred vision or dizziness in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

Contraception

Use of this medicine may increase the risk of harm to the unborn baby in pregnant women. Effective contraception is advised for women with the childbearing potential to avoid such risks. Birth controls should be administered while receiving this medicine and for 6 months post-therapy to prevent the pregnancy.

Missed Dose

Take the missed dose as soon as you remember. If it is almost 12 hours due for the next scheduled dose, then the missed dose can be skipped. Contact your doctor for further instructions if you miss more than one scheduled dose of this medicine.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Ondansetron

Vasopressin

Efavirenz

Ketoconazole

Sorafenib

Disease interactions

Heart rhythm disorders

This medicine should be used with caution in patients with cardiac rhythm dysfunctions due to the increased risk of worsening of the patient's condition. Close monitoring of cardiac function, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition. Discontinuation of the medicine is recommended in case of development of severe cardiac adverse effects.

Gastro-intestinal disease

This medicine should be used with caution in patients with gastro-intestinal disease due to increased risk of worsening of the condition. Use of this medicine has been associated with severe gastrointestinal toxicity. Close monitoring, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Liver Disease

This medicine should be used with caution in patients with liver dysfunction due to increased risk of worsening of the patient's condition. Regular monitoring of the liver function tests is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Pancreatitis

This medicine should be used with caution in patients with pancreatitis due to an increased risk of worsening of the condition. Close monitoring of the clinical condition, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Kidney Disease

This medicine should be used with caution in patients with kidney dysfunction due to increased risk of worsening of the patient's condition. Regular monitoring of the kidney function tests is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Lung Toxicity

This medicine should be used with caution in patients with a history of interstitial lung disease presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation due to the increased risk of the lung toxicity. Appropriate dose adjustments and frequent clinical monitoring are advised in such cases. Replacement with a suitable alternative may be required based on the clinical condition.
Food interactions
Avoid consumption of grapefruit or grapefruit juice while taking this medicine since it may cause severe adverse effects. Report to your doctor, if you experience any adverse effects such as irregular heart rhythm, diarrhea, nausea, vomiting, abdominal pain, and high blood sugar, etc.
Lab interactions
Information not available.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.
Take this medicine exactly as prescribed by the doctor. Do not take in larger or smaller quantities than recommended. Take this medicine with food at the same time daily. You may require frequent blood tests, cardiac tests, and liver function tests while taking this medicine. You may also require frequent followups with your doctor to check the progress of treatment. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

To be taken with food

To be taken as instructed by doctor

May cause sleepiness

How it works
This medicine works by inhibiting the actions of certain abnormal proteins that cause the cancer cells to multiply. This helps in stopping the growth and spread of cancer.
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Multikinase inhibitors, Antineoplastics

Schedule

Schedule H

[Internet]. Dailymed.nlm.nih.gov. 2018 [cited 20 December 2018]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fff5d805-4ffd-4e8e-8e63-6f129697563e

[Internet]. Medicines.org.uk. 2018 [cited 20 December 2018]. Available from:

https://www.medicines.org.uk/emc/product/7109#

Ceritinib - DrugBank [Internet]. Drugbank.ca. 2018 [cited 20 December 2018]. Available from:

https://www.drugbank.ca/drugs/DB09063

[Internet]. Ebs.tga.gov.au. 2018 [cited 20 December 2018]. Available from:

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-01610-1&d=201812201016933
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Information on this page was last updated on 5 Feb 2019

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