DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Depocyt (Cytarabine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following serious adverse reactions are described in greater detail in other sections of the label:


  • Chemical Arachnoiditis [see Warnings and Precautions ]
  • Neurotoxicity [see Warnings and Precautions]
  • Transient elevations in CSF protein and CSF white blood cells [see Warnings and Precautions]

Most Frequently Reported Reactions

After intrathecal administration of cytarabine the most frequently reported reactions (≥ 10%) are headache NOS, nausea, vomiting NOS, arachnoiditis, weakness, confusion, pyrexia, fatigue, constipation, back pain, gait abnormal NOS, convulsions NOS, dizziness NOS, lethargy, pain in limb, insomnia, urinary tract infection NOS, neck pain, death NOS, pain, memory impairment, dehydration, anemia NOS, diarrhea NOS, appetite decreased NOS, thrombocytopenia, edema peripheral, arthralgia, neck stiffness, vision blurred, muscle weakness, neutropenia, hypoesthesia, agitation, and dyspnea NOS.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The toxicity database consists of the observations made during Phase 1-4 studies. The most common adverse reactions in all patients and in patients with lymphoma are shown in Table 1. The incidences of symptoms possibly reflecting meningeal irritation are shown in Table 2.

Table 1.  Incidence of adverse reactions occurring in > 10% of patients in all Phase 1-4 adult study patients and in patients with lymphomatous meningitis receiving DepoCyt 50 mg or an active comparator
Lymphoma
System Organ Class / Preferred Term All DepoCyt
(N=257)
DepoCyt
(N=33)
Ara-C
(N=28)
Nervous System Disorders
   Headache NOS 144 (56%) 17 (52%) 9 (32%)
   Arachnoiditis 108 (42%) 14 (42%) 10 (36%)
   Confusion 86 (33%) 12 (36%) 3 (11%)
   Gait abnormal NOS 60 (23%) 7 (21 %) 8 (29%)
   Convulsions NOS 52 (20%) 7 (21%) 1 (4%)
   Dizziness NOS 47 (18%) 7 (21%) 6 (21%)
   Memory impairment 36 (14%) 4 (12%) 1 (4%)
   Hypoesthesia 26 (10%) 4 (12%) 3 (11%)
   Tremor 22 (9%) 5 (15%) 5 (18%)
   Peripheral neuropathy NOS 9 (4%) 4 (12%) 1 (4%)
   Syncope 8 (3%) 0 (0%) 3 (11%)
   Neuropathy NOS 7 (3%) 3 (9%) 3 (11%)
   Peripheral sensory neuropathy 7 (3%) 2 (6%) 3 (11%)
   Reflexes abnormal 7 (3%) 0 (0%) 3 (11%)
General Disorders and Administration Site
Conditions
   Weakness 103 (40%) 13 (39%) 15 (54%)
   Pyrexia 81 (32%) 15 (45%) 12 (43%)
   Fatigue 64 (25%) 9 (27%) 13 (46%)
   Lethargy 41 (16%) 4 (12%) 4 (14%)
   Death NOS 35 (14%) 9 (27%) 5 (18%)
   Pain NOS 35 (14%) 3 (9%) 5 (18%)
   Edema peripheral 27 (11 %) 6 (18%) 7 (25%)
   Fall 12 (5%) 0 (0%) 3 (11%)
   Mucosal inflammation NOS 8 (3%) 4 (12%) 2 (7%)
   Edema NOS 6 (2%) 1 (3%) 6 (21%)
Gastrointestinal Disorders
   Nausea 117 (46%) 11 (33%) 15 (54%)
   Vomiting NOS 112 (44%) 11 (33%) 9 (32%)
   Constipation 64 (25%) 8 (24%) 7 (25%)
   Diarrhea NOS 31 (12%) 9 (27%) 9 (32%)
   Abdominal pain NOS 22 (9%) 5 (15%) 4 (14%)
   Dysphagia 20 (8%) 3 (9%) 3 (11%)
   Hemorrhoids 8 (3%) 0 (0%) 3 (11%)
Musculoskeletal and Connective Tissue
Disorders
   Back pain 61 (24%) 7 (21%) 5 (18%)
   Pain in limb 39 (15%) 4 (12%) 8 (29%)
   Neck pain 36 (14%) 5 (15%) 3 (11%)
   Arthralgia 29 (11%) 3 (9%) 4 (14%)
   Neck stiffness 28 (11%) 2 (6%) 4 (14%)
   Muscle weakness NOS 25 (10%) 5 (15%) 2 (7%)
Psychiatric Disorders
   Insomnia 35 (14%) 6 (18%) 7 (25%)
   Agitation 26 (10%) 5 (15%) 2 (7%)
   Depression 21 (8%) 6 (18%) 4 (14%)
   Anxiety 17 (7%) 1 (3%) 3 (11%)
Infections and Infestations
   Urinary tract infection NOS 35 (14%) 6 (18%) 5 (18%)
   Pneumonia NOS 16 (6%) 2 (6%) 3 (11%)
Metabolism and Nutrition Disorders
   Dehydration 33 (13%) 6 (18%) 3 (11%)
   Appetite decreased NOS 29 (11%) 4 (12%) 3 (11%)
   Hyponatremia 18 (7%) 4 (12%) 1 (4%)
   Hypokalemia 17 (7%) 5 (15%) 2 (7%)
   Hyperglycemia 15 (6%) 4 (12%) 2 (7%)
   Anorexia 14 (5%) 1 (3%) 5 (18%)
Investigations
   Platelet count decreased 8 (3%) 0 (0%) 3 (11%)
Renal and Urinary Disorders
   Incontinence NOS 19 (7%) 3 (9%) 5 (18%)
   Urinary retention 14 (5%) 0 (0%) 3 (11%)
Respiratory, Thoracic and Mediastinal
Disorders
   Dyspnea NOS 25 (10%) 4 (12%) 6 (21%)
   Cough 17 (7%) 3 (9%) 6 (21%)
Eye Disorders
   Vision blurred 29 (11%) 4 (12%) 4 (14%)
Blood and Lymphatic Disorders
   Anemia NOS 31 (12%) 6 (18%) 5 (18%)
   Thrombocytopenia 27 (11%) 8 (24%) 9 (32%)
   Neutropenia 26 (10%) 12 (36%) 7 (25%)
Skin and Subcutaneous Tissue
Disorders
   Contusion 6 (2%) 1 (3%) 3 (11%)
   Pruritus NOS 6 (2%) 0 (0%) 4 (14%)
   Sweating increased 6 (2%) 1 (3%) 3 (11%)
Vascular Disorders
   Hypotension NOS 21 (8%) 6 (18%) 2 (7%)
   Hypertension NOS 15 (6%) 5 (15%) 1 (4%)
Ear and Labyrinth Disorders
   Hypacusis 15 (6%) 6 (18%) 3 (11%)
Cardiac Disorders
   Tachycardia NOS 22 (9%) 0 (0%) 5 (18%)
Neoplasms Benign, Malignant and
Unspecified (Incl Cysts and Polyps)
   Diffuse Large B-Cell Lymphoma NOS 1 (0%) 1 (3%) 3 (11%)
Table 2. Incidence of adverse reactions possibly reflecting meningeal irritation occurring in > 10% of all studied adult patients receiving DepoCyt 50 mg or an active comparator*
* Hydrocephalus acquired, CSF pleocytosis and meningism occurred in ≤ 10% of all studied adult patients receiving
DepoCyt or an active comparator
System Organ Class / Preferred Term DepoCyt
(N=257)
MTX
(N=78)
Ara-C
(N=28)
Nervous System Disorders
   Headache NOS 145 (56%) 33 (42%) 9 (32%)
   Arachnoiditis 108 (42%) 15 (19%) 10 (36%)
   Convulsions NOS 56 (22%) 11 (14%) 1 (4%)
Gastrointestinal Disorders
   Nausea 117 (46%) 24 (31%) 15 (54%)
   Vomiting NOS 112 (44%) 22 (28%) 9 (32%)
Musculoskeletal and Connective Tissue Disorders
   Back pain 61 (24%) 15 (19%) 5 (18%)
   Neck pain 36 (14%) 6 (8%) 3 (11%)
   Neck stiffness 28 (11%) 1 (1%) 4 (14%)
General Disorders and Administration
Site Conditions
   Pyrexia 81 (32%) 15 (19%) 12 (43%)

During the clinical studies, 2 deaths related to DepoCyt were reported. One patient at the 125 mg dose level died of encephalopathy 36 hours after receiving an intraventricular dose of DepoCyt. This patient, however, was also receiving concomitant whole brain irradiation and had previously received intraventricular methotrexate. The other patient received DepoCyt, 50 mg by the intraventricular route and developed focal seizures progressing to status epilepticus. This patient died approximately 8 weeks after the last dose of study medication. In the controlled lymphoma study, the patient incidence of seizures was higher in the DepoCyt group (4/17, 23.5%) than in the cytarabine group (1/16, 6.3%). The death of 1 additional patient was considered “possibly” related to DepoCyt. He was a 63-year-old with extensive lymphoma involving the nasopharynx, brain, and meninges with multiple neurologic deficits who died of apparent disease progression 4 days after his second dose of DepoCyt.



REPORTS OF SUSPECTED DEPOCYT SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Depocyt side effects / adverse reactions in 48 year old female

Reported by a physician from France on 2011-10-12

Patient: 48 year old female

Reactions: Dysarthria, Histiocytosis Haematophagic, Motor Dysfunction, Haemorrhagic Stroke, Coma, Encephalopathy, Thrombocytopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Depocyt
    Dosage: 50 mg;inth
    Start date: 2011-07-13
    End date: 2011-07-21

Methotrexate
    Dosage: iv
    Start date: 2011-07-13
    End date: 2011-07-21



Possible Depocyt side effects / adverse reactions in 28 year old male

Reported by a physician from France on 2011-10-20

Patient: 28 year old male

Reactions: Brain Oedema, Viith Nerve Paralysis

Suspect drug(s):
Depocyt



Possible Depocyt side effects / adverse reactions in 18 year old male

Reported by a physician from Spain on 2011-10-20

Patient: 18 year old male

Reactions: Arachnoiditis, Intracranial Pressure Increased, Papilloedema, Convulsion

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Depocyt

Other drugs received by patient: Septra; Allopurinol; Acyclovir



See index of all Depocyt side effect reports >>

Drug label data at the top of this Page last updated: 2015-01-02

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017