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 discussed in greater detail in other sections of the label: Neurologic [see Boxed Warning, Warnings and Precautions ( 5.1 )] Hematologic [see Warnings and Precautions ( 5.2 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.4 )] Effects on Ability to Drive and Use Machines [see Warnings and Precautions ( 5.6 )] The most common (≥ 20%) adverse reactions were: Adult: anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea ( 6.1 ) Pediatric: anemia, neutropenia, thrombocytopenia, and leukopenia ( 6.1 ) The most common (> 10%) neurological adverse reactions were: Adult: somnolence, dizziness, peripheral neurologic disorders, hypoesthesia, headache, and paresthesia ( 6.1 ) Pediatric: headache and peripheral neurologic disorders ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.
at 1-866-210-9797 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Relapsed or Refractory T-ALL and T-LBL Nelarabine injection was studied in 459 patients in Phase I and Phase II clinical trials.
Adult Patient: The safety profile of nelarabine injection is based on data from 103 adult patients treated with the recommended dose and schedule in 2 studies: an adult T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LBL) trial and an adult chronic lymphocytic leukemia trial.
The most common adverse reactions in adults were fatigue;
gastrointestinal (GI) disorders (nausea, diarrhea, vomiting, and constipation);
hematologic disorders (anemia, neutropenia, and thrombocytopenia);
respiratory disorders (cough and dyspnea);
nervous system disorders (somnolence and dizziness);
5 WARNINGS AND PRECAUTIONS Neurologic Adverse Reactions : Severe neurologic reactions have been reported.
Monitor for signs and symptoms of neurologic toxicity.
( 5.1 ) Hematologic Reactions : Complete blood counts including platelets should be monitored regularly.
( 5.2 ) Embryo-Fetal Toxicity : Can cause fetal harm.
Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception;
Like all medications, Nelarabine 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: