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Nipent (Pentostatin) - Side Effects and Adverse Reactions

 
 



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 (eg, 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.

Percent of Patients

All Adverse Eventsa

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

53b

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

7c

2c

36

Arthralgia

6

14

3

Thrombocytopenia

6

6

32

Skin Disorder

4

5

17

Allergic Reaction

2

1

11

Hepatic Disorder/Elevated Liver Function Testsd

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

NR = Not Reported

a Occurring in more than 10% of patients, in any group, regardless of drug association

b Includes only nausea with vomiting

c These figures represent only unspecified infections. Refer to infection table.

d Elevated liver enzymes and liver disorder for SWOG

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%).

Percent of Patients

Type of Infection

Frontline, Treated

With NIPENT

N=180

Frontline, Treated

With IFN

N=176

Upper Respiratory Infection

13

  8

Rhinitis

11

15

Herpes Zoster

 8

  1

Pharyngitis

 8

11

Viral Infection

 8

17

Infection (Unspecified)

 7

  2

Sinusitis

 6

  4

Cellulitis

 6

  3

Bacterial Infection

 5

  4

Pneumonia

 5

  7

Conjunctivitis

 4

  2

Furunculosis

 4

<1

Herpes Simplex

 4

  1

Bronchitis

 3

  2

Sepsis

 3

  2

Urinary Tract Infection

 3

  3

Abscess, Skin

 2

  4

Moniliasis, Oral

 2

<1

Mycotic Infection, Skin

<1

  3

Osteomyelitis

  1

  0

The drug relatedness of the adverse events listed below cannot be excluded. The following adverse events occurred in 3% to 10% of NIPENT-treated patients in the initial phase of the SWOG study:

Body as a Whole —Chest Pain, Death, Face Edema, Peripheral Edema

Cardiovascular System —Hemorrhage, Hypotension

Digestive System —Dental Abnormalities, Dyspepsia, Flatulence, Gingivitis

Hemic and Lymphatic System —Agranulocytosis

Laboratory Deviations —Elevated Creatinine

Musculoskeletal System —Arthralgia

Nervous System —Confusion, Dizziness, Insomnia, Paresthesia, Somnolence

Psychobiologic Function —Anxiety, Depression, Nervousness

Respiratory System —Asthma

Skin & Appendages —Skin Dry, Urticaria

The remaining adverse events which occurred in less than 3% of NIPENT-treated patients during the initial phase of the SWOG study:

Body as a Whole —Flu-like Symptoms, Hangover Effect, Neoplasm

Cardiovascular System —Angina Pectoris, Arrhythmia, A-V Block, Bradycardia, Extrasystoles Ventricular, Heart Arrest, Heart Failure, Hypertension, Pericardial Effusion, Phlebitis, Pulmonary Embolus, Sinus Arrest, Tachycardia, Thrombophlebitis Deep, Vasculitis

Digestive System —Constipation, Dysphagia, Glossitis, Ileus

Hemic and Lymphatic System —Acute Leukemia, Anemia-Hemolytic, Aplastic Anemia

Laboratory Deviations —Hypercalcemia, Hyponatremia

Musculoskeletal System —Arthritis, Gout

Nervous System —Amnesia, Ataxia, Convulsions, Dreaming Abnormal, Dysarthria, Encephalitis, Hyperkinesia, Meningism, Neuralgia, Neuritis, Neuropathy, Paralysis, Syncope, Twitching, Vertigo

Psychobiologic Function —Decrease/Loss Libido, Emotional Lability, Hallucination, Hostility, Neurosis, Thinking Abnormal

Respiratory System —Bronchospasm, Larynx Edema

Skin and Appendages —Acne, Alopecia, Eczema, Petechial Rash, Photosensitivity Reaction

Special Senses —Amblyopia, Deafness, Earache, Eyes Dry, Labyrinthitis, Lacrimation Disorder, Nonreactive Eye, Photophobia, Retinopathy, Tinnitus, Unusual Taste, Vision Abnormal, Watery Eyes

Urogenital System —Amenorrhea, Breast Lump, Impotence, Kidney Function Abnormal, Nephropathy, Renal Failure, Renal Insufficiency, Renal Stone

One patient with hairy cell leukemia treated with NIPENT during another clinical study developed unilateral uveitis with vision loss.

Nineteen (5%) patients withdrew from the Phase 3 SWOG 8691 study because of adverse events; 9 during initial NIPENT treatment, 4 during NIPENT crossover, 5 during initial IFN treatment, and 1 during both initial IFN treatment and NIPENT crossover. In the Phase 2 studies in IFN-refractory hairy cell leukemia, 11% of patients withdrew from treatment with NIPENT due to an adverse event.



REPORTS OF SUSPECTED NIPENT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nipent. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nipent side effects / adverse reactions in 47 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-18

Patient: 47 year old male weighing 130.9 kg (288.0 pounds)

Reactions: Lymphopenia

Suspect drug(s):
Cyclophosphamide
    Dosage: 600 mg/m2 (1506 mg total dose), day 1 of weeks 1,5,9.,14,17,21
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2011-08-04
    End date: 2011-08-04

Nipent
    Dosage: 4 mg/m2 (10 mg total dose) on weeks 1,5,9,13,17,21
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2011-08-04
    End date: 2011-08-04

Rituxan
    Dosage: 375 mg.m2 (941 mg total dose), on weeks 1,5,9,13,17,21; week 1,3 days/week; weeks 5-21; 1 day/week
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2011-08-04
    End date: 2011-08-04



Possible Nipent side effects / adverse reactions in 70 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-27

Patient: 70 year old male weighing 67.9 kg (149.4 pounds)

Reactions: Dyspnoea, Anaemia, Muscular Weakness, Hypoaesthesia, Fall, Paraesthesia, Fatigue, Dehydration, Platelet Count Decreased, Cytomegalovirus Infection, Blood Pressure Decreased, Immobile, Infestation

Adverse event resulted in: hospitalization

Suspect drug(s):
(Rituximab)
    Dosage: 758 mg, not reported
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-12-27
    End date: 2011-05-18

Campath
    Dosage: 30 mg, tiw x 18 weeks, subcutaneous
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2011-07-29
    End date: 2011-09-14

Cyclophosphamide
    Dosage: 1212 mg
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-12-27
    End date: 2011-05-18

Nipent
    Dosage: 8 mg
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-12-27
    End date: 2011-05-18



Possible Nipent side effects / adverse reactions in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-29

Patient: 43 year old male

Reactions: Vomiting, Diarrhoea, Nausea, Epstein-Barr Virus Associated Lymphoproliferative Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Busulfan
    Dosage: not reported, not reported, unknown, (unknown)
    Indication: Stem Cell Transplant

Nipent
    Dosage: not reported, not reported, unknown, (unknown)
    Indication: Stem Cell Transplant

Other drugs received by patient: Rituxan



See index of all Nipent side effect reports >>

Drug label data at the top of this Page last updated: 2014-01-21

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