Asparaginase Erwinia Chrysanthemi Recombinant-rywn (as-par-a-JIN-ase er-WIN-i-a kris-an-THEM-i re-KOM-bin-ant - rywn)

Treats acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL).

Brand Name(s):

Rylaze

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor may also give you other medicines (including acetaminophen, an allergy medicine, and a stomach medicine) 30 to 60 minutes before receiving this medicine to help prevent unwanted effects.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose.
• Do not breastfeed during treatment and for at least 1 week after your last dose.
• Tell your doctor if you have liver disease, bleeding or blood clotting problems, or pancreas problems.
• This medicine may cause the following problems:
  • Pancreatitis
  • Bleeding or blood clotting problems
  • Liver problems, including veno-occlusive liver disease
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, or coughing up blood
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Dry mouth, increased hunger, thirst, or urination
• Fever, chills, cough, sore throat, body aches
• Muscle or bone pain
• Numbness or weakness in your arm or leg, or on one side of your body, pain or swelling in your calf
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot given
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088