DepoCyt
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 Table3.
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
| 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%) |
| 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%) | 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%) |
| 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%) | 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 | |||
| 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%) | 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 | |||
| Hypoacusis | 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 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.
Generic Name: Cytarabine Liposome Injection
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