Information for US Healthcare Providers

Why PHYRAGO™ (dasatinib) tablets?

Not actual patient disclaimer

What makes PHYRAGO different

PHYRAGO is an amorphous solid dispersion formulation of dasatanib.1

PHYRAGO contains an amorphous formulation of dasatinib which may improve the solubility and dissolution rate under neutral pH conditions compared to the crystalline monohydrate form in Sprycel®.1-3

As a result, PHYRAGO may offer consistency in dasatinib levels across different pH conditions and maintains its bioavailability and absorbance when taken with proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs).2,3

PHYRAGO, when taken with PPIs and H2RAs, is bioequivalent to Sprycel® at steady state.2

PHYRAGO is effective at high gastric pH and with reduced acid secretion.2

PHYRAGO delivers the same clinical outcomes as Sprycel® (dasatinib) in a redeveloped formulation2

PHYRAGO is bioequivalent to and available at the same doses as Sprycel® in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg tablets.2,4,5

Data from an open-label, randomized, crossover, single-dose study of PHYRAGO vs. Sprycel® in 44 healthy adults showed that the Cmax, AUC0-t, and AUC0-∞ of dasatinib were within the bioequivalence criteria of 80%-125%.2

Table 1. Mean pharmacokinetic parameters of dasatinib comparing PHYRAGO and Sprycel®, under fasted conditions.2

Cmax (ng/mL)AUCt (ng∙h/mL)AUC∞ (ng∙h/mL)Tmax (h)
PHYRAGO93.13324151.25
Sprycel®1013253361.00
PHYRAGO
Cmax (ng/mL)93.1
AUCt (ng∙h/mL)332
AUC∞ (ng∙h/mL)415
Tmax (h)1.25
Sprycel®
Cmax (ng/mL)101
AUCt (ng∙h/mL)325
AUC∞ (ng∙h/mL)336
Tmax (h)1.00
Graph comparing dasatinib concentration of phyrago and Sprycel® over time

Figure 1. Mean dasatinib concentration against time, under fasted conditions.2

Co-medication with acid-reducing agents (ARAs)

The bioavailability of dasatinib remained bioequivalent, within 80.00-125.00%, when PHYRAGO was used concomitantly with PPIs and H2RAs. On the contrary, the bioavailability of dasatinib was significantly reduced when Sprycel® was used concomitantly with PPI and H2RAs (Figure 2 and Table 2).2

Expand Image

Figure 2. Ratio of dasatinib AUCs with and without concomitant ARA use, comparing the bioavailability of Sprycel® and PHYRAGO.

*Bioequivalence acceptance range: 0.80-1.25.

Table 2. Mean (± SD) pharmacokinetic parameters for PHYRAGO and Sprycel® after premedication with 20 mg famotidine three hours prior to dasatinib, under fasted conditions.2

Study ARL/18/2914
PHYRAGO (100 mg dasatinib) vs. Sprycel® (100 mg dasatinib)		Study ARL/18/2924
PHYRAGO (100 mg dasatinib) and Sprycel® (100 mg dasatinib), with 20 mg famotidine (H2RA) 3 hrs prior
PHYRAGO,
fasted		SPRYCEL®,
fasted		PHYRAGO
+ 20 mg famotidine		SPRYCEL®
+ 20 mg famotidine
Cmax (ng/mL)168.589 ± 50.384154.831 ± 66.198227.903 ± 69.6227.610 ± 4.360
AUCt (ng∙h/mL)687.872 ± 149.904602.29 ± 252.180889.09 ± 312.37677.828 ± 36.339
AUC∞
(ng∙h/mL)		718.799 ± 152.027657.858 ± 221.961920.751 ± 220.279157.566 ± 81.378
Tmax (h)21.252.52.75

Figure 2. Ratio of dasatinib AUCs with and without concomitant ARA use, comparing the bioavailability of Sprycel® and PHYRAGO.

*Bioequivalence acceptance range: 0.80-1.25.

Table 2. Mean (± SD) pharmacokinetic parameters for PHYRAGO and Sprycel® after premedication with 20 mg famotidine three hours prior to dasatinib, under fasted conditions.1

Study ARL/18/2913
PHYRAGO (100 mg dasatinib) vs. Sprycel® (100 mg dasatinib)

PHYRAGOPHYRAGO
+ 20 mg famotidine		GMR90% CI
Cmax1161110.9590.812-1.132
AUC0-last4034341.0760.995-1.164
AUC0-∞4274491.0510.983-1.123
Initial doseEscalated dose
Chronic phase Ph+ CML100 mg140 mg
Accelerated phase Ph+ CML140 mg180 mg
Myeloid/lymphoid blast phase Ph+ CML140 mg180 mg
Ph+ ALL140 mg180 mg

Study ARL/18/2923
PHYRAGO (100 mg dasatinib) and Sprycel® (100 mg dasatinib), with 20 mg famotidine (H2RA) 3 hrs prior

Body weight (kg)Daily dose (mg)Escalation (for CML only)
10 to <2040 mg50 mg
≥20 to <3060 mg70 mg
≥30 to <4070 mg90 mg
≥45100 mg120 mg
[table “20” not found /]

PHYRAGO (dasatinib, 100 mg) was administered two hours after a single dose of omeprazole (PPI, 40 mg). The GMR and 90% CI data indicate that omeprazole did not affect the bioavailability of dasatinib.2

Table 4. Summary of statistical comparison of pharmacokinetic parameters of dasatinib between administration of PHYRAGO alone and with pretreatment with omeprazole.2

PHYRAGOPHYRAGO
+ 40 mg famotidine		GMR90% CI
Cmax1161120.9730.895-1.058
AUC0-last4014301.0711.016-1.286
AUC0-∞4254451.0471.005-1.092

PHYRAGO (dasatinib, 100 mg) was administered three hours after a single dose of famotidine (H2RA, 20 mg). The geometric mean ratio (GMR) and 90% confidence interval (CI) data indicate that famotidine did not affect the bioavailability of dasatinib.2

Table 3. Summary of statistical comparison of pharmacokinetic parameters of dasatinib between administration of PHYRAGO alone and with pretreatment with famotidin.4

PHYRAGOPHYRAGO
+ 20 mg famotidine		GMR90% CI
Cmax1161110.9590.812-1.132
AUC0-last4034341.0760.995-1.164
AUC0-∞4274491.0510.983-1.123
How to prescribe PHYRAGO
How to enroll
References

1. REF-00093-HCP-US-DAS-APR-2026.
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/2024/216099Orig1s000ClinPharmR.pdf. [Accessed: November 25 2025].
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 5 2026].
4. PHYRAGO™ (dasatinib). Prescribing Information. Handa Therapeutics, LLC.
5. Sprycel® (dasatinib). Prescribing Information. Bristol-Myers Squibb Company.

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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