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.
ADVERSE REACTIONS Most patients treated for hairy cell leukemia in the five NCI-sponsored Phase 2 studies and the Phase 3 SWOG study experienced an adverse event.
The following table lists the most frequently occurring adverse events in patients treated with NIPENT (both frontline and IFN-refractory patients) compared with IFN (frontline only), regardless of drug association.
The drug association of some adverse events is uncertain as they may be associated with the disease itself (e.g., infection, hematologic suppression), but other events, such as the gastrointestinal symptoms, rashes, and abnormal liver function tests, can in many cases be attributed to the drug.
Most adverse events that were assessed for severity were either mild or moderate, and diminished in frequency with continued therapy.
NR = Not Reported Percent of Patients All Adverse Events Occurring in more than 10% of patients, in any group, regardless of drug association Frontline, Treated With NIPENT N=180 Frontline, Treated With IFN N=176 IFN-Refractory, Treated With NIPENT N=197 Nausea and/or Vomiting 63 22 53 Includes only nausea with vomiting Fever 46 59 42 Rash 43 30 26 Fatigue 42 55 29 Leukopenia 22 15 60 Pruritus 21 6 10 Coughing/Increased Cough 20 15 17 Myalgia 19 36 11 Chills 19 34 11 Headache 17 29 13 Diarrhea 17 17 15 Abdominal Pain 16 15 4 Anorexia 13 10 16 Upper Respiratory Infection 13 8 16 Asthenia 12 13 10 Stomatitis 12 7 5 Rhinitis 11 15 10 Dyspnea 11 13 8 Anemia 8 5 35 Pain 8 19 20 Pharyngitis 8 11 10 Sweating/Increased Sweating 8 21 10 Viral Infection 8 17 NR Infection 7 These figures represent only unspecified infections.
Refer to infection table.
2 36 Arthralgia 6 14 3 Thrombocytopenia 6 6 32 Skin Disorder 4 5 17 Allergic Reaction 2 1 11 Hepatic Disorder/Elevated Liver Function Tests Elevated liver enzymes and liver disorder for SWOG 2 2 19 Neurologic Disorder, CNS/CNS Toxicity 1 NR 11 Lung Disorder/Disease NR 1 12 Nausea NR NR 22 Genitourinary Disorder NR NR 15 The total incidence for all types of infections is considerably higher for both treatment groups in the SWOG 8691 study than is listed in the table above.
An intent-to-treat analysis of infections found that 38% of patients treated with NIPENT and 34% of patients treated with IFN averaged 2.4 and 1.9 documented infections during treatment, respectively.
The following table lists the different types of infections that were reported as adverse events during the initial phase of the SWOG study.
There were no apparent differences in the types of infection between the 2 treatment groups, with the possible exception of herpes zoster which was reported more frequently for NIPENT (8%) than for IFN (1%).
WARNINGS See Boxed Warning .
Patients with hairy cell leukemia may experience myelosuppression primarily during the first few courses of treatment.
Patients with infections prior to NIPENT treatment have in some cases developed worsening of their condition leading to death, whereas others have achieved complete response.
Patients with infection should be treated only when the potential benefit of treatment justifies the potential risk to the patient.
Efforts should be made to control the infection before treatment is initiated or resumed.
Like all medications, Nipent 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: