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Your Treatment With ALIMTA

ALIMTA is a chemotherapy that can be used in different ways in the treatment of advanced nonsquamous non-small cell lung cancer (NSCLC). In this section, you’ll learn more about when and how ALIMTA is used and the differences between initial and maintenance therapy. You’ll also learn what additional medicines you should take during treatment, what side effects to expect, and how to handle them.

Here’s how ALIMTA may be used to treat advanced nonsquamous NSCLC:

  • It can be used in combination with another chemotherapy drug, such as cisplatin, as initial therapy when you are first diagnosed
  • It can be used by itself if you have stable disease or better following 4 cycles of chemotherapy that contains platinum
  • It can be used by itself after another chemotherapy treatment if your cancer has returned or spread
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Overview

There are different treatment options available depending on the stage of your cancer, which is usually based on the size of your tumor, and if it has spread.

Your doctor may decide to treat your cancer with ALIMTA. If you are receiving ALIMTA for the first time, it may be given with another chemotherapy drug, such as cisplatin. It’s a good idea to talk with your doctor early about your treatment. Ask what to expect, and what you can do to try to maintain your body’s response if your treatment is working.

ALIMTA treatment has possible side effects. Not everyone will have the same side effects. During treatment, you will receive medicines to help reduce certain side effects.

Initial and maintenance therapy with ALIMTA for advanced nonsquamous NSCLC

Your first treatment for lung cancer is called initial therapy. Initial therapy usually consists of 4 to 6 rounds of chemotherapy, as determined by your doctor, and combines ALIMTA with another chemotherapy drug, such as cisplatin.

If you respond positively to initial therapy, your doctor may decide to proceed to maintenance therapy. This is additional rounds of chemotherapy using just ALIMTA by itself, and may continue as long as you keep responding.

ALIMTA initial therapy

ALIMTA has been shown to be an effective initial treatment for people with advanced nonsquamous NSCLC. Initial treatment is also called "first-line" therapy. It is the first therapy you receive after diagnosis.

If you are receiving ALIMTA for the first time, it may be given with cisplatin. Cisplatin is also a chemotherapy drug.

ALIMTA is not appropriate for people who have a different type of NSCLC called squamous cell.

ALIMTA maintenance therapy

Results from a large clinical trial showed that maintenance treatment (continuing* therapy with ALIMTA by itself after initial treatment with ALIMTA plus cisplatin) helped people live 2.9 months longer compared to people who didn’t continue chemotherapy.

You may be eligible for maintenance treatment if your tumor has not changed much, has gotten smaller, or has disappeared after initial therapy.*†

Depending on the results of your initial treatment with ALIMTA in combination with another chemotherapy drug, such as cisplatin, you may be able to continue treatment with ALIMTA by itself. Ask your doctor if you are eligible for maintenance therapy. Even before you complete your initial treatment, you and your doctor may discuss maintenance therapy and whether it could be right for you.

Initial and maintenance therapy with ALIMTA

* Ask your doctor if maintenance treatment is right for you.

† Your doctor may also delay or stop treatment for other reasons, such as side effects you may be experiencing.

How your treatment is given

How your initial treatment will be given:

Initial treatment with ALIMTA/cisplatinInitial treatment with ALIMTA/cisplatin

Your treatment with ALIMTA plus cisplatin will be given usually once every 21 days. Three weeks equals one treatment cycle. The "rest days" between treatments are a normal part of your treatment with ALIMTA.

Additional vitamins and medicines you will need

During your initial treatment, it is very important to take additional medicines (including vitamin B12, folic acid, and corticosteroids) to lower your risk of harmful side effects. You will get your first vitamin B12 injection 7 days (1 week) before your first dose of ALIMTA, and then every 3 cycles. It is also important to take a daily folic acid supplement and a medicine called a corticosteroid. Your doctor will tell you when to take these medications and how much to take.

How your maintenance treatment will be given:

Maintenance treatment with ALIMTAMaintenance treatment with ALIMTA

Additional vitamins and medicines you will need

During your maintenance treatment, it is very important to take additional medicines (including vitamin B12, folic acid, and corticosteroids) to lower your risk of harmful side effects. You will get your first vitamin B12 injection 7 days (1 week) before your first dose of ALIMTA, and then every 3 cycles. It is also important to take a daily folic acid supplement and a medicine called a corticosteroid. Your doctor will tell you when to take these medications and how much to take.

Understanding your treatment plan

Before you begin therapy, it is important for you to talk to your healthcare provider and ask all your questions.

Be sure to let your healthcare provider know:

  • If you have had a severe allergic reaction to any medicine that contains pemetrexed
  • About all of your medical conditions
  • If you have kidney problems
  • If you have had radiation therapy
  • If you are pregnant, planning to become pregnant, or nursing
  • If you are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements
  • If you have kidney problems and take a medicine that contains ibuprofen. You should avoid taking ibuprofen for 2 days before, the day of, and 2 days after receiving treatment with ALIMTA

As a part of your treatment, you will also receive additional medicines (including vitamin B12, folic acid, and corticosteroids) to help reduce your risk of certain side effects:

  • You must take folic acid every day by mouth beginning 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are being treated with ALIMTA, and every day for 21 days after you receive your last dose of ALIMTA
  • You will get your first vitamin B12 injection 1 week before your first dose of ALIMTA, and then about every 9 weeks during treatment. Do not substitute oral vitamin B12 for the vitamin B12 injection
  • Your doctor will prescribe a medicine called a “corticosteroid” that you must take by mouth twice daily for 3 consecutive days, beginning the day before each treatment with ALIMTA to reduce the possibility of experiencing skin-related side effects (like rash)

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, including any side effects that you may have had.

Possible side effects

Most people taking ALIMTA for initial or maintenance treatment will have side effects. You should always tell your healthcare provider if you are experiencing any new or worsening symptoms.

Side effects to watch for
with initial therapy

Most people taking ALIMTA plus cisplatin will have side effects. It’s not always possible to tell what is causing these side effects. It might be from ALIMTA, cisplatin, another medicine, or the cancer itself. You should always tell your healthcare provider if you are experiencing any possible symptom or side effect.

To learn more, choose a side effect from the menu or download a list of side effects in initial treatment.

Download information on side effects

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.

Choose a side effect for more information:

White blood cells help you fight infection. A low white blood cell count may give you a greater chance for infection. If you have any signs of infection or fever, tell your healthcare provider right away.
Red blood cells help carry oxygen from your lungs to the other parts of your body. A low red blood cell count is called anemia. If your red blood cell count is low, you may experience severe tiredness, appear pale, and become short of breath.
Platelets help your blood clot. A low platelet count puts you at more risk for bleeding. If you have a low platelet count, you may be asked to take some extra care. For example, you may need to avoid injury. It is important that you tell your healthcare provider right away if you see any signs of bleeding, such as unexplained bruising or blood in your stool (black, tarry stools).
Fever may be the first symptom of infection. There are medicines that may reduce a fever that can be given along with chemotherapy. If you have a temperature of 100.4°F or higher, you should call your healthcare provider right away. It could be a sign that you have an infection. This may be severe and could lead to death.
Chills may include shivering, paleness, and feeling cold. If you experience chills, contact your healthcare provider right away. It could be a sign that you have an infection. This may be severe and could lead to death.
You may experience severe tiredness or fatigue. If you do, it may help to balance your periods of activity with rest, increase your liquid intake, and follow a well-balanced diet.
It is important to tell your healthcare provider if you have nausea or vomiting. There are medicines that can help prevent this. Your healthcare provider can also help treat your constipation. It is important that you talk with them before you take any over-the-counter laxatives or stool softeners.
Diarrhea is frequent, soft, loose, or watery bowel movements. Tell your healthcare provider right away if you have diarrhea. It could mean that you have an infection or kidney problems, which may be severe and could lead to death. It is also very important that you talk with them before you take any over-the-counter diarrhea medicines.
You may lose your appetite and lose weight during your treatment. Talk to your healthcare provider if this is a problem for you.
You may get redness, sores, or ulcers in your mouth, throat, on your lips, or in the esophagus after ALIMTA treatment. Call your healthcare provider right away if this happens, or if you have pain or trouble drinking or swallowing food. Mouth sores could mean you have an infection, which may be severe and could lead to death.
Hair loss is rarely permanent. Talk with your healthcare provider about any hair loss that may happen.
Signs of nerve damage may include weakness, pain, a tingling sensation, and/or numbness. Numbness is most common in the toes and fingertips.
Radiation recall is a skin reaction that can happen in people who have received radiation treatment in the past and are treated with ALIMTA. Tell your healthcare provider if you get swelling, blistering, or a rash that looks like a sunburn in an area that was previously treated with radiation.

Side effects to watch for with
maintenance therapy

Your side effects with maintenance treatment may not be the same as those with initial treatment. You should always tell your healthcare provider if you are experiencing any possible symptom or side effect.

To learn more, choose a side effect from the menu.

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.

Choose a side effect for more information:

White blood cells help you fight infection. A low white blood cell count may give you a greater chance for infection. If you have any signs of infection or fever, tell your healthcare provider right away.
Red blood cells help carry oxygen from your lungs to the other parts of your body. A low red blood cell count is called anemia. If your red blood cell count is low, you may experience severe tiredness, appear pale, and become short of breath.
Platelets help your blood clot. A low platelet count puts you at more risk for bleeding. If you have a low platelet count, you may be asked to take some extra care. For example, you may need to avoid injury. It is important that you tell your healthcare provider right away if you see any signs of bleeding, such as unexplained bruising or blood in your stool (black, tarry stools).
You may experience severe tiredness or fatigue. If you do, it may help to balance your periods of activity with rest, increase your liquid intake, and follow a well-balanced diet.
It is important to tell your healthcare provider if you have nausea or vomiting. There are medicines that can help prevent nausea and vomiting.
Diarrhea is frequent, soft, loose, or watery bowel movements. Tell your healthcare provider right away if you have diarrhea. It could mean that you have an infection or kidney problems, which may be severe and could lead to death. It is also very important that you talk with them before you take any over-the-counter diarrhea medicines.
You may lose your appetite and lose weight during your treatment. Talk to your healthcare provider if this is a problem for you.
Radiation recall is a skin reaction that can happen in people who have received radiation treatment in the past and are treated with ALIMTA. Tell your healthcare provider if you get swelling, blistering, or a rash that looks like a sunburn in an area that was previously treated with radiation.

ALIMTA after earlier chemotherapy

ALIMTA may still be an option even if you’ve been treated with something else first.

It can be discouraging to find out your lung cancer has come back after treatment. If that’s the case, you may be treated with a different chemotherapy to help slow the cancer’s growth.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with nonsquamous NSCLC that has returned or spread after prior chemotherapy. This is known as second-line therapy. Only you and your healthcare provider can determine whether ALIMTA is right for you.

ALIMTA is not appropriate for people who have a different type of NSCLC called squamous cell.

For more information on treatment, side effects, and more, get the ALIMTA Second-line Therapy Guide.

Download Second-line Therapy Guide
GO TO LIVING WITH ADVANCED NS NSCLC
Indications and Important Safety Information

What Is ALIMTA® (pemetrexed for injection) Approved For?

ALIMTA® (pemetrexed for injection) is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the first (initial) treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC that has spread.

ALIMTA is approved by the FDA as a single agent (used alone) for maintenance treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after you have received 4 cycles of chemotherapy that contains platinum for first treatment and your cancer has not progressed.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with recurrent, metastatic nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, which has returned or spread after prior chemotherapy.

ALIMTA is not appropriate for people who have a different type of NSCLC called squamous cell.

Important Safety Information for ALIMTA

What is the most important information that I should know about ALIMTA?

ALIMTA can cause serious side effects including:

  • Low blood cell counts. Low blood cell counts can be severe, including low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and low red blood cell counts (anemia). Your healthcare provider will do blood test to check your blood cell counts regularly during your treatment with ALIMTA. Tell your healthcare provider right away if you have any signs of infection, fever, bleeding, or severe tiredness during your treatment with ALIMTA.
  • Kidney problems, including kidney failure. ALIMTA can cause severe kidney problems that can lead to death. Severe vomiting or diarrhea can lead to loss of fluids (dehydration) which may cause kidney problems to become worse. Tell your healthcare provider right away if you have a decrease in amount of urine.
  • Severe skin reactions. Severe skin reactions that may lead to death can happen with ALIMTA. Tell your healthcare provider right away if you develop blisters, skin sores, skin peeling, or painful sores, or ulcers in your mouth, nose, throat or genital area.
  • Lung problems (pneumonitis). ALIMTA can cause serious lung problems that can lead to death. Tell your healthcare provider right away if you get any new or worsening symptoms of shortness of breath, cough, or fever.
  • Radiation recall. Radiation recall is a skin reaction that can happen in people who have received radiation treatment in the past and are treated with ALIMTA. Tell your healthcare provider if you get swelling, blistering, or a rash that looks like a sunburn in an area that was previously treated with radiation.

Who should not take ALIMTA?

ALIMTA may not be appropriate for some patients. If you are allergic to pemetrexed, tell your doctor because you should not receive it. It is not known if ALIMTA is safe and effective in children.

What should I tell my healthcare provider before receiving ALIMTA?

  • Before receiving ALIMTA, tell your healthcare provider about all of your medical conditions including:
    • if you have kidney problems.
    • if you have had radiation therapy.
    • if you think you are pregnant, or are planning to become pregnant as ALIMTA can harm your unborn baby.
      • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ALIMTA and for 6 months after the final dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ALIMTA.
      • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ALIMTA and for 3 months after the final dose.
    • if you are breastfeeding or plan to breastfeed, as it is not known if ALIMTA passes into breast milk. Do not breastfeed during treatment with ALIMTA and for 1 week after the final dose.
  • Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Tell your healthcare provider if you have kidney problems and take a medicine that contains ibuprofen. You should avoid taking ibuprofen for 2 days before, the day of, and 2 days after receiving treatment with ALIMTA.

How is ALIMTA given?

  • It is very important to take folic acid by mouth and receive vitamin B12 injections from your healthcare provider during your treatment with ALIMTA to lower your risk of harmful side effects.
  • Your healthcare provider will prescribe a medicine called a corticosteroid for you to take 2 times a day for 3 days, beginning the day before each treatment with ALIMTA.
  • ALIMTA is given to you by intravenous (IV) infusion (injection) into your vein. The infusion is given over 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).

What are the possible side effects of ALIMTA?

The most common side effects of ALIMTA when given alone are:

  • Tiredness
  • Nausea
  • Loss of appetite

The most common side effects of ALIMTA when given with cisplatin are:

  • Vomiting
  • Swelling or sores in your mouth or sore throat
  • Constipation
  • Low white blood cell counts (neutropenia)
  • Low platelet counts (thrombocytopenia)
  • Low red blood cell counts (anemia)

ALIMTA may cause fertility problems in males. This may affect your ability to father a child. It is not known if these effects are reversible. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider will do blood tests to check for side effects during treatment with ALIMTA. Your healthcare provider may change your dose of ALIMTA, delay treatment, or stop treatment if you have certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of ALIMTA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

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.

ALIMTA is available by prescription only.

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.

PM_CON_ISI_All_16OCT2017

Indications and Important Safety Information