Precautions
Medically reviewed on Nov 1, 2018. Tarceva (erlotinib) is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. Tarceva is used to treat non-small cell lung cancer or pancreatic cancer that has spread to other parts of the body (metastatic).
What is Tarceva (erlotinib)?
Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies ( 14.5 )].
What is Tarceva used to treat pancreatic cancer?
Tarceva® is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva® is indicated when other treatment options are not considered suitable. 2
When is Tarceva used to treat NSCLC?
Tarceva comes as an oral tablet. The typical dosage of Tarceva for non-small cell lung cancer is 150 mg once daily. If you smoke cigarettes, your doctor may prescribe a higher initial dose (starting dose) of Tarceva. If you quit smoking during treatment, they’ll likely lower your dose to the typical recommended dose.
How much Tarceva can I take for lung cancer?
Is Tarceva a chemotherapy?
Note: Tarceva is not a chemotherapy drug. It's considered to be a targeted therapy.
How effective is Tarceva?
The overall anti-cancer response rate was 9% for patients treated with Tarceva™ and the average duration of response was nearly 8 months. Disease stabilization was achieved in 35% of patients treated with Tarceva™ and progression of cancer occurred in 38% of patients treated with Tarceva™.
What is the drug Tarceva used for?
Tarceva is prescribed for patients with non-small cell lung cancer (NSCLC) whose cancer has spread to other parts of the body and that has certain types of epidermal growth factor receptor (EGFR) mutations.
How is Tarceva given?
Recommended Dose - NSCLC The recommended daily dose of TARCEVA for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.
Does Tarceva shrink tumors?
Erlotinib can help shrink the cancer or stop it growing for a time.
Which of the following is a serious side effect to monitor for a patient receiving erlotinib?
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
Does Tarceva make you tired?
0 in Table 4. The most common adverse reactions in pancreatic cancer patients receiving TARCEVA 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea.
How much is Tarceva?
The cost for Tarceva oral tablet 25 mg is around $2,874 for a supply of 30 tablets, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
What is a known side effect of 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.
Is Tarceva a specialty drug?
Tarceva will be transitioning to a specialty pharmacy distribution model on July 1, 2013.
Is Tagrisso better than Tarceva?
Tagrisso improved overall survival duration compared to Tarceva and Iressa. Median overall survival was 38.6 months compared to 31.8 months with first generation EGFR-TKIs. More than half (54%) of Tagrisso treated patients were alive at three years compared to 44% for Tarceva or Iressa.
Can Tarceva be cut in half?
Erlotinib is taken by mouth, in tablet form, once a day. It is usually taken on an empty stomach, at least 1 hour before or 2 hours after eating a meal or snack. Take erlotinib at around the same time every day. Take the tablet whole, do not break, crush or chew.
Before Taking This Medicine
You should not take Tarceva if you are allergic to erlotinib.To make sure Tarceva is safe for you, tell your doctor if you have: 1. lung or breathi...
How Should I Take Tarceva?
Take Tarceva exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose...
Tarceva Dosing Information
Usual Adult Dose for Non-Small Cell Lung Cancer:150 mg orally once a dayDuration of therapy: Until disease progression or unacceptable toxicityComm...
What Happens If I Miss A Dose?
Take the missed dose as soon as you remember (take only on an empty stomach). Skip the missed dose if it is almost time for your next scheduled dos...
What Happens If I Overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Overdose symptoms may include severe diarrhea or severe skin rash.
What Should I Avoid While Using Tarceva?
Avoid taking an antacid within several hours before or after you take Tarceva. Ask a doctor or pharmacist before taking other stomach medicines suc...
What Other Drugs Will Affect Tarceva?
Many drugs can interact with erlotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible...
Does Tarceva have CBC?
You will be checked regularly by your health care professional while you are taking Tarceva, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
Can you take aspirin before taking Tarceva?
Certain medications can interfere with the levels/effects of Tarceva. It is important your oncologist is aware of all medications. Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
How much Tarceva should I take for pancreatic cancer?
Recommended Dose – Pancreatic Cancer. The recommended daily dose of Tarceva for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take Tarceva on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food.
How long does it take for a rash to appear after taking Tarceva?
In Tarceva-treated patients the median time to onset of rash was 15 days and the median time to onset of diarrhea was 32 days.
How long does Erlotinib stay in plasma?
Time to reach steady state plasma concentration would therefore be 7-8 days.
How long after taking Tarceva can I take ranitidine?
H 2 -receptor antagonists. If treatment with an H 2 -receptor antagonist such as ranitidine is required, separate dosing. Tarceva must be taken 10 hours after the H 2 -receptor antagonist dosing and at least 2 hours before the next dose of the H 2 -receptor antagonist. Antacids.
Does Tarceva cause rash?
The most common adverse reactions with Tarceva are rash and diarrhea usually with onset during the first month of treatment. The incidences of rash and diarrhea from clinical studies of Tarceva for the treatment of NSCLC and pancreatic cancer were 70% for rash and 42% for diarrhea.
Can Tarceva cause abortion?
Based on animal data and its mechanism of action, Tarceva can cause fetal harm when administered to a pregnant woman. When given during organogenesis, erlotinib administration resulted in embryo-fetal lethality and abortion in rabbits at exposures approximately 3 times the exposure at the recommended human daily dose of 150 mg. Advise pregnant women of the potential risk to a fetus.
Can Tarceva cause gastrointestinal perforation?
Gastrointestinal perforation, including fatal cases, can occur with Tarceva treatment . Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation [see Adverse Reactions ( 6.1, 6.2 )]. The pooled incidence of gastrointestinal perforation in the 3 monotherapy lung cancer studies was 0.2% in the Tarceva arms and 0.1% in the control arms. The incidence of gastrointestinal perforation in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0% in the control arm. Permanently discontinue Tarceva in patients who develop gastrointestinal perforation [see Dosage and Administration ( 2.4 )].
How much tarceva should I take daily?
Increase TARCEVA by 50 mg increments at 2-week intervals to a maximum of 300 mg. Immediately reduce the dose of TARCEVA to the recommended dose (150 mg or 100 mg daily) upon cessation of smoking.
How much taraceva should I take for pancreatic cancer?
Recommended Dose - Pancreatic Cancer. The recommended daily dose of TARCEVA for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take TARCEVA on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food.
How long does Erlotinib last?
Erlotinib has an apparent volume of distribution of 232 liters. Elimination. Erlotinib is eliminated with a median half-life of 36.2 hours in patients receiving the single-agent TARCEVA 2nd/3rd line regimen.
What is the chemical name of erlotinib?
DESCRIPTION. TARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N- (3-ethynylphenyl)-6,7-bis (2-methoxyethoxy)4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula: Erlotinib hydrochloride has the molecular formula C 22 H 23 N 3 O 4 .HCl ...
What inducers can be used with CYP3A4?
Concomitant use with CYP3A4 inducers, such as rifampin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John’s Wort. Increase TARCEVA by 50 mg increments at 2-week intervals to a maximum of 450 mg as tolerated. Avoid concomitant use if possible.
Can a TARCEVA treatment cause gastrointestinal perforation?
Gastrointestinal perforation, including fatal cases, can occur with TARCEVA treatment. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation [see ADVERSE REACTIONS ]. The pooled incidence of gastrointestinal perforation in the 3 monotherapy lung cancer studies was 0.2% in the TARCEVA arms and 0.1% in the control arms. The incidence of gastrointestinal perforation in the pancreatic cancer study was 0.4% in the TARCEVA plus gemcitabine arm and 0% in the control arm. Permanently discontinue TARCEVA in patients who develop gastrointestinal perforation [see DOSAGE AND ADMINISTRATION ].
Does TARCEVA increase erlotinib?
Co-administration of TARCEVA with a strong CYP3A4 inhibitor or a combined CYP3A4 and CYP1A2 inhibitor increased erlotinib exposure. Erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2. Increased erlotinib exposure may increase the risk of exposure-related toxicity [see CLINICAL PHARMACOLOGY ].
What Is Tarceva?
Tarceva (erlotinib) is a prescription oral medication used to treat lung cancer that has spread to other areas of the body (metastatic). It can also be used in combination with a chemotherapy called Gemzar (gemcitabine) to treat metastatic pancreatic cancer.
What Is Tarceva Used For?
The Food and Drug Administration (FDA) has approved Tarceva to treat metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or exon 21 substitution mutation. It can be used as the first therapy given, also known as first-line treatment, or after prior chemotherapy hasn’t worked. 1
What Are the Side Effects of Tarceva?
This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Dosage: How Much Tarceva Should I Take?
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
Overdose: What Happens If I Take Too Much Tarceva?
Notify your healthcare team if you take too much Tarceva and quickly manage any symptoms that you experience.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
What Other Medications Interact With Tarceva?
There are multiple medications and drug classes that can have interactions with Tarceva, including: 1
Before taking Tarceva, tell your doctor
If you are allergic to Tarceva; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
What are some things I need to know or do while I take Tarceva?
Tell all of your health care providers that you take Tarceva. This includes your doctors, nurses, pharmacists, and dentists.
How is Tarceva best taken?
Use Tarceva as ordered by your doctor. Read all information given to you. Follow all instructions closely.
What are the side effects of Tarceva that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
What are some other side effects of Tarceva?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
If overdose is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer information use and disclaimer
If your symptoms or health problems do not get better or if they become worse, call your doctor.
How to use Tarceva
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.
Side Effects
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.
Precautions
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.
Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overview TOP
Erlotinib is used for the treatment of metastatic (cancer that has already spread) non- small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) gene mutations. Your doctor will perform a test before you take this medicine.
Proper Use TOP
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Dosing TOP
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
Missed Dose TOP
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Use & Storage TOP
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Before Using TOP
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies TOP
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Indications and Usage For Tarceva
Erlotinib is used to treat lung and pancreatic cancer.
May Treat: Adenocarcinoma of pancreas · Metastatic NSCLC with EGFR exon 19 deletion · Metastatic NSCLC with EGFR exon 21 L858R substitution
Drug Class: Antineoplastic - 1st generation EGFR tyrosine kinase inhibitor
Availability: Prescription Required
Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.
Lactation: This drug should not be given to breastfeeding mothers
May Treat: Adenocarcinoma of pancreas · Metastatic NSCLC with EGFR exon 19 deletion · Metastatic NSCLC with EGFR exon 21 L858R substitution
Drug Class: Antineoplastic - 1st generation EGFR tyrosine kinase inhibitor
Availability: Prescription Required
Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.
Lactation: This drug should not be given to breastfeeding mothers
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: GENENTECH, INC.
- Do not take while breast feeding or when pregnant
- Pregnant women should not touch this medicine.
- Take on empty stomach 1hr prior or 2 hr after meals
- Do not take while breast feeding or when pregnant
- Pregnant women should not touch this medicine.
- Take on empty stomach 1hr prior or 2 hr after meals
- Do not use antacids within 2 hours
- Avoid taking grapefruit juice/grapefruit with med
- Call Dr if you have black stools or stomach pain
- Call MD if new abdominal pain/yellowing eyes/skin
- Tell MD now of unusual bleeding or breathing.
Tarceva Dosage and Administration
Dosage Forms and Strengths
Warnings and Precautions
Adverse Reactions
- 1.1 Non-Small Cell Lung Cancer
Tarceva®is indicated for: • The 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 as detected by an FDA-approved test receiving first-line, main… - Pancreatic Cancer
Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5)].
Drug Interactions
- 2.1 Selection of Patients with Metastatic NSCLC
Select patients for the treatment of metastatic NSCLC with Tarceva based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor or plasma specimens [See http://www.fda.gov/CompanionDiagnostics. - Recommended Dose – NSCLC
The recommended daily dose of Tarceva for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.
Use in Specific Populations
- 25 mg tablets: round, biconvex face and straight sides, white film-coated, printed in orange with “T” and “25” on one side and plain on other side. 100 mg tablets: round, biconvex face and straight sides, white film-coated, printed in gray with “T” and “100” on one side and plain on other side. 150 mg tablets: round, biconvex face and straight sides, white film-coated, printed in maroon with “T…
Overdosage
- Interstitial Lung Disease
Cases of serious ILD, including fatal cases, can occur with Tarceva treatment. The overall incidence of ILD in approximately 32,000 Tarceva-treated patients in uncontrolled studies and studies with concurrent chemotherapy was approximately 1.1%. In patients with ILD, the onset o… - Renal Failure
Hepatorenal syndrome, severe acute renal failure including fatal cases, and renal insufficiency can occur with Tarceva treatment. Renal failure may arise from exacerbation of underlying baseline hepatic impairment or severe dehydration. The pooled incidence of severe renal impairment in t…
Tarceva Description
- The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the labeling: • 1. Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.1)] • 1. Renal Failure [see Warnings and Precautions (5.2)] • 1. Hepatotoxicity with or without Hepatic Impairment [see Warnings and Precautions (5.3)] • 1. Gastrointestinal Perfora…
Tarceva - Clinical Pharmacology
- CYP3A4 Inhibitors Co-administration of Tarceva with a strong CYP3A4 inhibitor or a combined CYP3A4 and CYP1A2 inhibitor increased erlotinib exposure. Erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2. Increased erlotinib exposure may increase the risk of exposure-related toxicity [see Clinical Pharmacology (12.3)]. Avoid co-administering Tarceva wit…