Other drug names:	A-Am  An-Az  B  C-Ch  Ci-Cz  D-Dh  Di-Dz  E  F  G  H  I-J  K-L  M-Mh  Mi-Mz  N-Nh  Ni-Nz  O  P-Pl  Pm-Pz  Q-R  S-Sn  So-Sz  T-To  Tp-Tz  U-V  W-Z  0-9

In the U.S.—

Alimta

• Antineoplastic

Pemetrexed ( pem-ah-TREX-ed) belongs to the group of medicines called antineoplastics. It is used to treat a type of cancer called malignant pleural mesothelioma (MPM). This cancer affects the inside lining of the chest cavity. Pemetrexed is given with cisplatin, another anti-cancer medicine (chemotherapy).

To lower your chances of side effects of pemetrexed, you must also take folic acid and vitamin B₁₂ prior to and during your treatment with pemetrexed. Your doctor will prescribe a medicine called a “corticosteroid” to take for 3 days during your treatment with pemetrexed. Corticosteroid medicines lower your chances of getting skin reactions with pemetrexed.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pemetrexed, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pemetrexed. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This medicine has been shown to cause problems in unborn babies. However, this medicine may be needed in serious diseases. If you are pregnant or plan to become pregnant be sure you have discussed this with your doctor.

Breast-feeding—It is not known whether pemetrexed passes into breast milk. It is not recommended to use pemetrexed while you are breast-feeding because it may cause unwanted effects in nursing babies. You should stop breast-feeding once you start treatment with pemetrexed. Be sure you have discussed this with your doctor.

Children—Studies on this medicine have only been done in adult patients. There is no specific information comparing the use of pemetrexed in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of older patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. When you are using pemetrexed, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen [Motrin and others], naproxen [Aleve and others], celecoxib [Celebrex], rofecoxib [Vioxx])—Taking these medicines at the same time as pemetrexed can cause serious side effects. There are many NSAID medicines. If you have any questions ask your doctor or pharmacist if any of your medicines are NSAIDs.

Other medical problems—The presence of other medical problems may affect the use of pemetrexed. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease— Patients with kidney disease should not use pemetrexed. Patients with kidney disease may have more pemetrexed in their bodies.

• Third space fluid (extra fluid in your body), such as
• Ascites (extra fluid in your stomach area) or
• Pleural effusion (extra fluid in your lungs and chest)— Pemetrexed should be used carefully in these patients and the effects are not known

It is very important to take folic acid and vitamin B ₁₂ during your treatment with pemetrexed to lower your chances of harmful side effects. You must start taking 350-1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of pemetrexed. You must keep taking folic acid every day during the time you are getting treatment with pemetrexed, and for 21 days after your last treatment. You can get folic acid vitamins over-the-counter. Folic acid is also found in many multivitamin pills. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product. Your doctor will give you vitamin B₁₂ injections while you are getting treatment with pemetrexed. You will get your first vitamin B ₁₂injection during the week before your first dose of pemetrexed, and then about every 9 weeks during treatment.

Pemetrexed should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents.

Pemetrexed is given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

You will have regular blood tests before and during your treatment with pemetrexed. Your doctor may adjust your dose of pemetrexed or delay treatment based on the results of your blood tests and on your general condition.

Your doctor will prescribe a medicine called a “corticosteroid” to take for 3 days during your treatment with pemetrexed. Corticosteroid medicines lower your chances for getting skin reactions with pemetrexed.

Dosing—

The dose of pemetrexed can be different for different patients. Follow your doctor's orders or the directions on the label carefully if you are using pemetrexed at home. This medicine is used in combination with cisplatin, another anti-cancer medicine (chemotherapy). Pemetrexed is given by slowly infusing (injecting) it into a vein. The injection or infusion will last about 10 minutes. You will usually receive pemetrexed once every 21 days (3 weeks). Cisplatin is infused into your vein for about 2 hours starting 30 minutes after your treatment with pemetrexed.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visits. Your doctor may adjust your dose or delay your treatment based on your general condition.

It is important that you check with your doctor immediately if you have fever or chills, diarrhea, or mouth sores. These may be signs that you have an infection.

You may feel tired or weak for a few days after your pemetrexed treatments. If you have severe weakness or tiredness, call your doctor.

You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after pemetrexed treatment.

You may get a rash or itching during treatment. These usually appear between treatments with pemetrexed and usually go away before the next treatment. Call your doctor if you get a severe rash or itching.

Pemetrexed and the other anti-cancer medicine it is given with (cisplatin) can sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. You can get medicines to help control some of these symptoms. Talk with your doctor if you get any of these symptoms.

You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you.

While you are being treated with pemetrexed, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Pemetrexed may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Pemetrexed can temporarily affect your blood counts and your doctor will do blood tests to check your blood counts before and during treatment with pemetrexed. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4°F) or other signs of infection, call your doctor right away. Low platelets give you a greater chance for bleeding. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, diarrhea, lower back or side pain, mouth sores or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Black, tarry stools;  bleeding gums ;  chest pain;  chills;  cough;  fever;  loss of coordination;  lower back or side pain;  pains in chest, groin, or legs, especially calves of legs;  painful or difficult urination;  pale skin;  pinpoint red spots on skin;  severe headaches of sudden onset sudden;  shortness of breath;  sore throat;  sudden onset of slurred speech;  sudden vision changes ;  swollen glands;  troubled breathing;  ulcers, sores, or white spots in mouth ;  unusual bleeding or bruising;  unusual tiredness or weakness 
  
  

• Less common
  • Bloody urine or bloody stools;  decreased frequency/amount of urine;  fainting or loss of consciousness ;  fast or irregular breathing;  increased blood pressure;  increased thirst;  itching;  loss of appetite;  nausea;  skin rash;  swelling of eyes or eyelids;  swelling of face, fingers, lower legs;  tightness in chest, and/or wheezing;  vomiting;  weight gain 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Burning, tingling, numbness or pain in the hands, arms, feet, or legs;  confusion;  cough or hoarseness;  decreased urination;  diarrhea (without colostomy);  difficulty having a bowel movement (stool);  difficulty in swallowing ;  discouragement;  dizziness ;  dry mouth;  feeling sad or empty;  headache;  heartburn ;  increase in heart rate;  irritability;  lightheadedness;  loss of interest or pleasure;  mood changes;  muscle aches;  pain produced by swallowing ;  pain or burning in throat;  peeling of skin;  rapid breathing;  sensation of pins and needles;  stabbing pain;  stuffy or runny nose;  swelling or inflammation of the mouth;  sunken eyes;  thirst;  tiredness;  trouble concentrating;  trouble sleeping;  weight loss;  wheezing;  wrinkled skin 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 04/07/2004

Revised: 06/23/2004