DepoCyt (Cytarabine Liposome Injection) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

DepoCyt

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

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.