In the U.S.—

Another commonly used name is PEG-L-asparaginase.

• Antineoplastic

Pegaspargase (peg-AS-par-jase ) belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancer.

Pegaspargase seems to interfere with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells also may be affected by pegaspargase, other effects also occur. Some of these effects may be serious and must be reported to your doctor.

Before you begin treatment with pegaspargase, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Pegaspargase is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S.)

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 pegaspargase, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pegaspargase.

Pregnancy—Pegaspargase has not been studied in pregnant women or animals; however, many cancer medicines may cause sterility that could be permanent. Although sterility has not been reported with pegaspargase, the possibility of this effect in humans should be kept in mind. Cancer medicines may also cause birth defects; therefore, use during pregnancy is not recommended.

Be sure you have discussed this with your doctor before receiving this medicine. It is best to use some kind of birth control while you are receiving pegaspargase. Tell your doctor right away if you think you have become pregnant while receiving pegaspargase.

Breast-feeding—Because pegaspargase may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—Infants up to 1 year of age—Safety and efficacy have not been established.

Children 1 year of age and older—This medicine has been studied in children 1 year of age and older and has not been shown to cause different side effects or problems than it does in adults. In fact, the side effects of this medicine seem to be less severe in children than in adults.

Older adults—There is no specific information comparing the use of pegaspargase in the elderly with use in other age groups. Safety and efficacy of pegaspargase in the elderly have not been established.

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. When you are taking pegaspargase, it is especially important that your health care professional know if you are taking any of the following:

• Aspirin or
• Dipyridamole (e.g., Persantine) or
• Heparin or
• Inflammation or pain medicine, except narcotics or
• Warfarin (e.g., Coumadin)—Using any of these medicines together with pegaspargase may increase the risk of bleeding

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicines—Pegaspargase may increase the effects of these medicines or radiation therapy on the blood

• Anticoagulant therapy (treatment with blood thinners) or
• Bleeding problems—The chance of bleeding may be increased

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Diabetes mellitus (sugar diabetes)—The chance of side effects may be increased

• Infection—Pegaspargase can decrease your body's ability to fight infection

• Liver disease—Effects of pegaspargase may be increased because of slower removal of this medicine from the body

• Pancreatitis—The chance of side effects may be increased

Pegaspargase sometimes 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.

While you are receiving pegaspargase, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects, especially if they are severe.

Dosing—

The dose of pegaspargase will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is used for, the patient's size, and whether or not other medicines are also being taken. If you are receiving pegaspargase at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of pegaspargase, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with pegaspargase, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Pegaspargase 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 poliovirus vaccine, since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine. Do not get close to them, and do not stay in the same room with them for long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and the mouth.

Pegaspargase can temporarily lower the number of white blood cells in your blood, increasing the chance of getting infection. It can also lower the number of platelets, which are necessary for proper blood clotting. 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 infection. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have 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 safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury can occur.

If pegaspargase accidentally seeps out of the vein into which it is injected, it may damage some tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

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 as soon as possible if any of the following side effects occur:

• More common
  • Abdominal or stomach pain;  blurry vision ;  constipation;  dry mouth and skin;  fatigue;  increased hunger or thirst;  increased need to urinate;  nausea;  skin rash;  unexplained weight loss;  vomiting 
  
  

• Less common
  • Difficulty in breathing or swallowing;  hives;  itching, especially of hands and feet;  reddening of the skin, especially around ears;  swelling of eyes, face, or inside of nose;  unusual tiredness or weakness (sudden and severe) 
  
  

• Rare
  • Black, tarry stools;  blood in urine ;  cough or hoarseness;  fever or chills;  lower back or side pain;  painful or difficult urination;  pinpoint red spots on skin;  unusual bleeding or bruising 
  
  

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
  • General feeling of discomfort or illness 
  
  

• Less common
  • Anxiety;  behavior change similar to drunkenness;  blurred vision;  cold sweats;  confusion;  convulsions (seizures);  cool pale skin;  difficulty in concentrating;  drowsiness ;  fast heartbeat;  headache ;  lack of appetite;  nervousness ;  nightmares;  pain at place of injection;  pain in joints or muscles;  restless sleep;  shakiness;  severe or unusual tiredness or weakness;  slurred speech 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any other side effects not listed above.