Important Safety Information
What is the most important information I should know about Tarceva?
Everyone reacts differently to treatment with Tarceva. It’s important to know the most serious and common side effects with Tarceva.
Your healthcare provider (HCP) may lower the dose or stop treatment with Tarceva if any serious side effects occur. Contact your HCP right away if you experience any of the following side effects.
What are the possible side effects of Tarceva?
Tarceva can cause serious side effects, which include:
- Interstitial lung disease, or ILD, events. Tarceva has been shown to cause lung problems, including death. Symptoms of lung problems may include shortness of breath, cough, and fever. Tarceva may need to be stopped if you have any of these symptoms.
- Liver and kidney problems. Tarceva has been shown to cause severe kidney and liver problems, including death. Some people had their kidneys and liver stop working. Let your HCP know if you have a history of liver or kidney disease.
- Gastrointestinal (GI) perforation. Tarceva has been shown to cause GI perforation, a hole that develops in your stomach or intestine, which has led to death. People taking Tarceva at the same time as medications that may help block the growth of blood vessels, steroids, non-steroidal anti-inflammatory drugs (NSAIDs), or certain chemotherapies or those who have a history of ulcers or other stomach disease may be at higher risk of perforation.
- Serious skin conditions. Tarceva has been shown to cause blistering and skin peeling. This may result in other serious skin disorders or death.
- Blood, bleeding, and clotting problems. Tarceva has been shown to cause certain blood problems and other bleeding and clotting problems. These have led to heart attack, stroke, and death.
- Eye disorders. Tarceva has been shown to cause dry eyes, unusual eyelash growth, or swelling of the cornea. This swelling may irritate the eye or cause damage.
- Bleeding events when taking warfarin with Tarceva. Tell your HCP if you are taking a blood thinner, such as warfarin, or non-steroidal anti-inflammatory drugs, known as NSAIDs. Taking Tarceva with these medications can cause death.
- Pregnancy. Tarceva can cause harm to an unborn baby. Do not breast-feed when taking Tarceva. Women should use effective birth control during treatment and for at least 2 weeks after the last dose of Tarceva. Contact your HCP if you have become pregnant or if pregnancy is suspected, during treatment with Tarceva.
When should I call my HCP while taking Tarceva?
- Serious or ongoing diarrhea, nausea (feeling sick to your stomach), loss of appetite, or vomiting
- New or worsening shortness of breath or cough
- Eye irritation
- New or worsening rash, blistering, or peeling of the skin
- Any changes in smoking habits
What are some of the most common side effects?
- 1st-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, and loss of appetite
- Maintenance/2nd- or 3rd-line NSCLC treatment: Rash and diarrhea
- Pancreatic cancer treatment: Fatigue (feeling tired), rash, nausea, loss of appetite, and diarrhea
What should I know about skin (including rash), hair and nail problems or diarrhea while taking Tarceva?
- Skin (including rash):
- Your skin may look red with little bumps. It may look like acne, but is not. The rash most commonly occurs on the face, upper chest, and back, but it could spread to other parts of the body and may start peeling. It could happen or get worse if the skin is exposed to the sun. You may feel itching, tenderness, or burning.
- When taking Tarceva, you may see skin and nail darkening or dry skin, with or without cracking. This most often occurs with rash.
- While taking Tarceva, you may want to use alcohol-free lotions and sunscreens or avoid being out in the sun.
- In Tarceva clinical trials, rash was treated with steroids or antibiotics. Using acne medicines may dry your skin and make the rash worse. The treatment of rash has not been studied.
- Talk with your HCP if you notice a rash. He or she may be able to help you manage it.
- Hair and nails: Hair and nail problems have been seen in patients taking Tarceva, such as abnormal hairiness and brittle or loose nails.
- Diarrhea: Diarrhea can usually be treated by anti-diarrhea medicine. Your HCP can help you find the right medicine for you.
What should I do if I am taking or am prescribed other medicines or supplements while taking Tarceva?
- It is important to tell your HCP about all of the medicines and herbal supplements you are taking.
- DO NOT start taking any new medicines or herbal supplements before talking with your HCP.
- DO NOT eat grapefruit or drink grapefruit juice while taking Tarceva, except under the care of your HCP.
Will smoking affect my treatment with Tarceva?
- If you smoke, you should stop smoking before starting treatment with Tarceva.
- If you continue to smoke, your treatment with Tarceva may need to be adjusted. Talk to your HCP.
Call your HCP for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Who is Tarceva for?
Tarceva is approved as a 1st-line treatment, maintenance treatment, and 2nd- or 3rd-line treatment for advanced-stage non-small cell lung cancer (NSCLC).
- Tarceva is prescribed as initial treatment for patients with NSCLC whose cancer has spread to other parts of the body and that has certain types of epidermal growth factor receptor (EGFR) mutations. (1st-line treatment)
- Tarceva is prescribed as maintenance treatment for advanced-stage NSCLC in patients whose cancer has not spread or grown after prior treatment with certain types of chemotherapy.
- Tarceva is prescribed as 2nd- or 3rd-line treatment for advanced-stage NSCLC in patients whose cancer has spread or grown after receiving at least one round of chemotherapy.
- Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
- For initial treatment of patients with NSCLC whose cancer has spread to other parts of the body, it is not known if Tarceva is safe and effective in other EGFR mutations.
Tarceva is approved for advanced-stage pancreatic cancer.
- Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy.