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Tarceva is a brand name for Erlotinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Non-Small Cell Lung Cancer (NSCLC) Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations. Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with…
Verbatim from this product's EMA label. Tap a section to expand.
Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies. 1). The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food. Patients with pancreatic cancer The recommended daily dose of Tarceva is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication).
1). 4). Tarceva is available in strengths of 25 mg, 100 mg and 150 mg. 5). Hepatic impairment Erlotinib is eliminated by hepatic metabolism and biliary excretion. Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment.
Dose reduction or interruption of Tarceva should be considered if severe adverse reactions occur. The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT> 5 x ULN).
2). 5 times the upper normal limit). 2). Use of Tarceva in patients with severe renal impairment is not recommended. Paediatric population The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years.
Use of Tarceva in paediatric patients is not recommended. 4 Smokers Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%. The maximum tolerated dose of Tarceva in NSCLC patients who currently smoke cigarettes was 300 mg.
The 300 mg dose did not show improved efficacy in second line treatment after failure of chemotherapy compared to the recommended 150 mg dose in patients who continue to smoke cigarettes. Safety data were comparable between the 300 mg and 150 mg doses; however, there was a numerical increase in the incidence of rash, interstitial lung disease and diarrhoea, in patients receiving the higher dose of erlotinib.
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Summary of the safety profile Safety evaluation of Tarceva is based on the data from more than 1500 patients treated with at least one 150 mg dose of Tarceva monotherapy and more than 300 patients who received Tarceva 100 or 150 mg in combination with gemcitabine.
Non-small cell lung cancer (Tarceva administered as monotherapy) First-Line Treatment of Patients with EGFR Mutations In an open-label, randomised phase III study, ML20650 conducted in 154 patients, the safety of Tarceva for first-line treatment of NSCLC patients with EGFR activating mutations was assessed in 75 patients.
The most frequent adverse drug reactions (ADRs) seen in patients treated with Tarceva in study ML20650 were rash and diarrhoea, most were Grade 1/2 in severity and manageable without intervention. Full grade and incidence information for rash and diarrhoea for all clinical studies is available in the ‘Description of selected adverse reactions’ section below.
Maintenance treatment In two other double-blind, randomised, placebo-controlled Phase III studies BO18192 (SATURN) and BO25460 (IUNO); Tarceva was administered as maintenance after first-line chemotherapy. These studies were conducted in a total of 1532 patients with advanced, recurrent or metastatic NSCLC following first-line standard platinum-based chemotherapy.
The most frequent ADRs seen in patients treated with Tarceva in studies BO18192 and BO25460 were rash and diarrhoea. 21; Tarceva administered as second line therapy), rash and diarrhoea were the most commonly reported adverse drug reactions (ADRs).
Most were Grade 1/2 in severity and manageable without intervention. The median time to onset of rash was 8 days, and the median time to onset of diarrhoea was 12 days. 3 in pancreatic cancer patients receiving Tarceva 100 mg plus gemcitabine were fatigue, rash and diarrhoea.
Assessment of EGFR mutation status When considering the use of Tarceva as a first line or maintenance treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation status of a patient is determined. A validated, robust, reliable and sensitive test with a prespecified positivity threshold and demonstrated utility for the determination of EGFR mutation status, using either tumor DNA derived from a tissue sample or circulating free DNA (cfDNA) obtained from a blood (plasma) sample, should be performed according to local medical practice.
If a plasma-based cfDNA test is used and the result is negative for activating mutations, perform a tissue test wherever possible due to the potential for false negative results from a plasma-based test. Smokers Current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.
2). Interstitial Lung Disease Cases of interstitial lung disease (ILD)-like events, including fatalities, have been reported uncommonly in patients receiving Tarceva for treatment of non-small cell lung cancer (NSCLC), pancreatic cancer or other advanced solid tumours.
8%) was the same in both the placebo and Tarceva groups. 4% in patients in the control arms. 4% in the placebo plus gemcitabine treated group. Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.
Symptoms started from a few days to several months after initiating Tarceva therapy. Confounding or contributing factors such as concomitant or prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections were frequent.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively. Tabulated summary of adverse reactions The incidence of ADRs from clinical trials and the post marketing setting reported with Tarceva alone or in combination with chemotherapy are summarised in Table 1.
Adverse drug reactions are listed by MedDRA system organ class. The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 10 Table 1: Summary of ADRs from clinical trials and the post-marketing setting per frequency category: Infections and infestations Very common infection* Metabolism and nutrition disorders Very common anorexia, weight decreased Psychiatric disorders Very common depression Nervous system disorders Very common neuropathy, headache Eye disorders Very common keratoconjunctivitis sicca Common keratitis, conjunctivitis Uncommon eyelash changes* Very rare corneal perforations, corneal ulcerations, uveitis Respiratory, thoracic and mediastinal disorders Very common dyspnoea, cough Common epistaxis Uncommon interstitial lung disease* Gastrointestinal disorders Very common diarrhoea*, nausea, vomiting, stomatitis, abdominal pain, dyspepsia, flatulence Common gastro-intestinal bleeding* Uncommon gastro-intestinal perforations* Rare pneumatosis intestinalis Hepatobiliary disorders Very common liver function test abnormalities* Rare hepatic failure*, hepatitis Not known (Cannot be estimated from the available data) acute hepatitis Skin and subcutaneous tissue disorders Very common rash*, pruritus Common alopecia, dry skin, paronychia, folliculitis, acne/dermatitis acneiform, skin fissures Uncommon hirsutism, eyebrow changes, brittle and loose nails, mild skin reactions such as hyperpigmentation Rare palmar plantar erythrodysaesthesia syndrome Very rare Stevens-Johnson syndrome/Toxic epidermal necrolysis* Renal and urinary disorders Common renal insufficiency Uncommon nephritis, proteinuria General disorders and administration site conditions Very common fatigue, pyrexia, rigors *For additional details, see section "Description of selected adverse reactions" below.
Description of selected adverse reactions Rash Rash includes dermatitis acneiform. In general, rash manifests as a mild or moderate erythematous and papulopustular rash, which may occur or worsen in sun exposed areas. g. mineral-containing) may be advisable.
11 Diarrhoea Diarrhoea can lead to dehydration, hypokalemia and renal failure. 4). 3 Pancreatic cancer - 5 1 2 - 5 1 2 1 Discontinuation 2 Dose modification Infection This can be severe infections with or without neutropenia, including pneumonia, sepsis, and cellulitis.
Eyelash changes Changes include in-growing eyelashes, excessive growth and thickening of the eyelashes. 4). 4). In clinical studies, some cases have been associated with […]
5%) is seen among patients in studies conducted in Japan. In patients who develop acute onset of new and/or progressive unexplained pulmonary symptoms such as dyspnoea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation.
Patients treated concurrently with erlotinib and gemcitabine should be monitored carefully for the possibility to develop ILD-like toxicity. 8). g. loperamide. In some cases dose reduction may be necessary. In the clinical studies doses were reduced by 50 mg steps.
Dose reductions by 25 mg steps have not been investigated. 8). There have been rare reports of hypokalaemia and renal failure (including fatalities). Some cases were secondary to severe dehydration due to diarrhoea, vomiting and/or anorexia, while others were confounded by concomitant chemotherapy.
In more severe or persistent cases of diarrhoea, or cases leading to dehydration, particularly in groups of patients with aggravating risk factors (especially concomitant chemotherapy and other medications, symptoms or diseases or other predisposing conditions including advanced age), Tarceva therapy should be interrupted and appropriate measures should be taken to intensively rehydrate the patients intravenously.
In addition, renal function and serum electrolytes including potassium should be monitored in patients at risk of dehydration. Hepatotoxicity Serious cases of drug induced liver injury (DILI) including hepatitis, acute hepatitis and hepatic failure (including fatalities) have been reported during use of Tarceva.
Risk factors may include pre-existing liver disease or concomitant hepatotoxic medications. Periodic liver function testing is recommended during treatment with Tarceva. The frequency of monitoring of liver function should be increased in patients with pre-existing hepatic impairment or biliary obstruction.
Prompt clinical evaluation and measurement of liver function tests should be performed in patients who report symptoms that may indicate liver injury. 8). Tarceva is not recommended for use in patients with severe hepatic dysfunction.
Gastrointestinal perforation Patients receiving Tarceva are at increased risk of developing gastrointestinal perforation, which was observed uncommonly (including some cases with a fatal outcome). Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk.
8). Bullous and exfoliative skin disorders Bullous, blistering and exfoliative skin conditions have been reported, including very rare cases suggestive of Stevens-Johnson […]