DepoCyt
NIH Trial Shows Promising Results in Treating Lymphoma in Young People »
"Patients with a type of cancer known as primary mediastinal B-cell lymphoma who received infusions of chemotherapy, but who did not have radiation therapy to an area of the thorax known as the mediastinum, had excellent outcomes, according to "...
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DepoCyt
DepoCyt Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
DepoCyt (cytarabine liposome) Injection 50 mg is a cytotoxic anticancer drug used to treat lymphoma associated with meningitis. Common side effects of DepoCyt include mild nausea or vomiting, diarrhea, constipation, stomach pain, swelling in hands and feet, dizziness, tired feeling, joint pain, back pain, and pain in arms or legs.
This medication is administered in 50 mg doses through needle injection into the space around your spinal cord. Talk to your doctor about the number of doses recommended for you. You should not take DepoCyt if you have an active meningitis infection. Tell your doctor immediately if you experience nausea, and vomiting with headache as these may be early signs of central nervous system damage. DepoCyt may interact with other drugs. Before taking DepoCyt tell your doctor about all medical conditions and medications you use. It is not recommended to take DepoCyt if you are nursing or pregnant.
Our DepoCyt (cytarabine liposome injection) 50 mg Vial Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
DepoCyt in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- nausea and vomiting with headache and fever;
- neck stiffness or pain, seizure (convulsions);
- extreme drowsiness, loss of muscle control;
- confusion, personality changes, problems with memory or concentration, sleep problems, agitation;
- problems with speech, vision, hearing, or balance,
- numbness, tingling, or burning pain that interferes with daily activities;
- loss of bladder or bowel control;
- pale skin, feeling light-headed or short of breath, rapid heart rate;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
- flu symptoms, sores in your mouth and throat.
Less serious side effects may include:
- mild nausea or vomiting;
- diarrhea, constipation, stomach pain;
- swelling in your hands or feet;
- dizziness, tired feeling;
- joint pain, back pain; or
- pain in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for DepoCyt (Cytarabine Liposome Injection) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
DepoCyt Overview - Patient Information: Side Effects
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects.
Tell your doctor right away if you have any serious side effects, including: headache, tingling/numbness, muscle pain, back pain, neck pain/stiffness, seizures, swelling, loss of bladder/bowel control, unusual weakness/tiredness, easy bruising/bleeding, signs of infection (e.g., persistent sore throat), mental/mood changes (e.g., confusion).
Get medical help right away if any of these rare but very serious side effects occur: weakness/loss of movement on one side of the body, vision changes (including blindness), hearing changes.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for DepoCyt (Cytarabine Liposome Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
DepoCyt FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 entire FDA prescribing information for DepoCyt (Cytarabine Liposome Injection) »
Additional DepoCyt Information
DepoCyt - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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