Decitabin Teva (Decitabine)
Hypomethylating agent for the treatment of acute myeloid leukemia and myelodysplastic syndromes
Quick Facts About Decitabin Teva
Key Takeaways About Decitabin Teva
- Hospital-only treatment: Decitabin Teva is administered as an intravenous infusion and must only be given under the supervision of a physician experienced in chemotherapy
- Used for blood cancers: Primarily indicated for acute myeloid leukemia (AML) in patients not suitable for standard intensive chemotherapy, and myelodysplastic syndromes (MDS)
- Requires regular monitoring: Complete blood counts must be checked before each treatment cycle due to the risk of severe myelosuppression (low blood cell counts)
- Contraindicated in pregnancy: Must not be used during pregnancy or breastfeeding; effective contraception is required for both men and women during and after treatment
- Multiple cycles needed: Clinical response may take 4 to 6 cycles to appear; treatment should continue as long as the patient benefits
What Is Decitabin Teva and What Is It Used For?
Decitabin Teva is a prescription chemotherapy medication containing the active substance decitabine, a hypomethylating agent used to treat acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in adults. It works by inhibiting DNA methyltransferases, reactivating silenced tumour suppressor genes and promoting the death of abnormal blood cells.
Decitabine belongs to the class of medications known as hypomethylating agents, which are a subgroup of antineoplastic antimetabolites. It is a synthetic analogue of the natural nucleoside 2'-deoxycytidine. Decitabine was first approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of myelodysplastic syndromes and has since gained marketing authorization from the European Medicines Agency (EMA) for the treatment of AML in adults aged 65 years and older who are not candidates for standard induction chemotherapy.
The primary indications for Decitabin Teva include the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy. It is also used for the treatment of myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes, and patients in intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.
In AML, malignant myeloid precursor cells accumulate in the bone marrow, crowding out normal blood cell production. This leads to dangerously low levels of healthy red blood cells, white blood cells, and platelets. MDS represents a group of closely related bone marrow disorders characterised by ineffective haematopoiesis, cytopenias, and a variable risk of transformation to acute leukemia. Approximately 30% of MDS cases progress to AML.
At low concentrations, decitabine acts primarily as a hypomethylating agent. After incorporation into DNA, it irreversibly binds to and inhibits DNA methyltransferases (DNMTs). This leads to progressive loss of DNA methylation (hypomethylation) across the genome. In cancer cells, particularly in MDS and AML, abnormal hypermethylation of CpG islands in the promoter regions of tumour suppressor genes silences their expression. By reversing this methylation, decitabine reactivates these genes, restoring normal cell differentiation and apoptotic pathways. At higher doses, decitabine becomes directly cytotoxic through incorporation into DNA, leading to cell death.
Decitabin Teva is manufactured by Teva Pharmaceuticals and is available as a powder for concentrate for solution for infusion, with each vial containing 50 mg of decitabine. The powder must be reconstituted and then further diluted before intravenous administration. Other brand names for decitabine include Dacogen, which was the first approved formulation of decitabine in many markets.
What Should You Know Before Taking Decitabin Teva?
Before starting Decitabin Teva, your doctor will assess your blood counts, liver function, kidney function, and overall health status. This medication is contraindicated during pregnancy and breastfeeding and carries significant risks including severe myelosuppression, infections, and hepatotoxicity.
Contraindications
Decitabin Teva must not be used if you have a known hypersensitivity to decitabine or to any of the excipients contained in the formulation. It is absolutely contraindicated during pregnancy, as decitabine has demonstrated teratogenic effects in preclinical animal studies and can cause serious harm to an unborn child. Women who are breastfeeding must also not receive this medication, as it is unknown whether decitabine or its metabolites are excreted in human breast milk.
Patients with severe hepatic impairment should be closely monitored, as decitabine is metabolised in the liver and impaired hepatic function may increase drug exposure and toxicity. Similarly, patients with severe renal impairment require careful assessment, although dose adjustments have not been specifically established for renal impairment since decitabine is primarily metabolised by cytidine deaminase found in the liver and other tissues.
Warnings and Precautions
Decitabin Teva causes myelosuppression, which can lead to severe and potentially life-threatening neutropenia, thrombocytopenia, and anaemia. Complete blood counts must be performed before each treatment cycle. Patients should be monitored for signs of infection, bleeding, and anaemia. Dose delays or modifications may be necessary.
The most clinically significant risk associated with decitabine therapy is myelosuppression. This is an expected pharmacological effect of the drug, as it acts on rapidly dividing cells in the bone marrow. Neutropenia (low neutrophil count) increases the risk of serious and potentially fatal infections. Thrombocytopenia (low platelet count) increases the risk of bleeding, which can be severe. Anaemia (low red blood cell count) may require red blood cell transfusions.
Patients receiving decitabine are at increased risk of infections, including bacterial, viral, and fungal infections. Opportunistic infections such as pneumonia, sepsis, and invasive fungal infections can be life-threatening. Prophylactic antimicrobial therapy may be considered at the discretion of the treating physician. Patients should be advised to report any signs of infection promptly, including fever, chills, cough, or difficulty breathing.
Hepatotoxicity has been reported in patients receiving decitabine. Liver function tests should be monitored before and during treatment. If serum transaminases exceed five times the upper limit of normal or serum bilirubin exceeds three times the upper limit of normal, treatment should be withheld until liver function returns to acceptable levels.
Patients with pre-existing cardiovascular conditions should be monitored carefully, as cardiotoxicity has been reported rarely. Decitabine should be used with caution in patients with a history of congestive heart failure, recent myocardial infarction, or unstable angina.
Pregnancy and Breastfeeding
Decitabin Teva is contraindicated during pregnancy. Based on the mechanism of action and findings from animal studies, decitabine can cause foetal harm when administered to a pregnant woman. In preclinical reproductive toxicity studies, decitabine demonstrated teratogenicity, embryotoxicity, and reduced foetal growth at doses well below the clinical dose. There are no adequate and well-controlled studies in pregnant women.
Women of childbearing potential must use effective contraception during treatment with Decitabin Teva and for at least 6 months after the last dose. A pregnancy test should be performed before starting treatment. Male patients with female partners of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose, as decitabine may damage spermatozoa and cause chromosomal aberrations.
Breastfeeding must be discontinued during treatment with Decitabin Teva. It is not known whether decitabine or its metabolites are excreted in human breast milk. Given the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose.
How Does Decitabin Teva Interact with Other Drugs?
Decitabin Teva can interact with other medications, particularly those that affect bone marrow function, liver enzymes, or the immune system. Inform your treating physician about all medications, supplements, and herbal products you are taking before starting treatment.
Formal drug-drug interaction studies with decitabine are limited. However, based on its mechanism of action and metabolic pathway, several clinically important interactions should be considered. Decitabine is primarily metabolised by cytidine deaminase, an enzyme widely distributed in tissues including the liver, spleen, and blood. It is not significantly metabolised by cytochrome P450 enzymes, which reduces the likelihood of many conventional drug-drug interactions.
Major Interactions
| Interacting Drug | Type of Interaction | Clinical Significance |
|---|---|---|
| Live vaccines | Immunosuppression risk | Live vaccines are contraindicated during decitabine treatment due to risk of disseminated infection from the vaccine organism. Inactivated vaccines may have reduced efficacy. |
| Other myelosuppressive agents | Additive myelosuppression | Concurrent use with other chemotherapy agents, immunosuppressants, or radiation therapy increases risk of severe cytopenias. Close monitoring required. |
| Cytarabine | Pharmacological antagonism | Cytarabine may interfere with the hypomethylating activity of decitabine. Sequential administration should be carefully timed. |
| Hepatotoxic medications | Additive hepatotoxicity | Concurrent use with other hepatotoxic drugs (e.g. methotrexate, valproic acid) may increase risk of liver damage. Monitor liver function closely. |
| Nephrotoxic medications | Additive nephrotoxicity | Concurrent use with nephrotoxic agents may increase risk of renal impairment. Monitor renal function during treatment. |
Minor Interactions
Since decitabine is not significantly metabolised by the cytochrome P450 system and is not a known inhibitor or inducer of CYP enzymes, the potential for pharmacokinetic interactions with drugs metabolised by these pathways is considered low. However, as a general principle, any co-administered medications that could exacerbate the side effects of decitabine (such as bleeding tendency with anticoagulants, or infection risk with corticosteroids) should be used with appropriate caution and monitoring.
Patients taking anticoagulants or antiplatelet agents should be monitored more frequently for bleeding complications, as decitabine-induced thrombocytopenia can significantly increase bleeding risk. The use of non-steroidal anti-inflammatory drugs (NSAIDs) should also be approached with caution for the same reason.
What Is the Correct Dosage of Decitabin Teva?
Decitabin Teva is given as an intravenous infusion in hospital. The standard dosage for AML is 20 mg/m² body surface area administered over 1 hour, repeated daily for 5 consecutive days, in a treatment cycle of 4 weeks. The MDS regimen may involve different schedules. Dosage adjustments are based on haematological response and toxicity.
Adults
AML – Standard 5-Day Regimen
Dose: 20 mg/m² body surface area, administered as a 1-hour intravenous infusion.
Schedule: Once daily for 5 consecutive days (Days 1–5), repeated every 4 weeks (28-day cycle).
Duration: Treatment should be continued for a minimum of 4 cycles. It is recommended to continue treatment as long as the patient continues to show benefit or until disease progression or unacceptable toxicity.
MDS – 5-Day Regimen
Dose: 20 mg/m² body surface area, administered as a 1-hour intravenous infusion.
Schedule: Once daily for 5 consecutive days, repeated every 4 weeks (28-day cycle).
Duration: Continue until disease progression or unacceptable toxicity. A minimum of 4–6 cycles is recommended before assessing response.
MDS – Alternative 3-Day Regimen
Dose: 15 mg/m² body surface area, administered as a 3-hour intravenous infusion.
Schedule: Every 8 hours for 3 days (9 doses total), repeated every 6 weeks (42-day cycle).
Duration: Continue until disease progression, unacceptable toxicity, or for a minimum of 4 cycles.
| Indication | Dose | Schedule | Cycle Length |
|---|---|---|---|
| AML (standard) | 20 mg/m² IV over 1 hour | Days 1–5 | Every 28 days |
| MDS (5-day) | 20 mg/m² IV over 1 hour | Days 1–5 | Every 28 days |
| MDS (3-day) | 15 mg/m² IV over 3 hours | Every 8 hours × 3 days | Every 42 days |
Children
Decitabin Teva is not indicated for use in children and adolescents (under 18 years of age). The safety and efficacy of decitabine in the paediatric population have not been established. No data are available from clinical trials in paediatric patients. The use of this medication in children should only be considered within the context of a clinical trial and under the supervision of a paediatric oncologist.
Elderly
No dose adjustment is necessary based on age alone. The majority of patients treated with decitabine in clinical trials were elderly (65 years and older), and the drug is specifically indicated for older adults with AML who are not fit for intensive chemotherapy. However, elderly patients may be more susceptible to the myelosuppressive and infectious complications of treatment and should be monitored particularly closely. Supportive care measures including growth factor support, prophylactic antibiotics, and transfusions should be employed as clinically indicated.
Missed Dose
Because Decitabin Teva is administered in a hospital or clinic setting by healthcare professionals, missed doses are unlikely. However, if a dose is missed or treatment is delayed, the treating physician will determine the most appropriate course of action based on clinical circumstances. Treatment cycles may be delayed to allow recovery from haematological toxicity. The next treatment cycle should not begin until the absolute neutrophil count (ANC) recovers to at least 1.0 × 109/L and the platelet count recovers to at least 50 × 109/L.
Overdose
There is no specific antidote for decitabine overdose. In the event of overdose, the primary risks are prolonged and severe myelosuppression, including neutropenia, thrombocytopenia, and anaemia. Management should be supportive, including monitoring of blood counts, administration of blood products as needed (red blood cell and platelet transfusions), use of growth factors (G-CSF for neutropenia), and aggressive treatment of any infections. Patients should be monitored in a hospital setting until haematological recovery.
What Are the Side Effects of Decitabin Teva?
Like all chemotherapy medications, Decitabin Teva can cause side effects. The most common are myelosuppression (low blood counts), infections, fatigue, nausea, and fever. Serious side effects include severe infections, bleeding, and liver damage. Report any new or worsening symptoms to your healthcare team immediately.
Side effects from decitabine are common and largely reflect its mechanism of action on rapidly dividing cells. Myelosuppression is the most clinically significant adverse effect and is expected during treatment. The severity of side effects often depends on the dose, schedule, and individual patient factors. Most adverse reactions are manageable with appropriate supportive care, dose modifications, and treatment delays.
Very Common (affects more than 1 in 10 patients)
- Neutropenia – low neutrophil count, increasing infection risk
- Thrombocytopenia – low platelet count, increasing bleeding risk
- Anaemia – low red blood cell count, causing fatigue and weakness
- Febrile neutropenia – fever with low neutrophil count
- Pyrexia (fever) – elevated body temperature
- Nausea – feeling sick
- Fatigue – unusual tiredness or lack of energy
- Diarrhoea – loose or frequent bowel movements
- Constipation
- Pneumonia – lung infection
- Headache
- Petechiae – small red or purple spots on the skin from bleeding under the skin
Common (affects 1 to 10 in 100 patients)
- Sepsis – life-threatening blood infection
- Urinary tract infections
- Upper respiratory tract infections
- Oral candidiasis – fungal mouth infection
- Stomatitis – inflammation and sores in the mouth
- Vomiting
- Decreased appetite
- Dizziness
- Rash
- Hypokalaemia – low potassium levels
- Hyperglycaemia – high blood sugar levels
- Epistaxis – nosebleeds
- Abnormal liver function tests – elevated transaminases or bilirubin
Uncommon (affects 1 to 10 in 1,000 patients)
- Pancytopenia – deficiency of all three types of blood cells
- Tumour lysis syndrome – rapid breakdown of cancer cells causing metabolic disturbances
- Interstitial lung disease
- Acute febrile neutrophilic dermatosis (Sweet syndrome)
- Hepatic failure
- Cardiac arrhythmias
Rare (affects fewer than 1 in 1,000 patients)
- Differentiation syndrome – a serious reaction involving fever, lung infiltrates, and fluid retention
- Severe hypersensitivity reactions – including anaphylaxis
- Progressive multifocal leukoencephalopathy (PML)
Contact your healthcare team or seek emergency medical care immediately if you experience: fever or chills (signs of infection), unusual bleeding or bruising, severe shortness of breath, chest pain, sudden confusion, jaundice (yellowing of skin or eyes), or a rapid, irregular heartbeat. These may be signs of serious complications that require urgent treatment.
How Should You Store Decitabin Teva?
Decitabin Teva should be stored below 25°C in the original packaging to protect from light and moisture. As a hospital-use medication, storage is managed by pharmacy staff. Once reconstituted, the solution should be used promptly within the specified timeframe.
The unopened vials of Decitabin Teva powder should be stored at temperatures not exceeding 25°C (77°F). The vials should be kept in the original carton to protect from light. Do not freeze the powder. Keep out of reach of children.
After reconstitution with sterile water for injection, the concentrate should be used immediately or within 15 minutes. If further diluted with cold infusion fluids (refrigerated 0.9% sodium chloride or 5% glucose solution at 2–8°C), the diluted solution may be stored for up to a maximum of 7 hours under refrigeration (2–8°C), followed by up to 1 hour at room temperature (15–25°C) prior to administration.
As a cytotoxic medication, any unused product or waste material must be disposed of in accordance with local regulations for handling chemotherapy drugs. Healthcare professionals should follow appropriate procedures for safe handling, including the use of protective gloves, gowns, and eye protection during preparation and administration.
Do not use Decitabin Teva after the expiry date printed on the carton and vial label. The expiry date refers to the last day of that month. Visually inspect the reconstituted solution for particulate matter and discolouration before use. Do not use if the solution is not clear or if particulate matter is visible.
What Does Decitabin Teva Contain?
Each vial of Decitabin Teva contains 50 mg of the active substance decitabine, along with excipients including potassium dihydrogen phosphate, sodium hydroxide, and hydrochloric acid used to adjust the pH of the formulation.
The active substance in Decitabin Teva is decitabine (5-aza-2'-deoxycytidine), a synthetic nucleoside analogue. Each vial contains 50 mg of decitabine as a sterile lyophilised white to almost white powder.
The excipients (inactive ingredients) include:
- Potassium dihydrogen phosphate (E340) – used as a buffering agent to maintain the pH of the solution
- Sodium hydroxide (E524) – used for pH adjustment
- Hydrochloric acid (E507) – used for pH adjustment
After reconstitution with 10 mL of sterile water for injection, each mL of concentrate contains approximately 5 mg of decitabine. The resulting solution has a pH of approximately 6.7–7.3. The reconstituted solution should be clear and free of visible particulate matter. The concentrate is then further diluted with 0.9% sodium chloride or 5% glucose solution before intravenous administration.
Decitabin Teva does not contain preservatives, antimicrobial agents, or latex in the vial stopper. The product is intended for single-use only and any unused portion should be discarded.
Frequently Asked Questions About Decitabin Teva
Medical References
- European Medicines Agency (EMA). Dacogen (decitabine) – Summary of Product Characteristics. Updated 2024. Available at: www.ema.europa.eu
- Kantarjian HM, Thomas XG, Dmoszynska A, et al. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012;30(21):2670-2677. doi:10.1200/JCO.2011.38.9429 (DACO-016 trial)
- Steensma DP, Baer MR, Slack JL, et al. Multicenter study of decitabine administered daily for 5 days every 4 weeks to adults with myelodysplastic syndromes. J Clin Oncol. 2009;27(23):3842-3848. doi:10.1200/JCO.2008.20.7001
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia. Version 3.2025. Available at: www.nccn.org
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes. Version 1.2025. Available at: www.nccn.org
- Lubbert M, Suciu S, Baila L, et al. Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy: final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. J Clin Oncol. 2011;29(15):1987-1996. doi:10.1200/JCO.2010.30.9245
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: World Health Organization; 2023.
- Issa JP, Garcia-Manero G, Giles FJ, et al. Phase 1 study of low-dose prolonged exposure schedules of the hypomethylating agent 5-aza-2'-deoxycytidine (decitabine) in hematopoietic malignancies. Blood. 2004;103(5):1635-1640. doi:10.1182/blood-2003-03-0687
- Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009;10(3):223-232. doi:10.1016/S1470-2045(09)70003-8
- U.S. Food and Drug Administration (FDA). Dacogen (decitabine) for Injection – Prescribing Information. Revised 2023.
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