Erlotinib

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Generic Name: Erlotinib Brand Name(s): Generics only. No brands available.

Uses

What is Erlotinib used for?

Erlotinib is commonly used to treat lung and pancreatic cancer. It works by slowing or stopping the growth of cancer cells.

How should I take Erlotinib?

Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) as directed by your doctor, usually once daily.

The dosage is based on your medical condition, 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).

Medications that lower stomach acid (such as antacids, H2 blockers including ranitidine) may prevent erlotinib from working. Ask your doctor or pharmacist how to use these medications safely with erlotinib.

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.

Use this medication regularly to get the most benefit from it. To help you remember, take 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 tablets.

How do I store Erlotinib?

Erlotinib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Erlotinib in the bathroom or the freezer. There may be different brands of Erlotinib 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 Erlotinib 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 Erlotinib?

Before taking erlotinib, 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: liver disease, kidney disease, stomach/intestinal disease (such as ulcers, diverticulosis).

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

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages.

Sunlight may worsen any skin reactions that may occur while you are taking this drug. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

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 tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using erlotinib. Erlotinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 1 month after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. 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 Erlotinib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Erlotinib. Erlotinib 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 Erlotinib?

Diarrhea, dry skin, muscle/joint pain, mouth sores, unusual eyelash growth, or eye dryness/redness/irritation may occur. Diarrhea can be severe. In some cases, your doctor may prescribe medication to relieve diarrhea. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), signs of liver disease (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of dehydration (such as extreme thirst, muscle cramps, dizziness, fainting), redness/swelling around the nails, black stools, vomit that looks like coffee grounds, easy bleeding/bruising, unusual tiredness, eye pain, vision changes.

Get medical help right away if you have any very serious side effects, including: new or worsening shortness of breath or cough, chest/jaw/left arm pain, weakness on one side of the body, trouble speaking, confusion, seizures.

Erlotinib can commonly cause a mild 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 allergic reaction. Get medical help right away if you develop any rash.

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.

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 Erlotinib?

Some products that may interact with this drug are: “blood thinners” (such as warfarin), drugs that lower stomach acid (such as proton pump inhibitors including omeprazole).

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen) which may increase your risk for stomach bleeding while you are taking erlotinib. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should keep taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

Erlotinib 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 Erlotinib?

Erlotinib 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.

What health conditions may interact with Erlotinib?

Erlotinib 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 Erlotinib.

What is the dose of Erlotinib for an adult?

Usual Adult Dose for Non-Small Cell Lung Cancer

150 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

-There is no evidence that treatment beyond disease progression is beneficial.

Uses:

-First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

-Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

-Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Usual Adult Dose for Pancreatic Cancer

100 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

Use: First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

Renal Dose Adjustments

Severe renal dysfunction: Use is not recommended

Liver Dose Adjustments

Severe liver dysfunction: Use is not recommended

Treatment should be interrupted or discontinued, if:

-Total serum bilirubin doubles and/or serum transaminases triple in patients with baseline hepatic impairment

-Total serum bilirubin is greater than 3 times the upper limit of normal (3 x ULN) and/or serum transaminases are greater than 5 x ULN in patients with normal pre-treatment values.

Dose Adjustments

Discontinuation of Therapy:

-Interstitial Lung Disease

-Severe hepatic toxicity that does not improve significantly or resolve within three weeks

-Gastrointestinal perforation

-Severe bullous, blistering, or exfoliating skin conditions

-Corneal perforation or severe ulceration

Interruption of Therapy:

-During diagnostic evaluation for Interstitial Lung Disease

-For severe (grade 3 to 4) renal toxicity and consider discontinuation of therapy

-In patients without preexisting-existing hepatic impairment for total bilirubin levels greater than 3 x ULN or transaminases greater than 5 x ULN, and consider discontinuation of therapy

-In patients with preexisting-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline and consider discontinuation of therapy

-For persistent severe diarrhea not responsive to medical management

-For severe rash not responsive to medical management.

-For keratitis of grade 3-4 or for grade 2 lasting more than 2 weeks

-For acute/worsening ocular disorders such as eye pain and consider discontinuation of therapy

Reduce Dose by 50 mg Decrements:

-If severe reactions occur with concomitant use of strong CYP450 3A4 inhibitors or when using concomitantly with an inhibitor of CYP450 3A4 and CYP450 1A2. Avoid concomitant use if possible.

-When restarting therapy following interruption of treatment for a dose-limiting toxicity that has resolved to baseline or grade less than or equal to 1.

Increase Dose by 50 mg Increments:

-Concomitant use with CYP450 3A4 inducers. Increase dose by 50 mg increments every two weeks to a maximum dose of 450 mg. Avoid concomitant use if possible.

-Concurrent cigarette smoking. Increase the dose by 50 mg every two weeks to a maximum dose of 300 mg. Upon cessation of smoking, immediately reduce dose to the recommended dose (150 mg or 100 mg daily).

Other Comments

Administration advice:

-Take this drug at least one hour before or two hours after food.

-Avoid taking this drug with antacids, histamine-2 antagonists, and proton pump inhibitors.

Monitoring:

-Dermatologic: Bullous and exfoliative skin conditions

-Gastrointestinal: Diarrhea, gastrointestinal perforation

-Hepatic: Liver function tests (for hepatotoxicity, hepatitis, and hepatic failure)

-Metabolic: Dehydration, serum electrolytes (e.g., potassium)

-Ophthalmologic: Acute or worsening ocular disorders (e.g., corneal perforation or ulceration)

-Renal: Renal function

-Respiratory: Interstitial lung disease

What is the dose of Erlotinib 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 Erlotinib available?

Erlotinib is available in the following dosage forms and strengths:

  • Oral Tablet

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 Erlotinib, 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.

Review Date: January 26, 2018 | Last Modified: January 29, 2018

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