ADVERSE REACTIONS
The total safety data base is composed of 921 patients treated with ABELCET® (5 patients were enrolled twice and counted as separate patients), of whom 775 were treated with 5 mg/kg/day. Of these 775 patients, 194 patients were treated in four comparative studies; 25 were treated in open-label, non-comparative studies; and 556 patients were treated in an open-label, emergency-use program. Most had underlying hematologic neoplasms, and many were receiving multiple concomitant medications. Of the 556 patients treated with ABELCET® , 9% discontinued treatment due to adverse events regardless of presumed relationship to study drug.
In general, the adverse events most commonly reported with ABELCET® were transient chills and/or fever during infusion of the drug.
| Adverse Events a with an incidence of >/=3% (N=556) |
| Adverse Event |
Percentage (%) of Patients |
|
Chills
|
18
|
|
Fever
|
14
|
|
Increased Serum Creatitine
|
11
|
|
Multiple Organ Failure
|
11
|
|
Nausea
|
9
|
|
Hypotension
|
8
|
|
Respiratory Failure
|
8
|
|
Vomiting
|
8
|
|
Dyspnea
|
7
|
|
Sepsis
|
7
|
|
Diarrhea
|
6
|
|
Headache
|
6
|
|
Heart Arrest
|
6
|
|
Hypertension
|
5
|
|
Hypokalemia
|
5
|
|
Infection
|
5
|
|
Kidney Failure
|
5
|
|
Pain
|
5
|
|
Thrombocytopenia
|
5
|
|
Abdominal Pain
|
4
|
|
Anemia
|
4
|
|
Bilirubinemia
|
4
|
Gastrointestinal
Hemorrhage
|
4
|
|
Leukopenia
|
4
|
|
Rash
|
4
|
|
Respiratory Disorder
|
4
|
|
Chest Pain
|
3
|
|
Nausea and Vomiting
|
3
|
| a The causal association between these adverse events and ABELCET® is uncertain.
|
The following adverse events have also been reported in patients using ABELCET® in open-label, uncontrolled clinical studies. The causal association between these adverse events and ABELCET® is uncertain. Body as a whole: malaise, weight loss, deafness, injection site reaction including inflammation
Allergic bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions
Cardiopulmonary: cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.
Dermatological: maculopapular rash, pruritus, exfoliative dermatitis, erythema multiforme
Gastrointestinal: acute liver failure, hepatitis, jaundice, melena, anorexia, dyspepsia, cramping, epigastric pain, veno-occlusive liver disease, diarrhea, hepatomegaly, cholangitis, cholecystitis
Hematologic: coagulation defects, leukocytosis, blood dyscrasias including eosinophilia
Musculoskeletal: myasthenia, including bone, muscle, and joint pains
Neurologic: convulsions, tinnitus, visual impairment, hearing loss, peripheral neuropathy, transient vertigo, diplopia, encephalopathy, cerebral vascular accident, extrapyramidal syndrome and other neurologic symptoms
Urogenital: oliguria, decreased renal function, anuria, renal tubular acidosis, impotence, dysuria
Serum electrolyte abnormalities: hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia
Liver function test abnormalities: increased AST, ALT, alkaline phosphatase, LDH
Renal function test abnormalities: increased BUN
Other test abnormalities: acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia
|
REPORTS OF SUSPECTED ABELCET SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Abelcet. The information is not vetted and should not be considered as verified clinical evidence.
Possible Abelcet side effects / adverse reactions in 55 year old male
Reported by a physician from United States on 2011-10-18
Patient: 55 year old male
Reactions: Pyrexia, Tremor
Adverse event resulted in: hospitalization
Suspect drug(s):
Abelcet
Possible Abelcet side effects / adverse reactions in 15 year old female
Reported by a individual with unspecified qualification from United States on 2011-11-14
Patient: 15 year old female weighing 63.0 kg (138.6 pounds)
Reactions: Respiratory Disorder, Autonomic Nervous System Imbalance, Body Temperature Increased, Chills, Oxygen Saturation Decreased
Suspect drug(s):
Abelcet
Other drugs received by patient: Voxin; Piperacillin and Tazobactam; Metrogyl /00012501/; Lanomycin /00391001/
Possible Abelcet side effects / adverse reactions in 14 year old female
Reported by a physician from United States on 2011-11-14
Patient: 14 year old female weighing 54.0 kg (118.8 pounds)
Reactions: Autonomic Nervous System Imbalance, Body Temperature Increased, Chills, Respiratory Distress, Oxygen Saturation Decreased
Suspect drug(s):
Abelcet
Other drugs received by patient: Lanomycin /00391001/; Piperacillin and Tazobactam
|
