Pronunciation:

as-PAR-a-jin-ase

Brand Names:

• Elspar

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Asparaginase (class)

Uses of This Medicine:

Asparaginase injection is used together with other medicines to treat acute lymphoblastic leukemia (ALL), a cancer of the blood.

Asparaginase belongs to the group of medicines known as enzymes. All cells need a chemical called asparagine to stay alive. Normal cells can make this chemical, but cancer cells cannot. Asparaginase breaks down asparagine in the body. Since the cancer cells cannot make more asparagine, they die.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, asparaginase is used in certain patients with the following condition:

• Acute myeloid leukemia (cancer of the blood).

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 asparaginase injection in children.

Older adults—

Although appropriate studies on the relationship of age to the effects of asparaginase injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Methotrexate
• Mumps Virus Vaccine, Live
• Prednisolone
• Prednisone
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Vincristine
• Vincristine Sulfate Liposome
• Yellow Fever Vaccine

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 or
• Blood clotting problems or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Liver disease or
• Pancreatitis (inflamed pancreas)—Use with caution. May make these conditions worse.

• Bleeding problems due to asparaginase, history of or
• Blood clotting problems due to asparaginase, history of or
• Pancreatitis (inflamed pancreas) due to asparaginase, history of—Should not be given to patients with these conditions.

Proper Use of This Medicine:

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

This medicine is usually given together with other medicines. If you are taking some of these medicines by mouth, make sure you take them at the right times.

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 progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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

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

Pancreatitis may occur while you are receiving this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if you have increased thirst or hunger, increased urination, pale skin, nausea, sweating, or faintness. These may be symptoms of hyperglycemia (high blood sugar).

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.

Elspar® may cause a condition called posterior reversible encephalopathy syndrome (PRES) when used with other cancer medicines. Check with your doctor right away if you have headaches, confusion, seizures, blurred vision or changes in vision, dizziness, or a fast, slow, or pounding heartbeat.

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

Abdominal or stomach pain

bloating

blurred vision

chills

constipation

cough

darkened urine

difficulty with swallowing

dizziness

dry mouth

fast heartbeat

fever

flushed, dry skin

fruit-like breath odor

hives

increased hunger

increased thirst

increased urination

indigestion

itching

joint pain

loss of appetite

nausea

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

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

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

shortness of breath

skin rash

stomach pain (severe) with nausea and vomiting

sudden loss of coordination

sudden onset of severe headaches

sudden onset of slurred speech

sudden vision changes

sweating

tightness in the chest

troubled breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

yellow eyes or skin

Less common

Confusion

convulsions (seizures)

depression

drowsiness

frequent urination

loss of bladder control

lower back or side pain

muscle spasm or jerking of all extremities

nervousness

numbness or tingling in the hands, arms, or legs

seeing, hearing, or feeling things that are not there

severe weakness

sores in the mouth or on the lips

sudden loss of consciousness

swelling of the feet or lower legs

unusual thirst

Rare

Inability to move the arms or legs

Incidence not known

Abdominal or stomach tenderness

bloody or cloudy urine

change in consciousness

clay-colored stools

continuous nausea or vomiting

loss of consciousness

pounding in the ears

slow heartbeat

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

Stomach cramps

weight loss

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.