Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Pancreatic Toxicity [see Warnings and Precautions ( 5.2 )] • Thrombosis [see Warnings and Precautions ( 5.3 )] • Hemorrhage [see Warnings and Precautions ( 5.4 )] • Hepatotoxicity, including VOD [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence > 20%) are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals Ireland Limited at 1-800-520-5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of RYLAZE described in the WARNINGS AND PRECAUTIONS reflect exposure in 167 patients administered RYLAZE intramuscularly at various dosages when used in combination with chemotherapy in study JZP458-201 [see Clinical Studies ( 14 )] .
These patients received a median of 4 courses of RYLAZE (range: 1-15 courses);
65% of patients received at least four courses.
The safety of RYLAZE described below and in Table 3 was evaluated in study JZP458-201, a multi-cohort study.
Patients received RYLAZE administered intramuscularly at dosages of 25 mg/m 2 on Monday, Wednesday, and Friday or 25 mg/m 2 on Monday and Wednesday, and 50 mg/m 2 on Friday, for 6 doses as a replacement for a single dose of pegaspargase as a component of multi-agent chemotherapy [see Clinical Studies ( 14 )] .
The patients had a median age of 11 years (range: 1‑25 years);
the majority of patients were male (57%) and White (68%).
5 WARNINGS AND PRECAUTIONS • Hypersensitivity: Monitor for signs or symptoms.
Discontinue RYLAZE for serious reaction.
( 5.1 ) • Pancreatitis: Monitor for symptoms.
Discontinue if pancreatitis occurs.
( 5.2 ) • Thrombosis: Discontinue RYLAZE for severe or life-threatening thrombosis.
Like all medications, Rylaze can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: