Pemfexy is used to treat adults with non-squamous non-small cell lung cancer when the cancer has returned or spread after chemotherapy.

Pemfexy 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.

Pemfexy is sometimes used in combination with other cancer medicines.

Pemfexy may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Pemfexy 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 pemetrexed). 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 Pemfexy. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

Pemfexy 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.

You should not be treated with Pemfexy if you are allergic to it.

Tell your doctor if you have ever had:

• kidney disease; or

• radiation treatment.

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

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

• If you are a woman, do not use Pemfexy 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 Pemfexy.

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

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

Call your doctor for instructions if you miss an appointment for your Pemfexy.

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 Pemfexy.

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.

Get emergency medical help if you have signs of an allergic reaction (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).

Pemfexy may cause serious side effects. 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 side effects of Pemfexy 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.

Pemfexy 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 affect Pemfexy, 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.