Understanding Your Diagnosis

Facing an initial diagnosis 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. But by working together with your healthcare team — asking questions and exploring your treatment options — you can take back some control.

Not All Types of NSCLC Are Alike
Your Type of NSCLC Matters
Important Things to Know: Managing Therapy

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.

Not All Types of NSCLC Are Alike

According to the American Cancer Society, about 85% to 90% 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.¹
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 quickly, making it harder to treat.¹
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.¹ Please note that ALIMTA is not indicated for squamous cell carcinoma.

"Nonsquamous" includes adenocarcinoma, large cell carcinoma, and all other cell types except squamous cell.

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 adenocarcinoma, large cell carcinoma, and squamous cell carcinoma. Research has shown that there is a link between histology and the efficacy of ALIMTA in NSCLC.² A large clinical trial compared ALIMTA plus cisplatin to another proven therapy for NSCLC, and ALIMTA plus cisplatin was found to be more effective in adenocarcinoma and large cell histologies. Ask your healthcare team what specific type of histology you have.

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

Important Things to Know: Managing Therapy

Before you begin your treatment with ALIMTA, it is important for you to do some things to help manage your treatment. If you are unsure about any of the following safety information, be sure to ask your healthcare team — working with your team is very important to you throughout your course of therapy.

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 to 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.
Please 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.

Important Safety Information for ALIMTA (pemetrexed for injection)

ALIMTA as a single agent (used alone) is approved for maintaining the initial treatment effect of chemotherapy in patients with advanced nonsquamous non-small cell lung cancer whose disease has not worsened after initial therapy. ALIMTA is not indicated for patients who have another type of non-small cell lung cancer 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.

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 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.

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. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow function. 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.

Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal anti-inflammatory drugs used to treat pain or swelling). Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements.

The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.

Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare professional.

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.

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.

SG24

References:

American Cancer Society. What is Non-Small Cell Lung Cancer? Available at:
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?sitearea=.
Accessed May 1, 2008.
J Clin Oncol. 2008;26(21):3543-3551.