Azacitidine Lotus Pharma Bulgaria: Uses, Dosage & Side Effects
An oral hypomethylating agent used as maintenance therapy in acute myeloid leukemia (AML) for patients in first complete remission who are not candidates for haematopoietic stem cell transplantation
Azacitidine Lotus Pharma Bulgaria is a prescription oral medication containing the active substance azacitidine, a pyrimidine nucleoside analogue classified as a hypomethylating agent. Available as 200 mg film-coated tablets, it is used as maintenance therapy in adult patients with acute myeloid leukemia (AML) who have achieved complete remission or complete remission with incomplete blood count recovery following induction chemotherapy, with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, haematopoietic stem cell transplantation (HSCT). Azacitidine works by inhibiting DNA methylation and exerting direct cytotoxic effects on abnormal haematopoietic cells, thereby helping to maintain remission and delay relapse.
Quick Facts: Azacitidine Lotus Pharma Bulgaria
Key Takeaways
- Azacitidine Lotus Pharma Bulgaria is an oral tablet formulation of azacitidine specifically indicated for AML maintenance therapy following induction chemotherapy
- The recommended dose is 300 mg (one and a half tablets) taken orally once daily on days 1-14 of each 28-day treatment cycle
- Common side effects include nausea, vomiting, diarrhoea, and myelosuppression (low blood counts) requiring regular monitoring
- This medication must not be used during pregnancy or breastfeeding due to potential teratogenic effects
- Treatment is continued until disease relapse, unacceptable toxicity, or patient decision, with median treatment duration of approximately 12 months in clinical trials
What Is Azacitidine Lotus Pharma Bulgaria and What Is It Used For?
Azacitidine Lotus Pharma Bulgaria contains the active substance azacitidine, a pyrimidine nucleoside analogue that belongs to the class of medicines known as hypomethylating agents or antineoplastic agents. It is available as a 200 mg film-coated tablet and is specifically designed for oral administration as a maintenance treatment for acute myeloid leukemia (AML).
Acute myeloid leukemia is an aggressive cancer of the blood and bone marrow in which the bone marrow produces abnormal white blood cells (myeloid blasts) that accumulate and interfere with normal blood cell production. Initial treatment typically involves intensive induction chemotherapy aimed at achieving complete remission, which means that the number of blast cells in the bone marrow has returned to normal levels. However, even after achieving remission, there is a significant risk of relapse, particularly in patients who are older or who have certain genetic risk factors.
This oral azacitidine formulation was developed to address the unmet need for a convenient, effective maintenance therapy that can extend the duration of remission and improve overall survival in AML patients who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy. It is intended for patients who are not candidates for haematopoietic stem cell transplantation (HSCT) or who choose not to proceed to transplantation.
Mechanism of Action
Azacitidine exerts its antineoplastic effects through two principal mechanisms. At low concentrations, it acts as a DNA hypomethylating agent by inhibiting DNA methyltransferase, the enzyme responsible for adding methyl groups to DNA. In many cancers, including AML, tumour suppressor genes are inappropriately silenced by excessive DNA methylation (hypermethylation). By inhibiting this process, azacitidine can reactivate these silenced genes, restoring normal growth control and promoting differentiation or apoptosis (programmed cell death) of malignant cells.
At higher concentrations, azacitidine is incorporated directly into DNA and RNA, disrupting nucleic acid metabolism and protein synthesis. This dual mechanism results in both epigenetic reprogramming and direct cytotoxic effects on rapidly dividing abnormal cells, while relatively sparing normal haematopoietic progenitor cells.
Oral azacitidine (such as this product) and injectable azacitidine (subcutaneous or intravenous) are not interchangeable. They have different approved indications, dosing schedules, and bioavailability profiles. Oral azacitidine is specifically approved for AML maintenance, while injectable forms are used for treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML), and AML with certain blast percentages. Always follow your prescriber's specific instructions.
Clinical Evidence
The efficacy of oral azacitidine as AML maintenance therapy was established in the landmark QUAZAR AML-001 trial, a phase 3, randomised, double-blind, placebo-controlled international study published in the New England Journal of Medicine in 2020. This trial enrolled 472 patients aged 55 years or older with AML in first complete remission or CRi who were not proceeding to HSCT. Patients receiving oral azacitidine demonstrated a statistically significant improvement in overall survival (median 24.7 months vs. 14.8 months with placebo) and relapse-free survival (median 10.2 months vs. 4.8 months with placebo).
These results represented a major advance in AML treatment, as oral azacitidine became the first maintenance therapy to demonstrate a significant overall survival benefit in AML patients in first remission. The findings led to regulatory approvals by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), and the drug was subsequently incorporated into major clinical guidelines including those from the National Comprehensive Cancer Network (NCCN) and the European LeukemiaNet (ELN).
What Should You Know Before Taking Azacitidine Lotus Pharma Bulgaria?
Contraindications
You should not take Azacitidine Lotus Pharma Bulgaria if you are allergic (hypersensitive) to azacitidine or any of the other ingredients in this medicine. Additionally, azacitidine is contraindicated in patients with advanced malignant hepatic tumours, as the drug is primarily metabolised in the liver and may accumulate to toxic levels in the setting of severely impaired hepatic function.
Women who are pregnant or who could become pregnant must not use this medication, as azacitidine has been shown to be teratogenic (causing birth defects) and embryotoxic in preclinical animal studies. Women who are breastfeeding must also avoid this medicine, as it is unknown whether azacitidine is excreted in human breast milk, but a risk to the nursing infant cannot be excluded given the drug's mechanism of action.
Warnings and Precautions
Azacitidine can cause severe myelosuppression, including neutropenia (low white blood cells), thrombocytopenia (low platelets), and anaemia (low red blood cells). Complete blood counts must be performed before each treatment cycle and as clinically indicated. Treatment may need to be delayed or the dose reduced if blood counts are too low. Contact your doctor immediately if you develop fever, signs of infection, unusual bruising, or prolonged bleeding.
Before and during treatment with azacitidine, your doctor should monitor you for the following conditions:
- Haematological toxicity: Complete blood count (CBC) monitoring before each 28-day cycle is mandatory. Dose modifications, delays, or discontinuation may be necessary based on neutrophil and platelet counts
- Hepatotoxicity: Liver function tests (including bilirubin, ALT, AST, and alkaline phosphatase) should be performed before starting treatment and periodically during treatment. Cases of hepatic failure, including fatal cases, have been reported with azacitidine use
- Renal impairment: Serum creatinine and blood urea nitrogen should be monitored. Dose adjustments may be required in patients with renal impairment. Renal tubular acidosis has been reported rarely
- Gastrointestinal toxicity: Nausea and vomiting are very common. Anti-emetic prophylaxis is recommended before each dose
- Infections: Due to the immunosuppressive effects, patients are at increased risk of infections, including serious and potentially fatal infections. Live or live-attenuated vaccines should be avoided during treatment
- Cardiac disorders: Patients with a history of severe congestive heart failure, clinically unstable cardiac disease, or pulmonary disease should be monitored closely
Pregnancy and Breastfeeding
Azacitidine must not be used during pregnancy. Based on its mechanism of action and preclinical data, azacitidine is expected to cause serious harm to the developing fetus.
Women of childbearing potential must use highly effective contraception during treatment and for at least 6 months after the last dose. A pregnancy test should be performed before starting treatment. If pregnancy occurs during treatment, the patient must be informed of the potential hazard to the fetus.
Male patients with female partners of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Men should be advised to seek counselling on sperm preservation before starting treatment, as azacitidine may impair male fertility.
Breastfeeding must be discontinued during treatment with azacitidine. It is unknown whether azacitidine or its metabolites are excreted in human breast milk, but due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated.
Elderly Patients
The majority of patients in the pivotal QUAZAR AML-001 clinical trial were aged 55 years or older, with the median age being 68 years. No overall differences in safety or efficacy were observed between elderly patients and the general study population. However, elderly patients may be more susceptible to certain adverse effects, particularly myelosuppression and infections, and may require more careful monitoring and dose adjustments.
Driving and Operating Machinery
Azacitidine may have a minor to moderate influence on the ability to drive and use machines. Fatigue is a commonly reported side effect, and patients should be advised to exercise caution when driving or operating machinery if they experience fatigue, dizziness, or other side effects that could impair alertness.
How Does Azacitidine Lotus Pharma Bulgaria Interact with Other Drugs?
Drug interaction studies with oral azacitidine are limited. Based on the known pharmacological properties of azacitidine and clinical experience, several potential interactions should be considered. Azacitidine is primarily metabolised by spontaneous hydrolysis and by cytidine deaminase, and it is not a significant substrate or inhibitor of the major cytochrome P450 (CYP) enzymes, which reduces the likelihood of CYP-mediated drug interactions. However, other types of interactions are clinically relevant.
Major Interactions
| Drug / Class | Interaction | Recommendation |
|---|---|---|
| Live vaccines (e.g., BCG, MMR, varicella) | Azacitidine is immunosuppressive; live vaccines may cause disseminated infection | Avoid live vaccines during treatment and until immune recovery |
| Other myelosuppressive agents | Additive myelosuppression resulting in increased risk of severe cytopenias | Use with extreme caution; monitor blood counts frequently |
| Hepatotoxic drugs (e.g., methotrexate, paracetamol in high doses) | Increased risk of hepatotoxicity and liver failure | Monitor liver function closely; consider dose adjustments |
| Anticoagulants (e.g., warfarin, heparin) | Azacitidine-induced thrombocytopenia increases bleeding risk | Monitor platelet counts and coagulation parameters closely |
Minor Interactions
| Drug / Class | Interaction | Recommendation |
|---|---|---|
| Antacids and PPIs (e.g., omeprazole) | May affect gastric pH and oral absorption of azacitidine | Can generally be used together; no significant clinical impact expected |
| Anti-emetics (e.g., ondansetron) | No known pharmacokinetic interaction | Routinely co-administered; anti-emetic prophylaxis is recommended |
| Inactivated vaccines | Reduced immune response may decrease vaccine effectiveness | Inactivated vaccines may be given but efficacy may be reduced |
Patients should inform their healthcare provider about all prescription medicines, over-the-counter drugs, vitamins, nutritional supplements, and herbal products they are taking, as well as any planned dental procedures or surgeries, before starting treatment with azacitidine. Special attention should be given to drugs that may affect bone marrow function, liver function, or the immune system.
Azacitidine tablets should be taken on an empty stomach or with a light meal. High-fat meals may alter the absorption profile of the drug. Patients should aim to take their dose at approximately the same time each day to maintain consistent drug levels. Grapefruit and grapefruit juice do not have a known significant interaction with azacitidine, as the drug is not primarily metabolised by CYP3A4.
What Is the Correct Dosage of Azacitidine Lotus Pharma Bulgaria?
Azacitidine Lotus Pharma Bulgaria should only be initiated and supervised by a physician experienced in the use of anticancer therapies. The dosing regimen is based on 28-day treatment cycles, with the active medication taken for the first 14 days of each cycle followed by 14 days off treatment.
Adults
Standard Adult Dose
The recommended dose is 300 mg (one 200 mg tablet plus one half of a 200 mg tablet) taken orally once daily on days 1 through 14 of each repeated 28-day cycle.
- Take at approximately the same time each day
- Swallow tablets whole with water
- Do not cut, crush, or chew the tablets unless instructed by your pharmacist
- Take on an empty stomach or with a light meal
- Anti-emetic prophylaxis (e.g., ondansetron) is recommended 30 minutes before each dose for the first 2 cycles, and as needed thereafter
| Parameter | Detail |
|---|---|
| Dose per day | 300 mg orally |
| Treatment days | Days 1-14 of each 28-day cycle |
| Rest period | Days 15-28 (no medication) |
| Cycle duration | 28 days |
| Duration of therapy | Until relapse, unacceptable toxicity, or patient decision |
Dose Modifications for Adverse Reactions
Dose modifications may be required for haematological toxicity and certain non-haematological toxicities. The following adjustments are generally recommended:
| Condition | Action |
|---|---|
| ANC < 0.5 x 10⁹/L on Day 1 | Delay cycle start until ANC recovers to ≥ 0.5 x 10⁹/L |
| Platelets < 25 x 10⁹/L on Day 1 | Delay cycle start until platelets recover to ≥ 25 x 10⁹/L |
| Delay > 14 days for count recovery | Consider dose reduction to 200 mg daily for subsequent cycles |
| Grade 3-4 non-haematological toxicity | Withhold treatment until resolution to Grade ≤ 1, then resume at reduced dose or same dose per physician judgement |
Children
The safety and efficacy of oral azacitidine in children and adolescents (below 18 years of age) have not been established. There are no adequate data from clinical trials in the paediatric population. This medication should not be used in patients under 18 years of age.
Elderly
No specific dose adjustment is required for elderly patients based on age alone. The median age in the QUAZAR AML-001 trial was 68 years, and patients up to 86 years of age were included. However, elderly patients may be more susceptible to adverse effects and should be monitored more carefully. Renal function should be assessed before each cycle, as age-related decline in renal function is common.
Renal and Hepatic Impairment
No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance 30-89 mL/min). Azacitidine has not been studied in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease, and use in these populations is not recommended. For hepatic impairment, no dose adjustment is necessary for mild impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1-1.5x ULN). Use with caution in moderate hepatic impairment and avoid in severe hepatic impairment.
Missed Dose
If a dose is missed or not taken at the usual time, it should be taken as soon as possible on the same day. Patients should not take a double dose on the same day to make up for a missed dose. If an entire day's dose is missed, the patient should take the next scheduled dose at the normal time and continue with the regular dosing schedule. Patients should inform their doctor if they frequently miss doses, as this may affect treatment efficacy.
Overdose
There is no specific antidote for azacitidine overdose. In the event of overdose, the patient should be monitored for adverse reactions, particularly myelosuppression, gastrointestinal toxicity, and hepatotoxicity. Supportive care should be provided as appropriate, including blood count monitoring and management of any complications. Contact your local poison centre or emergency services immediately if overdose is suspected.
What Are the Side Effects of Azacitidine Lotus Pharma Bulgaria?
Like all medicines, Azacitidine Lotus Pharma Bulgaria can cause side effects, although not everybody gets them. The side effects listed below are based on clinical trial data from the QUAZAR AML-001 study and post-marketing surveillance. The frequency categories are defined as: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), and rare (affects fewer than 1 in 1,000 people).
Very Common (more than 1 in 10)
- Nausea - experienced by approximately 65% of patients; anti-emetic prophylaxis recommended
- Vomiting - occurs in approximately 60% of patients
- Diarrhoea - affects approximately 50% of patients
- Constipation
- Abdominal pain - including upper abdominal discomfort
- Neutropenia - low neutrophil (white blood cell) count; increases infection risk
- Thrombocytopenia - low platelet count; increases bleeding risk
- Anaemia - low red blood cell count; may cause fatigue and breathlessness
- Fatigue and asthenia - general tiredness and weakness
- Decreased appetite
- Febrile neutropenia - fever combined with low white blood cell count (medical emergency)
Common (1 in 10 to 1 in 100)
- Upper respiratory tract infection (including nasopharyngitis, sinusitis)
- Urinary tract infection
- Pneumonia - may be serious; report fever and cough to your doctor
- Dizziness
- Headache
- Arthralgia (joint pain) and myalgia (muscle pain)
- Back pain
- Stomatitis (mouth sores/inflammation)
- Dyspepsia (indigestion)
- Weight loss
- Elevated liver enzymes (ALT, AST, bilirubin)
- Rash and pruritus (itching)
- Insomnia
- Peripheral oedema (swelling of extremities)
- Hypokalaemia (low potassium levels)
Uncommon (1 in 100 to 1 in 1,000)
- Hepatotoxicity - including elevated bilirubin, hepatic failure
- Renal tubular acidosis
- Pancytopenia - severe reduction of all blood cell types
- Sepsis - life-threatening infection requiring immediate treatment
- Tumour lysis syndrome - rapid breakdown of cancer cells causing metabolic disturbances
- Interstitial lung disease
- Hypersensitivity reactions - including anaphylaxis (very rare)
Rare (fewer than 1 in 1,000)
- Sweet syndrome (acute febrile neutrophilic dermatosis)
- Pyoderma gangrenosum - ulcerating skin condition
- Necrotising fasciitis - severe soft tissue infection
- Progressive multifocal leukoencephalopathy (PML) - very rare brain infection
- Differentiation syndrome
Contact your doctor or go to the nearest emergency department immediately if you experience any of the following:
- Fever above 38°C (100.4°F), especially if you feel unwell or have chills
- Unusual bleeding, bruising, or blood in urine or stools
- Severe or persistent vomiting or diarrhoea leading to dehydration
- Signs of liver problems: yellowing of skin or eyes, dark urine, severe abdominal pain
- Signs of serious infection: high fever, rapid breathing, confusion
- Chest pain, shortness of breath, or rapid heartbeat
- Severe skin reactions: widespread rash, blistering, or skin peeling
This list does not include all possible side effects. Your doctor or pharmacist can provide more complete information. If you notice any side effects not listed here, or if any side effects become serious, please tell your doctor, pharmacist, or nurse. You can also report side effects directly via your national adverse drug reaction reporting system to help provide more information on the safety of this medicine.
How Should You Store Azacitidine Lotus Pharma Bulgaria?
Proper storage of Azacitidine Lotus Pharma Bulgaria is essential to maintain the quality and potency of the medication. The film-coated tablets should be stored at controlled room temperature, below 25°C (77°F). The tablets should be kept in their original blister packaging until ready to take, in order to protect them from moisture and light.
Keep this medicine out of the sight and reach of children. Children should never handle anticancer medications, and caregivers should wash their hands thoroughly after handling the tablets. If a tablet is accidentally broken or crushed, avoid direct skin contact with the powder and clean any contaminated surfaces thoroughly.
Do not use this medicine after the expiry date which is stated on the outer carton and blister after "EXP". The expiry date refers to the last day of that month. Do not use the medicine if you notice any visible signs of deterioration, such as discolouration, crumbling, or damaged blister packaging.
Do not throw away any medicines via household waste or wastewater. Ask your pharmacist how to throw away medicines you no longer use. Azacitidine is a cytotoxic medication and should be disposed of in accordance with local regulations for anticancer drugs to protect the environment and prevent accidental exposure.
What Does Azacitidine Lotus Pharma Bulgaria Contain?
Each Azacitidine Lotus Pharma Bulgaria 200 mg film-coated tablet contains the following:
Active Substance
- Azacitidine 200 mg per tablet
Other Ingredients (Excipients)
The following inactive ingredients are used in the manufacture of the film-coated tablets:
Tablet core:
- Croscarmellose sodium (disintegrant)
- Magnesium stearate (lubricant)
- Mannitol (filler)
- Microcrystalline cellulose (filler and binder)
- Sodium stearyl fumarate (lubricant)
Film coating:
- Hypromellose (film-forming agent)
- Titanium dioxide (E171) (colourant)
- Triacetin (plasticiser)
- Iron oxide red (E172) (colourant) – contributes to the characteristic colour of the tablet
Appearance
Azacitidine Lotus Pharma Bulgaria 200 mg tablets are film-coated tablets with a characteristic colour. They are supplied in blister packs within an outer carton. The tablets are designed with a score line to facilitate dose splitting when the prescribed dose requires half a tablet (e.g., the standard 300 mg daily dose requires one and a half tablets).
This medicine contains sodium. Each 300 mg dose (1.5 tablets) contains a small amount of sodium from the croscarmellose sodium and sodium stearyl fumarate excipients. The amount is below the threshold that would be considered clinically significant, and this medicine is essentially “sodium-free.” Patients on a controlled sodium diet do not need to adjust their dietary intake on account of this medication.
Frequently Asked Questions About Azacitidine Lotus Pharma Bulgaria
Azacitidine Lotus Pharma Bulgaria is an oral azacitidine formulation (200 mg film-coated tablets) used as maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission or complete remission with incomplete blood count recovery following induction chemotherapy. It is intended for patients who are not candidates for, or choose not to proceed to, haematopoietic stem cell transplantation. The medication works by inhibiting DNA methylation and has direct cytotoxic effects on abnormal blood cells, helping to maintain remission and delay relapse.
Oral azacitidine (200 mg tablets, such as this product) is specifically approved for AML maintenance therapy in patients already in remission. Injectable azacitidine (subcutaneous or intravenous) is used for treating myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML), and AML with certain blast percentages. The oral form has lower bioavailability (approximately 11% relative to subcutaneous administration) and uses a different dosing schedule (300 mg daily on days 1-14 of a 28-day cycle). These two formulations are not interchangeable and serve different clinical purposes.
The most common side effects include gastrointestinal symptoms (nausea affecting about 65% of patients, vomiting in about 60%, and diarrhoea in about 50%), myelosuppression (low blood cell counts including neutropenia, thrombocytopenia, and anaemia), fatigue, decreased appetite, and febrile neutropenia. Anti-emetic medication is routinely recommended before each dose to help manage nausea and vomiting. Regular blood count monitoring is essential to detect and manage myelosuppression.
No, azacitidine must not be used during pregnancy. Based on its mechanism of action and preclinical data, azacitidine is expected to cause serious birth defects and embryo-fetal toxicity. Women of childbearing potential must use highly effective contraception during treatment and for at least 6 months after the last dose. Male patients must also use effective contraception during treatment and for 3 months after the last dose. A pregnancy test should be performed before starting treatment.
Oral azacitidine is intended as a long-term maintenance treatment. In the QUAZAR AML-001 clinical trial, patients continued treatment for a median of approximately 12 months, with some patients receiving treatment for over 2 years. Treatment is continued until disease relapse, unacceptable toxicity, or the patient's decision to stop. Regular blood count monitoring is essential throughout the entire duration of therapy to detect and manage potential side effects.
Complete blood counts (CBC) with differential should be performed before each 28-day treatment cycle and as clinically indicated during treatment. Liver function tests (ALT, AST, bilirubin, alkaline phosphatase) and renal function tests (serum creatinine) should be checked before starting treatment and periodically thereafter. Your doctor will use these results to determine whether your blood counts are adequate to start each cycle and whether any dose adjustments are needed.
References
- Wei AH, Döhner H, Pocock C, et al. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020;383(26):2526-2537. doi:10.1056/NEJMoa2004444
- European Medicines Agency (EMA). Azacitidine oral formulation - Summary of Product Characteristics (SmPC). Updated 2025. Available at: www.ema.europa.eu
- Döhner H, Wei AH, Appelbaum FR, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022;140(12):1345-1377. doi:10.1182/blood.2022016867
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia. Version 3.2025. Available at: www.nccn.org
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. Geneva: WHO; 2023. Available at: www.who.int
- Savona MR, Kolibaba K, Conkling P, et al. Extended dosing with CC-486 (oral azacitidine) in patients with myeloid malignancies. Am J Hematol. 2018;93(10):1199-1206. doi:10.1002/ajh.25216
- Döhner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015;373(12):1136-1152. doi:10.1056/NEJMra1406184
- Fenaux P, Mufti GJ, Hellström-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
- British National Formulary (BNF). Azacitidine. Available at: bnf.nice.org.uk
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