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Azacitidine 100 mg Injection, Powder, Lyophilized, For Solution, 1 injection — NDC 43598-0678-11 package photo
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Azacitidine 100 mg Injection, Powder, Lyophilized, For Solution, 1 injection — NDC 43598-678-11 (Billing 43598-0678-11)

by Dr. Reddy's Laboratories Inc. · 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON

This is a package of 1 injection of Azacitidine 100 mg Injection, Powder, Lyophilized, For Solution from Dr. Reddy's Laboratories Inc., marketed since Dec 2017 and currently FDA-listed. It is this product's only package size.

NDC 43598-0678-11
🏷️ FDA NDC (as labeled) 43598-678-11 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-678-11
Product NDC 43598-678
11-digit billing NDC 43598067811
NCPDP billing unit EA — each (per item)
RxCUI 485246
UNII M801H13NRU
Application # ANDA207518
SPL Set ID d38a1247-28c8-a911-e691-a983a2f9a6e3
Established class (EPC) Nucleoside Metabolic Inhibitor
Mechanism of action Nucleic Acid Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-13
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance AZACITIDINE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21300003001920
GPI class azaCITIDine
GCN Seq No 054660
GCN 22663
HICL code 026361
Ingredient (HICL) Azacitidine
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1B
Therapeutic class — specific (HIC3) Antineoplastic - Antimetabolites
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name AZACITIDINE 100 MG VIAL
FDB brand name Azacitidine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 054660
  • GCN: 22663
  • GPI-14 (Medi-Span): 21300003001920
  • HICL (First Databank): 026361
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 485246
Why two NDCs? The FDA registers this code as 43598-678-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43598-0678-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Pyrimidine analogues
How it works Nucleic Acid Synthesis Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AZACITIDINE 100 MG VIAL Ingredient Azacitidine
📖 What it is MedlinePlus · NLM

Azacitidine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, azacitidine is a type of cancer treatment, though it works a bit differently from traditional chemotherapy. Instead of just killing cancer cells outright, it also reprograms h...
  • What exactly is azacitidine treating — is it chemotherapy?
  • They contain the same active ingredient, but you absolutely cannot swap one for the other. Onureg tablets and the injectable forms are approved for completely different conditions,...
  • Can I take the Onureg tablet instead of getting injections — they're the same drug, right?
📖 Read our full Azacitidine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9025 $0.401 / J9025 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)43598-678-11
11-digit billing NDC43598-0678-11
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9025
DescriptorINJECTION, AZACITIDINE, 1 MG
Billing units / pkg100 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 1 MG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$1,577,726 · 19,241 claims · $82.00 per claim (all NDCs under J9025)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43598-0678-11 You're viewing this Main listing 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON 2017-12-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Azacitidine 100 mg 00143-9606-01 Hikma 1 vial — AP FDA listed —
Azacitidine 100 mg 00781-3491-94 Sandoz 1 injection — AP FDA listed —
Azacitidine 100 mg 16714-0927-01 NorthStar 1 injection — AP FDA listed —
Azacitidine 100 mg 16729-0306-10 Accord 1 injection — AP FDA listed —
Azacitidine 100 mg 31722-0365-31 Camber 1 injection — AP FDA listed —
Azacitidine 100 mg 43598-0305-62 Dr. 1 injection — AP FDA listed —
Azacitidine 100 mg 43598-0465-62 Dr. 1 injection — AP FDA listed —
Azacitidine Azacitidine 100 mgthis 43598-0678-11 Dr. 1 injection — AP FDA listed —
Azacitidine 100 mg/50mL 43817-0906-01 Panacea 1 vial — AP FDA listed —
Azacitidine 100 mg/4mL 55150-0393-01 Eugia 1 vial — AP FDA listed —
Azacitidine 100 mg 58458-0002-02 Reliance 1 vial — AP FDA listed —
Vidaza 100 mg 59572-0102-01 Celgene 1 injection — AP FDA listed —
Azacitidine 100 mg 60505-6271-01 Apotex 1 injection — AP FDA listed —
Azacitidine 100 mg/30mL 63323-0771-39 Fresenius 1 vial — AP FDA listed —
Azacitidine 100 mg 68001-0313-56 BluePoint 1 injection — AP FDA listed —
Azacitidine 100 mg 68001-0527-54 BluePoint 1 injection — AP FDA listed —
Azacitidine 100 mg 68001-0620-54 BluePoint 1 injection — AP FDA listed —
Azacitidine 100 mg 69539-0112-01 MSN 1 injection — AP FDA listed —
Azacitidine 100 mg 70069-0857-01 Somerset 1 vial — AP FDA listed —
Azacitidine 100 mg 70121-1237-01 Amneal 1 injection — — FDA listed —
Azacitidine 100 mg 71288-0115-30 Meitheal 1 vial — AP FDA listed —
Azacitidine 100 mg 71288-0153-95 Meitheal 1 vial — AP FDA listed —
Azacitidine 100 mg 72485-0201-01 Armas 1 injection — AP FDA listed —
Azacitidine 100 mg 72572-0020-01 Civica, 1 injection — AP FDA listed —
Azacitidine 100 mg 75907-0225-11 Dr. 1 vial — AP FDA listed —
Azacitidine 100 mg 83774-0102-01 Pilnova 1 injection — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDr. Reddy's Laboratories Inc.
Application holderSHILPA MEDICARE LTD
FDA applicationANDA207518 (ANDA)
Labeler code43598
First marketedDec 2017
Product typeHuman Prescription Drug
Portfolio160 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 123 words ▾

1 INDICATIONS AND USAGE 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). (1)

1.1Myelodysplastic Syndromes (MDS) 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).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology values, is Azacitidine for injection 75 mg/m 2 daily for 7 days to be administered by subcutaneous (SC) injection or intravenous (IV) infusion. Premedicate for nausea and vomiting. ( 2.1 ) Repeat cycles every 4 weeks (2.2) .

After 2 cycles, may increase dose to 100 mg/m 2 if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred ( 2.2 ). Patients should be treated for a minimum of 4 to 6 cycles. Complete or partial response may require additional treatment cycles ( 2.2 ).

Continue treatment as long as the patient continues to benefit ( 2.2 ). Monitor patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate ( 2.3 , 2.4 , 2.5 ).

2.1First Treatment Cycle The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m 2 subcutaneously or intravenously, daily for 7 days. Premedicate patients for nausea and vomiting. Obtain complete blood counts, liver chemistries and serum creatinine prior to the first dose.

2.2Subsequent Treatment Cycles Repeat cycles every 4 weeks. The dose may be increased to 100 mg/m 2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles.

However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit. Monitor patients for hematologic response and renal toxicities [ see Warnings and Precautions (5.3) ], and delay or reduce dosage if necessary as described below.

2.3Dosage Adjustment Based on Hematology Laboratory Values For patients with baseline (start of treatment) WBC ≥3.0 x10 9 /L, ANC ≥1.5 x 10 9 /L, and platelets ≥75.0 x10 9 /L, adjust the dose as follows, based on nadir counts for any given cycle: Nadir Counts % Dose in the Next Course ANC ( x10 9 / L ) Platelets ( x10 9 / L ) <0.5 <25.0 50% 0.5 –1.5 25.0-50.0 67% >1.5 >50.0 100% For patients whose baseline counts are WBC <3.0 x10 9 /L, ANC<1.5 x10 9 /L, or platelets <75.0 x10 9 /L, base dose adjustments on nadir counts and bone marrow biopsy cellularity at the time of the nadir as noted below, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case continue the current dose.

Bone Marrow Biopsy Cellularity at Time of Nadir (%) WBC or Platelet Nadir % decrease in counts from baseline 30-60 15-30 <15 % Dose in the Next Course 50-75 100 50 33 >75 75 50 33 If a nadir as defined in the table above has occurred, give the next course 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are >25% above the nadir and rising. If a >25% increase above the nadir is not seen by day 28, reassess counts every 7 days. If a 25% increase is not seen by day 42, reduce the scheduled dose by 50%.

2.4Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity If unexplained reductions in serum bicarbonate levels to <20 mEq/L occur, reduce the dosage by 50% for the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, delay the next cycle until values return to normal or baseline and reduce the dose by 50% for the next course [ see Warnings and Precautions (5.3) ].

2.5Use in Geriatric Patients Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, select the dose carefully and monitor renal function [ see Warnings and Precautions (5.3) and Use in… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Azacitidine for injection is supplied as lyophilized powder in 100 mg single-dose vials. Lyophilized powder in 100 mg single-dose vials ( 3 ).

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS Advanced Malignant Hepatic Tumors ( 4.1 ). Hypersensitivity to Azacitidine or Mannitol ( 4.2 ).

4.1Advanced Malignant Hepatic Tumors Azacitidine is contraindicated in patients with advanced malignant hepatic tumors [ see Warnings and Precautions (5.2) ].

4.2Hypersensitivity to Azacitidine or Mannitol Azacitidine is contraindicated in patients with a known hypersensitivity to Azacitidine or mannitol.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anemia, Neutropenia and Thrombocytopenia: Monitor complete blood counts (CBC) frequently ( 5.1 ). Hepatotoxicity: Patients with severe preexisting hepatic impairment are at higher risk for toxicity ( 5.2 ). Renal Toxicity: Monitor patients with renal impairment for toxicity since Azacitidine and its metabolites are primarily excreted by the kidneys ( 5.3 ).

Tumor Lysis Syndrome: Azacitidine may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Assess baseline risk and monitor and treat as appropriate ( 5.4 ). Embryo-Fetal Risk: Azacitidine can cause fetal harm.

Advise females with reproductive potential of the potential risk to a fetus and to avoid pregnancy ( 5.5 ).

5.1Anemia, Neutropenia and Thrombocytopenia Azacitidine causes anemia, neutropenia and thrombocytopenia. Monitor complete blood counts frequently for response and/or toxicity, at a minimum, prior to each dosing cycle. After administration of the recommended dosage for the first cycle, adjust dosage for subsequent cycles based on nadir counts and hematologic response [ see Dosage and Administration (2.3) ].

5.2Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment Because Azacitidine is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease. Patients with extensive tumor burden due to metastatic disease have been reported to experience progressive hepatic coma and death during Azacitidine treatment, especially in such patients with baseline albumin <30 g/L. Azacitidine is contraindicated in patients with advanced malignant hepatic tumors [ see Contraindications (4.1) ].Monitor liver chemistries prior to initiation of therapy and with each cycle.

Safety and effectiveness of Azacitidine in patients with MDS and hepatic impairment have not been studied as these patients were excluded from the clinical trials.

5.3Renal Toxicity Renal toxicity ranging from elevated serum creatinine to renal failure and death have been reported in patients treated with intravenous Azacitidine in combination with other chemotherapeutic agents for nonMDS conditions. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to <20 mEq/L in association with an alkaline urine and hypokalemia (serum potassium <3 mEq/L) developed in 5 patients with CML treated with Azacitidine and etoposide. Monitor serum creatinine and electrolytes prior to initiation of therapy and with each cycle.

If unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur, reduce or hold the dose [ see Dosage and Administration (2.4) ]. Patients with renal impairment may be at increased risk for renal toxicity. Also, Azacitidine and its metabolites are primarily excreted by the kidney.

Therefore, monitor these patients closely for toxicity [ see Dosage and Administration (2.4 , 2.5) ]. Patients with MDS and renal impairment were excluded from the clinical studies.

5.4Tumor Lysis Syndrome Azacitidine may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Tumor lysis syndrome may occur despite concomitant use of allopurinol. Assess baseline risk and monitor and treat as appropriate.

5.5Embryo Fetal Risk Based on the mechanism of action and findings in animals, Azacitidine can cause fetal harm when administered to a pregnant woman. Azacitidine administered to pregnant rats via a single intraperitoneal (IP) dose approximating 8% of the recommended human daily dose caused fetal death and anomalies [ see Use in Specific Populations (8.1) ]. Advise females with reproductive potential to avoid pregnancy during treatment with Azacitidine for injection [ see Use in Specific Populations (8.3) ].

Men should be advised to not father a child while receiving treatment with Azacitidine.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in other labeling sections: Anemia, Neutropenia and Thrombocytopenia [see Warnings and Precautions (5.1) ] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [see Warnings and Precautions (5.2) ] Renal Toxicity [see Warnings and Precautions (5.3) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.4) ] Embryo-Fetal Risk [see Warnings and Precautions (5.5) ] Most Commonly Occurring Adverse Reactions (SC or IV Route) : nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, ecchymosis.

The most common adverse reactions by IV route also included petechiae, rigors, weakness and hypokalemia. Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (SC or IV Route): Discontinuation: leukopenia, thrombocytopenia, neutropenia. Dose Held: leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, febrile neutropenia.

Dose Reduced: leukopenia, neutropenia, thrombocytopenia. Most common adverse reactions (>30%) by SC route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. Most common adverse reactions by IV route also included petechiae, rigors, weakness and hypokalemia (6.1) .

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to azacitidine in 443 MDS patients from 4 clinical studies. Study 1 was a supportive-care controlled trial (SC administration), Studies 2 and 3 were single arm studies (one with SC administration and one with IV administration), and Study 4 was an international randomized trial (SC administration) [ see Clinical Studies (14) ].

In Studies 1, 2 and 3, a total of 268 patients were exposed to Azacitidine, including 116 exposed for 6 cycles (approximately 6 months) or more and 60 exposed for greater than 12 cycles (approximately one year). Azacitidine was studied primarily in supportive-care controlled and uncontrolled trials (n=150 and n=118, respectively). The population in the subcutaneous studies (n=220) was 23 to 92 years old (mean 66.4 years), 68% male, and 94% white, and had MDS or AML.

The population in the IV study (n=48) was 35 to 81 years old (mean 63.1 years), 65% male, and 100% white. Most patients received average daily doses between 50 and 100 mg/m 2 . In Study 4, a total of 175 patients with higher-risk MDS (primarily RAEB and RAEB-T subtypes) were exposed to Azacitidine.

Of these patients, 119 were exposed for 6 or more cycles, and 63 for at least 12 cycles. The mean age of this population was 68.1 years (ranging from 42 to 83 years), 74% were male, and 99% were white. Most patients received daily Azacitidine doses of 75 mg/m 2 .

Table 1 presents adverse reactions occurring in at least 5% of patients treated with Azacitidine (SC) in Studies 1 and 2. It is important to note that duration of exposure was longer for the Azacitidine -treated group than for the observation group: patients received Azacitidine for a mean of 11.4 months while mean time in the observation arm was 6.1 months. Table 1: Most Frequently Observed Adverse Reactions (≥ 5.0% in All SC Azacitidine Treated Patients; Studies 1 and 2) Number (%) of Patients System Organ Class Preferred Term* All Azacitidine for Injection † ( N = 220 ) Observation ‡ ( N = 92 ) Blood and lymphatic system disorders Anemia 153 (69.5) 59 (64.1) Anemia aggravated 12 (5.5) 5 (5.4) Febrile neutropenia 36 (16.4) 4 (4.3) Leukopenia 106 (48.2) 27 (29.3) Neu… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Discontinue nursing taking into consideration the importance of drug to mother (8.2) .

8.1Pregnancy Risk Summary Based on its mechanism of action and findings in animals, Azacitidine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no data on the use of Azacitidine in pregnant women. Azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended human daily dose [see Data].Advise pregnant women of the potential risk to the fetus.

The background rate of major birth defects and miscarriage is unknown for the indicated population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Early embryotoxicity studies in mice revealed a 44% frequency of intrauterine embryonal death (increased resorption) after a single IP (intraperitoneal) injection of 6 mg/m 2 (approximately 8% of the recommended human daily dose on a mg/m 2 basis) azacitidine on gestation day 10.

Developmental abnormalities in the brain have been detected in mice given azacitidine on or before gestation day 15 at doses of ~3-12 mg/m 2 (approximately 4%-16% the recommended human daily dose on a mg/m 2 basis). In rats, Azacitidine was clearly embryotoxic when given IP on gestation days 4-8 (postimplantation) at a dose of 6 mg/m 2 (approximately 8% of the recommended human daily dose on a mg/m 2 basis), although treatment in the preimplantation period (on gestation days 1-3) had no adverse effect on the embryos.

Azacitidine caused multiple fetal abnormalities in rats after a single IP dose of 3 to 12 mg/m 2 (approximately 8% the recommended human daily dose on a mg/m 2 basis) given on gestation day 9, 10, 11 or 12. In this study Azacitidine caused fetal death when administered at 3-12 mg/m 2 on gestation days 9 and 10; average live animals per litter was reduced to 9% of control at the highest dose on gestation day 9. Fetal anomalies included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly), and others (micrognathia, gastroschisis, edema, and rib abnormalities).

8.2Lactation Risk Summary There is no information regarding the presence of Azacitidine in human milk, the effects of Azacitidine on the breastfed infant, or the effects of Azacitidine on milk production. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for azacitidine in animal studies [ see Nonclinical Toxicology (13.1) ] and the potential for serious adverse reactions in nursing infants from Azacitidine, advise patients not to breastfeed during treatment with Azacitidine.

8.3Females and Males of Reproductive Potential Based on its mechanism of action and findings in animals, Azacitidine can cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating Azacitidine. Contraception Females Advise females of reproductive potential to avoid pregnancy during treatment with Azacitidine.

Males Males with female sexual partners of reproductive potential should not father a child and should use effective contraception during treatment with Azacitidine. Infertility Based on animal data, azacitidine could have an effect on male or female fertility [ see Nonclinical Toxicology (13.1) ].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Of the total number of patients in Studies 1, 2 and 3, 62% were 65 years and older and 21% were 75 years and older. No overall differences in effectiveness were observed between these patients and younger patients. In addition there were no relevant differences in the frequency of adverse reactions observed in… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on its mechanism of action and findings in animals, Azacitidine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no data on the use of Azacitidine in pregnant women. Azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended human daily dose [see Data].Advise pregnant women of the potential risk to the fetus.

The background rate of major birth defects and miscarriage is unknown for the indicated population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Early embryotoxicity studies in mice revealed a 44% frequency of intrauterine embryonal death (increased resorption) after a single IP (intraperitoneal) injection of 6 mg/m 2 (approximately 8% of the recommended human daily dose on a mg/m 2 basis) azacitidine on gestation day 10.

Developmental abnormalities in the brain have been detected in mice given azacitidine on or before gestation day 15 at doses of ~3-12 mg/m 2 (approximately 4%-16% the recommended human daily dose on a mg/m 2 basis). In rats, Azacitidine was clearly embryotoxic when given IP on gestation days 4-8 (postimplantation) at a dose of 6 mg/m 2 (approximately 8% of the recommended human daily dose on a mg/m 2 basis), although treatment in the preimplantation period (on gestation days 1-3) had no adverse effect on the embryos.

Azacitidine caused multiple fetal abnormalities in rats after a single IP dose of 3 to 12 mg/m 2 (approximately 8% the recommended human daily dose on a mg/m 2 basis) given on gestation day 9, 10, 11 or 12. In this study Azacitidine caused fetal death when administered at 3-12 mg/m 2 on gestation days 9 and 10; average live animals per litter was reduced to 9% of control at the highest dose on gestation day 9. Fetal anomalies included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly), and others (micrognathia, gastroschisis, edema, and rib abnormalities).

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 154 words ▾

8.5Geriatric Use Of the total number of patients in Studies 1, 2 and 3, 62% were 65 years and older and 21% were 75 years and older. No overall differences in effectiveness were observed between these patients and younger patients. In addition there were no relevant differences in the frequency of adverse reactions observed in patients 65 years and older compared to younger patients.

Of the 179 patients randomized to Azacitidine in Study 4, 68% were 65 years and older and 21% were 75 years and older. Survival data for patients 65 years and older were consistent with overall survival results. The majority of adverse reactions occurred at similar frequencies in patients < 65 years of age and patients 65 years of age and older.

Elderly patients are more likely to have decreased renal function. Monitor renal function in these patients [ see Dosage and Administration (2.5) and Warnings and Precautions (5.3) ].

🆘 Overdosage 83 words ▾

10 OVERDOSAGE One case of overdose with Azacitidine was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single IV dose of approximately 290 mg/m 2 , almost 4 times the recommended starting dose. The events resolved without sequelae, and the correct dose was resumed the following day.

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 overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Azacitidine is a pyrimidine nucleoside analog of cytidine. Azacitidine is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis.

Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of Azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to Azacitidine.

12.3Pharmacokinetics The pharmacokinetics of Azacitidine were studied in 6 MDS patients following a single 75 mg/m 2 subcutaneous (SC) dose and a single 75 mg/m 2 intravenous (IV) dose. Azacitidine is rapidly absorbed after SC administration; the peak plasma azacitidine concentration of 750 ± 403 ng/ml occurred in 0.5 hour. The bioavailability of SC Azacitidine relative to IV azacitidine is approximately 89%, based on area under the curve.

Mean volume of distribution following IV dosing is 76 ± 26 L. Mean apparent SC clearance is 167 ± 49 L/hour and mean half-life after SC administration is 41 ± 8 minutes. The AUC and C max of SC administration of Azacitidine in 21 patients with cancer were approximately dose proportional within the 25 to 100 mg/m 2 dose range.

Multiple dosing at the recommended dose-regimen does not result in drug accumulation. Published studies indicate that urinary excretion is the primary route of elimination of Azacitidine and its metabolites. Following IV administration of radioactive Azacitidine to 5 cancer patients, the cumulative urinary excretion was 85% of the radioactive dose.

Fecal excretion accounted for <1% of administered radioactivity over 3 days. Mean excretion of radioactivity in urine following SC administration of 14 C-Azacitidine was 50%. The mean elimination half-lives of total radioactivity (Azacitidine and its metabolites) were similar after IV and SC administrations, about 4 hours.

Specific Populations In patients with cancer the pharmacokinetics of Azacitidine in 6 patients with normal renal function (CLcr > 80 mL/min) and 6 patients with severe renal impairment (CLcr < 30 mL/min) were compared following daily SC dosing (Days 1 through 5) at 75 mg/m 2 /day. Severe renal impairment increased Azacitidine exposure by approximately 70% after single and 41% after multiple subcutaneous administrations. This increase in exposure was not correlated with an increase in adverse events.

The exposure was similar to exposure in patients with normal renal function receiving 100 mg/m 2 . Therefore, a Cycle 1 dose modification is not recommended. The effects of hepatic impairment, gender, age, or race on the pharmacokinetics of Azacitidine have not been studied.

Drug-Drug Interactions No formal clinical drug interaction studies with Azacitidine have been conducted. An in vitro study of Azacitidine incubation in human liver fractions indicated that Azacitidine may be metabolized by the liver. Whether Azacitidine metabolism may be affected by known microsomal enzyme inhibitors or inducers has not been studied.

An in vitro study with cultured human hepatocytes indicated that azacitidine at concentrations up to 100 μM (IV Cmax = 10.6 μM) does not cause any inhibition of CYP2B6 and CYP2C8. The potential of Azacitidine to inhibit other cytochrome P450 (CYP) enzymes is not known. In vitro studies with human cultured hepatocytes indicate that Azacitidine at concentrations of 1.0 μM to 100 μM does not induce CYP 1A2, 2C19, or 3A4/5.

🧬 Mechanism of Action 103 words ▾

12.1Mechanism of Action Azacitidine is a pyrimidine nucleoside analog of cytidine. Azacitidine is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis.

Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of Azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to Azacitidine.

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Azacitidine for injection is supplied as a lyophilized powder in 100 mg single-dose vials packaged in cartons of 1 vial (NDC 43598-678-11). Storage Store unreconstituted vials at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) (See USP Controlled Room Temperature). Handling and Disposal Azacitidine for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.¹

📋 Description 149 words ▾

11 DESCRIPTION Azacitidine for injection contains Azacitidine, which is a pyrimidine nucleoside analog of cytidine. Azacitidine is 4-amino-1-β-D-ribofuranosyl-1-s-triazin-2(1 H )-one. The structural formula is as follows: The empirical formula is C 8 H 12 N 4 O 5 .

The molecular weight is 244. Azacitidine is a white to off white crystalline powder. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO).

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. Vials of Azacitidine for injection contain 100 mg of Azacitidine and 100 mg mannitol as a sterile lyophilized powder. structure

💬 Information for Patients 176 words ▾

17 PATIENT COUNSELING INFORMATION Hepatotoxicity in Patients with Severe Pre-Existing Hepatic Impairment Instruct patients to inform their physician about any underlying liver disease [ see Warnings and Precautions (5.2) ]. Renal Toxicity Instruct patients to inform their physician about any underlying renal disease [ see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ]. Embryo-Fetal Risk Advise pregnant women of the potential risk to a fetus [ see Warnings and Precautions (5.5) and Use in Specific Populations (8.1 )].

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 Warnings and Precautions (5.5) and Use in Specific Populations (8.3) ].

Lactation Advise patients to avoid breastfeeding while receiving Azacitidine for injection [ see Use in Specific Populations (8.2) ]. Rx only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Issued: 07/2017

🍼 Nursing Mothers 109 words ▾

8.3Females and Males of Reproductive Potential Based on its mechanism of action and findings in animals, Azacitidine can cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating Azacitidine. Contraception Females Advise females of reproductive potential to avoid pregnancy during treatment with Azacitidine.

Males Males with female sexual partners of reproductive potential should not father a child and should use effective contraception during treatment with Azacitidine. Infertility Based on animal data, azacitidine could have an effect on male or female fertility [ see Nonclinical Toxicology (13.1) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The pharmacokinetics of Azacitidine were studied in 6 MDS patients following a single 75 mg/m 2 subcutaneous (SC) dose and a single 75 mg/m 2 intravenous (IV) dose. Azacitidine is rapidly absorbed after SC administration; the peak plasma azacitidine concentration of 750 ± 403 ng/ml occurred in 0.5 hour. The bioavailability of SC Azacitidine relative to IV azacitidine is approximately 89%, based on area under the curve.

Mean volume of distribution following IV dosing is 76 ± 26 L. Mean apparent SC clearance is 167 ± 49 L/hour and mean half-life after SC administration is 41 ± 8 minutes. The AUC and C max of SC administration of Azacitidine in 21 patients with cancer were approximately dose proportional within the 25 to 100 mg/m 2 dose range.

Multiple dosing at the recommended dose-regimen does not result in drug accumulation. Published studies indicate that urinary excretion is the primary route of elimination of Azacitidine and its metabolites. Following IV administration of radioactive Azacitidine to 5 cancer patients, the cumulative urinary excretion was 85% of the radioactive dose.

Fecal excretion accounted for <1% of administered radioactivity over 3 days. Mean excretion of radioactivity in urine following SC administration of 14 C-Azacitidine was 50%. The mean elimination half-lives of total radioactivity (Azacitidine and its metabolites) were similar after IV and SC administrations, about 4 hours.

Specific Populations In patients with cancer the pharmacokinetics of Azacitidine in 6 patients with normal renal function (CLcr > 80 mL/min) and 6 patients with severe renal impairment (CLcr < 30 mL/min) were compared following daily SC dosing (Days 1 through 5) at 75 mg/m 2 /day. Severe renal impairment increased Azacitidine exposure by approximately 70% after single and 41% after multiple subcutaneous administrations. This increase in exposure was not correlated with an increase in adverse events.

The exposure was similar to exposure in patients with normal renal function receiving 100 mg/m 2 . Therefore, a Cycle 1 dose modification is not recommended. The effects of hepatic impairment, gender, age, or race on the pharmacokinetics of Azacitidine have not been studied.

Drug-Drug Interactions No formal clinical drug interaction studies with Azacitidine have been conducted. An in vitro study of Azacitidine incubation in human liver fractions indicated that Azacitidine may be metabolized by the liver. Whether Azacitidine metabolism may be affected by known microsomal enzyme inhibitors or inducers has not been studied.

An in vitro study with cultured human hepatocytes indicated that azacitidine at concentrations up to 100 μM (IV Cmax = 10.6 μM) does not cause any inhibition of CYP2B6 and CYP2C8. The potential of Azacitidine to inhibit other cytochrome P450 (CYP) enzymes is not known. In vitro studies with human cultured hepatocytes indicate that Azacitidine at concentrations of 1.0 μM to 100 μM does not induce CYP 1A2, 2C19, or 3A4/5.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Myelodysplastic Syndromes (MDS) Study 1 was a randomized, open-label, controlled trial carried out in 53 U.S. sites compared the safety and efficacy of subcutaneous Azacitidine for injection plus supportive care with supportive care alone ("observation") in patients with any of the five FAB subtypes of myelodysplastic syndromes (MDS): refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), RAEB in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

RA and RARS patients were included if they met one or more of the following criteria: required packed RBC transfusions; had platelet counts ≤ 50.0 x 10 9 /L; required platelet transfusions; or were neutropenic (ANC <1.0 x 10 9 /L) with infections requiring treatment with antibiotics. Patients with acute myelogenous leukemia (AML) were not intended to be included. Supportive care allowed in this study included blood transfusion products, antibiotics, antiemetics, analgesics and antipyretics.

The use of hematopoeitic growth factors was prohibited. Baseline patient and disease characteristics are summarized in (Table 3); the 2 groups were similar. Azacitidine was administered at a subcutaneous dose of 75 mg/m 2 daily for 7 days every 4 weeks.

The dose was increased to 100 mg/m 2 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 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.

For purposes of assessing efficacy, the primary endpoint was response rate (as defined in Table 4). Of the 191 patients included in the study, independent review (adjudicated diagnosis) found that 19 had the diagnosis of AML at baseline. 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.

Approximately 55% of the patients randomized to observation crossed over to receive Azacitidine treatment. Table 3. Baseline Demographics and Disease Characteristics Azacitidine ( N = 99 ) Observation ( N = 92 ) Gender ( n %) Male 72 (72.7) 60 (65.2) Female 27 (27.3) 32 (34.8) Race ( n %) White 93 (93.9) 85 (92.4) Black 1 (1.0) 1 (1.1) Hispanic 3 (3.0) 5 (5.4) Asian/Oriental 2 (2.0) 1 (1.1) Age ( years ) N 99 91 Mean ± SD 67.3 ± 10.39 68 ±

10.23Range 31 - 92 35 - 88 Adjudicated MDS diagnosis at study entry ( n %) RA 21 (21.2) 18 (19.6) RARS 6 (6.1) 5 (5.4) RAEB 38 (38.4) 39 (42.4) RAEB-T 16 (16.2) 14 (15.2) CMMoL 8 (8.1) 7 (7.6) AML 10 (10.1) 9 (9.8) Transfusion product used in 3 months before study entry ( n %) Any transfusion product 70 (70.7) 59 (64.1) Blood cells, packed human 66 (66.7) 55 (59.8) Platelets, human blood 15 (15.2) 12 (13.0) Hetastarch 0 (0.0) 1 (1.1) Plasma protein fraction 1 (1.0) 0 (0.0) Other 2 (2.0) 2 (2.2) Table 4. Response Criteria RA RARS RAEB RAEB - T CMMoL Complete Response Marrow <5% blasts ( CR ), duration ≥ 4 weeks Peripheral Blood Normal CBC if abnormal at baseline Absence of blasts in the peripheral circulation Partial Response ( PR ), duration ≥ 4 weeks Marrow No marrow requirements ≥50% decrease in blasts Improvement of marrow dyspoiesis Peripheral Blood ≥50% restoration in the deficit from normal levels of baseline white cells, hemoglobin and platelets if abnormal at baseline No blasts in the peripheral circulation For CMMoL, if WBC is elevated at baseline, a ≥75% reduction in the excess count over the upper limit of normal The overall response rate (CR + PR) of 15.7% in Azacitidine -treated patients without AML (16.2% for all Azacitidine randomized patients including AML) was statistically significantly higher th… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The potential carcinogenicity of Azacitidine was evaluated in mice and rats. Azacitidine induced tumors of the hematopoietic system in female mice at 2.2 mg/kg (6.6 mg/m 2 , approximately 8% the recommended human daily dose on a mg/m 2 basis) administered IP three times per week for 52 weeks. An increased incidence of tumors in the lymphoreticular system, lung, mammary gland, and skin was seen in mice treated with Azacitidine IP at 2.0 mg/kg (6.0 mg/m 2 , approximately 8% the recommended human daily dose on a mg/m 2 basis) once a week for 50 weeks.

A tumorigenicity study in rats dosed twice weekly at 15 or 60 mg/m 2 (approximately 20-80% the recommended human daily dose on a mg/m 2 basis) revealed an increased incidence of testicular tumors compared with controls. The mutagenic and clastogenic potential of Azacitidine was tested in in vitro bacterial systems Salmonella typhimurium strains TA100 and several strains of trpE8, Escherichia coli strains WP14 Pro, WP3103P, WP3104P, and CC103; in in vitro forward gene mutation assay in mouse lymphoma cells and human lymphoblast cells; and in an in vitro micronucleus assay in mouse L5178Y lymphoma cells and Syrian hamster embryo cells.

Azacitidine was mutagenic in bacterial and mammalian cell systems. The clastogenic effect of Azacitidine was shown by the induction of micronuclei in L5178Y mouse cells and Syrian hamster embryo cells. Administration of Azacitidine to male mice at 9.9 mg/m 2 (approximately 9% the recommended human daily dose on a mg/m 2 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.

Treatment of male rats 3 times per week for 11 or 16 weeks at doses of 15-30 mg/m 2 (approximately 20-40%, the recommended human daily dose on a mg/m 2 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. In a related study, male rats treated for 16 weeks at 24 mg/m 2 resulted in an increase in abnormal embryos in mated females when examined on day 2 of gestation.

📚 References 10 words ▾

15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/ hazardousdrugs/ index.html

📄 Recent Major Changes 35 words ▾

RECENT MAJOR CHANGES Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 ) 8/2016 Warnings and Precautions ( 5.2 , 5.3 , 5.4 , 5.5 ) 8/2016

📄 Package Label / Principal Display Panel 30 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Azacitidine for Injection - Vial Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number Azacitidine for Injection - Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Onureg (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Onureg. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$21.19M
Claims incl. refills
919
Beneficiaries
396
Spend / beneficiary
$53,510.70
Spend / claim
$23,057.93
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Dr. Reddy's Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dr. Reddy's Laboratories Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9025 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43598-0677-11 · Dr. 43598-0684-30 · Dr.Reddys →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.