Azacitidine (Azacitidine)

Trade Name : Azacitidine

NorthStar RxLLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 100 mg/1

AZACITIDINE Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azacitidine (Azacitidine) which is also known as Azacitidine and Manufactured by NorthStar RxLLC. It is available in strength of 100 mg/1 per ml. Read more

Azacitidine (Azacitidine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Dosage and Administration () 7/2018
Dosage and Administration () 7/2018

Azacitidine for injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

No data

The recommended starting dose for the first treatment cycle,for all patients regardless of base line hematology values,is azacitidine for injection75 mg/m 7days to be administered by subcutaneous injection or intravenous infusion.Premedicate for nausea and vomiting.n
Repeat cycles every 4 weeks . After 2 cycles, may increase dose to 100 mg/m if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred . Patients should be treated for a minimum of 4 to 6 cycles.Complete or partial response may require additional treatment cycles n
Continue treatment as long as the patient continues to benefit .
Monitor patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate ,,).

Azacitidine for injection isu00a0supplied as lyophilized powder in 100 mg single-dose vials.

Lyophilized powder in 100 mg single-dose vials n

No data

Advanced Malignant Hepatic Tumors .
Hypersensitivity to Azacitidine or Mannitol .

No data

Anemia, Neutropenia and Thrombocytopenia: Monitor complete blood counts frequently (CBC) n
Hepatotoxicity: Patients with severe preexisting hepatic impairment are at higher risk for toxicity .
Renal Toxicity: Monitor patients with renal impairment for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys .
Tumor Lysis Syndrome: Azacitidine for injection may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Assess baseline risk and monitor and treat as appropriate .
Embryo-Fetal Risk: Azacitidine for injection can cause fetal harm. Advise females with reproductive potential of the potential risk to a fetus and to avoid pregnancy .

The following adverse reactions are described in other labeling sections:
u2022 Anemia, Neutropenia and Thrombocytopenia [see n
u2022 Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [see ]u00a0
u2022 Renal Toxicity [see ]
u2022 Tumor Lysis Syndrome [see ]
u2022 Embryo-Fetal Risk [see ]
Most Commonly Occurring Adverse Reactions ()
u00a0: Discontinuation: leukopenia, thrombocytopenia, neutropenia. u00a0u00a0Dose Held: leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, febrile neutropenia. Dose Reduced: leukopenia, neutropenia, thrombocytopenia. u00a0
Most common adverse reactions (>30%) by subcutaneous route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. Most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia n n
To report SUSPECTED ADVERSE REACTIONS, contact North Star RxLLc AT 1-844-375-6847 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.

u2022 Lactation: Discontinue nursing taking into consideration the importance of drug to mother .u00a0

One case of overdose with azacitidine for injection was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single intravenous dose of approximatelyu00a0290 mg/m, almost 4 times the recommended starting dose. u00a0The events resolved without sequelae, and the correct dose was resumed the following day.u00a0 In the event of overdosage, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary. There is no known specific antidote for azacitidine for injection overdosage.u00a0

Azacitidine for injection contains azacitidine, which is a pyrimidine nucleoside analog of cytidine.u00a0 Azacitidine is 4-amino-1-u03b2-D-ribofuranosyl-1,3,5-triazin-2(1H)-one. u00a0The structural formula is as follows:
The empirical formula is CHNO. u00a0The molecular weight is 244.20.u00a0 Azacitidine is a white to off- white powder.u00a0 Azacitidine was found to be soluble in dimethyl sulphoxide, sparingly soluble in water and insoluble in acetone and ethanol.
The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion.u00a0 Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.

No data

The potential carcinogenicity of azacitidine was evaluated in mice and rats.u00a0 Azacitidine induced tumors of the hematopoietic system in female mice at 2.2 mg/kg (6.6 mg/m, approximately 8% the recommended human daily dose on a mg/m basis) administered IP three times per week for 52 weeks.u00a0 An increased incidence of tumors in the lymphoreticular system, lung, mammary gland, and skin was seen in mice treated with azacitidine IP at 2 mg/kg (6 mg/m, approximately 8% the recommended human daily dose on a mg/m basis) once a week for 50 weeks.u00a0 A tumorigenicity study in rats dosed twice weekly at 15 or 60 mg/m (approximately 20 to 80% the recommended human daily dose on a mg/m basis) revealed an increased incidence of testicular tumors compared with controls.u00a0
The mutagenic and clastogenic potential of azacitidine was tested in bacterial systems Salmonella typhimurium strains TA100 and several strains of trpE8, Escherichia coli strains WP14 Pro, WP3103P, WP3104P, and CC103; in forward gene mutation assay in mouse lymphoma cells and human lymphoblast cells; and in an micronucleus assay in mouse L5178Y lymphoma cells and Syrian hamster embryo cells. Azacitidine was mutagenic in bacterial and mammalian cell systems.u00a0 The clastogenic effect of azacitidine was shown by the induction of micronuclei in L5178Y mouse cells and Syrian hamster embryo cells.u00a0
Administration of azacitidine to male mice at 9.9 mg/m (approximately 9% the recommended human daily dose on a mg/m basis) daily for 3 days prior to mating with untreated female mice resulted in decreased fertility and loss of offspring during subsequent embryonic and postnatal development.u00a0 Treatment of male rats 3 times per week for 11 or 16 weeks at doses of 15 to 30 mg/m (approximately 20 to 40%, the recommended human daily dose on a mg/m basis) resulted in decreased weight of the testes and epididymides, and decreased sperm counts accompanied by decreased pregnancy rates and increased loss of embryos in mated females.u00a0 In a related study, male rats treated for 16 weeks at 24 mg/m resulted in an increase in abnormal embryos in mated females when examined on day 2 of gestation.

Myelodysplastic Syndromes (MDS)
Array
Azacitidine for injection was administered at a subcutaneous dose of 75 mg/m daily for 7 days every 4 weeks. The dose was increased to 100 mg/m if no beneficial effect was seen after 2 treatment cycles. The dose was decreased and/or delayed based on hematologic response or evidence of renal toxicity. Patients in the observation arm were allowed by protocol to cross over to azacitidine for injection if they had increases in bone marrow blasts, decreases in hemoglobin, increases in red cell transfusion requirements, or decreases in platelets, or if they required a platelet transfusion or developed a clinical infection requiring treatment with antibiotics.u00a0 For purposes of assessing efficacy, the primary endpoint was response rate (as defined in Table 4).u00a0
Of the 191 patients included in the study, independent review (adjudicated diagnosis) found that 19 had the diagnosis of AML at baseline.u00a0 These patients were excluded from the primary analysis of response rate, although they were included in an intent-to-treat (ITT) analysis of all patients randomized.u00a0 Approximately 55% of the patients randomized to observation crossed over to receive azacitidine for injection treatment.u00a0
Tn- able 3.u00a0 Baseline Demographics and Disease Characteristics
The overall response rate (CR + PR) of 15.7% in azacitidine for injection-treated patients without AML (16.2% for all azacitidine for injection randomized patients including AML) was statistically significantly higher than the response rate of 0% in the observation group (p<0.0001) (Table 5).u00a0 The majority of patients who achieved either CR or PR had either 2 or 3 cell line abnormalities at baseline (79%; 11/14) and had elevated bone marrow blasts or were transfusion dependent at baseline. Patients responding to azacitidine for injection had a decrease in bone marrow blasts percentage, or an increase in platelets, hemoglobin or WBC. u00a0Greater than 90% of the responders initially demonstrated these changes by the 5th treatment cycle.u00a0 All patients who had been transfusion dependent became transfusion independent during PR or CR.u00a0 The mean and median duration of clinical response of PR or better was estimated as 512 and 330 days, respectively; 75% of the responding patients were still in PR or better at completion of treatment. Response occurred in all MDS subtypes as well as in patients with adjudicated baseline diagnosis of AML.
Tn- able 5.u00a0 Response Rates
Patients in the observation group who crossed over to receive azacitidine for injection treatment (47 patients) had a response rate of 12.8%.u00a0
Study 2, a multi-center, open-label, single-arm study of 72 patients with RAEB, RAEB-T, CMMoL, or AML was also carried out.u00a0 Treatment with subcutaneous azacitidine for injection resulted in a response rate (CR + PR) of 13.9%, using criteria similar to those described above.u00a0 The mean and median duration of clinical response of PR or better was estimated as 810 and 430 days, respectively; 80% of the responding patients were still in PR or better at the time of completion of study involvement.u00a0 In Study 3, another open-label, single-arm study of 48 patients with RAEB, RAEB-T, or AML, treatment with intravenous azacitidine for injection resulted in a response rate of 18.8%, again using criteria similar to those described above.u00a0 The mean and median duration of clinical response of PR or better was estimated as 389 and 281 days, respectively; 67% of the responding patients were still in PR or better at the time of completion of treatment.u00a0 Response occurred in all MDS subtypes as well as in patients with adjudicated baseline diagnosis of AML in both of these studies.u00a0 Azacitidine for injection dosage regimens in these 2 studies were similar to the regimen used in the controlled study.u00a0
Benefit was seen in patients who did not meet the criteria for PR or better, but were considered u201cimproved.u201du00a0 About 24% of azacitidine for injection-treated patients were considered improved, and about 2/3 of those lost transfusion dependence. In the observation group, only 5/83 patients met criteria for improvement; none lost transfusion dependence.u00a0 In all 3 studies, about 19% of patients met criteria for improvement with a median duration of 195 days.
u00a0Study 4 was an international, multicenter, open-label, randomized trial in MDS patients with RAEB, RAEB-T or modified CMMoL according to FAB classification and Intermediate-2 and High risk according to IPSS classification.u00a0 Of the 358 patients enrolled in the study, 179 were randomized to receive azacitidine plus best supportive care (BSC) and 179 were randomized to receive conventional care regimens (CCR) plus BSC (105 to BSC alone, 49 to low dose cytarabine and 25 to chemotherapy with cytarabine and anthracycline).u00a0 The primary efficacy endpoint was overall survival.u00a0The azacitidine and CCR groups were comparable for baseline parameters.u00a0 The median age of patients was 69 years (range was 38 to 88 years), 98% were Caucasian, and 70% were male.u00a0 At baseline, 95% of the patients were higher risk by FAB classification:u00a0 RAEB (58%), RAEB-T (34%), and CMMoL (3%).u00a0 By IPSS classification, 87% were higher risk:u00a0 Int-2 (41%), High (47%).u00a0 At baseline, 32% of patients met WHO criteria for AML.u00a0
Azacitidine was administered subcutaneously at a dose of 75 mg/m daily for 7 consecutive days every 28 days (which constituted one cycle of therapy). Patients continued treatment until disease progression, relapse after response, or unacceptable toxicity. Azacitidine patients were treated for a median of 9 cycles (range 1 to 39), BSC only patients for a median of 7 cycles (range 1 to 26), low dose cytarabine patients for a median of 4.5 cycles (range 1 to 15), and chemotherapy with cytarabine and anthracycline patients for a median of 1 cycle (range 1 to 3, i.e. induction plus 1 or 2 consolidation cycles).u00a0In the Intent-to-Treat analysis, patients treated with azacitidine demonstrated a statistically significant difference in overall survival as compared to patients treated with CCR (median survival of 24.5 months vs. 15 months; stratified log-rank p=0.0001). The hazard ratio describing this treatment effect was 0.58 (95% CI: 0.43, 0.77).n n
Kaplan-Meier Curve of Time to Death from Any Cause
Key:u00a0 AZA = azacitidine ; CCR = conventional care regimens; CI = confidence interval; HR = Hazard Ratiou00a0
Azacitidine treatment led to a reduced need for red blood cell transfusions (see Table 6). In patients treated with azacitidine who were RBC transfusion dependent at baseline and became transfusion independent, the median duration of RBC transfusion independence was 13 months.n
Table 6. Effect of Azacitidine on RBC Transfusions in MDS Patients

No data

How Supplied
Azacitidine for injection is supplied as a lyophilized powder in 100 mg single-dose vials packaged in cartons of 1 vial (NDC 16714-927-01).u00a0n
Storage
Store unreconstituted vials at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); [See USP Controlled Room Temperature].u00a0
Handling and Disposal
Azacitidine for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.n

u00a0Hepatotoxicity in Patients with Severe Pre-Existing Hepatic Impairment
Instruct patients to inform their physician about any underlying liver disease [see ].
Renal Toxicity
Instruct patients to inform their physician about any underlying renal disease [see n ) and Use in Specific Populations ()].
Embryo-Fetal Risk
Advise pregnant women of the potential risk to a fetus [see () and n ].u00a0
Advise females of reproductive potential to avoid pregnancy during treatment with azacitidine for injection. Advise males with female sexual partners of reproductive potential to not father a child and to use effective contraception during treatment with azacitidine for injection. Advise patients to report pregnancy to their physicians immediately [see () and ()].
Lactation
Advise patients to avoid breastfeeding while receiving azacitidine for injection [see ].
Rx only
Mfd. for: Northstar Rx LLC Memphis, TN 38141
Manufactured by:
Dr. Reddyu2019s Laboratories Limited
Visakhapatnam - 530 046 INDIA
Revised: 1218

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Azacitidine (Azacitidine)

Trade Name : Azacitidine

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Azacitidine (Azacitidine)

Trade Name : Azacitidine

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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