Information for US Healthcare Providers
Not actual patient disclaimer
PHYRAGO™ (dasatinib) tablets are an amorphous formulation of second-generation tyrosine kinase inhibitors (TKIs), built on years of established efficacy and safety data, offering a trusted therapy in an optimized form.3,4
Not actual patient disclaimer
PPI and H2RA compatibility

PHYRAGO’s unique formulation allows for concomitant use with proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs), maintaining TKI efficacy without compromising gastrointestinal comfort.5 ​

What makes PHYRAGO different
Bioequivalent to Sprycel® (dasatinib) tablets

PHYRAGO is an FDA-approved dasatinib, bioequivalent to Sprycel®, with a unique formulation that maintains bioavailability when administered concomitantly with acid-reducing agents.5

See bioequivalence data

PHYRAGO is a kinase inhibitor indicated for the treatment of:

Adults with Ph+ ALL

Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.3

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.3

Newly diagnosed adults

Newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.3

Pediatric patients with Ph+ CML

Pediatric patients 1 year of age and older with Ph+ CML in chronic phase.3

Pediatric patients with Ph+ ALL

Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.3

Connect with a representative to learn more

What makes PHYRAGO different

Formulation

PHYRAGO is an anhydrous formulation and amorphous solid dispersion of dasatinib.4

Bioequivalence

PHYRAGO, when taken with PPIs and H2RAs, is bioequivalent to Sprycel® at steady state.5

Effectiveness

PHYRAGO is effective at high gastric pH and with reduced acid secretion.5

Cycle Vita™ -dedicated support* for your patients

Cycle Vita is here to support your patients with the individualized product support they need to navigate treatment.

Co-Pay Assistance Program†

In 2025, 100% of PHYRAGO patients enrolled in Cycle Vita’s Co-Pay Program paid $0 out of pocket.6

Bridge Program

A free supply of PHYRAGO allows patients to begin therapy immediately while Cycle Vita secures appropriate Benefit Verification and assists with Prior Authorization. The Bridge Program is also available to patients who have enrolled via Cycle Vita and are experiencing a temporary lapse in insurance coverage. Bridge duration is driven by insurance coverage and the active pursuit of insurance coverage by you and your team.

Reimbursement Research Support

The Cycle Vita team are experts in assisting with securing coverage, and can help support you in the process, including a Benefit Investigation and Prior Authorization assistance. Where an appeal is needed, Cycle Vita will work with you and your patients’ insurers to understand the requirements and help with any reimbursement gaps.

Continuous Clinical Product Education and Support

Cycle Vita provides patients with product support to help manage every aspect of the PHYRAGO treatment journey, such as clinical education and onboarding onto therapy.

References

1. Larfors, G. et al. (2023). Despite warnings, co-medication with proton pump inhibitors and dasatinib is common in chronic myeloid leukemia, but XS004, a novel oral dasatinib formulation, provides reduced pH-dependence, minimizing undesirable drug-drug interactions. European journal of haematology, [online] 111(4), pp.644–654. doi: https://doi.org/10.1111/ejh.14059.​
2. Andersson, P., Magnus Brisander, Charlotta Liljebris, Jesson, G. and Lennernäs, H. (2024). Severe Impact of Omeprazole Timing on pH‐Sensitive Dasatinib Absorption: Unveiling Substantial Drug–Drug Interaction. The Journal of Clinical Pharmacology. doi: https://doi.org/10.1002/jcph.6173.
3. PHYRAGO™ (dasatinib). Prescribing Information. Handa Therapeutics, LLC.
4. Data on file: REF-00093.
5. 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: May 21 2025].
6. Data on file: REF-00098.

*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.

†Patients can apply for Co-Pay Assistance even if they are not enrolled in the Cycle Vita hub program.

††Please consult the National Comprehensive Cancer Network for the latest guidance.

Sprycel® is a registered trademark of 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.

© 2026 Cycle Pharmaceuticals Limited. All rights reserved.

Contact us

www.cyclepharma.com
@CycleVitaUSA
www.cyclevita.life
@CycleVitaUSA
@cycle-pharmaceuticals