Rylaze 10 mg/0.5 mL intramuscular solution

Generic name:
Asparaginase erwinia chrysanthemi (recombinant) - injection

Pronunciation
(as-PAR-a-jin-ase er-WIN-ee-a)

Brand name(s)
Rylaze

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

This medication is given by injection into a muscle as directed by your doctor. The injection is given by a health care professional. The dosage and treatment schedule are based on your medical condition, body size, and response to treatment.

Your doctor may prescribe other medications(s) before each dose to help prevent side effects (such as allergic reactions, nausea).

To get the most benefit, do not miss any doses. To help you remember, mark your calendar with a reminder.

Pain or swelling at the injection site, nausea, vomiting, diarrhea, 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:

• signs of liver disease (such as stomach/abdominal pain, yellowing eyes/skin, dark urine)
• swelling of the stomach/abdomen
• pain/redness/swelling of arms or legs
• muscle/joint pain
• unusual bleeding/bruising (such as nose bleeds, black or bloody stools)
• signs of high blood sugar (such as increased thirst, frequent urination)

Get medical help right away if you have any very serious side effects, including:

• vision changes
• 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 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:

• bleeding/blood problems
• pancreatitis
• liver disease

Tell your health care professional that you are using asparaginase erwinia chrysanthemi before having any immunizations/vaccinations. 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. You should not become pregnant while using this medication. Asparaginase erwinia chrysanthemi may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication and for 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, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

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

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

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

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.