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Tarceva

"April 19, 2010 (Washington, D.C.) -- New research offers hope that people with lung cancer will live longer if drug therapy is guided by the molecular traits of tumors.

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Tarceva

Tarceva Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tarceva (erlotinib) is used in the treatment of non-small cell lung cancer (NSCLC) or pancreatic cancer. It is a cancer chemotherapy medication. Common side effects include nausea, vomiting, loss of appetite, mouth sores, dry skin, or eye irritation.

The recommended daily dose of Tarceva for NSCLC is 150 mg taken on an empty stomach at least one hour before or two hours after the ingestion of food. The recommended daily dose of Tarceva for pancreatic cancer is 100 mg taken on an empty stomach at least one hour before or two hours after the ingestion of food, in combination with gemcitabine. For both conditions, treatment should continue until disease progression or unacceptable toxicity occurs. Tarceva may interact with HIV/AIDS medications, rifamycins, clarithromycin, nefazodone, telithromycin, troleandomycin, carbamazepine, phenobarbital, phenytoin, antifungal medications, or St. John's Wort. Tell your doctor all medications you are taking. Tarceva is not recommended for use during pregnancy. It may cause harm to a fetus or a miscarriage. Women of childbearing age should use reliable form(s) of birth control during treatment and for at least 2 weeks following the end of treatment with this drug. It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended.

Our Tarceva (erlotinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tarceva in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking erlotinib and call your doctor at once if you have a serious side effect such as:

  • new or worsening lung problems such as chest pain, dry cough with fever, wheezing, rapid breathing, feeling short of breath;
  • chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, sudden severe headache, or problems with vision, speech, or balance;
  • eye pain, redness, or irritation;
  • confusion, mood changes, increased thirst, urinating less than usual or not at all;
  • swelling, rapid weight gain;
  • severe or ongoing diarrhea, vomiting, or loss of appetite;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • pale or yellowed skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • white patches or sores inside your mouth or on your lips;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any type of skin rash, no matter how mild; or
  • nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild stomach upset, nausea, or diarrhea;
  • weight loss;
  • acne, dry skin; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tarceva (Erlotinib) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tarceva Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, loss of appetite, mouth sores, dry skin, or eye irritation may occur. Changes in diet such as eating several small meals or limiting activity may help lessen the chance of nausea. If any of these effects persist or worsen, notify 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.

Diarrhea is a common side effect. Drink plenty of fluids as directed by your doctor to reduce your risk of losing too much body water. Your doctor may prescribe anti-diarrhea medication (e.g., loperamide) to control your symptoms. Tell your doctor immediately if you develop: severe or persistent diarrhea, signs of dehydration (e.g., dizziness, decreased amount of urine).

Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, easy bleeding/bruising, stomach/abdominal pain, yellowing eyes or skin, dark urine, unusual fatigue, signs of infection (e.g., fever, chills, persistent sore throat), eye pain, vision changes.

Seek immediate medical attention if you develop any of these rare but very serious side effects: new or worsening shortness of breath or cough.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Tarceva (Erlotinib)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tarceva FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Safety evaluation of TARCEVA is based on more than 1200 cancer patients who received TARCEVA as monotherapy, more than 300 patients who received TARCEVA 100 or 150 mg plus gemcitabine, and 1228 patients who received TARCEVA concurrently with other chemotherapies. 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.

Non-Small Cell Lung Cancer

First-Line Treatment of Patients with EGFR Mutations

The most frequent ( ≥ 30%) adverse reactions in TARCEVA-treated patients were diarrhea, asthenia, rash, cough, dyspnea and decreased appetite. 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.

The most frequent Grade 3-4 adverse reactions in TARCEVA-treated patients were rash and diarrhea.

Dose interruptions or reductions due to adverse reactions occurred in 37% of TARCEVA-treated patients, and 14.3% of TARCEVA-treated patients discontinued therapy due to adverse reactions. In TARCEVA-treated patients, the most frequently reported adverse reactions leading to dose modification were rash (13%), diarrhea (10%), and asthenia (3.6%).

Selected, common adverse reactions in Study 4, occurring in at least 10% of patients who received TARCEVA or chemotherapy and an increase in ≥ 5% in the TARCEVA treated group, are summarized by NCI-CTC (version 3.0) Grade in Table 1. The median duration of TARCEVA treatment was 9.6 months in Study 4.

Table 1: Selected Adverse Reactions with an Incidence Rate ≥ 10% and an Increase of ≥ 5% in the TARCEVA-treated Group (Study 4)

MedDRA Preferred Term  TARCEVA
N = 84 
Chemotherapy †
N = 83 
All Grades %  Grades 3-4 %  All Grades %  Grades 3-4 % 
  Rash ‡  85 14 5 0
  Diarrhea  62 5 21 1
  Cough  48 1 40 0
  Dyspnea  45 8 30 4
  Dry skin  21 1 2 0
  Back pain  19 2 5 0
  Chest pain  18 1 12 0
  Conjunctivitis  18 0 0 0
  Mucosal inflammation  18 1 6 0
  Pruritus  16 0 1 0
  Paronychia  14 0 0 0
  Arthralgia  13 1 6 1
  Musculoskeletal pain  11 1 1 0
† Platinum based doublet chemotherapy (cisplatin or carboplatin with gemcitabine or docetaxel)
‡ Rash as a composite term includes: rash, acne, folliculitis, erythema, dermatitis acneiform, dermatitis, palmar-plantar erythrodysaesthesia syndrome, exfoliative rash, rash erythematous, rash pruritic, skin toxicity, eczema, rash follicular, skin ulcer.

Hepatic Toxicity: One TARCEVA-treated patient experienced fatal hepatic failure and four additional patients experienced grade 3-4 liver test abnormalities in Study 4 [see WARNINGS AND PRECAUTIONS].

Maintenance Treatment

Adverse reactions, regardless of causality, that occurred in at least 3% of patients treated with single-agent TARCEVA at 150 mg and at least 3% more often than in the placebo group in the randomized maintenance trial (Study 3) are summarized by NCI-CTC (version 3.0) Grade in Table 2.

The most common adverse reactions in patients receiving single-agent TARCEVA 150 mg were rash and diarrhea. Grade 3-4 rash and diarrhea occurred in 9% and 2%, respectively, in TARCEVA-treated patients. Rash and diarrhea resulted in study discontinuation in 1% and 0.5% of TARCEVA-treated patients, respectively. Dose reduction or interruption for rash and diarrhea was needed in 5% and 3% of patients, respectively. In TARCEVA-treated patients the median time to onset of rash was 10 days, and the median time to onset of diarrhea was 15 days.

Table 2: NSCLC Maintenance Study: Selected Adverse Reactions Occurring with an Incidence Rate ≥ 10% and an Increase of ≥ 5% in the Single-Agent TARCEVA Group compared to the Placebo Group (Study 3)

NCI-CTC Grade  TARCEVA
N = 433 
PLACEBO
N = 445 
Any Grade  Grade 3  Grade 4  Any Grade  Grade 3  Grade 4 
MedDRA Preferred Term 
Rash †  60 9 0 9 0 0
Diarrhea  20 2 0 4 0 0
† Rash as a composite term includes: rash, acne, dermatitis acneiform, skin fissures, erythema, rash papular, rash generalized, rash pruritic, skin exfoliation, urticaria, dermatitis, eczema, exfoliative rash, dermatitis exfoliative, furuncle, rash macular, rash pustular, skin hyperpigmentation, skin reaction, skin ulcer.

Liver test abnormalities including ALT elevations were observed at Grade 2 or greater severity in 3% of TARCEVA-treated patients and 1% of placebo-treated patients. Grade 2 and above bilirubin elevations were observed in 5% of TARCEVA-treated patients and in < 1% in the placebo group [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Second/Third Line Treatment

Adverse reactions, regardless of causality, that occurred in at least 10% of patients treated with single-agent TARCEVA at 150 mg and at least 5% more often than in the placebo group in the randomized trial of patients with NSCLC are summarized by NCI-CTC (version 2.0) Grade in Table 3.

The most common adverse reactions in this patient population were rash and diarrhea. Grade 3-4 rash and diarrhea occurred in 9% and 6%, respectively, in TARCEVA-treated patients. Rash and diarrhea each resulted in study discontinuation in 1% of TARCEVA-treated patients. Six percent and 1% of patients needed dose reduction for rash and diarrhea, respectively. The median time to onset of rash was 8 days, and the median time to onset of diarrhea was 12 days.

Table 3: NSCLC 2nd/3rd Line Study: Selected Adverse Reactions Occurring with an Incidence Rate ≥ 10% and an Increase of ≥ 5% in the Single-Agent TARCEVA Group compared to the Placebo Group (Study 1)

NCI-CTC Grade  TARCEVA 150 mg
N=485 
Placebo
N=242 
Any Grade  Grade 3  Grade 4  Any Grade  Grade 3  Grade 4 
MedDRA Preferred Term 
Rash †  75 8 < 1  17 0 0
Diarrhea  54 6 < 1  18 < 1  0
Anorexia  52 8 1 38 5 < 1 
Fatigue  52 14 4 45 16 4
Dyspnea  41 17 11 35 15 11
Nausea  33 3 0 24 2 0
Infection  24 4 0 15 2 0
Stomatitis  17 < 1  0 3 0 0
Pruritus  13 < 1  0 5 0 0
Dry skin  12 0 0 4 0 0
Conjunctivitis  12 < 1  0 2 < 1  0
Keratoconjunctivitis sicca  12 0 0 3 0 0
† Rash as a composite term includes: rash, palmar-plantar erythrodysaesthesia syndrome, acne, skin disorder, pigmentation disorder, erythema, skin ulcer, dermatitis exfoliative, rash papular, skin desquamation.

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent TARCEVA 150 mg. These elevations were mainly transient or associated with liver metastases. Grade 2 ( > 2.5 - 5.0 x ULN) ALT elevations occurred in 4% and < 1% of TARCEVA and placebo treated patients, respectively. Grade 3 ( > 5.0 - 20.0 x ULN) elevations were not observed in TARCEVA-treated patients. TARCEVA dosing should be interrupted or discontinued if changes in liver function are severe [see DOSAGE AND ADMINISTRATION].

Pancreatic Cancer -TARCEVA Administered Concurrently with Gemcitabine

This was a randomized, double blind placebo-controlled study of TARCEVA (150 mg or 100 mg daily) or placebo plus gemcitabine (1000 mg/m² IV) in patients with locally advanced, unresectable or metastatic pancreatic cancer (Study 2). The safety population comprised 282 patients in the erlotinib group (259 in the 100 mg cohort and 23 in the 150 mg cohort) and 280 patients in the placebo group (256 in the 100 mg cohort and 24 in the 150 mg cohort).

Adverse reactions that occurred in at least 10% of patients treated with TARCEVA 100 mg plus gemcitabine in the randomized trial of patients with pancreatic cancer (Study 2) are summarized by NCI-CTC (version 2.0) Grade 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. In the TARCEVA plus gemcitabine arm, Grade 3-4 rash and diarrhea were each reported in 5% of patients. The median time to onset of rash and diarrhea was 10 days and 15 days, respectively. Rash and diarrhea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving TARCEVA plus gemcitabine. Severe adverse reactions ( ≥ Grade 3 NCI-CTC) in the TARCEVA plus gemcitabine group with incidences < 5% included syncope, arrhythmias, ileus, pancreatitis, hemolytic anemia including microangiopathic hemolytic anemia with thrombocytopenia, myocardial infarction/ischemia, cerebrovascular accidents including cerebral hemorrhage, and renal insufficiency [see WARNINGS AND PRECAUTIONS].

The 150 mg cohort was associated with a higher rate of certain class-specific adverse reactions including rash and required more frequent dose reduction or interruption.

Table 4: Selected Adverse Reactions Occurring with an Incidence Rate ≥ 10% and an Increase of ≥ 5% in TARCEVA-treated Pancreatic Cancer Patients: 100 mg cohort (Study 2)

NCI-CTC Grade  TARCEVA + Gemcitabine 1000 mg/m² IV
N=259 
Placebo + Gemcitabine 1000 mg/m² IV
N=256 
Any Grade  Grade 3  Grade 4  Any Grade  Grade 3  Grade 4 
MedDRA Preferred Term 
Rash †  70 5 0 30 1 0
Diarrhea  48 5 < 1  36 2 0
Weight decreased  39 2 0 29 < 1  0
Infection *  39 13 3 30 9 2
Pyrexia  36 3 0 30 4 0
Stomatitis  22 < 1  0 12 0 0
Depression  19 2 0 14 < 1  0
Cough  16 0 0 11 0 0
Headache  15 < 1  0 10 0 0
* Includes all MedDRA preferred terms in the Infections and Infestations System Organ Class
† Rash as a composite term includes: rash, palmar-plantar erythrodysaesthesia syndrome, pigmentation disorder, dermatitis acneiform, folliculitis, photosensitivity reaction, Stevens-Johnson syndrome, urticaria, erythematous rash, skin disorder, skin ulcer.

Ten patients (4%) in the TARCEVA/gemcitabine group and three patients (1%) in the placebo/gemcitabine group developed deep venous thrombosis. The overall incidence of grade 3 or 4 thrombotic events, including deep venous thrombosis was 11% for TARCEVA plus gemcitabine and 9% for placebo plus gemcitabine.

The incidences of liver test abnormalities ( ≥ Grade 2) in Study 2 are provided in Table 5 [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Table 5: Liver Test Abnormalities in Pancreatic Cancer Patients: 100 mg Cohort (Study 2)

NCI-CTC Grade  TARCEVA + Gemcitabine 1000 mg/m² IV
N=259 
Placebo + Gemcitabine 1000 mg/m² IV
N=256 
Grade 2  Grade 3  Grade 4  Grade 2  Grade 3  Grade 4 
Bilirubin  17% 10% < 1%  11% 10% 3%
ALT  31% 13% < 1%  22% 9% 0%
AST  24% 10% < 1%  19% 9% 0%

NSCLC and Pancreatic Indications: Selected Low Frequency Adverse Reactions

Gastrointestinal Disorders

Cases of gastrointestinal bleeding (including fatalities) have been reported, some associated with concomitant warfarin or NSAID administration [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. These adverse reactions were reported as peptic ulcer bleeding (gastritis, gastroduodenal ulcers), hematemesis, hematochezia, melena and hemorrhage from possible colitis.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of TARCEVA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Musculoskeletal and Connective Tissue Disorders: myopathy, including rhabdomyolysis, in combination with statin therapy

Eye Disorders: ocular inflammation including uveitis

Read the entire FDA prescribing information for Tarceva (Erlotinib) »

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Tarceva - User Reviews

Tarceva User Reviews

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