April 30, 2016
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DepoCyt

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DepoCyt




Side Effects
Interactions

SIDE EFFECTS

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

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

System Organ Class / Preferred Term All DepoCyt
(N=257)
Lymphoma 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*

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 TissueDisorders
  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 AdministrationSite Conditions
  Pyrexia 81 (32%) 15 (19%) 12 (43%)
* Hydrocephalus acquired, CSF pleocytosis and meningism occurred in ≤ 10% of all studied adult patients receiving DepoCyt or an active comparator

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.

Read the DepoCyt (cytarabine liposome injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No formal assessments of pharmacokinetic drug-drug interactions between DepoCyt and other agents have been conducted. Concomitant administration of DepoCyt with other antineoplastic agents administered by the intrathecal route has not been studied. With intrathecal cytarabine and other cytotoxic agents administered intrathecally, enhanced neurotoxicity has been associated with coadministration of drugs.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/16/2016

Side Effects
Interactions

DepoCyt - User Reviews

DepoCyt User Reviews

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