Pronunciation:

peg-AS-par-jase

Brand Names:

• Oncaspar

Classifications:

Pharmacologic—

Asparaginase (class)

Uses of This Medicine:

Pegaspargase injection is used in combination with other cancer medicines to treat acute lymphoblastic leukemia (ALL), a type of blood cancer that affects the white blood cells. It is also used to treat ALL in patients who have had serious allergic reactions to L-asparaginase treatments. Pegaspargase belongs to the group of medicines called antineoplastics.

Pegaspargase interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells also may be affected by pegaspargase, other effects may also occur. Some of these effects may be serious and must be reported to your doctor.

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

Pegaspargase 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegaspargase injection in children. Safety and efficacy have been established.

Older adults—

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

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. 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.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

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 from a previous L-asparaginase treatment, history of or
• Blood clots from a previous L-asparaginase treatment, history of or
• Liver disease, severe or
• Pancreatitis (swelling of the pancreas), history of or from a previous L-asparaginase treatment—Should not be used in patients with these conditions.

• Diabetes—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles or through an IV catheter that is placed into one of your veins. The injection is given every 14 days.

You may also receive other medicines (eg, allergy medicine, fever medicine, stomach medicine) 30 to 60 minutes before receiving the injection to help prevent unwanted effects.

Pegaspargase injection is given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way 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 closely and at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, 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 right away if you have a rash, itching, hoarseness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may increase your risk of developing serious blood clots. Tell your doctor right away if you develop any sudden and severe headache, arm or leg swelling, trouble breathing, or chest pain.

This medicine may cause pancreatitis (swelling of the pancreas). Check with your doctor right away if you have sudden and severe stomach pain, nausea, vomiting, fever, or chills during treatment with this medicine.

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

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).

Pegaspargase can lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk bleeding:

• Check with your doctor immediately if you notice any unusual bleeding or bruising, black tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Be careful not to cut yourself when you are using sharp objects such as safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury can occur.

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

Black, tarry stools

bloating

blurry vision

chest tightness

chills

confusion

constipation

cough

dark urine

difficulty breathing

dizziness

dry mouth

fainting

fast heartbeat

fever

flushed, dry skin

fruit-like breath odor

hives, itching, skin rash

hoarseness

increased hunger

increased thirst

increased urination

indigestion

irritation

joint pain, stiffness, or swelling

lightheadedness

loss of appetite

lower back or side pain

nausea

pain in the chest, groin, or legs, especially the calves

painful or difficult urination

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

pale skin

redness of the skin

severe, sudden headache

slurred speech

sore throat

stomach pain

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sweating

swelling of the eyelids, face, lips, hands, or feet

trouble breathing

trouble swallowing

ulcers, sores, or white spots in the mouth

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vision changes

vomiting

yellow eyes or skin

Less common

Sneezing

Incidence not known

Continuing nausea or vomiting

increase in the frequency of seizures

light-colored stools

weight gain

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.