Calaspargase pegol

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

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

Calaspargase pegol is given through an infusion into a vein. A healthcare provider will administer this injection.

Calaspargase pegol is typically given once every 21 days. Your doctor will decide how long you will be treated with calaspargase pegol.

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

You will need to have frequent medical tests.

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.

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.

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

You will be monitored closely for at least 1 hour after each injection to ensure you do not have an allergic reaction.

Calaspargase pegol may cause serious side effects. Call your doctor immediately if you experience:

• easy bruising or unusual bleeding;
• high blood sugar, which may include increased thirst, increased urination, dry mouth, or a fruity breath odor;
• pancreatitis, which can cause severe pain in your upper stomach that spreads to your back, nausea, or vomiting;
• liver problems, which may present as loss of appetite, stomach pain (upper right side), dark urine, or jaundice (yellowing of the skin or eyes); or
• signs of a blood clot, such as headache, sudden numbness or weakness, blurred vision, chest pain, or swelling or redness in an arm or leg.

Your cancer treatments may be delayed or stopped permanently 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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

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

Call your doctor for guidance 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.

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.

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