Information for US patients

How to Enroll

Not actual patient disclaimer

If you are interested in enrolling in PHYRAGO™ (dasatinib) tablets, download the enrollment form below and share it with your doctor to discuss why you think PHYRAGO may be suitable for your needs.

Download enrollment form
Download patient consent form
Indication and Important Safety Information
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Indication and Important Safety Information
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Indications

PHYRAGO™ is a prescription medicine used to treat:

  • Adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
  • Adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including imatinib.
  • Adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment.
  • 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

Serious Adverse Reactions:

Low blood cell counts. Low blood cell counts are common with PHYRAGO and can be severe, including low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with PHYRAGO. Call your healthcare provider right away if you have a fever or any signs of an infection during treatment with PHYRAGO.

Bleeding problems. Bleeding problems are common with PHYRAGO. Sometimes these bleeding problems can be serious and lead to death. Call your healthcare provider right away if you have: unusual bleeding or bruising of your skin, bright red or dark tar-like stools, decreased alertness, headache or change in speech.

Your body may hold too much fluid (fluid retention). Fluid retention is common with PHYRAGO and can sometimes be severe. In severe cases, fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your healthcare provider right away if you get any of these symptoms: swelling all over your body, weight gain, shortness of breath, especially if this happens with low levels of physical activity or at rest, dry cough and chest pain when taking a deep breath.

Heart and blood vessel (cardiovascular) problems. PHYRAGO may cause heart problems, including an abnormal heart rate, a heart attack, or small strokes that last only a few minutes or a few hours, called transient ischemic attacks (TIAs). TIAs are often a warning sign that you are at risk for a more serious stroke. Your healthcare provider will monitor the potassium and magnesium levels in your blood and your heart function.

Pulmonary Arterial Hypertension (PAH). PHYRAGO may cause high blood pressure in the vessels of your lungs. PAH may happen at any time during your treatment with PHYRAGO. Your healthcare provider should check your heart and lungs before and during treatment with PHYRAGO. Call your healthcare provider right away if you have shortness of breath, tiredness, or swelling all over your body (fluid retention).

Severe skin reactions. PHYRAGO may cause skin reactions that can sometimes be severe. Get medical help right away if you get a skin reaction with fever, sore mouth or throat, or blistering or peeling of your skin or in the mouth.

Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment, and an abnormal heartbeat. Your healthcare provider may do blood tests to check you for TLS. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with PHYRAGO: nausea, vomiting, weakness, swelling, shortness of breath, muscle cramps and seizures.

Slowing of growth and development in children. Effects on bone growth and development in children have happened with dasatinib and can sometimes be severe. Your healthcare provider will monitor your child’s bone growth and development during treatment with dasatinib. Get medical help right away if your child develops bone pain.

Liver problems. PHYRAGO can cause liver problems. People who have had liver problems in the past may be at risk of getting liver problems with PHYRAGO. Your healthcare provider will monitor your liver function as needed during treatment with PHYRAGO. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including: stomach-area (abdominal) pain, yellowing of your skin or white part of your eyes, loss of appetite, bleeding, bruising or dark “tea-colored” urine.

Common Adverse Reactions:

The most common side effects in adults receiving dasatinib alone include: diarrhea, headache, skin rash, tiredness, nausea, muscle pain or shortness of breath.

The most common side effect in Pediatrics receiving dasatinib in combination with chemotherapy included mucositis (swelling and sores in the mouth or gut), febrile neutropenia (fever with signs of infection), fever, diarrhea, nausea, vomiting, muscle and bone pain, stomach pain, cough, headache, rash, tiredness, constipation, irregular heartbeat, high blood pressure, swelling, infections, low blood pressure, decreased appetite, hypersensitivity, shortness of breath, nosebleeds, peripheral neuropathy (damaged nerves in hands, feet or arms), and altered state of consciousness.

PHYRAGO may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you. Use contraception during and for 30 days after treatment. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PHYRAGO.

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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