Pegaspargase

Do not receive this medication if you are allergic to pegaspargase, or if you have ever been treated with asparaginase (Elspar) and had a severe allergic reaction or developed a stroke, blood clot, or pancreas problems.

Before receiving pegaspargase, tell your doctor if you are allergic to any drugs, or if you have diabetes or a bleeding disorder such as hemophilia.

While receiving pegaspargase, avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Get emergency medical help if you think you have received too much of this medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of the following side effects during your treatment with pegaspargase:

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• pain or swelling in one or both legs;
• fever, chills, body aches, flu symptoms;
• easy bruising or bleeding, unusual weakness;
• increased thirst or urination; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Pegaspargase is used with other chemotherapy drugs to treat a certain type of acute lymphocytic leukemia (ALL). ALL is a type of cancer of the white blood cells). Pegaspargase is also used with other chemotherapy drugs to treat a certain type of ALL in people who have had some types of allergic reactions to medications similar to pegaspargase such as asparaginase (Elspar).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pegaspargase may be found in some form under the following brand names:

• Oncaspar

Common side effects of pegaspargase include the following:

• nausea
• vomiting
• diarrhea
• fever
• tiredness
• dizziness

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Pegaspargase is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Pegaspargase is used in combination with other cancer medications to treat acute lymphoblastic leukemia. This medicine is also used to treat allergic reactions to another cancer medication called asparaginase (Elspar).

Pegaspargase may also be used for purposes not listed in this medication guide.

Other drugs may interact with pegaspargase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Have available appropriate agents for maintenance of an adequate airway and treatment of a hypersensitivity reaction (antihistamine, epinephrine, oxygen, IV corticosteroids). Be prepared to treat anaphylaxis at each administration.

IM: Must only be administered as a deep intramuscular injection into a large muscle. Do not exceed 2 mL per injection site; use multiple injection sites for IM injection volume >2 mL.

IV: Administer over 1 to 2 hours through a running IV infusion line; do not administer IV push.

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Pegloticase: May diminish the therapeutic effect of Pegaspargase. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

CBC with differential, platelets, amylase/lipase, liver function tests (baseline and periodically during treatment), fibrinogen, PT, PTT (coagulation parameters [baseline and periodically during and after treatment]), renal function tests; urine glucose, blood glucose; triglycerides; uric acid; vital signs during administration; monitor for onset of abdominal pain; observe for allergic reaction (for 1 hour after administration); signs/symptoms of thrombosis or bleeding

Animal reproduction studies have not been conducted with pegaspargase.

Applies to pegaspargase: solution

Along with its needed effects, pegaspargase 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 as soon as possible if any of the following side effects occur while taking pegaspargase:

• Abdominal or stomach pain
• blurry vision
• constipation
• dry mouth and skin
• faintness
• fatigue
• fruit-like breath odor
• increased hunger or thirst
• increased need to urinate
• nausea
• skin paleness
• skin rash
• sweating
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• vomiting

• Bloating
• chest pain
• confusion
• cough
• darkened urine
• difficulty in breathing or swallowing
• dizziness
• fast heartbeat
• fever or chills
• headache
• hives or itching
• indigestion
• itching, especially of hands and feet
• loss of appetite
• numbness, tingling, or swelling in arms or legs
• pains in stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• reddening of the skin, especially around ears
• shortness of breath
• swelling of eyes, face, or inside of nose
• tightness in chest
• unusual tiredness or weakness (sudden and severe)
• wheezing
• yellow eyes or skin

• Black, tarry stools
• blood in urine
• hoarseness
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin

Some side effects of pegaspargase 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:

• General feeling of discomfort or illness

• Anxiety
• behavior change similar to drunkenness
• blurred vision
• cold sweats
• convulsions (seizures)
• cool pale skin
• difficulty in concentrating
• drowsiness
• lack of appetite
• nervousness
• nightmares
• pain at place of injection
• pain in joints or muscles
• restless sleep
• shakiness
• slurred speech

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.