Azacitidine for Injection 100mg Technical Specification:
| Product Name: | Azacitidine for Injection 100mg |
| Brand Name: | Dessraunt |
| Strength: | 50mg, 100mg, 150mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For Subcutaneous, Intravenous use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Cancer |
| Indication: | Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia. |
| Storage: | Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Azacitidine for Injection 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Azacitidine for Injection 100mg
Each vial contains:
Azacitidine……………………100mg
(as Lyophillized powder)
Excipients……………………..q.s.
THERAPEUTIC INDICATION:
Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia.
DIRECTION OF USE:
For Subcutaneous, Intravenous use only
Use sterile water for Injections IP for subcutaneous & for intravenous use.
See prescribing information for dosing and administration.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CYTOTOXIC AGENT: Handle with care
Lyophilized Injection, should reconstitute prior to administration.
Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.
Why Taj Pharmaceuticals?
Discover why Taj Pharma is your top choice for Azacitidine for Injection. With a legacy of pharmaceutical excellence, we deliver trusted quality and efficacy in cancer treatment. Our commitment to patient care sets us apart. Choose Taj Pharma for your healthcare needs.
- Proven Pharmaceutical Excellence: Taj Pharma has established itself as a leader in the pharmaceutical industry, with a long-standing legacy of expertise and innovation. Our dedication to producing high-quality medications is reflected in every Azacitidine for Injection we provide, ensuring consistent, reliable cancer treatment.
- Cancer Treatment You Can Trust: Azacitidine is a crucial medication used in the treatment of certain types of cancer, particularly myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). At Taj Pharma, we understand the critical importance of this treatment and are committed to delivering medication that patients and healthcare professionals can trust.
- Quality Assurance: We uphold the highest standards of quality control and adhere to stringent international pharmaceutical guidelines. Every Azacitidine for Injection undergoes rigorous testing and quality assurance measures to ensure safety, efficacy, and the best possible outcomes for patients.
- Patient-Centric Approach: Taj Pharma places patients at the center of everything we do. We are dedicated to improving the lives of individuals facing cancer and other health challenges. Our Azacitidine for Injection is just one example of our commitment to patient care and well-being.
- Global Reputation: Taj Pharma is a globally recognized name in the pharmaceutical sector, known for its unwavering dedication to patient care and the quality of its products. When you choose Taj Pharma, you choose a brand trusted by healthcare professionals and patients worldwide.
Select Taj Pharma for Azacitidine for Injection and experience the difference in quality, efficacy, and patient-centered care. Trust us for your healthcare needs and cancer treatment.
What is Azacitidine for Injection and its use?
Azacitidine for Injection is a medication used in the treatment of certain blood disorders, specifically myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). It is an important therapeutic option for patients diagnosed with these conditions.
Use of Azacitidine for Injection:
- Myelodysplastic Syndromes (MDS): Azacitidine is frequently prescribed to individuals with MDS, a group of bone marrow disorders characterized by ineffective blood cell production. MDS can lead to low levels of healthy blood cells, including red blood cells, white blood cells, and platelets. Azacitidine helps improve blood cell production and may delay the progression of MDS to more severe forms, such as AML.
- Acute Myeloid Leukemia (AML): Azacitidine is also used in the treatment of AML, a type of cancer that affects the bone marrow and blood. In AML, there is an overproduction of immature white blood cells, which can crowd out healthy blood cells. Azacitidine can be beneficial for some individuals with AML, especially those who are not candidates for intensive chemotherapy.
Azacitidine works by inhibiting the abnormal growth and division of bone marrow cells, including those with cancerous or pre-cancerous changes. It helps promote the production of more mature and healthy blood cells, which can improve blood counts and reduce the risk of complications associated with low blood cell levels.
The use of Azacitidine for Injection should be carefully determined by a healthcare provider based on the specific diagnosis, disease stage, and individual patient factors. It is typically administered as an injection into the bloodstream under the supervision of a medical professional. Azacitidine may be used as a primary treatment or as part of a combination therapy approach for these blood disorders. The treatment regimen, including dosage and duration, will be determined by the healthcare team, and regular monitoring of blood counts and overall health is essential during treatment.
How does Azacitidine for Injection Work?
Azacitidine for Injection works as a cytotoxic (cell-killing) medication that targets abnormal and rapidly dividing cells in the bone marrow. It belongs to a class of drugs known as hypomethylating agents, and its mechanism of action involves several key steps:
- DNA Demethylation: Azacitidine is incorporated into the DNA (genetic material) of cells. It acts as a DNA methyltransferase inhibitor, which means it interferes with the addition of methyl groups to specific regions of DNA. Methylation is a chemical modification that typically silences genes by preventing their expression.
- Reactivation of Tumor Suppressor Genes: In cancer cells, including those found in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), certain genes that act as tumor suppressors are often silenced or downregulated due to hypermethylation. By inhibiting DNA methylation, Azacitidine helps reactivate these tumor suppressor genes. This reactivation can lead to a decrease in cell proliferation and the promotion of cell differentiation (maturation).
- Cell Cycle Arrest: Azacitidine interferes with the cell cycle, preventing abnormal cells from dividing and replicating rapidly. This leads to cell cycle arrest, which can inhibit the growth of cancerous cells.
- Apoptosis (Cell Death): Azacitidine’s impact on DNA methylation and gene expression can trigger apoptosis, a programmed cell death process. Apoptosis is a mechanism by which abnormal or damaged cells are eliminated from the body.
- Promotion of Differentiation: Azacitidine promotes the differentiation of immature or abnormal cells into more mature and functional blood cells. This is particularly important in MDS and AML, where the presence of immature or blast cells can be problematic.
By targeting these molecular and cellular processes, Azacitidine for Injection helps restore more normal cell growth and function in the bone marrow. This can lead to improvements in blood cell counts, a reduction in cancer cell burden, and an overall positive impact on the management of MDS and AML.
Benefits of Azacitidine for Injection:
- Treatment of Myelodysplastic Syndromes (MDS): Azacitidine is an effective treatment option for individuals diagnosed with myelodysplastic syndromes. It can improve blood cell counts, reduce the risk of progression to acute myeloid leukemia (AML), and enhance overall quality of life.
- Management of Acute Myeloid Leukemia (AML): In some cases, Azacitidine is used to treat AML, particularly in individuals who are not candidates for intensive chemotherapy due to factors such as age or overall health. It can help control the disease and improve survival rates.
- Promotion of Cell Differentiation: Azacitidine encourages the maturation and differentiation of blood cells, particularly in AML. This can lead to a decrease in the number of immature blast cells in the bone marrow.
- Extended Survival: Azacitidine therapy has been associated with increased survival rates and a reduced risk of disease progression in individuals with MDS and AML.
Common Side Effects of Azacitidine for Injection:
- Nausea and Vomiting: Nausea and vomiting are common side effects but can often be managed with anti-nausea medications.
- Injection Site Reactions: Pain, redness, or swelling at the injection site may occur. Rotating injection sites can help alleviate this.
- Fatigue: Fatigue or weakness is a common side effect and may require rest and adjustment of daily activities.
- Low Blood Cell Counts: Azacitidine can lead to low white blood cell counts (neutropenia), low red blood cell counts (anemia), and low platelet counts (thrombocytopenia). Regular blood tests and monitoring are necessary during treatment.
- Gastrointestinal Issues: Diarrhea, constipation, abdominal pain, and other gastrointestinal symptoms may occur. A healthcare provider can recommend management strategies.
- Fever: Some individuals may experience fever during Azacitidine treatment. It’s essential to promptly report any fever to a healthcare provider.
- Infections: Due to reduced white blood cell counts, there may be an increased risk of infections. Taking precautions to avoid infection is crucial.
- Skin Rash: Skin reactions, including rashes, may occur as a side effect.
- Liver Function Abnormalities: Azacitidine can affect liver function, and periodic monitoring of liver enzyme levels is typically required.
- Renal Function Changes: Changes in kidney function may also occur, necessitating monitoring of kidney function.
It’s important to remember that not everyone will experience these side effects, and the severity and duration of side effects can vary among individuals. Healthcare providers will carefully monitor patients during treatment and may adjust the dosage or provide supportive care to manage side effects effectively. Patients should communicate openly with their healthcare team about any side effects or concerns during Azacitidine therapy. The potential benefits of the medication in treating MDS or AML should be weighed against the risks and side effects in each individual case.
Frequently asked questions (FAQs) about Azacitidine for Injection:
- What is Azacitidine for Injection used to treat?
Azacitidine for Injection is primarily used to treat myelodysplastic syndromes (MDS) and may also be used to manage acute myeloid leukemia (AML) in certain cases.
- How does Azacitidine for Injection work?
Azacitidine works by inhibiting DNA methylation, reactivating tumor suppressor genes, promoting cell differentiation, and inducing apoptosis (cell death) in rapidly dividing cells, including cancer cells.
- What are the benefits of using Azacitidine for MDS and AML treatment?
The benefits include improved blood cell counts, reduced risk of disease progression, enhanced survival rates, and a potential reduction in the number of immature blast cells in the bone marrow.
- What are the common side effects of Azacitidine for Injection?
Common side effects may include nausea, vomiting, injection site reactions, fatigue, low blood cell counts, gastrointestinal issues, fever, skin rash, and liver or kidney function abnormalities.
- How is Azacitidine for Injection administered?
Azacitidine is typically administered as an injection into the bloodstream by a healthcare professional. The frequency and dosage depend on the specific treatment plan
- Can Azacitidine for Injection be used during pregnancy or breastfeeding?
Azacitidine may harm an unborn baby, so it should only be used during pregnancy if the potential benefits outweigh the risks. It is not recommended during breastfeeding.
- Is Azacitidine for Injection curative for MDS or AML?
Azacitidine is not a curative treatment but is used to manage and control the diseases. The effectiveness varies among individuals, and the treatment approach may differ based on the patient’s condition.
- Are there any drug interactions with Azacitidine for Injection?
Some medications may interact with Azacitidine, so it’s important to inform your healthcare provider about all the medications and supplements you are taking to prevent potential interactions.
- How often will I need to undergo blood tests during Azacitidine treatment?
Blood tests are typically performed regularly during treatment to monitor blood cell counts and overall health. The frequency may vary based on your specific treatment plan.
- What should I do if I experience side effects during Azacitidine treatment?
If you experience side effects or have concerns, it’s crucial to communicate with your healthcare team promptly. They can provide guidance, adjust the treatment plan, or recommend supportive care measures to manage side effects effectively.
As Azacitidine for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Azacitidine for Injection product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Azacitidine for Injection Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Azacitidine for Injection, Taj Pharmaceuticals Limited to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Azacitidine for Injection 50mg
b) Azacitidine for Injection 100mg
c) Azacitidine for Injection 150mg
b) Azacitidine for Injection 100mg
c) Azacitidine for Injection 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Azacitidine for Injection 50mg
Each vial contains:
Azacitidine……………………50mg
(as Lyophillized powder)
Excipients……………………..q.s.
b) Azacitidine for Injection 100mg
Each vial contains:
Azacitidine……………………100mg
(as Lyophillized powder)
Excipients……………………..q.s.
c) Azacitidine for Injection 150mg
Each vial contains:
Azacitidine…………………….150mg
(as Lyophillized powder)
Excipients………………………q.s.
Each vial contains:
Azacitidine……………………50mg
(as Lyophillized powder)
Excipients……………………..q.s.
b) Azacitidine for Injection 100mg
Each vial contains:
Azacitidine……………………100mg
(as Lyophillized powder)
Excipients……………………..q.s.
c) Azacitidine for Injection 150mg
Each vial contains:
Azacitidine…………………….150mg
(as Lyophillized powder)
Excipients………………………q.s.
THERAPEUTIC INDICATION:
Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia.
DIRECTION OF USE:
For Subcutaneous, Intravenous use only
Use sterile water for Injections IP for subcutaneous & for intravenous use.
See prescribing information for dosing and administration.
Use sterile water for Injections IP for subcutaneous & for intravenous use.
See prescribing information for dosing and administration.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CYTOTOXIC AGENT: Handle with care
Lyophilized Injection, should reconstitute prior to administration.
Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Discard Unused portion.
Keep out of the reach of the children.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CYTOTOXIC AGENT: Handle with care
Lyophilized Injection, should reconstitute prior to administration.
Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Protect from light.
Do not freeze.
Dosage: As directed by an Oncologist.
Protect from light.
Do not freeze.
Dosage: As directed by an Oncologist.
