Pegaspargase

Pegaspargase is used along with other medicines to treat acute lymphoblastic leukemia.

Pegaspargase is also used to treat allergic reactions to another cancer medicine called asparaginase.

Pegaspargase may also be used for reasons not mentioned in this medication guide.

Pegaspargase is injected into a muscle or given as an infusion into a vein. A healthcare provider will give you this injection.

You will be watched closely for at least 1 hour to make sure you do not have an allergic reaction.

Pegaspargase can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Your liver function may also need to be checked.

You should not use pegaspargase if you are allergic to pegaspargase or asparaginase, or if you have ever received asparaginase and it caused pancreatitis, severe bleeding, or a blood clot.

You should not use this medicine if you are allergic to pegaspargase or asparaginase, or if you have ever received asparaginase and it caused any of the following conditions:

• a blood clot;
• pancreatitis;
• severe bleeding; or
• a severe allergic reaction.

Tell your doctor if you have ever had:

• a pancreas disorder;
• liver disease;
• diabetes;
• bleeding problems;
• any allergies; or
• a stroke or blood clot.

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

Pegaspargase may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Pegaspargase can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using pegaspargase, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Do not breastfeed while using this medicine, and for at least 3 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Pegaspargase may cause serious side effects. Call your doctor immediately if you have:

• easy bruising, unusual bleeding, purple or red spots under your skin;
• low white blood cell counts—fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
• signs of liver or pancreas problems—loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
• high blood sugar—increased thirst, increased urination, dry mouth, fruity breath odor; or
• signs of a blood clot—sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of pegaspargase may include:

• blood clot symptoms;
• an allergic reaction;
• pancreas or liver problems;
• high blood sugar; or
• low white blood cells.

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.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

18 to 21 years:2500 international units/m2 IM or IV no more frequently than every 14 days21 years and older: 2000 international units/m2 IM or IV no more frequently than every 14 daysComments:-Monitor patients at least weekly, with bilirubin, transaminases, glucose. and clinical examinations until recovery from the cycle of therapy.Use: Component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) and hypersensitivity to native forms of L-asparaginase

Usual Pediatric Dose for Acute Lymphoblastic Leukemia:

1 year and older:2500 international units/m2 IM or IV no more frequently than every 14 daysComments:-IM: Single injection site volume administered should be limited to 2 mL. If volume to be administered is greater than 2 mL, multiple injection sites should be used.-IV: Give over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running. -Monitor patients at least weekly, with bilirubin, transaminases, glucose. and clinical examinations until recovery from the cycle of therapy.Use: Component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) and hypersensitivity to native forms of L-asparaginase

Call your doctor for instructions if you miss an appointment for your Pegaspargase injection.

Since pegaspargase is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Avoid activities that may raise your risk of bleeding or injury. Be extra careful to prevent bleeding while shaving or brushing your teeth.

Other drugs may affect pegaspargase, 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.

• How does Asparlas (calaspargase pegol-mknl) compare to Oncaspar (pegaspargase)?