Note: This document contains side effect information about asparaginase erwinia chrysanthemi. Some dosage forms listed on this page may not apply to the brand name Rylaze.

Applies to asparaginase erwinia chrysanthemi: injection powder for solution. Other dosage forms:

• intramuscular solution

Serious side effects of Rylaze

Along with its needed effects, asparaginase erwinia chrysanthemi (the active ingredient contained in Rylaze) 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 while taking asparaginase erwinia chrysanthemi:

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

Other side effects of Rylaze

Some side effects of asparaginase erwinia chrysanthemi 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

For Healthcare Professionals

Applies to asparaginase erwinia chrysanthemi: injectable powder for injection, intramuscular solution.

General

The most frequent nonhematological serious adverse reactions (in greater than 5% of patients) were febrile neutropenia, infection, drug hypersensitivity, pyrexia, nausea, dehydration, stomatitis, acute kidney injury, pancreatitis, diarrhea, and viral infection.^[Ref]

Hypersensitivity

Very common (15% or more): Hypersensitivity reactions including rash, infusion related reaction, lip swelling, periorbital edema, throat irritation, urticaria, dry skin, eczema, erythema, hand dermatitis, rash maculo-papular, rash papular (21% to 24%)

Very rare (less than 0.01%): Anaphylaxis^[Ref]

Gastrointestinal

Very common (15% or more): Stomatitis (24% to 27%), nausea (45% to 47%), abdominal pain (21% to 25%), diarrhea (18% to 25%), pancreatitis (12% to 22%)^[Ref]

Nervous system

Very common (15% or more): Headache (22% to 36%), peripheral neuropathy including peripheral motor neuropathy, neuropathy peripheral, peripheral sensory neuropathy (6% to 15%)^[Ref]

Dermatologic

Common (1% to 10%): Rash (19%)

Frequency not reported: Toxic epidermal necrosis^[Ref]

Hepatic

Very common (15% or more): Abnormal liver tests (70% to 75%)

Frequency not reported: Hepatomegaly, cholestatic jaundice^[Ref]

Hematologic

Very common (15% or more): Febrile neutropenia (27% to 30%), hemorrhage including contusion, epistaxis, catheter site hemorrhage, petechiae, hematochezia, menorrhagia, mouth hemorrhage, increased tendency to bruise, rectal hemorrhage (24 to 27%)

Frequency not reported: clotting factor decreased, antithrombin III decreased, protein C decreased, protein S decreased, fibrinogen decreased^[Ref]

Cardiovascular

Very common (reported as 15% or more): Tachycardia (16 to 18%)^[Ref]

Metabolic

Very common (15% or more): Hyperglycemia (12% to 21%), hypokalemia (9% to 22%, dehydration (12% to 15%), decreased appetite (21% to 27%)

Rare (0.01% to 0.1%): Diabetic ketoacidosis

Very rare (less than 0.01%): Hyperammonemia^[Ref]

Other

Infections:

Very common (15% or more): Including sepsis, upper respiratory tract infection, enterocolitis infectious, skin infection, bacteremia, paronychia, pneumonia, otitis externa, soft tissue infection, abdominal infection, conjunctivitis, device related infection, folliculitis, lymph gland infection, necrotizing fasciitis, perirectal abscess, peritonsillar abscess, sinusitis, subcutaneous abscess, wound infection (27% to 36%)^[Ref]

Musculoskeletal

Very common (15% or more): Musculoskeletal pain, including arthralgia, back pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, pain in extremity (35% to 45%)^[Ref]

Psychiatric

Very common (15% or more): Insomnia (4% to 15%)^[Ref]

Respiratory

Very common (15% or more): Cough (15%)^[Ref]