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Tarceva 150mg Tablet
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Indications & Clinical Uses
- The Tarceva brand of erlotinib has been discontinued from sale in the United States: an FDA Federal Register notice (8 August 2024, covering NDA 021743) confirms this was a manufacturer/commercial discontinuation, not a withdrawal for safety or effectiveness reasons, and generic erlotinib tablets remain available and approved.
- Tarceva's EU marketing authorisation, held by Roche Registration GmbH, remains active.
- Tarceva/erlotinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
- Since a 2016 FDA label change, its non-small cell lung cancer (NSCLC) indication is restricted to patients whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, confirmed by an FDA-approved test, for first-line, maintenance or later-line treatment; a large trial (IUNO) showed no benefit without these mutations.
- Tarceva/erlotinib 150 mg tablets are also approved, in combination with gemcitabine, as first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer, without an EGFR mutation requirement for this indication.
Side Effects
- The most common side effects of Tarceva/erlotinib, each affecting about half or more of patients, are skin rash and diarrhoea; loss of appetite and fatigue are also very common, and nausea is common in patients also receiving gemcitabine for pancreatic cancer.
- There is no boxed warning on the current label, but several serious reactions need urgent attention: interstitial lung disease (unexplained new or worsening cough, shortness of breath or fever), liver failure and hepatorenal syndrome (yellowing skin or eyes, dark urine, severe fatigue), gastrointestinal perforation (severe abdominal pain), and bullous, blistering or exfoliative skin reactions have all been reported, some fatal.
- Stop Tarceva/erlotinib and seek urgent medical care for any of these.
- Diarrhoea should be managed promptly with anti-diarrhoeal medicine and fluids, since severe or persistent diarrhoea can lead to dehydration and kidney problems.
Precautions & Warnings
- Before starting Tarceva/erlotinib, your healthcare provider will confirm EGFR mutation status for lung cancer using an FDA-approved test, since the tablet is not effective, and may be harmful without benefit, in tumours lacking these mutations.
- Tell your healthcare provider about any history of lung disease, liver disease, or gastrointestinal ulcers or bleeding, and about corneal problems, since eye irritation and corneal perforation have been reported.
- Tarceva/erlotinib can cause fetal harm; women who can become pregnant should use effective contraception during treatment and for a month after the last dose, and breastfeeding is not recommended.
- Monitor liver function periodically, particularly if you have pre-existing liver impairment.
- Tarceva/erlotinib is an oral tablet taken once daily on an empty stomach (at least 1 hour before or 2 hours after food); it is not given by injection or infusion.
Avoid Interactions
- Smoking reduces erlotinib blood levels by roughly half, so people who smoke may need dose adjustment, and quitting smoking during treatment can raise erlotinib exposure; discuss any change in smoking habit with your healthcare provider.
- Strong CYP3A4 inhibitors, such as certain antifungals and some antibiotics, increase erlotinib levels and the risk of side effects, while CYP3A4 inducers such as rifampin can lower its effectiveness.
- Proton pump inhibitors reduce erlotinib absorption by about 46% because erlotinib needs stomach acid to dissolve properly, and should generally be avoided; if an acid-reducing medicine is needed, an H2-blocker taken well apart from Tarceva/erlotinib, or an antacid, is preferred instead.
- Warfarin and other anticoagulants combined with Tarceva/erlotinib require closer INR monitoring because of increased bleeding risk.
- Tell your healthcare provider and pharmacist about all medicines, including over-the-counter acid reducers, and your smoking status.
References
Frequently Asked Questions
Tarceva (erlotinib) treats non-small cell lung cancer with specific EGFR gene mutations, confirmed by an FDA-approved test, and, with gemcitabine, treats advanced pancreatic cancer. The Tarceva brand has been discontinued for commercial reasons in the US, but generic erlotinib remains available and equally approved.
Take erlotinib once daily on an empty stomach, at least 1 hour before or 2 hours after eating, at the same time each day. Do not crush or chew tablets. Missing food timing reduces absorption, so consistency matters for the medicine to work properly.
Rash and diarrhoea are very common; loss of appetite and fatigue are also frequent. Seek urgent care for new cough or breathlessness (lung disease), yellowing skin (liver problems), severe stomach pain (perforation), or blistering skin reactions — all serious but uncommon effects.
Avoid proton pump inhibitors, which cut absorption by about 46%; ask about alternatives like antacids taken well apart from your dose. Smoking lowers erlotinib levels, so tell your doctor if you smoke or quit. Report all medicines, especially warfarin, antifungals and antibiotics, before starting.
The Tarceva brand was discontinued from US sale in 2024 for commercial reasons, not safety, according to an FDA notice; it remains approved in the EU under Roche. Generic erlotinib 150 mg tablets are widely available in the US as an equivalent substitute.
Yes, for lung cancer. Since a 2016 FDA label change, erlotinib is only approved for non-small cell lung cancer with confirmed EGFR exon 19 deletion or exon 21 L858R mutations, since it gives no benefit without them. No mutation test is required for the pancreatic cancer use.
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