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Indication and Important Safety Information
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Indication and Important Safety Information
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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.

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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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