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DepoCyt

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DepoCyt

Side Effects
Interactions

SIDE EFFECTS

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 2 below.

Arachnoiditis is an expected and well-documented side effect of both neoplastic meningitis and of intrathecal chemotherapy. The incidence of severe and life-threatening arachnoiditis in patients receiving DepoCyt was 19% (48/257) in all patients and 30% (10/33) in patients with lymphomatous meningitis. The incidence of symptoms possibly reflecting meningeal irritation are shown in Table 3.

In the early dose-finding study, chemical arachnoiditis was observed in 100% of cycles without dexamethasone prophylaxis. When concurrent dexamethasone was administered, chemical arachnoiditis was observed in 33% of cycles. Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION).

Table 2: 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
Depo Cyt (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%)
  Hypoaesthesia 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%) 00%) 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%)
  Oedema peripheral 27(11%) 6(18%) 7(25%)
  Fall 12(5%) 0(0%) 3(11%)
  Mucosal inflammation NOS 8(3%) 4(12%) 2(7%)
  Oedema 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%)
  Diarrhoea NOS 31(12%) 9(27%) 9(32%)
  Abdominal pain NOS 22(9%) 5(15%) 4(14%)
  Dysphagia 20(8%) 3(9%) 3(11%)
  Haemorrhoids 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%)
  Hyponatraemia 18(7%) 4(12%) 1(4%)
  Hypokalaemia 17(7%) 5(15%) 2(7%)
  Hyperglycaemia 15(6%) 4(12%) 2(7%)
  Anorexia 14(5%) 1(3%) 5(18%)
Investigations
  Platelet count decreased  8(3%) 00%) 3(11%)
Renal and Urinary Disorders
  Incontinence NOS 19(7%) 3(9%) 5(18%)
  Urinary retention 14(5%) 00%) 3(11%)
Respiratory, Thoracic and Mediastinal Disorders
  Dyspnoea 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
  Anaemia 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%) 00%) 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
  Hypoacusis 15(6%) 6(18%) 3(11%)
Cardiac Disorders 
  Tachycardia NOS 22(9%) 00%) 5(18%)
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps)
  Diffuse Large B-Cell Lymphoma NOS 10%) 1(3%) 3(11%)

Table 3: 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%)
Musculoskeltal 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%)
* Hydrocephalus acquired, CSF pleocytosis and meningism occurred in ≤ 10% of all studied adult patients receiving DepoCyt or an active comparator

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

DRUG INTERACTIONS

No formal drug interaction studies of DepoCyt and other drugs were 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.

Laboratory Test Interactions

Since DepoCyt particles are similar in size and appearance to white blood cells, care must be taken in interpreting CSF examinations following DepoCyt administration.

Last reviewed on RxList: 8/19/2011
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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