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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