Tarceva Side Effects
Generic Name: Erlotinib
Please note - some side effects for Tarceva may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Tarceva - for the consumer
Tarceva
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tarceva:
Seek medical attention right away if any of these SEVERE side effects occur when using Tarceva:Diarrhea; dry skin; fatigue; infection; itching; loss of appetite; mouth ulcers and inflammation; nausea; stomach pain; vomiting.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; cough; dry eyes; eye irritation, redness, or discharge; fever; severe or persistent diarrhea, nausea, loss of appetite, or vomiting; shortness of breath; sore throat; swelling of the hands, legs, or feet; vision problems; vomit that looks like coffee grounds; yellowing of the skin or eyes.
For the professional
Tarceva
Safety evaluation of Tarceva is based on 856 cancer patients who received Tarceva as monotherapy, 308 patients who received Tarceva 100 or 150 mg plus gemcitabine, and 1228 patients who received Tarceva concurrently with other chemotherapies.
There have been reports of serious events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors.
Non-Small Cell Lung Cancer
Adverse events, regardless of causality, that occurred in at least 10% of patients treated with single-agent Tarceva 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 5.
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 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.
| Tarceva 150 mg N = 485 |
Placebo N = 242 |
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| NCI CTC Grade | 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 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 if changes in liver function are severe.
Pancreatic Cancer
Adverse events, regardless of causality, that occurred in at least 10% of patients treated with Tarceva 100 mg plus gemcitabine in the randomized trial of patients with pancreatic cancer are summarized by NCI-CTC (version 2.0) Grade in Table 6.
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 Tarceva 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 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.
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| Tarceva + Gemcitabine 1000 mg/m2 IV N=259 |
Placebo + Gemcitabine 1000 mg/m2 IV N=256 |
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| NCI CTC Grade | 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 |
In the pancreatic carcinoma trial, 10 patients in the Tarceva plus gemcitabine group developed deep venous thrombosis (incidence: 3.9%). In comparison, 3 patients in the placebo plus 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 plus gemcitabine and 9% for placebo plus gemcitabine.
No differences in Grade 3 or Grade 4 hematologic laboratory toxicities were detected between the Tarceva plus gemcitabine group compared to the placebo plus gemcitabine group.
Severe adverse events (≥ 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.
Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) have been observed following the administration of Tarceva plus gemcitabine in patients with pancreatic cancer. Table 7 displays the most severe NCI-CTC Grade of liver function abnormalities that developed. Tarceva dosing should be interrupted if changes in liver function are severe.
| Tarceva + Gemcitabine 1000 mg/m2 IV N = 259 |
Placebo + Gemcitabine 1000 mg/m2 IV N = 256 |
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| NCI CTC Grade | 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 Cancer Indications
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. These adverse events were reported as peptic ulcer bleeding (gastritis, gastroduodenal ulcers), hematemesis, hematochezia, melena and hemorrhage from possible colitis. Cases of acute renal failure or renal insufficiency, including fatalities, with or without hypokalemia have been reported. Cases of Grade 1 epistaxis were also reported in both the single-agent NSCLC and the pancreatic cancer clinical trials.
NCI-CTC Grade 3 conjunctivitis and keratitis have been reported infrequently in patients receiving Tarceva therapy in the NSCLC and pancreatic cancer clinical trials. Corneal ulcerations may also occur.
Hepatic failure has been reported in patients treated with single-agent Tarceva or Tarceva combined with chemotherapy in clinical studies and during post-marketing use of Tarceva; it is not possible to reliably estimate the frequency or establish a causal relationship to Tarceva treatment.
In general, no notable differences in the safety of Tarceva 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. The safety of Tarceva appears similar in Caucasian and Asian patients.
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