Information for US Healthcare Providers
A TKI TREATMENT WITHOUT COMPROMISE:
The first dasatinib
that can be taken
with PPIs and H2RAs.1

PHYRAGO™ (dasatinib) tablets are a kinase inhibitor indicated for the treatment of:

Newly diagnosed adults: Newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.1

Adults with Ph+ CML: Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.1

Adults with Ph+ ALL: Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.1

Pediatric patients 1 year of age and older with Ph+ CML in chronic phase.1

Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.1

Compatible with proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs)

PHYRAGO contains an amorphous solid dispersion form of dasatinib which may improve the solubility and dissolution rate under neutral pH conditions compared to the crystalline monohydrate form in Sprycel® (dasatinib) tablets.2-4

As a result, PHYRAGO may offer consistency in dasatinib levels across different pH conditions and maintains its bioavailability and absorbance when taken with PPIs and H2RAs.2,3

Bar chart showing ratio of dasatinib AUCs with and without concomitant ARA use, comparing the bioavailability of Sprycel® and PHYRAGO

Figure 1. No reduction in PHYRAGO bioavailability with concomitant use of PPIs and H2RAs even at worst-case coadministration timing,1,3 while Sprycel® had a notable reduction in bioavailability.5

Bioequivalence acceptance range: 0.80 – 1.25

Bioequivalent to Sprycel® (dasatinib) tablets

PHYRAGO tablets are bioequivalent to Sprycel® tablets,2 delivering the same therapeutic efficacy with the added benefit of being compatible with PPIs and H2RAs.1

Available in the same dosage sizes of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg tablets,1,5 and taken once daily,1 making switching patients simple.

Graph comparing dasatinib concentration of phyrago and Sprycel® over time

Figure 2: An open-label, randomized, crossover, single dose study of PHYRAGO vs. Sprycel® in 44 healthy adult individuals.2

Results: 90% confidence intervals (CI) of the geometric mean ratio (GMR) for Cmax, AUC0-t, and AUC0-∞ were within the acceptable bioequivalence limits of 80%-125%.2

Flexibility to be taken with or without food

PHYRAGO can be taken with or without food1, offering greater flexibility and convenience for your patients compared with other second-generation tyrosine kinase inhibitors (TKIs).

Administration

PHYRAGO™ (dasatinib) tablets1Tasigna® (nilotinib) tablets6Bosulif® (bosutinib) tablets7
Once daily, with or without foodTwice daily, avoid food 2hrs before and 1hr afterOnce daily, with food
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References

1. PHYRAGO (dasatinib). Prescribing Information. Handa Therapeutics, LLC.
2. Study NC9013-002. Center for Drug Evaluation and Research – Clinical Pharmacology Review(s). (2022). [online]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216099Orig1s000SumR.pdf. [Accessed: February 18 2026].
3. Center for Drug Evaluation and Research. 2022. Application Number: 216099Orig1s000 Non-Clinical Review(s). [online]. Available at:  https://www.accessdata.fda.gov/drugsatfda_docs/ nda/2024/216099Orig1s000PharmR.pdf. [Accessed: February 18 2026].
4. REF-00093-HCP-US-DAS-APR-2026.
5. Sprycel® (dasatinib). Prescribing Information. Bristol-Myers Squibb Company.
6. Tasigna® (nilotinib). Prescribing Information. Novartis Pharma.
7. Bosulif® (bosutinib). Prescribing Information. Pfizer Inc.

Sprycel® is a registered trademark of Bristol-Myers Squibb Company.
Tasigna® is a registered trademark of Novartis AG.
Bosulif® is a registered trademark of Pfizer Inc.

Indication and Important Safety Information
PHYRAGO Logo
Indication and Important Safety Information
PHYRAGO Logo

Indications

PHYRAGO™ is a kinase inhibitor indicated for the treatment of:

  • Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
  • Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
  • Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance or intolerance to prior therapy.
  • Pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
  • Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

Important Safety Information

Warnings and Precautions:

Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia and anemia may occur. Use caution if used concomitantly with medication that inhibits platelet function or anticoagulants. Monitor complete blood counts regularly. Transfuse and interrupt PHYRAGO when indicated.

Fluid Retention: Fluid retention, sometimes severe, including pleural effusions. Manage with supportive care measures and/or dose modification.

Cardiovascular Toxicity: Monitor patients for signs or symptoms and treat appropriately.

Pulmonary Arterial Hypertension (PAH): PHYRAGO 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 PHYRAGO if PAH is confirmed.

QT Prolongation: Use PHYRAGO with caution in patients who have or may develop prolongation of the QT interval.

Severe Dermatologic Reactions: Individual cases of severe mucocutaneous dermatologic reactions have been reported.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain adequate hydration and correct uric acid levels prior to initiating therapy with PHYRAGO.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential, of potential risk to fetus and to use effective contraception.

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.

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.

Adverse Reactions:

Most common adverse reactions (≥15%) in patients receiving dasatinib as a single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.

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.

Postmarketing Experience:

The following adverse reactions have been identified during post approval use of dasatinib:

Hepatitis B virus reactivation, atrial fibrillation/atrial flutter, interstitial lung disease, chylothorax, Stevens-Johnson syndrome, nephrotic syndrome, thrombotic microangiopathy, hepatotoxicity.

Drug Interactions:

Strong CYP3A4 Inhibitors: Dose reduction may be necessary.

Strong CYP3A4 Inducers: Dose increase may be necessary.

Antacids: Avoid concomitant use.

Use in Specific Populations:

Pregnancy: Based on limited human data, PHYRAGO can cause fetal harm when administered to a pregnant woman which may result in neonatal death. Advise a pregnant woman of the potential risk to a fetus.

Contraception: Advise females of reproductive potential and males with female partners with reproductive potential to use effective contraception during treatment and for 30 days after the last dose.

Lactation: Breastfeeding is not recommended during treatment with PHYRAGO and for 2 weeks after the last dose.

Pediatric Use:

Ph+ CML in Chronic Phase

Safety and effectiveness of dasatinib monotherapy have been demonstrated in pediatric patients with newly diagnosed chronic phase CML. There is no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported.

Ph+ ALL

Safety and effectiveness of dasatinib in combination with chemotherapy have been demonstrated in pediatric patients 1 year and over with newly diagnosed Ph+ ALL. There is no data in children under 1 year of age.

Monitor bone growth and development in pediatric patients.

Refer to the full USPI for pediatric patients with difficulty swallowing tablets.

Monitor bone growth and development in pediatric patients.

Refer to the full USPI for pediatric patients with difficulty swallowing tablets.

Geriatric Use: Patients aged 65 years and older may experience commonly reported adverse reactions such as fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance. Less frequently reported adverse reactions include abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema, and weight decrease. Careful monitoring is recommended in this population.

For more detailed information, please refer to the full Prescribing Information at https://phyrago.com/pi/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-844-784-1807, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

White PHYRAGO dasatinib tablets logo

PHYRAGO™ is a trademark of Handa Therapeutics, LLC.
Cycle Vita™ is a trademark of Cycle Pharmaceuticals Limited in the United States.

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