AZACITIDINE FOR INJECTION 100 MG

What is AZACITIDINE FOR INJECTION?

AZACITIDINE FOR INJECTION 100 MG contains AZACITIDINE : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02529599, held by SANDOZ CANADA INCORPORATED, supplied as POWDER FOR SUSPENSION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 17-Apr-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is AZACITIDINE FOR INJECTION used for?

Azacitidine for Injection is indicated for the treatment of adult patients who are not eligible for hematopoietic stem cell transplantation with: Intermediate-2 and High-risk Myelodysplastic Syndrome (MDS) according to the International Prognostic Scoring System (IPSS), Acute Myeloid Leukemia (AML) with 20-30% blasts and multi lineage dysplasia, according to World Health Organization (WHO) classification.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 of body surface area, injected subcutaneously, daily for 7 consecutive days, followed by a rest period of 21 days (28-day treatment cycle). Patients should be treated for a minimum of 6 cycles unless unacceptable toxicities occur. Treatment should be continued as long as the patient continues to benefit or until disease progression. Patients should be monitored for hematologic response/toxicity and renal toxicities; a delay in starting the next cycle or a dose reduction may be necessary. Patients should be premedicated with anti-emetics for nausea and vomiting. Azacitidine for Injection (azacitidine for injection) is for subcutaneous use only. Reconstitution: 100 mg vial with 4 mL water for injection to achieve 25 mg/mL concentration. The suspension should be vigorously shaken until uniform and cloudy. Discard if large particles or agglomerates. Administer within 45 minutes of reconstitution or store in refrigerator (2°C to 8°C) for a maximum of 8 hours. Administer subcutaneously (45-90° angle) into upper arm, thigh or abdomen. Rotate injection sites. New injections should be at least 2.5 cm from previous site and not into tender, bruised, red, or hardened areas. Doses requiring more than 1 vial should be divided and injected into separate sites. Re-suspend immediately prior to administration by rolling syringe between palms until uniform, cloudy suspension is achieved. Discard if large particles or agglomerates. Missed Dose: If a dose is missed during the 7-day cycle, it should be added to the end of the current dosing cycle.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at room temperature (15 to 30°C). Keep out of reach and sight of children. Stability after reconstitution: Reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than 8 hours at 2°C to 8°C. Room Temperature (non-refrigerated water): 60 minutes in vial and syringe. 2°C to 8°C (non-refrigerated water): 24 hours in vial and syringe. 2°C to 8°C (refrigerated water): 36 hours in vial, 30 hours in syringe.

How is it supplied?

Azacitidine for Injection is supplied in 100 mg single-use vials packaged in cartons of 1 vial. Each vial contains 100 mg of azacitidine and 100 mg mannitol as a sterile white lyophilized powder for reconstitution as a suspension for subcutaneous injection.

Contraindications

Patients who are hypersensitive to azacitidine or to any ingredient in the formulation or component of the container. Advanced malignant hepatic tumors.

Warnings and precautions

Serious Warnings and Precautions: Thrombocytopenia, Renal failure (including fatalities), Differentiation Syndrome. Azacitidine for Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Treatment may require supportive care for serious bleeding, infection, nausea, and vomiting. Azacitidine is mutagenic and clastogenic. Tumor Lysis Syndrome (TLS) has been reported; patients at risk should be monitored closely. Differentiation syndrome (retinoic acid syndrome) has been reported and may be fatal; symptoms include respiratory distress, pulmonary infiltrates, fever, rash, pulmonary oedema, peripheral oedema, rapid weight gain, pleural effusions, pericardial effusions, hypotension and renal dysfunction. Treatment with high-dose IV corticosteroids and hemodynamic monitoring should be considered. Temporary discontinuation may be necessary. Hematologic toxicity (anemia, neutropenia, thrombocytopenia) is common, especially in the first 2 cycles. Complete blood counts should be monitored. Patients should report febrile episodes and signs of bleeding. Supportive measures (transfusions, growth factors, prophylactic antibiotics) may be needed. Necrotizing fasciitis, including fatal cases, has been reported; discontinue therapy and initiate appropriate treatment. Injection site necrosis has been reported; monitor for signs and manage as warranted.

What can be used instead?

Other Canadian products sharing ATC code L01BC07 AZACITIDINE. 7 of 14 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies AZACITIDINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. AZACITIDINE appears in 411 registered pack listings across 10 markets, published on 7 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.