PHYRAGO 50 mg/1
dasatinib · TABLET · Cycle Pharmaceuticals Ltd
PHYRAGO is a tablet containing dasatinib at 50 mg/1, taken oral. Manufactured by Cycle Pharmaceuticals Ltd.
Key Facts
- Brand Name
- PHYRAGO
- Generic Name
- dasatinib
- NDC Code (Product)
70709-152- Manufacturer
- Cycle Pharmaceuticals Ltd
- Strength
- 50 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA216099
- Marketing Start
- 09/22/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE PHYRAGO is 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. PHYRAGO is 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. PHYRAGO TM is 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 ) pedia…
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Chronic phase CML in adults: 100 mg orally once daily. ( 2 ) Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults: 140 mg orally once daily. ( 2 ) Chronic phase CML and ALL in pediatrics: starting dose based on body weight. ( 2 ) Administer with or without a meal. Do not crush, cut, or chew tablets. ( 2 ) 2.1 Recommended Dosage in Adult Patients The recommended starting dosage of PHYRAGO for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of PHYRAGO for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg administered orally once daily. Swallow PHYRAGO whole. Do not crush, cut, or chew the tablets. PHYRAGO can be taken with or without a meal, either in the morning or in the evening. 2.2 Recommended Dosage 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…
Contraindications
4. CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
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 concomitant use. ( 2.3 , 7.1 ) 7.1 Effect 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 dose reduction [see Dosage and Administration ( 2.3 )] . Strong CYP3A4 Inducers The coadministration of PHYRAGO 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 dose increase [see Dosage and Administration ( 2.3 )] . Antacids Avoid concomitant use of PHYRAGO with antacids. If concomitant use of an antacid cannot be avoided,…
Adverse Reactions
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…
Frequently Asked Questions
What is PHYRAGO used for?
PHYRAGO contains dasatinib. It is a tablet taken oral. Consult your doctor for specific uses.
Is PHYRAGO a controlled substance?
PHYRAGO is not classified as a controlled substance by the DEA.
What is the generic name for PHYRAGO?
The generic name for PHYRAGO is dasatinib. There are 12 other brand versions of dasatinib.
What is the NDC code for PHYRAGO 50 mg/1?
The NDC (National Drug Code) for PHYRAGO 50 mg/1 is 70709-152, listed by Cycle Pharmaceuticals Ltd.