Ceritinib

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Generic Name: Ceritinib Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: D

Uses

What is Ceritinib used for?

Ceritinib is used to treat lung cancer that has spread to other parts of the body. It is used for lung cancers that have a certain type of abnormal “ALK” gene. Ceritinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How should I take Ceritinib?

Take this medication by mouth with food as directed by your doctor, usually once daily.

The dosage is based on your medical condition, laboratory tests, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Drugs that reduce stomach acid (including antacids, proton pump inhibitors such as omeprazole, H2 blockers such as ranitidine) may make you absorb less ceritinib. This could make ceritinib work less well. Talk to your doctor or pharmacist if you are taking any of these medications.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

How do I store Ceritinib?

Ceritinib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Ceritinib in the bathroom or the freezer. There may be different brands of Ceritinib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ceritinib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ceritinib?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes or high blood sugar, liver problems.

Ceritinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ceritinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ceritinib safely.

This drug may rarely cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss using reliable forms of birth control (such as condoms, birth control pills) while using this medication. Women of childbearing age should continue using reliable forms of birth control for 6 months after stopping treatment. Men with female partners of childbearing age should continue using condoms for 3 months after stopping treatment. If you or your partner become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended and for 2 weeks after stopping treatment. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ceritinib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ceritinib. Ceritinib is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ceritinib?

Diarrhea, nausea, vomiting, abdominal pain, loss of appetite, heartburn, constipation, or tiredness may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, or diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling, symptoms of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), vision changes (such as blurred vision, decreased vision), weakness.

Get medical help right away if you have any very serious side effects, including: trouble breathing, cough with or without phlegm, fast/slow/irregular heartbeat, severe dizziness, fainting, seizure.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Ceritinib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ceritinib?

Diarrhea, nausea, vomiting, abdominal pain, loss of appetite, heartburn, constipation, or tiredness may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, or diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling, symptoms of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), vision changes (such as blurred vision, decreased vision), weakness.

Get medical help right away if you have any very serious side effects, including: trouble breathing, cough with or without phlegm, fast/slow/irregular heartbeat, severe dizziness, fainting, seizure.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Ceritinib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash.

Ceritinib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ceritinib?

Ceritinib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

What health conditions may interact with Ceritinib?

Ceritinib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ceritinib.

What is the dose of Ceritinib for an adult?

Usual Adult Dose for Non-Small Cell Lung Cancer

750 mg orally once daily on an empty stomach.

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

-If a dose is missed, make it up unless it is 12 hours or less until the next dose.

-Discontinue in patients unable to tolerate 300 mg a day.

-An improvement in survival or disease-related symptoms has not been established

Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Renal Dose Adjustments

Mild to moderate renal impairment (CrCl 30 to less than 90 mL/min): No adjustment recommended.

Severe renal impairment (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

Mild hepatic impairment: No dose adjustment.

Monitor liver tests including ALT, AST, and bilirubin once a month and as clinically indicated.

If during treatment ALT or AST is greater than 5 times ULN and bilirubin is 2 times ULN or less:

-Withhold until return to baseline or until 3 times or less ULN, resume at 150 mg less than previous dose.

If during treatment ALT or AST is greater than 3 times ULN and bilirubin is greater than 2 times ULN (in the absence of cholestasis or hemolysis):

-Permanently discontinue drug.

Dose Adjustments

Strong CYP450 3A4 Inhibitors

Strong CYP450 3A inhibitors (e.g. ketoconazole):

-Avoid use

-If use cannot be avoided, reduce dose of ceritinib by approximately one third.

-Resume previous dose of ceritinib after discontinuation of strong CYP450 3A inhibitor.

QTc interval prolongation:

QTc interval greater than 500 msec on 2 separate ECGs:

-Withhold until QTc interval is less than 481 msec or recovery to baseline, whichever is higher, then resume ceritinib with a 150 mg dose reduction.

QTc interval prolongation with one of the following: Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia:

-Permanently discontinue.

GI side effects:

Severe/intolerable nausea, vomiting, or diarrhea despite optimal therapy:

-Withhold until improved, then resume with a 150 mg dose reduction.

Hyperglycemia:

Persistent hyperglycemia (greater than 250 mg/dL) despite optimal therapy:

-Withhold until hyperglycemia is adequately controlled, then resume with a 150 mg dose reduction.

-If adequate glycemic control cannot be achieved with optimal medical management, discontinue.

Bradycardia:

Non-life threatening symptomatic bradycardia:

-Withhold until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, evaluate concomitant medications known to cause bradycardia, and adjust the dose of ceritinib.

Life threatening or intervention requiring bradycardia in patients on other medications known to cause bradycardia or hypotension:

-Withhold until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. If the concomitant medication can be adjusted or discontinued, resume ceritinib with a 150 mg dose reduction, with frequent monitoring.

Life threatening bradycardia in patients not on medications known to cause bradycardia or hypotension:

-Permanently discontinue.

Interstitial Lung Disease (ILD)/Pneumonitis:

-Permanently discontinue for any grade of treatment related ILD/pneumonitis or any symptoms of ILD/pneumonitis if other causes cannot be excluded.

What is the dose of Ceritinib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Ceritinib available?

Ceritinib is available in the following dosage forms and strengths:

  • Oral capsule.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ceritinib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 16, 2018 | Last Modified: August 16, 2018

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