What Is ALIMTA?

ALIMTA is a chemotherapy that can be used in different ways to treat 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 therapy, maintenance therapy, and treatment with ALIMTA if you’ve had chemotherapy before and your cancer has come back or spread.

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

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Overview

There are two main types of lung cancer, small cell and non-small cell. The difference between them has to do with the type of cancer cells, how quickly they grow, and how they respond to treatment. About 80% to 85% of lung cancers are non-small cell.

NSCLC is further divided into squamous and nonsquamous types. About 70% of non-small cell lung cancers are nonsquamous.

There are different treatment options available for nonsquamous non-small cell lung cancer (NSCLC) 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 advanced nonsquamous NSCLC with ALIMTA.

  • It can be given in combination with carboplatin (a common chemotherapy also known as carbo) and an immunotherapy called KEYTRUDA® (pembrolizumab) as your first treatment once you are diagnosed (initial therapy)
  • It may also be used as an initial therapy combination with another chemotherapy drug called cisplatin
  • It can be used by itself as maintenance therapy if you have stable disease or better after 4 cycles of chemotherapy that contains platinum
  • It can be used by itself as a second-line treatment if your cancer has come back or spread after earlier chemotherapy

Initial treatment with ALIMTA as a combination therapy for advanced nonsquamous NSCLC

ALIMTA and carbo plus KEYTRUDA as your first treatment

Your first treatment for lung cancer is called initial therapy or first-line therapy. Initial therapy usually consists of 4 rounds of chemotherapy, as determined by your doctor. Your first treatment with ALIMTA may be in combination with carbo (a common chemotherapy drug that contains platinum) and KEYTRUDA (an immunotherapy).

The use of chemotherapy with immunotherapy* as a treatment for lung cancer has been studied in clinical trials. As the result of a clinical study, ALIMTA and carbo with KEYTRUDA became the first FDA-approved chemotherapy/immunotherapy combination for the initial treatment of people with nonsquamous NSCLC that has spread. Using these two different treatments together may help to attack your cancer* in a more effective way than ALIMTA and carbo alone.

*An immunotherapy works with your immune system to help fight cancer. The combination of ALIMTA and carbo plus KEYTRUDA has the potential to attack healthy cells too, which can become serious and could lead to death.

There are ongoing studies to verify how well ALIMTA works in combination with carbo and KEYTRUDA.

ALIMTA plus cisplatin as your first treatment

Your first treatment for lung cancer is called initial therapy or first-line therapy. Initial therapy usually consists of 4 to 6 rounds of chemotherapy, as determined by your doctor.

After you are diagnosed with advanced nonsquamous NSCLC, your doctor may offer you the option to receive ALIMTA combined with another chemotherapy called cisplatin, as your first treatment. Cisplatin contains platinum and is used to treat many types of cancer. Cisplatin is believed to kill cancer cells by damaging their DNA and stopping them from dividing.

ALIMTA maintenance therapy

After receiving 4 cycles of initial combination therapy with ALIMTA, you may be able to continue treatment with ALIMTA without the platinum-based chemotherapy if your tumor has not changed much (stable disease), if your tumor has gotten smaller (partial response), or if your tumor has disappeared (complete response).

Ask your doctor if maintenance treatment is right for you.

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.

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 carboplatin (another chemotherapy drug) and pembrolizumab (an immunotherapy) as a first treatment for nonsquamous non-small cell lung cancer (NSCLC) that has spread. There are ongoing studies to verify how well ALIMTA works in combination with carboplatin and pembrolizumab.

ALIMTA 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 a 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)

The most common side effects of ALIMTA when given with carboplatin and pembrolizumab are:

  • Tiredness
  • Constipation
  • Vomiting
  • Diarrhea
  • Loss of appetite
  • Nausea
  • Rash
  • Shortness of breath
  • Headache

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, visit www.ALIMTA.com, or call 1-800-545-5979.

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