Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 50mg/vial
Myelodysplastic Syndromes
3-day regimen: 15 mg/m² IV infusion over 3 hr repeated q8hr x3 days; repeat q6weeks; repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/μL and platelets at least 50,000/μL) for a minimum of 4 cycles; a complete or partial response may take longer than 4 cycles; delay and reduce dose for hematologic toxicity
5-day regimen: 20 mg/m² IV infusion over 1 hr qDay x5 days, repeat cycle q4weeks upon hematologic recovery (ANC at least 1,000/μL and platelets at least 50,000/μL) for a minimum of 4 cycles; a complete or partial response may take longer than 4 cycles
Dosage Modifications
Hematologic Toxicity
- If hematologic recovery from previous treatment cycle requires more than 6 weeks, delay next cycle of therapy and reduce dose temporarily by following the following algorithm
- Recovery requiring more than 6, but less than 8 weeks: Delay dosing for up to 2 weeks and reduce dose temporarily to 11 mg/m2 q8hr (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy
- Recovery requiring more than 8, but less than 10 weeks: Perform bone marrow aspirate to assess for disease progression; in absence of progression, delay dosing for up to 2 more weeks and reduce dose to 11 mg/m2 q8hr (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy, then maintain or increase dose in subsequent cycles as clinically indicated
Non-hematologic Toxicity
- Delay subsequent treatment for any the following nonhematologic toxicities and do not restart until toxicities resolve:
- Serum creatinine > 2 mg/dL
- Alanine transaminase (ALT), total bilirubin greater than or equal to 2 times upper limit of normal (ULN)
- Active or uncontrolled infection
Renal impairment
- Not studied; use caution
Hepatic Impairment
- Not studied; use caution
Sickle Cell Disease (Orphan)
Orphan designation for treatment sickle cell disease in combination with tetrahydrouridine
Orphan indication sponsor
- EpiDestiny Inc; 7536 Royal Portrush Drive; Solon, Ohio 44139
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- palifermin
palifermin increases toxicity of decitabine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, decitabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
Monitor Closely (10)
- acalabrutinib
acalabrutinib, decitabine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- cholera vaccine
decitabine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
decitabine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- dichlorphenamide
dichlorphenamide and decitabine both decrease serum potassium. Use Caution/Monitor.
dichlorphenamide, decitabine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis. - ethotoin
decitabine increases levels of ethotoin by unknown mechanism. Use Caution/Monitor. Based on case reports.
- fingolimod
decitabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
decitabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ponesimod
ponesimod and decitabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- siponimod
siponimod and decitabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
decitabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
Minor (4)
- maitake
maitake increases effects of decitabine by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- taurine
decitabine decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.
- vitamin A
vitamin A, decitabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
- vitamin E
vitamin E, decitabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
Adverse Effects
>10%
Neutropenia (90%)
Thrombocytopenia (89%)
Anemia (82%)
Pyrexia (53%)
Nausea (42%)
Cough (40%),
Petechiae (39%)
Constipation (35%)
Diarrhea (34%)
Hyperglycemia (33%)
Febrile neutropenia (29%)
Headache (28%)
Insomnia (28%)
Leukopenia (28%)
Vomiting (25%)
Peripheral edema (25%)
Hypoalbuminemia (24%)
Hypomagnesemia (24%)
Pallor (23%)
Hypokalemia (22%)
Pneumonia (22%)
Rigors (22%)
Ecchymosis (22%)
Arthralgia (20%)
Limb pain (19%)
Hyponatremia (19%)
Rash (19%)
Edema (18%)
Dizziness (18%)
Back pain (17%)
Appetite decreased (16%)
Pharyngitis (16%)
Cardiac murmur (16%)
Anorexia (16%)
Hyperbilirubinemia (14%)
Abdominal pain (14%)
Erythema (14%)
Crackles in lung (14%)
Oral mucosal petechiae (13%)
Pain (13%)
Hyperkalemia (13%)
Confusional state (12%)
Lethargy (12%)
Stomatitis (12%)
Dyspepsia (12%)
Lymphadenopathy (12%)
Cellulitis (12%)
Anxiety (11%)
Hypoesthesia (11%)
Tenderness (11%)
Blood alkaline phosphatase increased (11%)
Skin lesion (11%)
Pruritus (11%)
1-10%
Aspartate aminotransferase increase (10%)
Blood urea increase (10%)
Breath sounds decrease (10%)
Hypoxia (10%)
Candidal infection (10%)
Ascites (10%)
Blood lactate dehydrogenase increase (8%)
Catheter related infection (8%)
Gingival bleeding (8%)
Hemorrhoids (8%)
Alopecia (8%)
Fall (8%)
Rales (8%)
Loose stools (7%)
Transfusion reaction (7%)
Tongue ulceration (7%)
Chest discomfort (7%)
Chest wall pain (7%)
Blood albumin decrease (7%)
Urinary tract infection (7%)
Staphylococcal infection (7%)
Oral candidiasis (6%)
Dysuria (6%)
Dysphagia (6%)
Pulmonary edema (6%)
Blurred vision (6%)
Oral soft tissue disorder (6%)
Urticaria (6%)
Swelling of face (6%)
Blood Cl decrease (6%)
Blood bicarbonate increase (6%)
Musculoskeletal discomfort (6%)
Hypotension (6%)
Dehydration (6%)
Intermittent pyrexia (6%)
Lip ulceration (5%)
Thrombocythemia (5%)
Hematoma (5%)
Abdominal distension (5%)
Upper abdominal pain (5%)
Gastro-esophageal reflux disease (5%)
Glossodynia (5%)
Myalgia (5%)
Malaise (5%)
Crepitations (5%)
Catheter site erythema (5%)
Catheter site pain (5%)
Injection site swelling (5%)
Urinary frequency (5%)
Sinusitis (5%)
Postnasal drip (5%)
Bacteremia (5%)
Abrasion (5%)
Protein total decrease (5%)
Blood bicarbonate decrease (5%)
Blood bilirubin decreased (5%)
Postmarketing Reports
Sweet’s syndrome (acute febrile neutrophilic dermatosis)
Differentiation syndrome
Interstitial lung disease
Warnings
Contraindications
Hypersensitivity
Cautions
Use caution in renal/hepatic impairment
Fatal and serious myelosuppression occurs in treated patients; myelosuppression (anemia, neutropenia, and thrombocytopenia) is the most frequent cause of dose reduction, delay, and discontinuation; manage toxicity using dose-delay, dose-reduction, growth factors, and anti-infective therapies as needed; myelosuppression and worsening neutropenia may occur more frequently in first or second treatment cycles, and may not necessarily indicate progression of underlying MDS
Therapy can cause fetal harm when administered to a pregnant woman; based on mechanism of action, drug alters DNA synthesis and is expected to result in adverse reproductive effects; advise men with female partners of childbearing potential to avoid fathering a child while receiving treatment and for 3 months following the last dose; counsel patients of childbearing potential to use effective contraception during this time
Bone marrow suppression may occur (dose limiting); dose adjustment may be necessary
Pregnancy & Lactation
Pregnancy
Based on findings from human data, animal studies, and the mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited published data on use throughout first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities); advise pregnant women of potential risk to fetus
Based on findings of decitabine in animals, male fertility may be compromised by treatment; reversibility of effect on fertility is unknown
Conduct pregnancy testing of females of reproductive potential prior to initiating treatment
Advise females of reproductive potential to avoid pregnancy and use effective contraception while receiving therapy and for 6 months following last dose
Advise males with female partners of reproductive potential to use effective contraception while receiving treatment and for 3 months following last dose
Animal data
- In animal reproduction studies, administration of decitabine to pregnant mice and rats during organogenesis caused adverse developmental outcomes and was teratogenic, fetotoxic, and embryotoxic starting at doses approximately 7% of the recommended human dose on a mg/m2 basis
Lactation
There are no data on presence of drug or metabolites in human milk, effects on breastfed child, or on milk production; because many drugs are excreted in human milk, and because of potential for serious adverse reactions in a nursing child, advise lactating women to avoid breastfeeding during treatment and for at least 1 week after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Inhibits DNA methyltransferase, causing hypomethylation of DNA & cellular differentiation or apoptosis
Pharmacokinetics
Protein Bound: <1%
Vd: 63-89 L/m²
Half-life: 30-35 min
Administration
IV Compatibilities
Solution: NS, D5W, LR
IV Preparation
Aseptically reconstitute drug with room temperature (20°C to 25°C) 10 mL of Sterile Water for Injection, USP.
Upon reconstitution, the final concentration of the reconstituted drug solution is 5 mg/mL; you must dilute the reconstituted solution with 0.9% sodium chloride injection or 5% dextrose injection prior to administration
Temperature of the diluent (0.9% sodium chloride injection or 5% dextrose injection) depends on time of administration after preparation
For administration within 15 minutes of preparation
- If drug is intended to be administered within 15 minutes from time of preparation, dilute reconstituted solution with room temperature (20-25 oC) 0.9% sodium chloride injection or 5% dextrose injection to a final concentration of 0.1 mg/mL to 1 mg/mL; discard unused portion
For delayed administration
- If drug is intended to be administered after 15 minutes of preparation, dilute reconstituted solution with cold (2-8 oC) 0.9% sodium chloride injection or 5% dextrose injection to a final concentration of 0.1 mg/mL to1 mg/mL
- Store at 2-8 oC for up to 4 hours; diluted stored solution must be used within 4 hours from time of preparation; discard unused portion
- Use the diluted, refrigerated solution within 4 hours from time of preparation or discard; parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
- Do not use if there is evidence of particulate matter or discoloration
IV Administration
Infuse IV continuously over 3 hr
Storage
Store diluted solution at 2-8°C (36-46°F) not to exceed 7 hr
Store vials at 25°C (77°F)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Dacogen intravenous - | 50 mg vial |  | |
| Dacogen intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  | |
| decitabine intravenous - | 50 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
decitabine intravenous
DECITABINE - INJECTION
(dee-SYE-ta-been)
COMMON BRAND NAME(S): Dacogen
USES: This medication is used to treat a group of blood/bone marrow disorders (myelodysplastic syndromes-MDS) in which the bone marrow does not produce enough healthy blood cells. People with MDS may have problems such as infections, anemia, and easy bleeding/bruising. Decitabine is a chemotherapy drug. It is believed to work by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions. Decitabine also kills abnormal blood cells that have grown too fast and do not work properly.
HOW TO USE: This medication is given by injection into a vein by a health care professional in a hospital or infusion clinic.The dosage is based on your medical condition, body size, lab test results, and response to treatment. Keep all medical/lab appointments.This medication can be injected once a day for 5 days in a row or injected every 8 hours for 3 days in a row, as directed by your doctor. Your treatment cycle will be repeated every 4 weeks if you are on a 5-day course, or every 6 weeks if you are on a 3-day course, and depending on your response to the medication and blood tests.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day during your treatment cycle.Tell your doctor if your condition gets worse.
SIDE EFFECTS: Redness/pain/bruising at the injection site, nausea, constipation, diarrhea, vomiting, upset stomach, trouble sleeping, hair loss, or muscle/joint pain may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: confusion, easy bleeding/bruising, unusual tiredness, pale skin, mouth/tongue sores, swollen belly, shortness of breath.This medication may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Though decitabine is supposed to improve the body's immune system, in some patients this medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using decitabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Tell your health care professional that you are using decitabine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should have a pregnancy test before starting this medication. You should not become pregnant while using decitabine. Decitabine may harm an unborn baby. Females using this medication should ask about reliable forms of birth control while using this medication and for at least 6 months after stopping treatment. Males using this medication should ask about reliable forms of birth control while using this medication and for at least 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for at least 2 weeks after stopping treatment. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab tests (such as complete blood counts, platelet counts, liver function tests, kidney function tests) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised December 2021. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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