Phyrago

Pronunciation: FYE-rah-go
Generic name: dasatinib
Dosage form: oral tablet
Drug class: BCR-ABL tyrosine kinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 11, 2023.

Phyrago (dasatinib) is an oral kinase inhibitor that may be used to treat adults:

• with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
• with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib
• with Ph+ acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

Phyrago (dasatinib) works by inhibiting the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ.

Kinases are important proteins that couple extracellular signals with intracellular signaling pathways, which contribute to all stages of cancer development. They are particularly important in the development of CML and ALL. CML occurs due to a single genetic abnormality, known as the Philadelphia chromosome. During the translocation when the Philadelphia chromosome is created, a fusion gene called BCR-ABL is formed. The BCR-ABL gene encodes for BCR-ABL tyrosine kinase. The BCR-ABL-positive cells in chronic myelogenous leukemia have increased proliferation and resistance to cell death. Dasatinib has been shown to inhibit the growth of CML and AML cell lines overexpressing BCR-ABL and has other properties such as overcoming imatinib resistance.

Dasatinib was first approved in 2006. Phyrago is a new oral formulation of dasatinib.

Warnings

Severe thrombocytopenia, neutropenia, and anemia have occurred with Phyrago. Be cautious if using medications that inhibit platelet function or anticoagulants. Your healthcare provider will monitor your complete blood counts regularly.

Fluid retention, sometimes severe, including pleural effusions may occur.

May cause cardiovascular toxicity including QT prolongation. Your healthcare provider will monitor you for this and treat it if necessary.

Phyrago may increase the risk of developing Pulmonary Arterial Hypertension (PAH) which may be reversible on discontinuation. Your doctor will consider your baseline risk and monitor you for signs and symptoms of PAH during treatment.

Severe mucocutaneous dermatologic reactions have occurred with Phyrago.

Tumor lysis syndrome has also been reported. Ensure you keep well hydrated and your doctor will correct any abnormal uric acid levels you have before initiating therapy.

Can cause fetal harm. Women of childbearing age should use effective contraception.

May affect the growth and development of young children. Epiphyses, delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Your healthcare provider will monitor your child’s bone growth and development.

May cause liver toxicity. Your healthcare provider will assess your liver function before starting treatment and monthly thereafter or as clinically indicated.

Before taking

Tell your healthcare provider about all of your medical conditions, including if you:

• have problems with your immune system
• have heart problems, including a condition called congenital long QT syndrome
• have low potassium or low magnesium levels in your blood
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy and breastfeeding

Phyrago can harm your unborn baby. Your doctor should conduct a pregnancy test before starting treatment if you are of childbearing age. Females who can become pregnant should not become pregnant during treatment. You should use effective birth control (contraception) during treatment and for 30 days after your last dose of Ohyrgo.

Talk to your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.

Males with female partners who can become pregnant should use effective birth control (contraception) during treatment and for 30 days after their last dose of Phyrago. Your female partner should call her healthcare provider if she becomes pregnant or thinks she is pregnant during your treatment.

Breastfeeding

It is not known if Phyrago passes into your breast milk. You should not breastfeed during treatment and for 2 weeks after your last dose.

Fertility

Phyrago may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

How should I take Phyrago?

Take Phyrago exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose or temporarily stop treatment. Do not change your dose or stop taking Phyrago without first talking to your healthcare provider.

• Phyrago is administered by mouth (orally) once daily.
• Take with or without a meal, either in the morning or in the evening.
• Swallow the tablets whole. Do not crush, cut, or chew the tablets.
• Do not drink grapefruit juice during treatment.

Related/similar drugs

Blincyto, prednisone, methotrexate, triamcinolone, dexamethasone, Decadron, hydroxyurea

What is the dosage of Phyrago?

• Chronic phase CML in adults: 100 mg orally once daily.
• Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults: 140 mg orally once daily.

What are the side effects of Phyrago?

Phyrago may cause serious side effects, including the following

Low blood cell counts – these 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. Call your healthcare provider right away if you have a fever or any signs of an infection during treatment.

Bleeding problems are also common and can be severe and life-threatening. 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.

Fluid retention is a common side effect of 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 during treatment:

• 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
• 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.

Get medical help right away if you develop any of the following symptoms during treatment:

• chest pain
• shortness of breath
• feeling like your heart is beating too fast or you feel abnormal heartbeats
• vision changes that may last for a short time
• slurred speech.

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. Your healthcare provider should check your heart and lungs before and during treatment. Call your healthcare provider right away if you have shortness of breath, tiredness, or swelling all over your body (fluid retention).

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) 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
• shortness of breath
• vomiting
• muscle cramps
• weakness
• seizures
• swelling.

Phyrago may slow 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.

Phyrago can cause liver problems. People who have had liver problems in the past may be more at risk. Your healthcare provider will monitor your liver function as needed during treatment. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including:

• stomach-area (abdominal) pain
• bleeding
• yellowing of your skin or the white part of your eyes
• bruising
• loss of appetite
• dark “tea-colored” urine
• The most common side effects of Phyrago occurring in 15% or more of adults include:
• diarrhea
• tiredness
• headache
• nausea
• skin rash
• muscle pain
• shortness of breath

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. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What happens if I miss a dose?

If you miss a dose of Phyrago then take the next scheduled dose at its regular time. Do not take two doses at the same time.

What happens if I overdose?

If you take too much Phyrago, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Phyrago?

Avoid grapefruit juice as it may increase the amount of dasatinib in your blood and increase the risk of side reactions.

What other drugs will affect Phyrago?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, antacids, and herbal supplements.

• If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of Phyrago
• If you take strong CYP3A4 Inhibitors then your doctor may need to reduce your dose.
• If you take strong CYP3A4 Inducers then your doctor may need to increase your dose.

This is not a full list of interactions. See the prescribing information for a full list.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Keep in the original container which has a child-resistant closure. Bottles contain a desiccant container (drying agent) to help keep the medicine dry. Keep this in the bottle after opening. Do not swallow or eat the desiccant container.

Ask your healthcare provider or pharmacist about the right way to throw away expired or unused Phyrago. Phyrago is a hazardous product and special handling and disposal procedures should be followed.

Avoid exposure to the tablets if you are pregnant. Wear latex or nitrile gloves when handling or disposing of the tablets.

Keep Phyrago and all medicines out of the reach of children.

Ingredients

Active: dasatinib (anhydrous)

Inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, propyl gallate, and silica dimethyl silylate.

Available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg tablets.

Manufacturer

Bristol-Myers Squibb.

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