Tarceva
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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
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
Because clinical trials are conducted under widely varying conditions, adverse reactions 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 (erlotinib) is based on more than 1200 cancer patients who received TARCEVA (erlotinib) as monotherapy, more than 300 patients who received TARCEVA (erlotinib) 100 or 150 mg plus gemcitabine, and 1228 patients who received TARCEVA (erlotinib) concurrently with other chemotherapies.
There have been reports of serious events, including fatalities, in patients receiving TARCEVA (erlotinib) for treatment of NSCLC, pancreatic cancer or other advanced solid tumors [see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION].
Clinical Trial Experience
Non-Small Cell Lung Cancer
Maintenance Study
Adverse reactions, regardless of causality, that occurred in at least 3% of patients treated with single-agent TARCEVA (erlotinib) at 150 mg and at least 3% more often than in the placebo group in the randomized maintenance trial are summarized by NCI-CTC (version 3.0) Grade in Table 1.
The most common adverse reactions in patients receiving single-agent TARCEVA (erlotinib) 150 mg were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 6.0% and 1.8%, respectively, in TARCEVA (erlotinib) -treated patients. Rash and diarrhea resulted in study discontinuation in 1.2% and 0.5% of TARCEVA (erlotinib) -treated patients, respectively. Dose reduction or interruption for rash and diarrhea was needed in 5.1% and 2.8% of patients, respectively. In TARCEVA (erlotinib) -treated patients who developed rash, the onset was within two weeks in 66% and within one month in 81%.
Table 1: NSCLC Maintenance Study: Adverse Reactions Occurring
More Frequently ( ≥ 3%) in the Single-Agent TARCEVA (erlotinib) Group than in the Placebo
Group and in ≥ 3% of Patients in the TARCEVA (erlotinib) Group.
| 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 | 49.2 | 6.0 | 0 | 5.8 | 0 | 0 |
| Diarrhea | 20.3 | 1.8 | 0 | 4.5 | 0 | 0 |
| Fatigue | 9.0 | 1.8 | 0 | 5.8 | 1.1 | 0 |
| Anorexia | 9.2 | < 1 | 0 | 4.9 | < 1 | 0 |
| Pruritus | 7.4 | < 1 | 0 | 2.7 | 0 | 0 |
| Acne | 6.2 | < 1 | 0 | 0 | 0 | 0 |
| Dermatitis Acneiform | 4.6 | < 1 | 0 | 1.1 | 0 | 0 |
| Dry Skin | 4.4 | 0 | 0 | < 1 | 0 | 0 |
| Weight Decreased | 3.9 | < 1 | 0 | < 1 | 0 | 0 |
| Paronychia | 3.9 | < 1 | 0 | 0 | 0 | 0 |
Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent TARCEVA (erlotinib) 150 mg in the Maintenance study. Grade 2 ( > 2.5 - 5.0 x ULN) ALT elevations occurred in 2% and 1%, and Grade 3 ( > 5.0 - 20.0 x ULN) ALT elevations were observed in 1% and 0% of TARCEVA (erlotinib) and placebo treated patients, respectively. The TARCEVA (erlotinib) treatment group had Grade 2 ( > 1.5-3.0 x ULN) bilirubin elevations in 4% and Grade 3 ( > 3.0-10.0 x ULN) in < 1% compared with < 1% for both Grades 2 and 3 in the placebo group. TARCEVA (erlotinib) dosing should be interrupted or discontinued if changes in liver function are severe [see DOSAGE AND ADMINISTRATION].
Second/Third Line Study
Adverse reactions, regardless of causality, that occurred in at least 10% of patients treated with single-agent TARCEVA (erlotinib) at 150 mg and at least 3% 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 2.
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 (erlotinib) -treated patients. Rash and diarrhea each resulted in study discontinuation in 1% of TARCEVA (erlotinib) -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 2: NSCLC 2nd/3rd Line Study: Adverse Reactions Occurring
More Frequently ( ≥ 3%) in the Single-agent TARCEVA (erlotinib) 150 mg Group than in the
Placebo Group and in ≥ 10% of Patients in the TARCEVA (erlotinib) Group.
| 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 |
| Cough | 33 | 4 | 0 | 29 | 2 | 0 |
| Nausea | 33 | 3 | 0 | 24 | 2 | 0 |
| Infection | 24 | 4 | 0 | 15 | 2 | 0 |
| Vomiting | 23 | 2 | < 1 | 19 | 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 |
| Abdominal pain | 11 | 2 | < 1 | 7 | 1 | < 1 |
Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent TARCEVA (erlotinib) 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 (erlotinib) and placebo treated patients, respectively. Grade 3 ( > 5.0 - 20.0 x ULN) elevations were not observed in TARCEVA (erlotinib) -treated patients. TARCEVA (erlotinib) dosing should be interrupted or discontinued if changes in liver function are severe [see DOSAGE AND ADMINISTRATION].
Pancreatic Cancer
Adverse reactions, regardless of causality, that occurred in at least 10% of patients treated with TARCEVA (erlotinib) 100 mg plus gemcitabine in the randomized trial of patients with pancreatic cancer are summarized by NCI-CTC (version 2.0) Grade in Table 3.
The most common adverse reactions in pancreatic cancer patients receiving TARCEVA (erlotinib) 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea. In the TARCEVA (erlotinib) plus gemcitabine arm, Grade 3/4 rash and diarrhea were each reported in 5% of TARCEVA (erlotinib) plus gemcitabine-treated 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 (erlotinib) plus gemcitabine. 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 3: Adverse Reactions Occurring in ≥ 10% of TARCEVA (erlotinib) -treated
Pancreatic Cancer Patients: 100 mg cohort
| NCI-CTC Grade | TARCEVA + Gemcitabine 1000 mg/m² IV N=259 |
Placebo + Gemcitabine1000 mg/m² IV N=256 |
||||
| Any Grade | Grade 3 | Grade 4 | Any Grade | Grade 3 | Grade 4 | |
| MedDRA Preferred Term | % | % | % | % | % | % |
| Fatigue | 73 | 14 | 2 | 70 | 13 | 2 |
| Rash | 69 | 5 | 0 | 30 | 1 | 0 |
| Nausea | 60 | 7 | 0 | 58 | 7 | 0 |
| Anorexia | 52 | 6 | < 1 | 52 | 5 | < 1 |
| Diarrhea | 48 | 5 | < 1 | 36 | 2 | 0 |
| Abdominal pain | 46 | 9 | < 1 | 45 | 12 | < 1 |
| Vomiting | 42 | 7 | < 1 | 41 | 4 | < 1 |
| Weight decreased | 39 | 2 | 0 | 29 | < 1 | 0 |
| Infection* | 39 | 13 | 3 | 30 | 9 | 2 |
| Edema | 37 | 3 | < 1 | 36 | 2 | < 1 |
| Pyrexia | 36 | 3 | 0 | 30 | 4 | 0 |
| Constipation | 31 | 3 | 1 | 34 | 5 | 1 |
| Bone pain | 25 | 4 | < 1 | 23 | 2 | 0 |
| Dyspnea | 24 | 5 | < 1 | 23 | 5 | 0 |
| Stomatitis | 22 | < 1 | 0 | 12 | 0 | 0 |
| Myalgia | 21 | 1 | 0 | 20 | < 1 | 0 |
| Depression | 19 | 2 | 0 | 14 | < 1 | 0 |
| Dyspepsia | 17 | < 1 | 0 | 13 | < 1 | 0 |
| Cough | 16 | 0 | 0 | 11 | 0 | 0 |
| Dizziness | 15 | < 1 | 0 | 13 | 0 | < 1 |
| Headache | 15 | < 1 | 0 | 10 | 0 | 0 |
| Insomnia | 15 | < 1 | 0 | 16 | < 1 | 0 |
| Alopecia | 14 | 0 | 0 | 11 | 0 | 0 |
| Anxiety | 13 | 1 | 0 | 11 | < 1 | 0 |
| Neuropathy | 13 | 1 | < 1 | 10 | < 1 | 0 |
| Flatulence | 13 | 0 | 0 | 9 | < 1 | 0 |
| Rigors | 12 | 0 | 0 | 9 | 0 | 0 |
| *Includes all MedDRA preferred terms in the Infections and Infestations System Organ Class | ||||||
In the pancreatic carcinoma trial, 10 patients in the TARCEVA (erlotinib) /gemcitabine group developed deep venous thrombosis (incidence: 3.9%). In comparison, 3 patients in the placebo/gemcitabine group developed deep venous thrombosis (incidence 1.2%). The overall incidence of grade 3 or 4 thrombotic events, including deep venous thrombosis, was similar in the two treatment arms: 11% for TARCEVA (erlotinib) plus gemcitabine and 9% for placebo plus gemcitabine.
No differences in Grade 3 or Grade 4 hematologic laboratory toxicities were detected between the TARCEVA (erlotinib) plus gemcitabine group compared to the placebo plus gemcitabine group.
Severe adverse reactions ( ≥ grade 3 NCI-CTC) in the TARCEVA (erlotinib) 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].
Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) have been observed following the administration of TARCEVA (erlotinib) plus gemcitabine in patients with pancreatic cancer. Table 4 displays the most severe NCI-CTC grade of liver function abnormalities that developed. TARCEVA (erlotinib) dosing should be interrupted or discontinued if changes in liver function are severe [see DOSAGE AND ADMINISTRATION].
Table 4 :Liver Function Test Abnormalities (most severe NCI-CTC
grade) in Pancreatic Cancer Patients: 100 mg Cohort
| NCI-CTC Grade | TARCEVA (erlotinib) + 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: Low Frequency Adverse Reactions
Gastrointestinal Disorders
Gastrointestinal perforations have been reported [see WARNINGS AND PRECAUTIONS].
During the NSCLC and the combination pancreatic cancer trials, infrequent cases of gastrointestinal bleeding have been reported, some associated with concomitant warfarin or NSAID administration [see WARNINGS AND PRECAUTIONS]. These adverse reactions were reported as peptic ulcer bleeding (gastritis, gastroduodenal ulcers), hematemesis, hematochezia, melena and hemorrhage from possible colitis.
Renal Disorders
Cases of acute renal failure or renal insufficiency, including fatalities, with or without hypokalemia have been reported [see WARNINGS AND PRECAUTIONS].
Hepatic Disorders
Hepatic failure has been reported in patients treated with single-agent TARCEVA (erlotinib) or TARCEVA (erlotinib) combined with chemotherapy [see WARNINGS AND PRECAUTIONS].
Ocular Disorders
Corneal ulcerations or perforations have been reported in patients receiving TARCEVA (erlotinib) treatment. Abnormal eyelash growth including in-growing eyelashes, excessive growth and thickening of the eyelashes have been reported [see WARNINGS AND PRECAUTIONS] and are risk factors for corneal ulceration/perforation.
NCI-CTC Grade 3 conjunctivitis and keratitis have been reported infrequently in patients receiving TARCEVA (erlotinib) therapy in the NSCLC and pancreatic cancer clinical trials. [see PATIENT INFORMATION].
Skin, Hair, and Nail Disorders
Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome/Toxic epidermal necrolysis [seeWARNINGS AND PRECAUTIONS].
In patients who develop skin rash, the appearance of the rash is typically erythematous and maculopapular and it may resemble acne with follicular pustules, but is histopathologically different. This skin reaction commonly occurs on the face, upper chest and back, but may be more generalized or severe (NCI-CTC Grade 3 or 4) with desquamation. Skin reactions may occur or worsen in sun exposed areas; therefore, the use of sunscreen or avoidance of sun exposure is recommended. Associated symptoms may include itching, tenderness and/or burning. Also, hyperpigmentation or dry skin with or without digital skin fissures may occur.
Hair and nail disorders including alopecia, hirsutism, eyelash/eyebrow (see above) changes, paronychia and brittle and loose nails have been reported.
Other Disorders
Epistaxis was also reported in both the single-agent NSCLC and the pancreatic cancer clinical trials.
In general, no notable differences in the safety of TARCEVA (erlotinib) monotherapy or in combination with gemcitabine could be discerned between females or males and between patients younger or older than the age of 65 years [see Use in Specific Populations]. The safety of TARCEVA (erlotinib) appears similar in Caucasian and Asian patients.
Post-marketing Experience
The following adverse reactions have been identified during post approval use of TARCEVA (erlotinib) . 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.
Skin and subcutaneous tissue disorders
Hair and nail changes, mostly non-serious e.g. hirsutism, eyelash/eyebrow changes, paronychia and brittle and loose nails. Bullous, blistering and exfoliative skin conditions have been reported including cases suggested of Stevens-Johnson syndrome/Toxic epidermal necrolysis [seeWARNINGS AND PRECAUTIONS].
Gastrointestinal Disorders
Gastrointestinal perforations [seeWARNINGS AND PRECAUTIONS].
Hepatic Disorders
Hepatic failure has been reported in patients treated with single-agent TARCEVA (erlotinib) or TARCEVA (erlotinib) combined with chemotherapy [seeWARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Tarceva (Erlotinib) »
Additional Tarceva Information
Tarceva - User Reviews
Tarceva User Reviews
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