Azacitid
Generic Name
Azacitidine 100 mg Injection
Manufacturer
Various (e.g., Celgene, Dr. Reddy's)
Country
Global (e.g., USA, India)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| azacitid 100 mg injection | ৳ 6,500.00 | N/A |
Description
Overview of the medicine
Azacitidine is an antineoplastic agent used in the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). It works by correcting abnormal DNA methylation and restoring normal cell function, leading to reduced cancer cell growth.
Uses & Indications
Dosage
Adults
For MDS and AML: 75 mg/m² subcutaneously or intravenously daily for 7 days, repeated every 28 days. A minimum of 4 treatment cycles is recommended.
Elderly
No specific dose adjustment is generally required for elderly patients based on age alone, but renal function should be considered.
Renal_impairment
Initial dose of 75 mg/m² for patients with mild to moderate renal impairment. For severe renal impairment, monitor closely for toxicity and consider dose reduction or interruption if necessary.
How to Take
Administer subcutaneously (SC) into the thigh, abdomen, or upper arm. Rotate injection sites. May also be administered intravenously (IV) as a 10-40 minute infusion.
Mechanism of Action
Azacitidine is a pyrimidine nucleoside analogue of cytidine. It incorporates into DNA and RNA. When incorporated into DNA, it inhibits DNA methyltransferases, leading to hypomethylation of DNA. This can restore normal function to genes that are critical for cell differentiation and proliferation, which were abnormally silenced in cancer cells. In RNA, it interferes with RNA metabolism.
Pharmacokinetics
Onset
Therapeutic effects are not immediate; clinical response usually observed after multiple treatment cycles (e.g., 2-4 cycles).
Excretion
Mainly excreted renally (approximately 50-85% of the dose within 24 hours), with a small amount excreted in feces.
Half life
Plasma terminal half-life is approximately 0.5 to 2 hours after IV administration and 3.5 to 4 hours after SC administration.
Absorption
Rapidly absorbed after subcutaneous (SC) administration; bioavailability is ~89%. Intravenous (IV) administration provides 100% bioavailability.
Metabolism
Primarily metabolized in the liver by cytidine deaminase. Also metabolized by esterases.
Side Effects
Contraindications
- Hypersensitivity to azacitidine or mannitol
- Patients with advanced hepatic malignancy
Drug Interactions
Other myelosuppressive agents
Increased risk of myelosuppression. Concurrent use should be avoided or managed with dose adjustments and close monitoring.
Drugs metabolized by cytidine deaminase (e.g., Gemcitabine)
Potential for altered metabolism, though clinical significance is generally limited.
Storage
Store unopened vials at 20°C to 25°C (68°F to 77°F). Protect from light. Store reconstituted solution as directed by package insert, typically at 2°C to 8°C.
Overdose
Symptoms of overdose include severe myelosuppression, gastrointestinal toxicity (e.g., nausea, vomiting, diarrhea), and hepatic toxicity. Treatment is supportive and symptomatic, with close monitoring of hematological and hepatic parameters.
Pregnancy & Lactation
Pregnancy Category D: May cause fetal harm. Avoid use in pregnant women unless the potential benefit justifies the potential risk to the fetus. Lactation: It is unknown whether azacitidine is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment.
Side Effects
Contraindications
- Hypersensitivity to azacitidine or mannitol
- Patients with advanced hepatic malignancy
Drug Interactions
Other myelosuppressive agents
Increased risk of myelosuppression. Concurrent use should be avoided or managed with dose adjustments and close monitoring.
Drugs metabolized by cytidine deaminase (e.g., Gemcitabine)
Potential for altered metabolism, though clinical significance is generally limited.
Storage
Store unopened vials at 20°C to 25°C (68°F to 77°F). Protect from light. Store reconstituted solution as directed by package insert, typically at 2°C to 8°C.
Overdose
Symptoms of overdose include severe myelosuppression, gastrointestinal toxicity (e.g., nausea, vomiting, diarrhea), and hepatic toxicity. Treatment is supportive and symptomatic, with close monitoring of hematological and hepatic parameters.
Pregnancy & Lactation
Pregnancy Category D: May cause fetal harm. Avoid use in pregnant women unless the potential benefit justifies the potential risk to the fetus. Lactation: It is unknown whether azacitidine is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years when stored unopened. Reconstituted solution stability varies (e.g., 8 hours at 25°C or 22 hours at 2°C to 8°C).
Availability
Hospital pharmacies, specialized oncology centers
Approval Status
FDA Approved
Patent Status
Generic versions available, original patent expired
WHO Essential Medicine
YesClinical Trials
Azacitidine has been extensively studied in clinical trials for MDS and AML, demonstrating improved overall survival and hematologic responses. Ongoing trials investigate its use in other hematologic malignancies and solid tumors, sometimes in combination with other agents.
Lab Monitoring
- Complete blood counts (CBC) with differential, including platelet counts, before each cycle and as needed
- Renal function tests (serum creatinine, BUN) periodically
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) periodically
Doctor Notes
- Ensure proper hydration, especially for elderly patients or those with pre-existing renal impairment.
- Monitor CBCs rigorously and adjust dose/schedule for hematologic toxicity.
- Educate patients on signs of myelosuppression (fever, bleeding) and injection site care.
Patient Guidelines
- Report any signs of infection (fever, chills) or bleeding (unusual bruising, prolonged bleeding) immediately.
- Maintain adequate hydration throughout treatment.
- Avoid contact with people who have infections.
- Follow specific instructions from your healthcare provider regarding injection administration and site rotation.
Missed Dose Advice
If a dose is missed, contact your healthcare provider immediately to determine the best course of action. Do not take a double dose to make up for a missed one.
Driving Precautions
Azacitidine may cause fatigue, dizziness, or weakness. Patients should be cautioned about driving or operating machinery until they know how azacitidine affects them.
Lifestyle Advice
- Practice good hygiene to prevent infections.
- Avoid activities that could lead to injury or bleeding.
- Maintain a balanced diet.
- Discuss any complementary therapies with your doctor.
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