Fludarabine Phosphate (Page 3 of 5)

6.8 Genitourinary System

Hemorrhagic cystitis has been reported in patients treated with fludarabine phosphate.

6.9 Skin

Skin toxicity, consisting primarily of skin rashes, has been reported in patients treated with fludarabine phosphate. Erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis and pemphigus have been reported, with fatal outcomes in some cases.

6.10 Neoplasms

Worsening or flare-up of preexisting skin cancer lesions, as well as new onset of skin cancer, has been reported in patients during or after treatment with fludarabine phosphate.

6.11 Hepatobiliary Disorders

Elevations of hepatic enzyme levels have been reported.

6.12 Adverse Reactions from Clinical Trials

Data in Table 1 are derived from the 133 patients with CLL who received fludarabine phosphate in the MDAH and SWOG studies.

TABLE 1: PERCENT OF CLL PATIENTS REPORTING NON-HEMATOLOGIC ADVERSE REACTIONS

ADVERSE REACTIONS

MDAH

(N=101)

SWOG

(N=32)

ANY ADVERSE REACTION

88%

91%

BODY AS A WHOLE

72

84

FEVER

60

69

CHILLS

11

19

FATIGUE

10

38

INFECTION

33

44

PAIN

20

22

MALAISE

8

6

DIAPHORESIS

1

13

ALOPECIA

0

3

ANAPHYLAXIS

1

0

HEMORRHAGE

1

0

HYPERGLYCEMIA

1

6

DEHYDRATION

1

0

NEUROLOGICAL

21

69

WEAKNESS

9

65

PARESTHESIA

4

12

HEADACHE

3

0

VISUAL DISTURBANCE

3

15

HEARING LOSS

2

6

SLEEP DISORDER

1

3

DEPRESSION

1

0

CEREBELLAR SYNDROME

1

0

IMPAIRED MENTATION

1

0

PULMONARY

35

69

COUGH

10

44

PNEUMONIA

16

22

DYSPNEA

9

22

SINUSITIS

5

0

PHARYNGITIS

0

9

UPPER RESPIRATORY INFECTION

2

16

ALLERGIC PNEUMONITIS

0

6

EPISTAXIS

1

0

HEMOPTYSIS

1

6

BRONCHITIS

1

0

HYPOXIA

1

0

GASTROINTESTINAL

46

63

NAUSEA/VOMITING

36

31

DIARRHEA

15

13

ANOREXIA

7

34

STOMATITIS

9

0

GI BLEEDING

3

13

ESOPHAGITIS

3

0

MUCOSITIS

2

0

LIVER FAILURE

1

0

ABNORMAL LIVER FUNCTION TEST

1

3

CHOLELITHIASIS

0

3

CONSTIPATION

1

3

DYSPHAGIA

1

0

CUTANEOUS

17

18

RASH

15

15

PRURITUS

1

3

SEBORRHEA

1

0

GENITOURINARY

12

22

DYSURIA

4

3

URINARY INFECTION

2

15

HEMATURIA

2

3

RENAL FAILURE

1

0

ABNORMAL RENAL FUNCTION TEST

1

0

PROTEINURIA

1

0

HESITANCY

0

3

CARDIOVASCULAR

12

38

EDEMA

8

19

ANGINA

0

6

CONGESTIVE HEART FAILURE

0

3

ARRHYTHMIA

0

3

SUPRAVENTRICULAR TACHYCARDIA

0

3

MYOCARDIAL INFARCTION

0

3

DEEP VENOUS THROMBOSIS

1

3

PHLEBITIS

1

3

TRANSIENT ISCHEMIC ATTACK

1

0

ANEURYSM

1

0

CEREBROVASCULAR ACCIDENT

0

3

MUSCULOSKELETAL

7

16

MYALGIA

4

16

OSTEOPOROSIS

2

0

ARTHRALGIA

1

0

TUMOR LYSIS SYNDROME

1

0

More than 3000 adult patients received fludarabine phosphate in studies of other leukemias, lymphomas, and other solid tumors. The spectrum of adverse effects reported in these studies was consistent with the data presented above.

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