Rylaze

This product is used to treat certain types of cancers (acute lymphoblastic leukemia-ALL, lymphoblastic lymphoma-LBL). Erwinia asparaginase works by starving tumor cells of needed nutrients and slowing tumor cell growth.

This medication is given by injection into a muscle by a health care professional. The dosage is based on your medical condition and response to treatment.

Your doctor will give you pre-medication to help prevent allergic reactions.

Pain or swelling at the injection site, nausea, vomiting, stomach cramps, loss of appetite, headache, or tiredness may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including severe stomach pain with nausea/vomiting, mental/mood changes, tremor, muscle stiffness, joint pain, swelling of hands/feet/lower legs, yellowing eyes/skin, unusual bleeding/bruising (such as nose bleeds, black or bloody stools), signs of high blood sugar (such as unusual thirst, frequent urination).

Get medical help right away if you have any very serious side effects, including abnormally high fever, vision changes, fainting, severe headache, severe dizziness, seizures, chest pain.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving this product, tell your doctor or pharmacist if you are allergic to it; or to any erwinia asparaginase products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of pancreatitis, liver disease.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using erwinia asparaginase. Erwinia asparaginase may harm a pregnant woman and her unborn baby. Ask about reliable forms of birth control while using this medication and for at least 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for some time after the last dose. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a hospital and will not be stored at home.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This product may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

It is important to get each dose of erwinia asparaginase as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Lab and/or medical tests (such as complete blood counts, liver function, amylase levels, blood sugar) should be done while you are using this medication. Keep all medical and lab appointments.