Pronunciation:

as-par-a-JIN-ase er-WIN-i-a kris-an-THEM-i re-KOM-bin-ant - rywn

Brand Names:

• Rylaze

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Asparaginase Erwinia Chrysanthemi Recombinant

Uses of This Medicine:

Asparaginase Erwinia chrysanthemi recombinant-rywn is used together with other cancer medicines to treat certain types of blood cancer called acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). This medicine is used in patients who have had an allergic reaction to E. coli-derived asparaginase.

Asparaginase Erwinia chrysanthemi recombinant-rywn belongs to the group of medicines known as antineoplastic agents. It interferes with the growth of the cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by this medicine, other effects will also occur. Some of these may be serious and must be reported to your doctor.

Before you begin treatment with Rylaze®, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Rylaze® in children younger than 1 month of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of Rylaze® in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems caused by L-asparaginase treatment, history of or
• Blood clotting problems caused by L-asparaginase treatment, history of or
• Liver disease, severe or
• Pancreatitis caused by L-asparaginase treatment, history of—Should not be given to patients with these conditions.

• Bleeding problems or
• Blood clotting problems or
• Liver disease or
• Pancreatitis (swelling of the pancreas)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you or your child this medicine in a hospital or cancer treatment center. This medicine is given as a shot into a muscle.

This medicine is usually given every 2 days or on a Monday, Wednesday, and Friday schedule.

Your doctor may also give you other medicines (eg, acetaminophen, an allergy medicine, and a stomach medicine) 30 to 60 minutes before receiving this medicine to help prevent unwanted effects.

Rylaze® is sometimes given together with other medicines. If you are receiving a combination of medicines, it is important that you or your child receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan to take them at the right times.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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 during treatment and for at least 3 months after your last dose to keep from getting pregnant. If you think you have become pregnant, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis or angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you or your child have a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, chills, fever, lightheadedness, dizziness, or fainting, fast, pounding heartbeat, swelling of the face, tongue, and throat, or trouble breathing after you receive the medicine.

Pancreatitis (swelling of the pancreas) may occur during treatment with this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Tell your doctor right away if you or your child develop confusion, headache, nausea and vomiting, numbness or tingling in the arms or legs, or chest pain after receiving this medicine. These may be symptoms of a serious bleeding or blood clotting problem.

Check with your doctor right away if you have bloated stomach, pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, weight gain, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, hepatic veno-occlusive disease).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Anxiety

black, tarry stools

bleeding gums

bloating

blood in the stools

blood in the urine

blurred vision

chest pain

chills

confusion

constipation

cough or hoarseness

coughing or vomiting blood

darkened urine

decreased urination

dizziness or lightheadedness

dry mouth

fainting

fast, pounding, or irregular heartbeat or pulse

fever

flushed, dry skin

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

indigestion

large, flat, blue or purplish patches in the skin

loss of appetite

lower back or side pain

muscle or bone pain

nausea

nosebleeds

numbness or tingling in the arms or legs

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

persistent bleeding or oozing from puncture sites, mouth, or nose

sore throat

sunken eyes

sweating

trouble breathing

ulcers, sores, or white spots in the mouth

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

wrinkled skin

yellow eyes or skin

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry, red, hot, or irritated skin

Incidence not known

Chest tightness

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

flushing, redness of the skin

hives, itching, or skin rash

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy breathing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusually warm skin

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, numbness, tingling, or painful sensations

swelling or inflammation of the mouth

trouble sleeping

unsteadiness or awkwardness

weakness in arms, hands, legs, or feet

Less common

Full or bloated feeling

irritability

muscle spasms or weakness

pressure or swelling in the stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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