Pegaspargase (E. coli) Solution for injection

What is this medicine?

PEGASPARGASE (peg AS par jase) is a chemotherapy drug. This medicine is used to treat certain types of leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders
• diabetes or other problems with blood sugar
• history of pancreatitis
• an unusual or allergic reaction to pegaspargase, L-asparaginase, e-coli proteins, other chemotherapy agents, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein or an injection into a muscle. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cytarabine, ARA-C
• methotrexate
• vaccines
• vincristine

Talk to your doctor or health care professional before taking any of these medicines:

• acetaminophen
• aspirin
• ibuprofen
• ketoprofen
• naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional if you get a severe headache or have a severe stomach pain with nausea and vomiting.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain
• confusion, agitation, or hallucinations
• feeling faint or lightheaded, falls
• increased thirst
• loss of appetite, nausea
• nausea and vomiting
• pain, swelling, warmth in the leg
• problems with balance, walking, talking
• seizures
• stomach pain or swelling
• sudden headache
• swelling of the ankles, feet, hands
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• sweating
• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.