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Decitabine is a cancer medicine that is used to treat myelodysplastic syndromes (certain types of blood or bone marrow cancer).
Decitabine may also be used for purposes not listed in this medication guide.
Decitabine affects your immune system. You may get infections more easily. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, cough, sore throat, trouble breathing).
Tell your doctor if you have ever had:
kidney disease; or
liver disease.
Decitabine can harm an unborn baby or cause birth defects if the mother or the father is using decitabine.
If you are a woman, do not use decitabine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.
If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 2 months after your last dose.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using decitabine.
You should not breast-feed while using decitabine.
Decitabine is given as an infusion into a vein. A healthcare provider will give you this injection.
In most cases, a decitabine injection is given every 8 hours for 3 days. This 3-day treatment is usually repeated every 6 weeks at least 4 times.
You may be given other medications to prevent nausea or vomiting while you are receiving decitabine.
Decitabine affects your immune system. You may get infections more easily. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.
Call your doctor for instructions if you miss an appointment for your decitabine injection.
Since decitabine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
decitabine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
fever, chills, body aches, cough, sore throat, flu symptoms;
easy bruising, unusual bleeding, purple or red spots under your skin;
pale skin, cold hands and feet;
slow heart rate, weak pulse, slow breathing; or
cough with mucus, chest pain, feeling short of breath.
Common side effects may include:
bruising or bleeding;
fever, and other signs of infection;
anemia, cough, trouble breathing;
headache, dizziness, tiredness;
diarrhea, constipation; or
sleep problems (insomnia).
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.
Usual Adult Dose for Myelodysplastic Syndrome:
TREATMENT REGIMEN OPTION 1:
15 mg/m2 IV over 3 hours; repeat every 8 hours for 3 days; repeat this cycle every 6 weeks; patients may be premedicated with standard antiemetic therapy
If hematologic recovery (ANC 1,000/mcL or greater and platelets 50,000/mcL or greater) from a previous treatment cycle requires more than 6 weeks, then the next cycle should be delayed and dosing temporarily reduced by following this algorithm:
-Recovery requiring more than 6, but less than 8 weeks: Delay dosing for up to 2 weeks and temporarily reduce the dose to 11 mg/m2 IV every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) when restarting therapy
-Recovery requiring more than 8, but less than 10 weeks: Assess patient for disease progression (by bone marrow aspirates); in the absence of progression, the dose should be delayed up to 2 more weeks and then reduced to 11 mg/m2 IV every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) when restarting therapy, then maintained or increased in subsequent cycles as clinically indicated
TREATMENT REGIMEN OPTION 2:
20 mg/m2 IV over 1 hour; repeat daily for 5 days; repeat this cycle every 4 weeks; patients may be premedicated with standard antiemetic therapy
If myelosuppression is present, subsequent treatment cycles should be delayed until there is hematologic recovery (ANC 1,000/mcL or greater and platelets 50,000/mcL or greater)
Comments:
-With either regimen, it is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles.
-Perform complete blood and platelet counts prior to each cycle and as needed to monitor response and toxicity.
-Perform liver chemistries and serum creatinine prior to initiation of therapy.
Use: For the treatment of myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups
Other drugs may affect decitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Decitabine (www.drugs.com/mtm/decitabine.html).
Commonly reported side effects of decitabine include: neutropenia and thrombocytopenia. See below for a comprehensive list of adverse effects.
Applies to decitabine: intravenous powder for solution
Along with its needed effects, decitabine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking decitabine:
More common
Less common
Some side effects of decitabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to decitabine: intravenous powder for injection
Very common (10% or more): Neutropenia (90%), thrombocytopenia (89%), anemia (68%), febrile neutropenia (29%), leukopenia (28%), lymphadenopathy (12%)
Common (1% to 10%): Thrombocythemia
Uncommon (0.1% to 1%): Pancytopenia
Very common (10% or more): Nausea (42%), constipation (35%), diarrhea (34%), vomiting (25%), abdominal pain (14%), oral mucosal petechiae (13%), stomatitis (12%), dyspepsia (12%), ascites (10%)
Common (1% to 10%): Gingival bleeding, hemorrhoids, loose stools, tongue ulceration, dysphagia, oral soft tissue disorder, lip ulceration, abdominal distension, upper abdominal pain, gastroesophageal reflux disease, glossodynia
Frequency not reported: Enterocolitis (including neutropenic colitis, cecitis)
Very common (10% or more): Cough (40%), pneumonia (24%), pharyngitis (16%), epistaxis (14%), lung crackles (14%), breath sounds decreased (10%), hypoxia (10%)
Common (1% to 10%): Sinusitis, rales, postnasal drip
Frequency not reported: Interstitial lung disease
Very common (10% or more): Pyrexia (53%), peripheral edema (25%), rigors (22%), edema (18%), pain (13%), lethargy (12%), tenderness (11%), blood alkaline phosphatase increased (11%), blood urea increased (10%)
Common (1% to 10%): Fall, chest wall pain, intermittent pyrexia, malaise, crepitations, blood lactate dehydrogenase increased, blood albumin decreased, blood bicarbonate increased, blood chloride decreased, decreased total protein, blood bilirubin decreased
Very common (10% or more): Hyperglycemia (33%), hypoalbuminemia (24%), hypomagnesemia (24%), hypokalemia (22%), hyponatremia (19%), appetite decreased (16%), anorexia (16%), hyperkalemia (13%)
Common (1% to 10%): Dehydration
Very common (10% or more): Headache (28%), dizziness (18%), hypoesthesia (11%)
Very common (10% or more): Insomnia (28%), confusion (12%), anxiety (11%)
Very common (10% or more): Bacterial, viral, fungal infections (63%), candida infection (10%)
Common (1% to 10%): Septic shock, sepsis, staphylococcal infection, oral candidiasis, bacteremia
Very common (10% or more): Ecchymosis (22%), rash (19%), erythema (14%), cellulitis (12%) skin lesion (11%), pruritus (11%)
Common (1% to 10%): Alopecia, urticaria, swelling face
Uncommon (0.1% to 1%): Acute febrile neutrophilic dermatosis (Sweet's syndrome)
Very common (10% or more): Arthralgia (20%), pain in limb (19%), back pain (17%)
Common (1% to 10%): Chest wall pain, musculoskeletal discomfort, myalgia
Very common (10% or more): Petechiae (39%), pallor (23%), cardiac murmur (16%)
Common (1% to 10%): Pulmonary edema, hypotension, hematoma
Very common (10% or more): Hyperbilirubinemia (14%)
Common (1% to 10%): Hypersensitivity including anaphylaxis
Common (1% to 10%): Blurred vision
Very common (10% or more): Urinary tract infection (15%)
Common (1% to 10%): Dysuria, urinary frequency
.
Common (1% to 10%): Injection site erythema, injection site pain, injection site swelling
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Decitabine (www.drugs.com/mtm/decitabine.html).
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