Pronunciation:

as-par-a-JIN-ase er-WIN-i-a kris-an-THEM-i

Brand Names:

• Erwinaze

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Asparaginase

Uses of This Medicine:

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

Asparaginase Erwinia chrysanthemi 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 Erwinase®, 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 immediate 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Erwinase® in children 4 months of age and older.

Older adults—

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

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cytarabine
• Methotrexate
• Prednisolone
• Prednisone
• Vincristine
• Vincristine Sulfate Liposome

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:

• Pancreatitis, active or
• Pancreatitis caused by L-asparaginase treatment, active or history of—Should not be given to patients with these conditions.

• Bleeding problems or
• Blood clotting problems or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Kidney disease or
• Pancreatitis (inflammation 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 or a vein.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have chills, fever, lightheadedness, dizziness, or fainting, fast, pounding heartbeat, swelling of the face, tongue, and throat, or trouble breathing after you receive the medicine.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Pancreatitis may occur while you are using 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

Erwinase® can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor right away if you or your child start having increased thirst or hunger, increased urination, pale skin, nausea, sweating, or faintness. These may be signs that you are having problems with the amount of blood sugar in your body.

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.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Agitation

back pain

black, tarry stools

bleeding gums

bloating

blood in the urine or stools

blurred vision

chest pain

chills

coma

confusion

constipation

cough or hoarseness

difficulty in walking

dizziness

drooping eyelids

drowsiness

dry mouth

lightheadedness

fainting

fast heartbeat

fever

flushed, dry skin

fruit-like breath odor

hallucinations

headache

increased hunger

increased menstrual flow or vaginal bleeding

increased thirst

increased urination

indigestion

irritability

jaw pain

lower back or side pain

mood or mental changes

nosebleeds

numbness or tingling in the fingers and toes

pain in the fingers and toes

pain in the testicles

pains in the chest, groin, or legs, especially calves of the legs

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

painful or difficult urination

pale skin

paralysis

pinpoint red spots on the skin

prolonged bleeding from cuts

rapid, shallow breathing

seizures

severe headaches of sudden onset

sleepiness or unusual drowsiness

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stiff neck

stomach pain

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

sweating

swollen glands

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

yellow eyes or skin

Less common

Chest tightness

difficulty swallowing

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

hives, itching, skin rash

increase in frequency of seizures

loss of appetite

loss of consciousness

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

Incidence not known

Diarrhea

nervousness

pounding in the ears

slow or fast heartbeat

unpleasant breath odor

vomiting of blood

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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.