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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 health care provider doctor 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 you 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.

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