Home › NDC Lookup › Ingredients › Dasatinib › 00480-5102-06
Dasatinib 50 mg Tablet, Film Coated, 60-count — NDC 00480-5102-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dasatinib 50 mg Tablet, Film Coated, 60-count — NDC 0480-5102-06 (Billing 00480-5102-06)

by Teva Pharmaceuticals, Inc. · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Dasatinib 50 mg Tablet, Film Coated from Teva Pharmaceuticals, Inc., marketed since Sep 2025 and currently FDA-listed. It is this product's only package size.

NDC 00480-5102-06
🏷️ FDA NDC (as labeled) 0480-5102-06 billing pads the labeler 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 Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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) 0480-5102-06
Product NDC 0480-5102
11-digit billing NDC 00480510206
NCPDP billing unit EA — each (per item)
RxCUI 643105, 643107, 643109, 799047, 1045402, 1045406
UNII RBZ1571X5H
Application # ANDA211094
SPL Set ID 3000fd91-1b09-4d72-8522-1ca5e35ed956
Established class (EPC) Kinase Inhibitor
Mechanism of action Cytochrome P450 3A4 Inhibitors; Protein Kinase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-18
Route ORAL
Dosage form TABLET, FILM COATED
Substance DASATINIB
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 061100
GCN 27258
HICL code 033855
Ingredient (HICL) Dasatinib
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name DASATINIB 50 MG TABLET
FDB brand name Dasatinib
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 061100
  • GCN: 27258
  • HICL (First Databank): 033855
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 643105
Why two NDCs? The FDA registers this code as 0480-5102-06 — a 4-4-2 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 labeler segment → 00480-5102-06. 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 Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) BCR-ABL tyrosine kinase inhibitors
How it works Protein Kinase Inhibitors, Cytochrome P450 3A4 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 DASATINIB 50 MG TABLET Ingredient Dasatinib
📗 Our plain-language guide HelloPharmacist
  • It treats certain leukemias that carry the Philadelphia chromosome. These are Ph+ chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL). The exact approval depe...
  • Take it by mouth once a day, with or without food. Swallow the tablet whole. Do not crush, cut or chew it. Follow your prescriber’s directions for your dose.
  • Expect possible low blood counts, fluid retention, diarrhea, headache, rash, fatigue, nausea and shortness of breath. Call your doctor for bleeding, fever, swelling or trouble brea...
  • Usually not. H2 blockers and proton pump inhibitors can lower dasatinib levels, so they should not be used with it. If you need an antacid, take it at least 2 hours before or after...
📖 Read our full Dasatinib 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 eachPer 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 · Q2 2026 $87.46 $5,247.38 / 60 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00480-5102-06 You're viewing this Main listing 60 TABLET, FILM COATED in 1 BOTTLE 2025-09-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sprycel 50 mg 00003-0528-11 E.R. 60 tablets — AB FDA listed —
Dasatinib 50 mgthis 00480-5102-06 Teva 60 tablets — AB FDA listed —
Dasatinib 50 mg 43598-0600-60 Dr.Reddys 60 tablets — AB FDA listed —
Dasatinib 50 mg 46708-0685-60 Alembic 60 tablets — AB FDA listed —
Dasatinib 50 mg 59651-0543-15 Aurobindo 15 tablets — AB FDA listed —
Dasatinib 50 mg 60505-3629-06 Apotex 60 tablets — AB FDA listed —
Dasatinib 50 mg 62332-0685-60 Alembic 60 tablets — AB FDA listed —
Dasatinib 50 mg 66993-0234-60 Prasco 60 tablets — AB FDA listed —
Dasatinib 50 mg 68001-0661-06 BluePoint 60 tablets — AB FDA listed —
Dasatinib 50 mg 70377-0084-11 Biocon 60 tablets — AB FDA listed —
Phyrago 50 mg 70709-0152-50 Cycle 60 tablets — — FDA listed —
dasatinib 50 mg 70710-1742-06 Zydus 60 tablets — AB FDA listed —
Dasatinib 50 mg 70748-0209-07 Lupin 60 tablets — AB FDA listed —
dasatinib 50 mg 70771-1902-06 Zydus 60 tablets — AB FDA listed —
Dasatinib 50 mg 72603-0923-01 NorthStar 60 tablets — AB FDA listed —
Dasatinib 50 mg 73190-0047-60 AvKARE 60 tablets — AB FDA listed —
Dasatinib 50 mg 72205-0320-60 Novadoz 60 tablets — — 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color white
ShapeRound
Imprint140
Size11 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerTeva Pharmaceuticals, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA211094 (ANDA)
Labeler code00480
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio166 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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 208 words ▾

1 INDICATIONS AND USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.

Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Chronic phase CML in adults: 100 mg once daily. ( 2 ) Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults: 140 mg once daily. ( 2 ) Chronic phase CML and ALL in pediatrics: starting dose based on body weight. ( 2 ) Administer orally, with or without a meal. Do not crush, cut, or chew tablets. ( 2 )

2.1Dosage of Dasatinib Tablets in Adult Patients The recommended starting dosage of dasatinib tablets for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of dasatinib tablets for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg administered orally once daily. Tablets should not be crushed, cut, or chewed; they should be swallowed whole.

Dasatinib tablets can be taken with or without a meal, either in the morning or in the evening.

2.2Dosage of Dasatinib Tablets in Pediatric Patients with CML or Ph+ ALL The recommended starting dosage for pediatrics is based on body weight as shown in Table 1. The recommended dose should be administered orally once daily with or without food. Recalculate the dose every 3 months based on changes in body weight, or more often if necessary.

Do not crush, cut or chew tablets. Swallow tablets whole. There are additional administration considerations for pediatric patients who have difficulty swallowing tablets whole [see Use in Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.3 )] .

Table 1: Dosage of Dasatinib Tablets for Pediatric Patients a Body Weight (kg) b Daily Dose (mg) 10 to less than 20 40 mg 20 to less than 30 60 mg 30 to less than 45 70 mg at least 45 100 mg a For pediatric patients with Ph+ ALL, begin dasatinib tablets therapy on or before day 15 of induction chemotherapy, when diagnosis is confirmed and continue for 2 years. b Tablet dosing is not recommended for patients weighing less than 10 kg. Refer to Section 2.4 for recommendations on dose escalation in adults with CML and Ph+ ALL, and pediatric patients with CML.

2.3Dose Modification Strong CYP3A4 Inducers Avoid the use of concomitant strong CYP3A4 inducers and St. John’s wort. If patients must be coadministered a strong CYP3A4 inducer, consider a dasatinib tablets dose increase.

If the dose of dasatinib tablets is increased, monitor the patient carefully for toxicity [see Drug Interactions ( 7.1 )] . Strong CYP3A4 Inhibitors Avoid the use of concomitant strong CYP3A4 inhibitors and grapefruit juice. Recommend selecting an alternate concomitant medication with no or minimal enzyme inhibition potential, if possible.

If dasatinib tablets must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to: 40 mg daily for patients taking dasatinib tablets, 140 mg daily. 20 mg daily for patients taking dasatinib tablets, 100 mg daily. 20 mg daily for patients taking dasatinib tablets, 70 mg daily.

For patients taking dasatinib tablets 60 mg or 40 mg daily, consider interrupting dasatinib tablets until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating dasatinib tablets. These reduced doses of dasatinib tablets are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors.

If dasatinib tablets are not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or interrupt dasatinib tablets until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before the dasatinib tablets dose is increased [see Drug Interactions ( 7.1 )] .

2.4Dose Escalation in Adults with CML and Ph+ ALL, and Pediatric Patients with CML For adult patients with CML and Ph+ ALL, consider dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML an… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS Dasatinib tablets are available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg white to off-white, film-coated tablets. Tablets: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia, and anemia may occur. Use caution if used concomitantly with medications that inhibit platelet function or anticoagulants. Monitor complete blood counts regularly.

Transfuse and interrupt dasatinib when indicated. ( 2.5 , 5.1 , 5.2 ) Fluid Retention: Fluid retention, sometimes severe, including pleural effusions. Manage with supportive care measures and/or dose modification.

( 2.5 , 5.3 ) Cardiovascular Toxicity : Monitor patients for signs or symptoms and treat appropriately. ( 5.4 ) Pulmonary Arterial Hypertension (PAH): Dasatinib may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment.

Stop dasatinib if PAH is confirmed. ( 5.5 ) QT Prolongation: Use dasatinib with caution in patients who have or may develop prolongation of the QT interval. ( 5.6 ) Severe Dermatologic Reactions: Individual cases of severe mucocutaneous dermatologic reactions have been reported.

( 5.7 ) Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain adequate hydration and correct uric acid levels prior to initiating therapy with dasatinib. ( 5.8 ) Embryo-Fetal Toxicity: Can cause fetal harm.

Advise patients of reproductive potential of potential risk to fetus and to use effective contraception. ( 5.9 , 8.1 , 8.3 ) Effects on Growth and Development in Pediatric Patients: epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development in pediatric patients.

( 5.10 ) Hepatotoxicity: Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction. ( 5.11 )

5.1Myelosuppression Treatment with dasatinib is associated with severe (NCI CTCAE Grade 3 or 4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML [see Adverse Reactions ( 6.1 )] . In patients with chronic phase CML, perform complete blood counts (CBCs) every 2 weeks for 12 weeks, then every 3 months thereafter, or as clinically indicated. In patients with advanced phase CML or Ph+ ALL, perform CBCs weekly for the first 2 months and then monthly thereafter, or as clinically indicated.

In pediatric patients with Ph+ ALL treated with dasatinib in combination with chemotherapy, perform CBCs prior to the start of each block of chemotherapy and as clinically indicated. During the consolidation blocks of chemotherapy, perform CBCs every 2 days until recovery. Myelosuppression is generally reversible and usually managed by withholding dasatinib temporarily and/or dose reduction [see Dosage and Administration ( 2.5 )] .

5.2Bleeding-Related Events Dasatinib can cause serious and fatal bleeding. In all CML or Ph+ ALL clinical studies, Grade ≥3 central nervous system (CNS) hemorrhages, including fatalities, occurred in <1% of patients receiving dasatinib. The incidence of Grade 3/4 hemorrhage occurred in 5.8% of adult patients and generally required treatment interruptions and transfusions.

The incidence of Grade 5 hemorrhage occurred in 0.4% of adult patients. The most frequent site of hemorrhage was gastrointestinal [see Adverse Reactions ( 6.1 )] . Most bleeding events in clinical studies were associated with severe thrombocytopenia.

In addition to causing thrombocytopenia in human subjects, dasatinib caused platelet dysfunction in vitro . Concomitant medications that inhibit platelet function or anticoagulants may increase the risk of hemorrhage.

5.3Fluid Retention Dasatinib may cause fluid retention [see Adverse Reactions ( 6.1 )] . After 5 years of follow-up in the adult randomized newly diagnosed chronic phase CML study (n=258), Grade 3 or 4 fluid r… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Myelosuppression [see Dosage and Administration ( 2.5 ) and Warnings and Precautions ( 5.1 )] . Bleeding-related events [see Warnings and Precautions ( 5.2 )] . Fluid retention [see Warnings and Precautions ( 5.3 )] .

Cardiovascular toxicity [see Warnings and Precautions ( 5.4 )] . Pulmonary arterial hypertension [see Warnings and Precautions ( 5.5 )] . QT prolongation [see Warnings and Precautions ( 5.6 )] .

Severe dermatologic reactions [see Warnings and Precautions ( 5.7 )] . Tumor lysis syndrome [see Warnings and Precautions ( 5.8 )] . Effects on growth and development in pediatric patients [see Warnings and Precautions ( 5.10 )] .

Hepatotoxicity [see Warnings and Precautions ( 5.11 )] . Most common adverse reactions (≥15%) in patients receiving dasatinib as single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain. ( 6 ) Most common adverse reactions (≥30%) in pediatric patients receiving dasatinib in combination with chemotherapy included mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience 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 dasatinib administered as single-agent therapy at all doses tested in clinical studies (n=2809), including 324 adult patients with newly diagnosed chronic phase CML, 2388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 97 pediatric patients with chronic phase CML.

The median duration of therapy in a total of 2712 adult patients was 19.2 months (range 0 to 93.2 months). In a randomized trial in patients with newly diagnosed chronic phase CML, the median duration of therapy was approximately 60 months. The median duration of therapy in 1618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).

The median duration of therapy in 1094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0 to 93.2 months). In two non-randomized trials in 97 pediatric patients with chronic phase CML (51 patients newly diagnosed and 46 patients resistant or intolerant to previous treatment with imatinib), the median duration of therapy was 51.1 months (range 1.9 to 99.6 months). In the overall population of 2712 adult patients, 88% of patients experienced adverse reactions at some time and 19% experienced adverse reactions leading to treatment discontinuation.

In the randomized trial in adult patients with newly diagnosed chronic phase CML, drug was discontinued for adverse reactions in 16% of patients with a minimum of 60 months of follow-up. After a minimum of 60 months of follow-up, the cumulative discontinuation rate was 39%. Among the 1618 patients with chronic phase CML, drug-related adverse reactions leading to discontinuation were reported in 329 (20.3%) patients; among the 1094 patients with advanced phase CML or Ph+ ALL, drug-related adverse reactions leading to discontinuation were reported in 191 (17.5%) patients.

Among the 97 pediatric subjects, drug-related adverse reactions leading to discontinuation were reported in 1 patient (1%). Adverse reactions… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Dose reduction may be necessary. ( 2.3 , 7.1 ) Strong CYP3A4 Inducers: Dose increase may be necessary. ( 2.3 , 7.1 ) Antacids: Avoid simultaneous administration. ( 7.1 ) H 2 Antagonists and Proton Pump Inhibitors: Avoid coadministration. ( 7.1 )

7.1Effect of Other Drugs on Dasatinib Strong CYP3A4 Inhibitors The coadministration with strong CYP3A inhibitors may increase dasatinib concentrations [see Clinical Pharmacology ( 12.3 )] . Increased dasatinib concentrations may increase the risk of toxicity. Avoid concomitant use of strong CYP3A4 inhibitors.

If concomitant administration of a strong CYP3A4 inhibitor cannot be avoided, consider a dasatinib dose reduction [see Dosage and Administration ( 2.5 )] . Strong CYP3A4 Inducers The coadministration of dasatinib with strong CYP3A inducers may decrease dasatinib concentrations [see Clinical Pharmacology ( 12.3 )] . Decreased dasatinib concentrations may reduce efficacy.

Consider alternative drugs with less enzyme induction potential. If concomitant administration of a strong CYP3A4 inducer cannot be avoided, consider a dasatinib dose increase. Gastric Acid Reducing Agents The coadministration of dasatinib with a gastric acid reducing agent may decrease the concentrations of dasatinib.

Decreased dasatinib concentrations may reduce efficacy. Do not administer H 2 antagonists or proton pump inhibitors with dasatinib. Consider the use of antacids in place of H 2 antagonists or proton pump inhibitors.

Administer the antacid at least 2 hours prior to or 2 hours after the dose of dasatinib. Avoid simultaneous administration of dasatinib with antacids.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman. Adverse pharmacologic effects including hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to dasatinib. Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and in neonates.

Skeletal malformations were observed in a limited number of surviving rat and rabbit conceptuses. These findings occurred at dasatinib plasma concentrations below those in humans receiving therapeutic doses of dasatinib [see Data] . Advise a pregnant woman of the potential risk to a fetus.

The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Fetal/Neonatal Adverse Reactions Transplacental transfer of dasatinib has been reported. Dasatinib has been measured in fetal plasma and amniotic fluid at concentrations comparable to those in maternal plasma.

Hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to dasatinib. These adverse pharmacologic effects on the fetus are similar to adverse reactions observed in adult patients and may result in fetal harm or neonatal death [see Warnings and Precautions ( 5.1 , 5.3 )] . Data Human Data Based on human experience, dasatinib is suspected to cause congenital malformations, including neural tube defects, and harmful pharmacological effects on the fetus when administered during pregnancy.

Animal Data In nonclinical studies at plasma concentrations below those observed in humans receiving therapeutic doses of dasatinib, embryo-fetal toxicities were observed in rats and rabbits. Fetal death was observed in rats. In both rats and rabbits, the lowest doses of dasatinib tested (rat: 2.5 mg/kg/day [15 mg/m 2 /day] and rabbit: 0.5 mg/kg/day [6 mg/m 2 /day]) resulted in embryo-fetal toxicities.

These doses produced maternal AUCs of 105 ng•h/mL and 44 ng•h/mL (0.1-fold the human AUC) in rats and rabbits, respectively. Embryo-fetal toxicities included skeletal malformations at multiple sites (scapula, humerus, femur, radius, ribs, and clavicle), reduced ossification (sternum; thoracic, lumbar, and sacral vertebrae; forepaw phalanges; pelvis; and hyoid body), edema, and microhepatia. In a pre- and postnatal development study in rats, administration of dasatinib from gestation day (GD) 16 through lactation day (LD) 20, GD 21 through LD 20, or LD 4 through LD 20 resulted in extensive pup mortality at maternal exposures that were below the exposures in patients treated with dasatinib at the recommended labeling dose.

8.2Lactation Risk Summary No data are available regarding the presence of dasatinib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. However, dasatinib is present in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing children from dasatinib, breastfeeding is not recommended during treatment with dasatinib and for 2 weeks after the last dose.

8.3Females and Males of Reproductive Potential Dasatinib can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Contraception Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with dasatinib and for 30 days after the last dose. Infertility Based on animal data, dasatinib may result in damage to female and male reproductive tissues [see Nonclinical Toxicology ( 13.1 )] .

8.4Pediatric Use Ph+ CML in Chronic Phase The safety and effectiveness of dasatinib monotherapy have been demonstrated in pediatric patients with newly diagnosed chronic… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman. Adverse pharmacologic effects including hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to dasatinib. Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and in neonates.

Skeletal malformations were observed in a limited number of surviving rat and rabbit conceptuses. These findings occurred at dasatinib plasma concentrations below those in humans receiving therapeutic doses of dasatinib [see Data] . Advise a pregnant woman of the potential risk to a fetus.

The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Fetal/Neonatal Adverse Reactions Transplacental transfer of dasatinib has been reported. Dasatinib has been measured in fetal plasma and amniotic fluid at concentrations comparable to those in maternal plasma.

Hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to dasatinib. These adverse pharmacologic effects on the fetus are similar to adverse reactions observed in adult patients and may result in fetal harm or neonatal death [see Warnings and Precautions ( 5.1 , 5.3 )] . Data Human Data Based on human experience, dasatinib is suspected to cause congenital malformations, including neural tube defects, and harmful pharmacological effects on the fetus when administered during pregnancy.

Animal Data In nonclinical studies at plasma concentrations below those observed in humans receiving therapeutic doses of dasatinib, embryo-fetal toxicities were observed in rats and rabbits. Fetal death was observed in rats. In both rats and rabbits, the lowest doses of dasatinib tested (rat: 2.5 mg/kg/day [15 mg/m 2 /day] and rabbit: 0.5 mg/kg/day [6 mg/m 2 /day]) resulted in embryo-fetal toxicities.

These doses produced maternal AUCs of 105 ng•h/mL and 44 ng•h/mL (0.1-fold the human AUC) in rats and rabbits, respectively. Embryo-fetal toxicities included skeletal malformations at multiple sites (scapula, humerus, femur, radius, ribs, and clavicle), reduced ossification (sternum; thoracic, lumbar, and sacral vertebrae; forepaw phalanges; pelvis; and hyoid body), edema, and microhepatia. In a pre- and postnatal development study in rats, administration of dasatinib from gestation day (GD) 16 through lactation day (LD) 20, GD 21 through LD 20, or LD 4 through LD 20 resulted in extensive pup mortality at maternal exposures that were below the exposures in patients treated with dasatinib at the recommended labeling dose.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Ph+ CML in Chronic Phase The safety and effectiveness of dasatinib monotherapy have been demonstrated in pediatric patients with newly diagnosed chronic phase CML [see Clinical Studies ( 14.3 )] . There are no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported in 5 (5.2%) of patients [see Warnings and Precautions ( 5.10 )] .

Ph+ ALL The safety and effectiveness of dasatinib in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. Use of dasatinib in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year of age.

One case of grade 1 osteopenia was reported. The safety profile of dasatinib tablets in pediatric subjects was comparable to that reported in studies in adult subjects [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 , 14.4 )] . Monitor bone growth and development in pediatric patients [see Warnings and Precautions ( 5.10 )] .

Pediatric Patients with Difficulty Swallowing Tablets Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of dasatinib tablet dispersed in juice on Study CA180372. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients [see Clinical Pharmacology ( 12.3 )] . Due to the limited available clinical data, it is unclear whether dispersing dasatinib tablets significantly alters the safety and/or efficacy of dasatinib.

🧓 Geriatric Use 126 words ▾

8.5Geriatric Use Of the 2712 patients in clinical studies of dasatinib, 617 (23%) were 65 years of age and older, and 123 (5%) were 75 years of age and older. No differences in confirmed Complete Cytogenetic Response (cCCyR) and MMR were observed between older and younger patients. While the safety profile of dasatinib in the geriatric population was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance, and more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema, and weight decrease, and should be monitored closely.

🆘 Overdosage 126 words ▾

10 OVERDOSAGE Experience with overdose of dasatinib in clinical studies is limited to isolated cases. The highest overdosage of 280 mg per day for 1 week was reported in two patients and both developed severe myelosuppression and bleeding. Since dasatinib is associated with severe myelosuppression [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] , monitor patients who ingest more than the recommended dosage closely for myelosuppression and give appropriate supportive treatment.

Acute overdose in animals was associated with cardiotoxicity. Evidence of cardiotoxicity included ventricular necrosis and valvular/ventricular/atrial hemorrhage at single doses ≥100 mg/kg (600 mg/m 2 ) in rodents. There was a tendency for increased systolic and diastolic blood pressure in monkeys at single doses ≥10 mg/kg (120 mg/m 2 ).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro , dasatinib was active in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease.

Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib could overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.

12.2Pharmacodynamics Cardiac Electrophysiology Of 2440 patients treated with dasatinib at all doses tested in clinical trials, 16 patients (<1%) had QTc prolongation reported as an adverse reaction. Twenty-two patients (1%) experienced a QTcF >500 ms. In 865 patients with leukemia treated with dasatinib 70 mg BID in five Phase 2 studies, the maximum mean changes in QTcF (90% upper bound CI) from baseline ranged from 7 ms to 13.4 ms.

An analysis of the data from five Phase 2 studies in patients (70 mg BID) and a Phase 1 study in healthy subjects (100 mg single dose) suggests that there is a maximum increase of 3 to 6 milliseconds in Fridericia corrected QTc interval from baseline for subjects receiving therapeutic doses of dasatinib, with associated upper 95% confidence intervals <10 msec.

12.3Pharmacokinetics The pharmacokinetics of dasatinib exhibits dose proportional increases in AUC and linear elimination characteristics over the dose range of 15 mg/day (0.15 times the lowest approved recommended dose) to 240 mg/day (1.7 times the highest approved recommended dose). At 100 mg QD, the maximum concentration at steady state (C max ) is 82.2 ng/mL (CV% 69%), area under the plasma drug concentration time curve (AUC) is 397 ng/mL*hr (CV% 55%). The clearance of dasatinib is found to be time-invariant.

When administered to adult healthy subjects as dispersed tablets in juice, the adjusted geometric mean ratio was 0.97 (90% CI: 0.85, 1.10) for C max and 0.84 (90% CI: 0.78, 0.91) for AUC as compared to intact tablets. Absorption The maximum plasma concentrations (C max ) of dasatinib are observed between 0.5 hours and 6 hours (T max ) following oral administration. Food Effect A high-fat meal increased the mean AUC of dasatinib following a single dose of 100 mg by 14%.

The total calorie content of the high-fat meal was 985 kcal. The calories derived from fat, carbohydrates, and protein were 52%, 34%, and 14% for the high-fat meal. Distribution The apparent volume of distribution is 2505 L (CV% 93%).

Binding of dasatinib to human plasma proteins in vitro was approximately 96% and of its active metabolite was 93%, with no concentration dependence over the range of 100 ng/mL to 500 ng/mL. Dasatinib is a P-gp substrate in vitro . Elimination The mean terminal half-life of dasatinib is 3 hours to 5 hours.

The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%). Metabolism Dasatinib is metabolized in humans, primarily by CYP3A4. CYP3A4 is the primary enzyme responsible for the formation of the active metabolite.

Flavin-containing monooxygenase 3 (FMO-3) and uridine diphosphate-glucuronosyltransferase (UGT) enzymes are also involved in the formation of dasatinib metabolites. The exposure of the active metabolite, which is equipotent to dasatinib, represents approximately 5% of the AUC of dasatinib. The active metabolite of dasatinib is unlikely to play a major role in the observed pharmacology of the drug.

Dasatinib also has several other inactive oxidative metabolites. Excretion Elimination is primarily via the feces. Following a single radiolabeled dose of oral dasatinib, 4% of the administered radioactivity was recovered… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 109 words ▾

12.1Mechanism of Action Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro , dasatinib was active in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease.

Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib could overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Dasatinib tablets are supplied as follows: 20 mg: Each white to off-white, round, beveled edge, film-coated tablet, debossed with “20” on one side and plain on the other side contains 20 mg of dasatinib. Tablets are available in bottles of 60 (NDC 0480-5101-06). 50 mg: Each white to off-white, oval, beveled edge, film-coated tablet, debossed with “50” on one side and plain on the other side contains 50 mg of dasatinib.

Tablets are available in bottles of 60 (NDC 0480-5102-06). 70 mg: Each white to off-white, round, beveled edge, film-coated tablet, debossed with “70” on one side and plain on the other side contains 70 mg of dasatinib. Tablets are available in bottles of 60 (NDC 0480-5103-06).

80 mg: Each white to off-white, triangle, beveled edge, film-coated tablet, debossed with “80” on one side and plain on the other side contains 80 mg of dasatinib. Tablets are available in bottles of 30 (NDC 0480-3523-56). 100 mg: Each white to off-white, oval, beveled edge, film-coated tablet, debossed with “100” on one side and plain on the other side contains 100 mg of dasatinib.

Tablets are available in bottles of 30 (NDC 0480-5104-56). 140 mg: Each white to off-white, round, beveled edge, film-coated tablet, debossed with “140” on one side and plain on the other side contains 140 mg of dasatinib. Tablets are available in bottles of 30 (NDC 0480-3524-56).

Storage Dasatinib tablets should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Handling and Disposal Dasatinib tablets are an antineoplastic product. Follow special handling and disposal procedures.

1 Personnel who are pregnant should avoid exposure to crushed or broken tablets. Dasatinib tablets consist of a core tablet, surrounded by a film coating to prevent exposure of healthcare professionals to the active substance. The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimize the risk of dermal exposure.

📋 Description 124 words ▾

11 DESCRIPTION Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22 H 26 ClN 7 O 2 S • H 2 O, which corresponds to a formula weight of 506.02 (monohydrate).

The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure: Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol.

Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin. 1

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Myelosuppression Inform patients of the possibility of developing low blood cell counts. Advise patients to immediately report fever particularly in association with any suggestion of infection [see Warnings and Precautions ( 5.1 )] .

Bleeding Inform patients of the possibility of serious bleeding and to report immediately any signs or symptoms suggestive of hemorrhage (unusual bleeding or easy bruising) [see Warnings and Precautions ( 5.2 )] . Fluid Retention Patients should be informed of the possibility of developing fluid retention (swelling, weight gain, dry cough, chest pain on respiration, or shortness of breath) and advised to seek medical attention promptly if those symptoms arise [see Warnings and Precautions ( 5.3 )] . Cardiovascular Toxicity Inform patients of the possibility of developing cardiovascular toxicity, including cardiac ischemic events, cardiac-related fluid retention, conduction abnormalities, and TIAs.

Advise patients to seek immediate medical attention if symptoms suggestive of cardiovascular toxicity occur, such as chest pain, shortness of breath, palpitations, transient vision problems, or slurred speech [see Warnings and Precautions ( 5.4 )] . Pulmonary Arterial Hypertension Inform patients of the possibility of developing pulmonary arterial hypertension (dyspnea, fatigue, hypoxia, and fluid retention) and advise them to seek medical attention promptly if those symptoms arise [see Warnings and Precautions ( 5.5 )] .

Tumor Lysis Syndrome Inform patients to immediately report and seek medical attention for any symptoms such as nausea, vomiting, weakness, edema, shortness of breath, muscle cramps, and seizures, which may indicate tumor lysis syndrome [see Warnings and Precautions ( 5.8 )] . Growth and Development in Pediatric Patients Inform pediatric patients and their caregivers of the possibility of developing bone growth abnormalities, bone pain, or gynecomastia and advise them to seek medical attention promptly if those symptoms arise [see Warnings and Precautions ( 5.10 )] .

Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions ( 5.9 ) and Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with dasatinib tablets and for 30 days after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking dasatinib tablets [see Warnings and Precautions ( 5.9 ) and Use in Specific Populations ( 8.1 , 8.3 )] .

Lactation Advise women that breastfeeding is not recommended during treatment with dasatinib tablets and for 2 weeks after the final dose [see Use in Specific Populations ( 8.2 )] . Gastrointestinal Complaints Inform patients that they may experience nausea, vomiting, or diarrhea with dasatinib tablets. Advise patients to seek medical attention if these symptoms are bothersome or persistent.

Advise patients using antacids to avoid taking dasatinib tablets and antacids less than 2 hours apart [see Drug Interactions ( 7.1 )] . Pain Inform patients that they may experience headache or musculoskeletal pain with dasatinib tablets. Advise patients to seek medical attention if these symptoms are bothersome or persistent.

Fatigue Inform patients that they may experience fatigue with dasatinib tablets. Advise patients to seek medical attention if this symptom is bothersome or persistent. Rash Inform patients that they may experience skin rash with dasatinib tablets.

Advise patients to seek medical attention if this symptom is bothersome or persistent. Lactose Inform patients that dasatinib tablets contain 131 mg of lactose monohydrate in a 100 mg daily dose and 184 mg of lactose monohydrate in a 140 mg daily dose. Hepatotoxicity Advise p… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of dasatinib exhibits dose proportional increases in AUC and linear elimination characteristics over the dose range of 15 mg/day (0.15 times the lowest approved recommended dose) to 240 mg/day (1.7 times the highest approved recommended dose). At 100 mg QD, the maximum concentration at steady state (C max ) is 82.2 ng/mL (CV% 69%), area under the plasma drug concentration time curve (AUC) is 397 ng/mL*hr (CV% 55%). The clearance of dasatinib is found to be time-invariant.

When administered to adult healthy subjects as dispersed tablets in juice, the adjusted geometric mean ratio was 0.97 (90% CI: 0.85, 1.10) for C max and 0.84 (90% CI: 0.78, 0.91) for AUC as compared to intact tablets. Absorption The maximum plasma concentrations (C max ) of dasatinib are observed between 0.5 hours and 6 hours (T max ) following oral administration. Food Effect A high-fat meal increased the mean AUC of dasatinib following a single dose of 100 mg by 14%.

The total calorie content of the high-fat meal was 985 kcal. The calories derived from fat, carbohydrates, and protein were 52%, 34%, and 14% for the high-fat meal. Distribution The apparent volume of distribution is 2505 L (CV% 93%).

Binding of dasatinib to human plasma proteins in vitro was approximately 96% and of its active metabolite was 93%, with no concentration dependence over the range of 100 ng/mL to 500 ng/mL. Dasatinib is a P-gp substrate in vitro . Elimination The mean terminal half-life of dasatinib is 3 hours to 5 hours.

The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%). Metabolism Dasatinib is metabolized in humans, primarily by CYP3A4. CYP3A4 is the primary enzyme responsible for the formation of the active metabolite.

Flavin-containing monooxygenase 3 (FMO-3) and uridine diphosphate-glucuronosyltransferase (UGT) enzymes are also involved in the formation of dasatinib metabolites. The exposure of the active metabolite, which is equipotent to dasatinib, represents approximately 5% of the AUC of dasatinib. The active metabolite of dasatinib is unlikely to play a major role in the observed pharmacology of the drug.

Dasatinib also has several other inactive oxidative metabolites. Excretion Elimination is primarily via the feces. Following a single radiolabeled dose of oral dasatinib, 4% of the administered radioactivity was recovered in the urine and 85% in the feces within 10 days.

Unchanged dasatinib accounted for 0.1% of the administered dose in the urine and 19% of the administered dose in the feces with the remainder of the dose being metabolites. Specific Populations Age (15 to 86 years old), sex, and renal impairment (creatinine clearance 21.6 mL/min to 342.3 mL/min as estimated by Cockcroft Gault) have no clinically relevant effect on the pharmacokinetics of dasatinib. Pediatric Patients The pharmacokinetics of dasatinib were evaluated in 43 pediatric patients with leukemia or solid tumors at oral doses ranging from 60 mg/m 2 to 120 mg/m 2 once daily, taken with or without food.

The pharmacokinetics showed dose proportionality with a dose-related increase in exposure. The mean T max was observed between 0.5 hours and 6 hours and the mean half-life was 2 hours to 5 hours. The geometric mean (CV%) of body weight normalized clearance in these 43 pediatric patients is 5.98 (41.5%) L/h/kg.

In pediatric patients with a dosing regimen of 60 mg/m 2 , the model simulated geometric mean (CV%) steady-state plasma average concentrations of dasatinib were 14.7 (64.6%) ng/mL (for 2 to <6 years old), 16.3 (97.5%) ng/mL (for 6 to <12 years old), and 18.2 (67.7%) ng/mL (for 12 years and older) [see Dosage and Administration ( 2.2 )] . Dasatinib clearance and volume of distribution change with body weight in pediatric patients. Dasatinib has not been studied in patients < 1 year old.

The bioavailability of dispersed tablets in pediatric patients was estimated to be 36% lower than that of intact tablets. Patients with Hepatic Impairment Comp… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 132 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology Of 2440 patients treated with dasatinib at all doses tested in clinical trials, 16 patients (<1%) had QTc prolongation reported as an adverse reaction. Twenty-two patients (1%) experienced a QTcF >500 ms. In 865 patients with leukemia treated with dasatinib 70 mg BID in five Phase 2 studies, the maximum mean changes in QTcF (90% upper bound CI) from baseline ranged from 7 ms to 13.4 ms.

An analysis of the data from five Phase 2 studies in patients (70 mg BID) and a Phase 1 study in healthy subjects (100 mg single dose) suggests that there is a maximum increase of 3 to 6 milliseconds in Fridericia corrected QTc interval from baseline for subjects receiving therapeutic doses of dasatinib, with associated upper 95% confidence intervals <10 msec.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Newly Diagnosed Chronic Phase CML in Adults DASISION (Dasatinib vs Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients) (NCT00481247) was an open-label, multicenter, international, randomized trial conducted in adult patients with newly diagnosed chronic phase CML. A total of 519 patients were randomized to receive either dasatinib 100 mg once daily or imatinib 400 mg once daily. Patients with a history of cardiac disease were included in this trial except those who had a myocardial infarction within 6 months, congestive heart failure within 3 months, significant arrhythmias, or QTc prolongation.

The primary endpoint was the rate of confirmed complete cytogenetic response (CCyR) within 12 months. Confirmed CCyR was defined as a CCyR noted on two consecutive occasions (at least 28 days apart). Median age was 46 years in the dasatinib group and 49 years in the imatinib groups, with 10% and 11% of patients ≥65 years of age, respectively.

There were slightly more male than female patients in both groups (59% vs 41%). Fifty-three percent of all patients were Caucasian and 39% were Asian. At baseline, the distribution of Hasford scores was similar in the dasatinib and imatinib treatment groups (low risk: 33% and 34%; intermediate risk: 48% and 47%; high risk: 19% and 19%, respectively).

With a minimum of 12 months follow-up, 85% of patients randomized to dasatinib and 81% of patients randomized to imatinib were still on study. With a minimum of 24 months follow-up, 77% of patients randomized to dasatinib and 75% of patients randomized to imatinib were still on study and with a minimum of 60 months follow-up, 61% and 62% of patients, respectively, were still on treatment at the time of study closure. Efficacy results are summarized in Table 16.

Table 16: Efficacy Results in a Randomized Newly Diagnosed Chronic Phase CML Trial Dasatinib (n=259) Imatinib (n=260) Confirmed CCyR a Within 12 months (95% CI) 76.8% (71.2 to 81.8) 66.2% (60.1 to 71.9) P-value 0.007* Major Molecular Response b 12 months (95% CI) 52.1% (45.9 to 58.3) 33.8% (28.1 to 39.9) P-value <0.0001 60 months (95% CI) 76.4% (70.8 to 81.5) 64.2% (58.1 to 70.1) a Confirmed CCyR is defined as a CCyR noted on two consecutive occasions at least 28 days apart. b Major molecular response (at any time) was defined as BCR-ABL ratios ≤0.1% by RQ-PCR in peripheral blood samples standardized on the International scale.

These are cumulative rates representing minimum follow up for the time frame specified. * Adjusted for Hasford score and indicated statistical significance at a pre-defined nominal level of significance. CI = confidence interval. The confirmed CCyR within 24, 36, and 60 months for dasatinib versus imatinib arms were 80% versus 74%, 83% versus 77%, and 83% versus 79%, respectively.

The MMR at 24 and 36 months for dasatinib versus imatinib arms were 65% versus 50% and 69% versus 56%, respectively. After 60 months follow-up, median time to confirmed CCyR was 3.1 months in 215 dasatinib responders and 5.8 months in 204 imatinib responders. Median time to MMR after 60 months follow-up was 9.3 months in 198 dasatinib responders and 15.0 months in 167 imatinib responders.

At 60 months, 8 patients (3%) on the dasatinib arm progressed to either accelerated phase or blast crisis while 15 patients (6%) on the imatinib arm progressed to either accelerated phase or blast crisis. The estimated 60-month survival rates for dasatinib- and imatinib-treated patients were 90.9% (CI: 86.6% to 93.8%) and 89.6% (CI: 85.2% to 92.8%), respectively. Based on data 5 years after the last patient was enrolled in the trial, 83% and 77% of patients were known to be alive in the dasatinib and imatinib treatment groups, respectively, 10% were known to have died in both treatment groups, and 7% and 13% had unknown survival status in the dasatinib and imatinib treatment groups, respectively.

At 60 months follow-up in the dasatinib arm, the rate of MMR at any time… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 191 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day. The highest dose resulted in a plasma drug exposure (AUC) level approximately 60% of the human exposure at 100 mg once daily. Dasatinib induced a statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and prostate adenoma in low-dose males.

Dasatinib was clastogenic when tested in vitro in Chinese hamster ovary cells, with and without metabolic activation. Dasatinib was not mutagenic when tested in an in vitro bacterial cell assay (Ames test) and was not genotoxic in an in vivo rat micronucleus study. Dasatinib did not affect mating or fertility in male and female rats at plasma drug exposure (AUC) similar to the human exposure at 100 mg daily.

In repeat dose studies, administration of dasatinib resulted in reduced size and secretion of seminal vesicles, and immature prostate, seminal vesicle, and testis. The administration of dasatinib resulted in uterine inflammation and mineralization in monkeys, and cystic ovaries and ovarian hypertrophy in rodents.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 188 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day. The highest dose resulted in a plasma drug exposure (AUC) level approximately 60% of the human exposure at 100 mg once daily. Dasatinib induced a statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and prostate adenoma in low-dose males.

Dasatinib was clastogenic when tested in vitro in Chinese hamster ovary cells, with and without metabolic activation. Dasatinib was not mutagenic when tested in an in vitro bacterial cell assay (Ames test) and was not genotoxic in an in vivo rat micronucleus study. Dasatinib did not affect mating or fertility in male and female rats at plasma drug exposure (AUC) similar to the human exposure at 100 mg daily.

In repeat dose studies, administration of dasatinib resulted in reduced size and secretion of seminal vesicles, and immature prostate, seminal vesicle, and testis. The administration of dasatinib resulted in uterine inflammation and mineralization in monkeys, and cystic ovaries and ovarian hypertrophy in rodents.

📚 References 4 words ▾

15 REFERENCES 1. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

Dispense with Patient Package Insert available at: www.tevausa.com/PatientPI PATIENT INFORMATION Dasatinib (da sa' ti nib) Tablets What are dasatinib tablets? Dasatinib tablets are a prescription medicine used to treat: adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including imatinib. adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment. children 1 year of age and older with Ph+ CML in chronic phase. children 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

It is not known if dasatinib tablets are safe and effective in children under 1 year of age. Before taking dasatinib tablets, tell your healthcare provider about all of your medical conditions, including if you: have problems with your immune system have heart problems, including a condition called congenital long QT syndrome have low potassium or low magnesium levels in your blood have liver problems are lactose (milk sugar) intolerant are pregnant or plan to become pregnant. Dasatinib can harm your unborn baby.

Females who can become pregnant: You should not become pregnant during treatment with dasatinib tablets. You should use effective birth control (contraception) during treatment and for 30 days after your last dose of dasatinib tablets. Talk to your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with dasatinib tablets.

Males with female partners who can become pregnant: You should use effective birth control (contraception) during treatment and for 30 days after your last dose of dasatinib tablets. Your female partner should call her healthcare provider if she becomes pregnant or thinks she is pregnant during your treatment with dasatinib tablets. are breastfeeding or plan to breastfeed. It is not known if dasatinib passes into your breast milk.

You should not breastfeed during treatment and for 2 weeks after your last dose of dasatinib tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, antacids, and herbal supplements. If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of dasatinib tablets.

How should I take dasatinib tablets? Take dasatinib tablets exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of dasatinib tablets or temporarily stop treatment with dasatinib tablets.

Do not change your dose or stop taking dasatinib tablets without first talking to your healthcare provider. Take dasatinib tablets 1 time a day. Take dasatinib tablets with or without food, either in the morning or in the evening.

Swallow dasatinib tablets whole. Do not crush, cut or chew the tablets. If your child cannot swallow tablets whole, talk with your healthcare provider.

You should not drink grapefruit juice during treatment with dasatinib tablets. If you miss a dose of dasatinib tablets, take your next scheduled dose at your regular time. Do not take two doses at the same time.

If you take too many dasatinib tablets, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of dasatinib tablets? Dasatinib tablets may cause serious side effects, including: Low blood cell counts.

Low blood cell counts are common with dasatinib tablets and can be severe, including low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with dasatinib tablets. Call your healthcare provider right away if you have a fever or any signs of an infection during treatment with dasatinib tablets.

Bleedi… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 168 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-5101-06 Dasatinib Tablets 20 mg Do not crush, cut or chew tablets. Swallow tablets whole. Rx only 60 Tablets label, 20 mg, 60s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-5102-06 Dasatinib Tablets 50 mg Do not crush, cut or chew tablets. Swallow tablets whole. Rx only 60 Tablets label, 50 mg, 60s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-5103-06 Dasatinib Tablets 70 mg Do not crush, cut or chew tablets. Swallow tablets whole. Rx only 60 Tablets label, 70 mg, 60s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-3523-56 Dasatinib Tablets 80 mg Do not crush, cut or chew tablets. Swallow tablets whole. Rx only 30 Tablets label, 80 mg, 30s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-5104-56 Dasatinib Tablets 100 mg Do not crush, cut or chew tablets. Swallow tablets whole. Rx only 30 Tablets label, 100 mg, 30s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-3524-56 Dasatinib Tablets 140 mg Do not crush, cut or chew tablets. Swallow tablets whole. Rx only 30 Tablets label, 140 mg, 30s

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 Dasatinib — the program that covers self-administered drugs. 8 manufacturers.
⚠️ 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 Dasatinib. 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
$68.02M
Claims incl. refills
13.6K
Beneficiaries
5.5K
Spend / beneficiary
$12,380.63
Spend / claim
$4,985.28
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Teva Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Teva Pharmaceuticals, 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.
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.
← 00480-5101-06 · Teva 00480-5103-06 · Teva →
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.