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If Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer Returns
  • Safety Information
  • Prescribing Information
  • Patient Prescribing Information

Understanding Your Diagnosis

Facing a recurrence of non-small cell lung cancer (NSCLC) is not easy. Like any person living with cancer, you are probably facing situations you never encountered before. And it is understandable if you are concerned about the new challenge that lies ahead. Yet it is important to work together with your healthcare team — by asking questions and exploring your treatment options.

Not All Types of NSCLC Are Alike
Your Type of NSCLC Matters
What Do I Need to Know About ALIMTA Treatment?

ALIMTA® (pemetrexed for injection) is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA can suppress bone marrow function, which may cause low blood cell counts.

Not All Types of NSCLC Are Alike

According to the American Cancer Society, about 85% of lung cancers are non-small cell lung cancer.1 NSCLC is defined as a group of histologies, that is, tumor types differentiated by the structure of their cells. These histologies are often classified together because to date, approaches to diagnosis, staging, prognosis, and treatment have been similar.

The most common NSCLC histology types are adenocarcinoma, large cell carcinoma, and squamous cell carcinoma.

  • Adenocarcinoma: This type of non-small cell lung cancer accounts for about 40% of all lung cancers. Adenocarcinomas are usually found in the outer portions of lung.2
  • Large cell (undifferentiated) carcinoma: This type of non-small cell lung cancer accounts for about 10% to 15% of all lung cancers. A large cell carcinoma may appear in any part of the lung, and tends to grow and spread rapidly, making it more difficult to treat.2
  • Squamous cell carcinoma: About 25% to 30% of all lung cancers are called "squamous" cell carcinomas. These cancers tend to be found in the middle of the lungs.2 Please note that ALIMTA is not indicated for squamous cell carcinoma.

When discussing NSCLC, "nonsquamous" includes adenocarcinoma, large cell carcinoma, and all other cell types except squamous cell.

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Your Type of NSCLC Matters

Your healthcare team may have discussed the histology of your tumor with you. Histology is a classification of the cellular composition of a tumor. As discussed above, within NSCLC, the major classifications are nonsquamous (including adenocarcinoma and large cell carcinoma) and squamous cell carcinoma. Research has shown that there is a link between histology and the effectiveness of ALIMTA in NSCLC.3,4 Ask your healthcare team what specific type of histology you have.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA can suppress bone marrow function, which may cause low blood cell counts.

Most patients taking ALIMTA will have side effects. Learn more about side effects.

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What Do I Need to Know About ALIMTA Treatment?

Like many patients, you might wonder what treatment is like. There are several things you'll need to know. You will get your treatment at your doctor's office, a clinic, or a hospital. ALIMTA therapy is given through a needle into one of your veins. This is called an "infusion," and an infusion of ALIMTA takes about 10 minutes. You may also receive another type of chemotherapy treatment at this time. Your doctor will explain the exact type of therapy you will be receiving.

  • If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

  • For at least 5 of the 7 days before you start taking ALIMTA, you will need to take a folic acid pill (a type of B vitamin) once per day. Your healthcare team will tell you exactly what to take, but make sure that you are taking between 350 and 1,000 micrograms each day. This is the amount that is usually found in a standard multivitamin tablet, which is available over the counter. Ask your healthcare team or pharmacist for help in choosing a folic acid product. You will continue to take a folic acid pill every day until 21 days after your last cycle of ALIMTA.

  • Your healthcare team will give you a shot (into a muscle) of vitamin B12 during the week before you start ALIMTA. Your healthcare team will then give you a shot approximately every 9 weeks, most likely on the same day that you receive your ALIMTA chemotherapy, for the rest of your cycles.

  • To help your healthcare team effectively manage your treatment, make sure you tell them about all of your medical conditions.

  • If you have liver or kidney problems, be sure to tell this to your healthcare team. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.

  • Tell your healthcare team if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements.

  • If you are taking a nonsteroidal anti-inflammatory drug (an NSAID, like ibuprofen, or other drugs used to treat pain and arthritis conditions), you should make sure to tell your healthcare team. Depending on your situation, you may be asked to stop taking these for a period of time.

  • You will be given an oral steroid medication called a corticosteroid to minimize the risk of a skin rash or certain other side effects that can occur with the use of this treatment. Be sure to take this drug twice daily on the day before, the day of, and the day after treatment, unless your healthcare team gives you different instructions.

  • You may find it helpful to use a therapy calendar to help keep track of your treatment plan. Use the calendar to mark when you have taken your daily folic acid pill. You may also want to use it to keep track of your appointments, side effects, or information you want to communicate to your healthcare team.

There is additional important information on the safety profile and side effects of ALIMTA therapy that you must be aware of. Please see the Important Safety Information for ALIMTA.

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Indications and Important Safety Information for ALIMTA® (pemetrexed for injection)

Indications

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.

Important Safety Information

What is the most important information that I should know about ALIMTA?
ALIMTA can suppress bone marrow function, which may cause low blood cell counts.

ALIMTA may not be appropriate for some patients.

If you are allergic to ALIMTA, tell your doctor because you should not receive it.

If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.

Your doctor will prescribe a medicine called a “corticosteroid” to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA.

It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.

  • You must take folic acid every day for at least 5 days out of the 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are getting treatment with ALIMTA, and for 21 days after your last treatment.
     
  • Your doctor will give you vitamin B12 injections while you are getting treatment with ALIMTA. You will get your first vitamin B12 injection during the week before your first dose of ALIMTA, and then about every 9 weeks during treatment.

You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.

What should I tell my doctor before receiving ALIMTA?
If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs) for pain or swelling.

What are the possible side effects of ALIMTA?
Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects.

Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death.

The most common side effects of ALIMTA when given alone or in combination with cisplatin are:

  • Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms.
  • Low blood cell counts:
    • Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.
    • Low white blood cells. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4°F) or other signs of infection, call your doctor right away.
    • Low platelets. Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with ALIMTA.
  • Tiredness. You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor.
  • Mouth, throat, or lip sores (stomatitis, pharyngitis). You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor about proper mouth and throat care.
  • Loss of appetite. You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you.
  • Rash. You may get a rash or itching during treatment. These reactions usually appear between treatments with ALIMTA and usually go away before the next treatment. Skin reactions or rashes that include blistering or peeling may be severe and could lead to death. Call your doctor if you have any of these symptoms.

Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn’t go away.

These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist.

How is ALIMTA given?
ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).

For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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References:

  1. American Cancer Society. Lung Cancer (Non-Small Cell). Atlanta, GA: American Cancer Society; updated September 15, 2011. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Accessed September 15, 2011.
  2. American Cancer Society. Lung Cancer Non-Small Cell Overview. Atlanta, GA: American Cancer Society; updated September 15, 2011. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003060-pdf.pdf. Accessed September 15, 2011.
  3. J Clin Oncol. 2008;26(21):3543-3551.
  4. ALIMTA (pemetrexed for injection) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2011.