Calaspargase pegol is used to treat acute lymphoblastic leukemia in children and young adults from 1 month to 21 years old.

Calaspargase pegol may also be used for purposes not listed in this medication guide.

You should not use calaspargase pegol if you have ever received pegaspargase and it caused an allergic reaction, a blood clot, pancreatitis, bleeding, or liver problems.

Calaspargase pegol is given as an infusion into a vein. A healthcare provider will give you this injection.

Calaspargase pegol is usually given once every 21 days. Your doctor will determine how long to treat you with calaspargase pegol.

Calaspargase pegol doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight or if you are still growing.

You will need frequent medical tests.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

18 to 21 years:
2500 units/m2 IV over 60 minutes no more frequently than every 21 days

Use: This drug indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in adults 18 to 21 years old

Usual Pediatric Dose for Acute Lymphoblastic Leukemia:

1 month and older:
2500 units/m2 IV over 60 minutes no more frequently than every 21 days

Use: This drug indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric patients age 1 month and older

You should not use calaspargase pegol if you are allergic to it, or if:

• you have liver disease;

• you have had a serious allergic reaction to pegaspargase; or

• you have had a blood clot, pancreatitis, or serious bleeding caused by using asparaginase.

Tell your doctor if you have ever had:

• pancreatitis;

• heart problems;

• a blood clot; or

• liver disease.

Calaspargase pegol 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.

Calaspargase pegol may interact with birth control pills. To prevent pregnancy while using calaspargase pegol, use an effective non-oral form of birth control (injection, implant, skin patch, vaginal ring) plus a barrier form of birth control (condom, diaphragm, cervical cap, contraceptive sponge).

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

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, redness; feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

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

Calaspargase pegol may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or

• signs of a blood clot--headache, sudden numbness or weakness, blurred vision, chest pain, swelling or redness in an arm or leg.

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

Common side effects of calaspargase pegol may include:

• pancreatitis;

• blood clotting problems; or

• abnormal liver function tests.

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.

Other drugs may affect calaspargase pegol, 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.