pemetrexed Intravenous

pem-e-TREX-ed

Commonly used brand name(s)

In the U.S.

• Alimta

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Uses For pemetrexed

Pemetrexed injection treats lung cancer and belongs to the group of medicines called antineoplastics. It is used together with cisplatin (a cancer medicine) to treat a type of cancer called malignant pleural mesothelioma (MPM). This cancer affects the inside lining of the chest cavity. Pemetrexed injection may also be used alone or together with cisplatin to treat a type of lung cancer called nonsquamous non-small cell lung cancer.

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

pemetrexed is available only with your doctor's prescription.

Before Using pemetrexed

In deciding to use a medicine, the risks of taking 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 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have been performed on the relationship of age to the effects of pemetrexed injection in the pediatric population. However, efficacy has not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pemetrexed injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving pemetrexed injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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. When you are receiving pemetrexed, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using pemetrexed with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac


• Acemetacin


• Alclofenac


• Apazone


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carprofen


• Celecoxib


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Rofecoxib


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Ticrynafen


• Tolmetin


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Ascites (extra fluid in your stomach area) or


• Bone marrow problems (e.g., anemia, neutropenia, thrombocytopenia)—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of pemetrexed from the body.

• Kidney disease, severe—Should not be given in patients with this condition.

Proper Use of pemetrexed

It is very important to take folic acid and vitamin B12 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 B12 injection during the week before your first dose of pemetrexed, and then about every 9 weeks during treatment.

You will receive pemetrexed while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you pemetrexed. pemetrexed is given through a needle placed in one of your veins.

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 doctor to help you create a plan to take them at the right times.

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

pemetrexed comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using pemetrexed

It is very important that your doctor check your progress at regular visits to make sure pemetrexed is working properly. Blood tests may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant before you receive pemetrexed. Using pemetrexed while you are pregnant can harm your unborn baby. If you are a woman of childbearing potential, you should use two forms of birth control together to avoid getting pregnant while you are receiving pemetrexed. If you have become pregnant during your treatment, tell your doctor right away.

It is important that you check with your doctor right away 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 treatment. If you have severe weakness or tiredness, call your doctor.

You may get redness or sores in your mouth, throat, or 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 cisplatin (a cancer medicine) can sometimes cause 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 the nausea and vomiting. Talk with your doctor if you get any of these symptoms.

You may lose your appetite and some 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 degrees 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 the 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.

Make sure your doctor knows if you are also using a pain or arthritis medicine (e.g., ibuprofen, Motrin®) while you are receiving pemetrexed. These medicines should be used with caution in patients with kidney problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

pemetrexed Side Effects

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 or nurse 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


• painful or difficult urination


• pains in the chest, groin, or legs, especially calves of the legs


• pale skin


• pinpoint red spots on the skin


• severe headaches of sudden onset


• shortness of breath


• sore throat


• sudden onset of slurred speech


• sudden vision changes


• swollen glands


• troubled breathing


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Bloody urine or bloody stools


• decreased frequency or 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 the eyes or eyelids


• swelling of the face, fingers, or lower legs


• tightness in the chest or wheezing


• vomiting


• weight gain

Incidence not known

• Blistering, peeling, or loosening of the skin


• joint or muscle pain


• pain and redness of the skin in the area of earlier radiation treatment


• red skin lesions, often with a purple center


• red, irritated eyes


• stomach cramps, tenderness, or pain


• watery diarrhea

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 with moving


• difficulty with swallowing


• discouragement


• dizziness


• dry mouth


• feeling sad or empty


• hair loss


• headache


• heartburn


• increase in heart rate


• irritability


• lightheadedness


• loss of interest or pleasure


• mood changes


• muscle aches or cramping


• muscle stiffness


• pain or burning in the throat


• pain produced by swallowing


• rapid breathing


• sensation of pins and needles


• stabbing pain


• stuffy or runny nose


• sunken eyes


• swelling


• swelling or inflammation of the mouth


• swollen joints


• thinning of the hair


• thirst


• tiredness


• trouble concentrating


• trouble sleeping


• weight loss


• wheezing


• wrinkled skin

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pemetrexed Intravenous side effects (in more detail)

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More pemetrexed Intravenous resources

• Pemetrexed Intravenous Side Effects (in more detail)
• Pemetrexed Intravenous Use in Pregnancy & Breastfeeding
• Pemetrexed Intravenous Drug Interactions
• Pemetrexed Intravenous Support Group
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