Alimta is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Alimta is used to treat non-small cell lung cancer when the cancer has returned or spread after chemotherapy.

Alimta is also used to treat adults with malignant pleural mesothelioma (a form of lung cancer associated with exposure to asbestos) that cannot be removed by surgery or people are not able to have surgery.

Alimta is sometimes used in combination with other cancer medicines.

Do not use Alimta if you are pregnant. It could harm the unborn baby.

Before you receive Alimta, tell your doctor you have kidney or liver disease, bone marrow suppression, a weak immune system, or excess fluid in the space around your lung, liver, or other internal organs.

Tell your doctor about all other medicines you use, especially an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

To prevent certain side effects of Alimta, you will need to take folic acid supplements and receive vitamin B12 injections (starting 7 days before your first dose of Alimta). Take only the amount of folic acid that your doctor has prescribed.

Alimta can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

Call your doctor at once if you have a serious side effect while using Alimta such as fever, flu symptoms, sore throat, mouth sores, pale skin, easy bruising or bleeding, ongoing vomiting or diarrhea, increased thirst, urinating less than usual, pounding heartbeats, and swelling or rapid weight gain.

Alimta is given as an infusion into a vein. A healthcare provider will give you this injection.

Alimta is usually given every 3 weeks. Your doctor will determine how many treatment cycles you should receive.

To prevent certain side effects of pemetrexed, you will need to take folic acid supplements and receive vitamin B12 injections (starting 7 days before your first dose of Alimta). Take only the amount of folic acid that your doctor has prescribed.

Your doctor may also prescribe steroid medication to reduce certain side effects of pemetrexed. Follow your doctor's dosing instructions very carefully.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Alimta. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

Pemetrexed can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Usual Adult Dose for Malignant Pleural Mesothelioma:

COMBINATION USE WITH CISPLATIN in patients with a CrCl of 45 mL/min or greater: 500 mg/m2 as IV over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

PREMEDICATION REGIMEN AND CONCURRENT MEDICATIONS:
-Vitamin Supplementation: Patients should initiate folic acid 400 to 1000 mcg orally once daily beginning 7 days before the first dose of chemotherapy. Folic acid should be continued during the full course of therapy and for 21 days after the last dose.
-Vitamin B12 1 mg should be administered IM 1 week prior to the first dose of chemotherapy and every 3 cycles thereafter.
-Subsequent vitamin B12 injections may be given the same day as therapy.
-Corticosteroids: Dexamethasone 4 mg orally 2 times a day the day before, the day of, and the day after chemotherapy administration.

Usual Adult Dose for Non-Small Cell Lung Cancer:

COMBINATION USE WITH CISPLATIN for initial treatment of nonsquamous non-small cell lung cancer in patients with a CrCl of 45 mL/min or greater: 500 mg/m2 IV over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to 6 cycles in the absence of disease progression or unacceptable toxicity

FOR MAINTENANCE TREATMENT of NSCLC in patients with a CrCl of 45 mL/min or greater: 500 mg/m2 as IV over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after 4 cycles of platinum-based first-line chemotherapy

FOR TREATMENT OF RECURRENT NSCLC in patients with a CrCl of 45 mL/min or greater: 500 mg/m2 IV over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

COMBINATION USE CARBOPLATIN AND PEMBROLIZUMAB for the initial treatment of NSCLC in patients with a CrCl of 45 mL/min or greater: 500 mg/m2 IV over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after 4 cycles. Following completion of platinum-based therapy, this drug may be administered as maintenance therapy, alone or with pembrolizumab, until disease progression or unacceptable toxicity. Pembrolizumab should be administered prior to this drug when given on the same day. Please refer to the full prescribing information for pembrolizumab and for carboplatin.

PREMEDICATION REGIMEN AND CONCURRENT MEDICATIONS:
-Vitamin Supplementation: Patients should initiate folic acid 400 to 1000 mcg orally once daily beginning 7 days before the first dose of chemotherapy. Folic acid should be continued during the full course of therapy and for 21 days after the last dose.
-Vitamin B12 1 mg should be administered IM 1 week prior to the first dose of chemotherapy and every 3 cycles thereafter.
-Subsequent vitamin B12 injections may be given the same day as therapy.
-Corticosteroids: Dexamethasone 4 mg orally 2 times a day the day before, the day of, and the day after chemotherapy administration.

You should not be treated with Alimta if you are allergic to pemetrexed.

To make sure Alimta is safe for you, tell your doctor if you have ever had:

• kidney disease; or

• radiation treatment.

You may need to have a negative pregnancy test before starting treatment with Alimta.

Pemetrexed can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Alimta if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Alimta.

Alimta may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because pemetrexed can harm an unborn baby.

You should not breastfeed while you are using Alimta, and for at least 1 week after your last dose.

Call your doctor for instructions if you miss an appointment for your Alimta injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you have kidney disease, avoid taking ibuprofen (Advil, Motrin) for 2 days before or 2 days after you are treated with Alimta.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Do not receive a "live" vaccine while using Alimta, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Pemetrexed can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Alimta (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• little or no urination;

• new or worsening cough, fever, trouble breathing;

• swelling, redness, or blistering of skin that was treated with radiation in the past; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common Alimta side effects may include:

• tiredness, feeling short of breath, cough;

• swelling or sores in mouth, sore throat;

• fever, rash;

• low blood cell count;

• loss of appetite; or

• nausea, vomiting, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Alimta can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may interact with pemetrexed, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.