DepoCyt Side Effects
Generic Name: cytarabine liposomal
Please note - some side effects for DepoCyt may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of DepoCyt - for the Consumer
DepoCyt
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using DepoCyt:
Seek medical attention right away if any of these SEVERE side effects occur when using DepoCyt:Change in appetite; constipation; cough; diarrhea; dizziness; drowsiness; mouth or tongue sores; stomach pain; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bowel or bladder problems; burning, pain, numbness, or tingling; confusion; decreased sense of touch; difficult or painful urination; difficulty walking; fast or irregular heartbeat; fainting; fever, chills, or persistent sore throat; headache; hearing problems (eg, hearing loss); joint pain; memory problems; mental or mood changes (eg, agitation, anxiety, depression); muscle pain, weakness, or cramping; nausea; neck pain or rigidity; one-sided weakness; pain, redness, or swelling at the injection site; seizures; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent dry mouth or eyes; shortness of breath; sluggishness; swelling of the hands, ankles, or feet; tremor; trouble sleeping; trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, blurred vision, vision loss); vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopDepoCyt Side Effects - for the Professional
DepoCyt
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.
| 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%) |
|
* 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%) | ||
| 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%) | ||
Side Effects by Body System - for Healthcare Professionals
Nervous system
Nervous system side effects including headache (56%), arachnoiditis (42%) confusion (up to 33%) abnormal gait (up to 23%), convulsions (20%), dizziness (18%), memory impairment (14%), somnolence (12%), hypoesthesia (10%), tremor (9%), peripheral neuropathy (4%), syncope (3%), neuropathy (3%), peripheral sensory neuropathy (3%), and abnormal reflexes (3%) have been reported. Hydrocephalus, hemiplegia, visual disturbances (including blindness), deafness, and cranial nerve palsies, numbness, paresthesia, weakness, and impaired bowel and bladder control have also been reported.
Chemical arachnoiditis is a syndrome which is a common adverse event associated with the use of cytarabine liposomal. This syndrome includes headache, fever, and back pain. The incidence and severity of chemical arachnoiditis may be reduced by coadministration with dexamethasone.
Hydrocephalus may have been precipitated by arachnoiditis.
Infectious meningitis may be associated with intrathecal drug administration.
Gastrointestinal
Gastrointestinal side effects including nausea (46%), vomiting (up to 44%), constipation (25%), diarrhea (12%), nausea (11%), abdominal pain (9%), dysphagia (8%), constipation (7%), and hemorrhoids (3%) have been reported.
Other
Other side effects including weakness (40%), pyrexia (up to 32%), fatigue (25%), asthenia (19%), lethargy (16%), death (14%), pain (up to 14%), peripheral edema (11%), back pain (7%), hypoacusis (6%), fall (5%), mucosal inflammation (3%), and edema (2%) have been reported.
Musculoskeletal
Musculoskeletal side effects including back pain (24%), pain in limb (15%), neck pain (14%), arthralgia (11%), neck stiffness (11%), and muscle weakness (10%) have been reported.
Psychiatric
Psychiatric side effects including insomnia (14%), agitation (10%), depression (8%), and anxiety (7%) have been reported.
Renal
Renal side effects including urinary tract infection (14%) have been reported.
Metabolic
Metabolic side effects including dehydration (13%), decreased appetite (11%), hyponatremia (7%), peripheral edema (7%), hypokalemia (7%), hyperglycemia (6%), and anorexia (5%) have been reported.
Hematologic
Hematologic side effects including anemia (12%), thrombocytopenia (up to 11%), and neutropenia (up to 10%) have been reported.
Ocular
Ocular side effects including blurred vision (11%) have been reported.
Respiratory
Respiratory side effects including dyspnea (10%), cough (7%), and pneumonia (6%) have been reported.
Cardiovascular
Cardiovascular side effects including tachycardia (9%), hypotension (8%), and hypertension (6%) have been reported.
Genitourinary
Genitourinary side effects including urinary incontinence (7%) and urinary retention (5%) have been reported.
Dermatologic
Dermatologic side effects including contusion (2%), pruritus (2%), and increased sweating (2%) have been reported.
Oncologic
Oncologic side effects including a case of diffuse large B-cell lymphoma have been reported.
TopMore DepoCyt resources
- DepoCyt Prescribing Information (FDA)
- DepoCyt Concise Consumer Information (Cerner Multum)
- DepoCyt Monograph (AHFS DI)
- DepoCyt MedFacts Consumer Leaflet (Wolters Kluwer)
- Cytarabine Liposomal Professional Patient Advice (Wolters Kluwer)
- Depocyt Advanced Consumer (Micromedex) - Includes Dosage Information
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