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Decitabine Safety Reports
Total Decitabine reports: 22.Decitabine FDA safety alerts: No.
Reported deaths: 8 Reported hospitalizations: 19.
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Reported Decitabine Side Effects: febrile neutropenia, hypotension, thrombocytopenia, haemolysis, gastrointestinal haemorrhage, pneumonia, haemoglobin decreased, melaena, haematuria, platelet count decreased, pulmonary embolism.
More About Decitabine.
Decitabine Side Effects Report #5256975-4
Pharmacist from UNITED STATES reported DECITABINE problem on Mar 05, 2007. Male patient, 78 years of age, weighting 225.0 lb, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, interstitial lung disease. DECITABINE dosage: 20MG/M2 DAILY IV. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5302025-0
DECITABINE problem was reported by a Physician from CANADA on Mar 29, 2007. Female patient, 77 years of age, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood lactic acid increased, clostridial infection, colitis ischaemic, hypotension, international normalised ratio decreased, large intestine perforation, necrotising colitis. DECITABINE dosage: 20 MG/M**2; QD X5DQ28D; IV. During the same period patient was treated with DESFERAL, DIURETICS. Patient was hospitalized. Patient died on 07/04/2006.
Decitabine Side Effects Report #5328352-9
Physician from TURKEY reported DECITABINE problem on May 07, 2007. Female patient, 64 years of age, weighting 163.1 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, caecitis, diarrhoea, haemoglobin decreased, haemorrhage intracranial, hypotension, liver function test abnormal, neutropenia, prothrombin time prolonged. DECITABINE dosage: 15 MG/M**2; Q8H; IV. During the same period patient was treated with DEFEROXAMINE MESYLATE. Patient was hospitalized. Patient died on 03/22/2007.
Decitabine Side Effects Report #5328356-6
DECITABINE problem was reported by a Physician from GERMANY on May 07, 2007. Female patient, 65 years of age, weighting 121.3 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: haemolysis, pneumonia, pulmonary haemorrhage. DECITABINE dosage: 15 MG; Q8H; IV. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5339312-6
Physician from GERMANY reported DECITABINE problem on May 18, 2007. Female patient, 65 years of age, weighting 121.3 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: haemolysis, haemorrhage, pneumonia. DECITABINE dosage: 15 MG; Q8H; IV. Patient was hospitalized. Patient died.
Decitabine Side Effects Report #5345134-2
DECITABINE problem was reported by a Physician from UNITED STATES on May 16, 2007. Female patient, 69 years of age, weighting 160.0 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: arthralgia, burning sensation, gait disturbance, hyperaesthesia, hypoaesthesia, joint swelling, muscular weakness, musculoskeletal pain, neuralgia. DECITABINE dosage: unknown. During the same period patient was treated with SENOKOT, ZOFRAN. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5361362-4
Physician from AUSTRIA reported DECITABINE problem on May 29, 2007. Female patient, 65 years of age, weighting 121.3 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: haemolysis, haemorrhagic disorder, lung infiltration, pneumonia. DECITABINE dosage: 135 MG/M2; INTRAVENOUS. During the same period patient was treated with PREDNISOLONE, COL D VIDA, LEGALON, URSOFALK. Patient was hospitalized. Patient died on 05/17/2002.
Decitabine Side Effects Report #5371366-3
DECITABINE problem was reported by a Physician from FRANCE on June 06, 2007. Male patient, 70 years of age, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: aplasia, cellulitis, exophthalmos, fungal sepsis, nasal necrosis, neutropenia, septic shock, sinusitis. DECITABINE dosage: unknown. Patient died on 04/11/2007.
Decitabine Side Effects Report #5371367-5
Physician from GERMANY reported DECITABINE problem on June 15, 2007. Male patient, 73 years of age, weighting 169.8 lb, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. DECITABINE dosage: unknown. During the same period patient was treated with PREDNISOLONE. Patient was hospitalized. Patient died on 02/05/2007.
Decitabine Side Effects Report #5375697-2
DECITABINE problem was reported by a Physician from AUSTRIA on May 31, 2007. Female patient, 65 years of age, weighting 121.3 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: haemolysis, haemolytic anaemia, lung infection, multi-organ failure, pneumocystis jiroveci infection, pulmonary haemorrhage, pulmonary toxicity, thrombocytopenia. DECITABINE dosage: 135 MG/M2, INTRAVENOUS. During the same period patient was treated with PREDNISOLONE, COL D VIDA, LEGALON, URSOFALK. Patient was hospitalized. Patient died on 05/17/2007.
Decitabine Side Effects Report #5175313-9
Consumer or non-health professional from UNITED STATES reported DECITABINE problem on Dec 12, 2006. Male patient, 75 years of age, weighting 144.4 lb, was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: neutropenia. DECITABINE dosage: unknown. During the same period patient was treated with ALLOPURINOL, GLIPIZIDE, LISINOPRIL, POTASSIUM CHLORIDE, FUROSEMIDE, ONDANSETRON, METOPROLOL TARTRATE, FILGRASTIM. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5400223-9
DECITABINE problem was reported by a Consumer or non-health professional from UNITED STATES on July 27, 2007. Male patient, 75 years of age, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, condition aggravated, febrile neutropenia, myelodysplastic syndrome, thrombocytopenia. DECITABINE dosage: 49MG OTHER IV. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5406890-8
Physician from GERMANY reported DECITABINE problem on July 20, 2007. Female patient, 64 years of age, weighting 216.1 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, myalgia, proctitis, thrombocytopenia. DECITABINE dosage: 270 MG, IN 6 WEEK, INTRAVENOUS. During the same period patient was treated with UNACID. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5424227-5
DECITABINE problem was reported by a Health Professional from CANADA on Aug 17, 2007. Female patient, 48 years of age, weighting 142.4 lb, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. DECITABINE dosage: 20 MG/M2, INTRAVENOUS. During the same period patient was treated with VORINOSTAT. Patient recovered.
Decitabine Side Effects Report #5429978-4
Physician from GERMANY reported DECITABINE problem on Aug 15, 2007. Female patient, 77 years of age, weighting 103.6 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: gastroenteritis. DECITABINE dosage: 207 MG, INTRAVENOUS. During the same period patient was treated with DIOVAN, BISOPROLOL FUMARATE, PANTOZOL. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5442923-0
DECITABINE problem was reported by a Physician from CANADA on Aug 16, 2007. Female patient, 79 years of age, weighting 207.2 lb, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, blood creatinine increased, candida pneumonia, cardiac failure congestive, cardiac valve vegetation, endocarditis, hypophosphataemia, hypotension, mucosal inflammation. DECITABINE dosage: 20 MG/M2, INTRAVENOUS. Patient was hospitalized. Patient died on 12/22/2006.
Decitabine Side Effects Report #5442924-2
Health Professional from CANADA reported DECITABINE problem on Aug 17, 2007. Female patient, 48 years of age, weighting 142.4 lb, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: platelet count decreased, pulmonary embolism. DECITABINE dosage: 20 MG/M2, INTRAVENOUS. Patient recovered.
Decitabine Side Effects Report #5442925-4
DECITABINE problem was reported by a Physician from GERMANY on Aug 16, 2007. Female patient, 76 years of age, was diagnosed with acute myeloid leukaemia and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: oedema peripheral, thrombocytopenia. DECITABINE dosage: unknown. During the same period patient was treated with PANTOZOL, IBUPROFEN, CIPROFLOXACIN. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5444077-3
Health Professional from UNITED STATES reported DECITABINE problem on Aug 20, 2007. Female patient, 67 years of age, weighting 196.0 lb, was diagnosed with myelofibrosis and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: acute febrile neutrophilic dermatosis, febrile neutropenia, pancytopenia. DECITABINE dosage: 264 MG, IN 1 TOTAL, SUBCUTANEOUS. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5449580-8
DECITABINE problem was reported by a Health Professional from ARGENTINA on Aug 28, 2007. Male patient, 68 years of age, weighting 176.4 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, gastrointestinal haemorrhage, haematuria, haemoglobin decreased, hypotension, melaena, platelet count decreased, white blood cell count decreased. DECITABINE dosage: 20 MG/M2, INTRAVENOUS. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5460621-4
Physician from ITALY reported DECITABINE problem on Sept 05, 2007. Male patient, 76 years of age, weighting 169.8 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: fatigue, nausea, neutropenia, pneumonitis, pyrexia. DECITABINE dosage: unknown. Patient was hospitalized. Patient recovered.
Decitabine Side Effects Report #5468289-8
DECITABINE problem was reported by a Health Professional from ARGENTINA on Sept 13, 2007. Male patient, 68 years of age, weighting 176.4 lb, was diagnosed with myelodysplastic syndrome and was treated with DECITABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, gastroduodenitis, gastrointestinal haemorrhage, haematuria, haemoglobin decreased, hiatus hernia, hypotension, melaena, oesophagitis. DECITABINE dosage: 20 MG/M2, INTRAVENOUS. Patient was hospitalized. Patient recovered.
Drug Information: Decitabine Injection
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a608009.html
(dee sye' ta been)Why is this medication prescribed?
Decitabine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow.
How should this medicine be used?
Decitabine comes as a powder to be to be added to fluid and injected slowly over 3 hours intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic. It is usually injected every 8 hours for 3 days. This treatment period is called a cycle, and the cycle may be repeated every 6 weeks for as long as your doctor recommends. Decitabine should usually be given for at least four cycles but may be continued if your doctor decides that you will benefit from additional treatment.
Your doctor may also need to delay your treatment and reduce your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with decitabine.
Your doctor will give you medication to prevent nausea and vomiting before you receive each dose of decitabine.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before receiving a dose of decitabine,
- tell your doctor and pharmacist if you are allergic to decitabine or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have kidney or liver disease.
- tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are using decitabine. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with decitabine and for 2 months afterwards. Talk to your doctor about birth control methods that will work for you. If you or your partner becomes pregnant while using decitabine, call your doctor. Decitabine may harm the fetus.
- tell your doctor if you are breast-feeding.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Call your doctor right away if you are unable to keep an appointment to receive a dose of decitabine.
What side effects can this medication cause?
Decitabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- excessive tiredness
- pale skin
- headache
- dizziness
- confusion
- fast heartbeat
- difficulty falling asleep or staying asleep
- weakness
- shortness of breath
- nausea
- constipation
- diarrhea
- vomiting
- stomach pain
- heartburn or indigestion
- painful sores in mouth, or on tongue or lips
- red spots on the skin
- rash
- change in skin color
- hair loss
- joint or muscle pain
- chest discomfort or chest wall pain
- swelling of the hands, feet, ankles, lower legs, or stomach
- pain, swelling, or redness at injection spot
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- unusual bleeding or bruising
- hives
- itching
- difficulty breathing or swallowing
- swelling of the face
- sore throat, fever, chills, cough, or other signs of infection
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
Decitabine may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- unusual bleeding or bruising
- sore throat, fever, chills, cough, or other signs of infection
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to decitabine.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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