Sprycel (Dasatinib)

Generic Name

Dasatinib

Brand Names

Sprycel, Phyrago

FDA approval date: June 27, 2006

Classification: Kinase Inhibitor

Form: Tablet

What is Sprycel (Dasatinib)?

Receiving a leukemia diagnosis can be overwhelming. For many people, it brings uncertainty about treatment, recovery, and what life will look like moving forward. Sprycel (dasatinib) is a medication that gives patients with certain types of leukemia a powerful tool for controlling their disease and reclaiming stability in their lives.

Sprycel is an oral chemotherapy medicine classified as a tyrosine kinase inhibitor (TKI). It is primarily used to treat chronic myeloid leukemia (CML) and Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) in both adults and children. These are cancers of the white blood cells that result from genetic changes causing uncontrolled cell growth.

Approved by the U.S. Food and Drug Administration (FDA) in 2006, Sprycel is considered one of the cornerstone targeted therapies for these conditions. Unlike traditional chemotherapy, it specifically targets the abnormal proteins driving leukemia growth, which allows for effective disease control with fewer generalized side effects.

What does Sprycel do?

Sprycel is used to treat:

Chronic myeloid leukemia (CML): a slow-growing bone marrow cancer that produces too many white blood cells.

Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL): a faster-growing leukemia with a specific genetic abnormality that drives cancer cell growth.

Both diseases involve the presence of an abnormal gene called the Philadelphia chromosome, which produces a faulty protein that signals cells to multiply uncontrollably. Sprycel blocks this signal, helping to slow or stop cancer progression.

For many patients, this treatment has transformed leukemia from a life-threatening disease into a manageable chronic condition. Clinical studies have shown that dasatinib can cause deep and durable remissions, significantly improving survival rates and quality of life (NIH, 2024). Some patients even achieve treatment-free remission under careful medical supervision after sustained response.

How does Sprycel work?

Sprycel works by targeting and blocking an enzyme called BCR-ABL, a type of tyrosine kinase produced by the Philadelphia chromosome. This enzyme acts like a stuck accelerator pedal, continuously signaling the bone marrow to produce immature white blood cells that crowd out healthy ones.

Dasatinib attaches to the BCR-ABL enzyme and turns off this overactive signal, helping restore normal blood cell production. It also blocks other related tyrosine kinases involved in cancer growth, giving it a broader range of action than some older TKIs.

In simpler terms, Sprycel stops leukemia cells from growing and multiplying while allowing healthy blood cells to recover. Clinically, this targeted approach matters because it minimizes damage to noncancerous cells, leading to more tolerable long-term therapy compared with traditional chemotherapy.

Patients typically begin to see improvement in blood counts within weeks, and the drug’s continued use helps maintain remission and prevent relapse.

Sprycel side effects

While Sprycel is generally well tolerated, it can cause side effects that vary in intensity from person to person. Most are manageable with monitoring and supportive care.

Common side effects include:

Headache or fatigue

Diarrhea or stomach discomfort

Fluid retention (swelling around the ankles or eyes)

Skin rash or mild itching

Muscle or joint pain

Serious side effects (less common) may include:

Shortness of breath or chest discomfort (possible fluid buildup around the lungs)

Low blood cell counts, leading to fatigue, bruising, or increased infection risk

Irregular heartbeat or changes in heart rhythm

Severe bleeding or unusual bruising

Liver function changes

Sprycel patients need regular blood tests (white/red cells, platelets, liver function) and heart monitoring (especially with prior heart disease).

Use with caution for severe liver issues, heart rhythm problems, or dasatinib allergies. Avoid grapefruit to prevent increased Sprycel levels and side effects.

Seek immediate medical attention if you experience chest pain, sudden shortness of breath, or signs of severe bleeding.

Sprycel dosage

Sprycel comes in tablet form and is taken by mouth once daily, with or without food. Patients should swallow the tablets whole and avoid crushing or breaking them.

The exact dose depends on the type of leukemia, age, body weight (in children), and individual response to treatment. Doctors may adjust the dose based on how well the cancer responds and whether side effects occur.

Physicians monitor blood and liver function due to Sprycel’s effects, adjusting doses as needed. Swallowing difficulties may allow alternative administration. While older adults and those with existing conditions need closer observation, the medication is generally effective across ages.

Does Sprycel have a generic version?

Yes. Dasatinib, the active ingredient in Sprycel, is available as a generic medication in the United States and many other countries. The FDA has approved several generic versions, which are considered bioequivalent, meaning they provide the same strength, effectiveness, and safety as the brand-name drug.

Generic dasatinib, a more affordable and accessible alternative to brand-name Sprycel, offers identical cancer-fighting benefits. Both are available in various tablet strengths for tailored dosing.

Conclusion

Sprycel (dasatinib) represents a major advancement in the treatment of chronic myeloid leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia. By targeting the abnormal protein driving these cancers, it helps patients achieve remission, maintain stable blood counts, and live longer, healthier lives.

With medical supervision, Sprycel is a safe and effective long-term treatment for leukemia, offering improved quality of life with manageable side effects. Open communication with the healthcare team, reporting new symptoms, and adhering to testing schedules are crucial. Sprycel transforms leukemia from a devastating diagnosis into a treatable, manageable condition.

References

U.S. Food and Drug Administration (FDA). (2024). Sprycel (dasatinib) prescribing information. Retrieved from https://www.accessdata.fda.gov

MedlinePlus. (2024). Dasatinib: Drug information and usage guide. National Library of Medicine. Retrieved from https://medlineplus.gov

Mayo Clinic. (2024). Dasatinib (oral route) description and precautions. Retrieved from https://www.mayoclinic.org

National Institutes of Health (NIH). (2024). Tyrosine kinase inhibitors in leukemia treatment. Retrieved from https://www.nih.gov

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Brand Information

SPRYCEL (dasatinib)

1INDICATIONS AND USAGE

SPRYCEL (dasatinib) 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.

SPRYCEL (dasatinib) 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.

2DOSAGE FORMS AND STRENGTHS

SPRYCEL (dasatinib) Tablets are available as 20-mg, 50-mg, 70-mg, 80-mg, 100-mg, and 140-mg white to off-white, biconvex, film-coated tablets.

3CONTRAINDICATIONS

None.

4ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

Myelosuppression
Bleeding-related events
Fluid retention
Cardiovascular toxicity
Pulmonary arterial hypertension
QT prolongation
Severe dermatologic reactions
Tumor lysis syndrome
Effects on growth and development in pediatric patients
Hepatotoxicity

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to SPRYCEL administered as single-agent therapy at all doses tested in clinical studies (n=2809), including 324 adult patients with newly diagnosed chronic phase CML, 2388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 97 pediatric patients with chronic phase CML. The median duration of therapy in a total of 2712 adult patients was 19.2 months (range 0 to 93.2 months). In a randomized trial in patients with newly diagnosed chronic phase CML, the median duration of therapy was approximately 60 months. The median duration of therapy in 1618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).

The median duration of therapy in 1094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0 to 93.2 months).

In two non-randomized trials in 97 pediatric patients with chronic phase CML (51 patients newly diagnosed and 46 patients resistant or intolerant to previous treatment with imatinib), the median duration of therapy was 51.1 months (range 1.9 to 99.6 months).

In the overall population of 2712 adult patients, 88% of patients experienced adverse reactions at some time and 19% experienced adverse reactions leading to treatment discontinuation.

In the randomized trial in adult patients with newly diagnosed chronic phase CML, drug was discontinued for adverse reactions in 16% of patients with a minimum of 60 months of follow-up. After a minimum of 60 months of follow-up, the cumulative discontinuation rate was 39%. Among the 1618 patients with chronic phase CML, drug-related adverse reactions leading to discontinuation were reported in 329 (20.3%) patients; among the 1094 patients with advanced phase CML or Ph+ ALL, drug-related adverse reactions leading to discontinuation were reported in 191 (17.5%) patients.

Among the 97 pediatric subjects, drug-related adverse reactions leading to discontinuation were reported in 1 patient (1%).

Adverse reactions reported in ≥10% of adult patients, and other adverse reactions of interest, in a randomized trial in patients with newly diagnosed chronic phase CML at a median follow-up of approximately 60 months are presented in Table 6.

Adverse reactions reported in ≥10% of adult patients treated at the recommended dose of 100 mg once daily (n=165), and other adverse reactions of interest, in a randomized dose-optimization trial of patients with chronic phase CML resistant or intolerant to prior imatinib therapy at a median follow-up of approximately 84 months are presented in Table 8.

Adverse reactions reported in ≥10% of pediatric patients at a median follow-up of approximately 51.1 months are presented in Table 11.

Drug-related serious adverse reactions (SARs) were reported for 16.7% of adult patients in the randomized trial of patients with newly diagnosed chronic phase CML. Serious adverse reactions reported in ≥5% of patients included pleural effusion (5%).

Drug-related SARs were reported for 26.1% of patients treated at the recommended dose of 100 mg once daily in the randomized dose-optimization trial of adult patients with chronic phase CML resistant or intolerant to prior imatinib therapy. Serious adverse reactions reported in ≥5% of patients included pleural effusion (10%).

Drug-related SARs were reported for 14.4% of pediatric patients.

4.1.1Chronic Myeloid Leukemia (CML)

Adverse reactions (excluding laboratory abnormalities) that were reported in at least 10% of adult patients are shown in Table 6 for newly diagnosed patients with chronic phase CML and Tables 8 and 10 for CML patients with resistance or intolerance to prior imatinib therapy.

A comparison of cumulative rates of adverse reactions reported in ≥10% of patients with minimum follow-up of 1 and 5 years in a randomized trial of newly diagnosed patients with chronic phase CML treated with SPRYCEL are shown in Table 7.

At 60 months, there were 26 deaths in dasatinib-treated patients (10.1%) and 26 deaths in imatinib-treated patients (10.1%); 1 death in each group was assessed by the investigator as related to study therapy.

Cumulative rates of selected adverse reactions that were reported over time in patients treated with the 100 mg once daily recommended starting dose in a randomized dose-optimization trial of imatinib-resistant or -intolerant patients with chronic phase CML are shown in Table 9.

Adverse reactions associated with bone growth and development were reported in 5 (5.2%) of pediatric patients with chronic phase CML

4.1.1.1Laboratory Abnormalities

Myelosuppression was commonly reported in all patient populations. The frequency of Grade 3 or 4 neutropenia, thrombocytopenia, and anemia was higher in patients with advanced phase CML than in chronic phase CML (Tables 12 and 13). Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.

In patients who experienced severe myelosuppression, recovery generally occurred following dose interruption or reduction; permanent discontinuation of treatment occurred in 2% of adult patients with newly diagnosed chronic phase CML and 5% of adult patients with resistance or intolerance to prior imatinib therapy

Grade 3 or 4 elevations of transaminases or bilirubin and Grade 3 or 4 hypocalcemia, hypokalemia, and hypophosphatemia were reported in patients with all phases of CML but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML. Elevations in transaminases or bilirubin were usually managed with dose reduction or interruption. Patients developing Grade 3 or 4 hypocalcemia during SPRYCEL therapy often had recovery with oral calcium supplementation.

Laboratory abnormalities reported in adult patients with newly diagnosed chronic phase CML are shown in Table 12. There were no discontinuations of SPRYCEL therapy in this patient population due to biochemical laboratory parameters.

Laboratory abnormalities reported in patients with CML resistant or intolerant to imatinib who received the recommended starting doses of SPRYCEL are shown by disease phase in Table 13.

Among adult patients with chronic phase CML with resistance or intolerance to prior imatinib therapy, cumulative Grade 3 or 4 cytopenias were similar at 2 and 5 years including: neutropenia (36% vs 36%), thrombocytopenia (23% vs 24%), and anemia (13% vs 13%).

In the pediatric studies in CML, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults.

4.1.2Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) in Adults

A total of 135 adult patients with Ph+ ALL were treated with SPRYCEL in clinical studies. The median duration of treatment was 3 months (range 0.03–31 months). The safety profile of patients with Ph+ ALL was similar to those with lymphoid blast phase CML. The most frequently reported adverse reactions included fluid retention events, such as pleural effusion (24%) and superficial edema (19%), and gastrointestinal disorders, such as diarrhea (31%), nausea (24%), and vomiting (16%). Hemorrhage (19%), pyrexia (17%), rash (16%), and dyspnea (16%) were also frequently reported. Serious adverse reactions reported in ≥5% of patients included pleural effusion (11%), gastrointestinal bleeding (7%), febrile neutropenia (6%), and infection (5%).

4.1.3Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) in Pediatric Patients

The safety of SPRYCEL administered continuously in combination with multiagent chemotherapy was determined in a multicohort study of 81 pediatric patients with newly diagnosed Ph+ ALL.

Fatal adverse reactions occurred in 3 patients (4%), all of which were due to infections. Eight (10%) patients experienced adverse reactions leading to treatment discontinuation, including fungal sepsis, hepatotoxicity in the setting of graft versus host disease, thrombocytopenia, CMV infection, pneumonia, nausea, enteritis and drug hypersensitivity.

The most common serious adverse reactions (incidence ≥10%) were pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections (bacterial, viral and fungal), hypersensitivity, vomiting, renal insufficiency, abdominal pain, and musculoskeletal pain.

The incidence of common adverse reactions (incidence ≥20%) on study are shown in Table 14:

The incidence of common adverse reactions attributed by the investigator to SPRYCEL (reported at a frequency of ≥10%, all grades and grade 3/4, respectively) on study (N=81), included febrile neutropenia (23%, 23%), nausea (21%, 4%), vomiting (19%, 4%), mucositis (17%, 6%), musculoskeletal pain (17%, 2%), abdominal pain (16%, 5%), diarrhea (16%, 7%), rash (15%, 0%), fatigue (12%, 0%), pyrexia (12%, 6%), and headache (12%, 5%).

CTCAE grade 3/4 laboratory abnormalities in pediatric patients with Ph+ ALL treated with SPRYCEL in combination with chemotherapy are shown in Table 15.

Additional Pooled Data from Clinical Trials

The following additional adverse reactions were reported in adult and pediatric patients (n=2809) in SPRYCEL CML clinical studies and adult patients in Ph+ ALL clinical studies at a frequency of ≥10%, 1%– <10%, 0.1%– <1%, or < 0.1%. These adverse reactions are included based on clinical relevance.

Gastrointestinal Disorders: 1%–<10% – mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, gastritis, colitis (including neutropenic colitis), oral soft tissue disorder; 0.1%–<1% – ascites, dysphagia, anal fissure, upper gastrointestinal ulcer, esophagitis, pancreatitis, gastroesophageal reflux disease; <0.1% – protein losing gastroenteropathy, ileus, acute pancreatitis, anal fistula.

General Disorders and Administration-Site Conditions:≥10% – peripheral edema, face edema; 1%–<10% – asthenia, chest pain, chills; 0.1%–<1% – malaise, other superficial edema, peripheral swelling; <0.1% – gait disturbance.

Skin and Subcutaneous Tissue Disorders: 1%–<10% – alopecia, acne, dry skin, hyperhidrosis, urticaria, dermatitis (including eczema); 0.1%–<1% – pigmentation disorder, skin ulcer, bullous conditions, photosensitivity, nail disorder, neutrophilic dermatosis, panniculitis, palmar-plantar erythrodysesthesia syndrome, hair disorder; <0.1% – leukocytoclastic vasculitis, skin fibrosis.

Respiratory, Thoracic, and Mediastinal Disorders: 1%–<10% – lung infiltration, pneumonitis, cough; 0.1%– <1% – asthma, bronchospasm, dysphonia, pulmonary arterial hypertension; <0.1% – acute respiratory distress syndrome, pulmonary embolism.

Nervous System Disorders: 1%–<10% – neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence; 0.1%–<1% – amnesia, tremor, syncope, balance disorder; <0.1% – convulsion, cerebrovascular accident, transient ischemic attack, optic neuritis, VIIth nerve paralysis, dementia, ataxia.

Blood and Lymphatic System Disorders: 0.1%–<1% – lymphadenopathy, lymphopenia; <0.1% – aplasia pure red cell.

Musculoskeletal and Connective Tissue Disorders: 1%–<10% – muscular weakness, musculoskeletal stiffness; 0.1%–<1% – rhabdomyolysis, tendonitis, muscle inflammation, osteonecrosis, arthritis; <0.1% – epiphyses delayed fusion (reported at 1%–<10% in the pediatric studies), growth retardation (reported at 1%–<10% in the pediatric studies).

Investigations: 1%–<10% – weight increased, weight decreased; 0.1%–<1% – blood creatine phosphokinase increased, gamma-glutamyltransferase increased.

Infections and Infestations: 1%–<10% – pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection, enterocolitis infection, sepsis (including fatal outcomes [0.2%]).

Metabolism and Nutrition Disorders: 1%–<10% – appetite disturbances, hyperuricemia; 0.1%–<1% – hypoalbuminemia, tumor lysis syndrome, dehydration, hypercholesterolemia; <0.1% – diabetes mellitus.

Cardiac Disorders: 1%–<10% – arrhythmia (including tachycardia), palpitations; 0.1%–<1% – angina pectoris, cardiomegaly, pericarditis, ventricular arrhythmia (including ventricular tachycardia), electrocardiogram T-wave abnormal, troponin increased; <0.1% – cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis.

Eye Disorders: 1%–<10% – visual disorder (including visual disturbance, vision blurred, and visual acuity reduced), dry eye; 0.1%–<1% – conjunctivitis, visual impairment, lacrimation increased, <0.1% – photophobia.

Vascular Disorders: 1%–<10% – flushing, hypertension; 0.1%–<1% – hypotension, thrombophlebitis, thrombosis; <0.1% – livedo reticularis, deep vein thrombosis, embolism.

Psychiatric Disorders: 1%–<10% – insomnia, depression; 0.1%–<1% – anxiety, affect lability, confusional state, libido decreased.

Pregnancy, Puerperium, and Perinatal Conditions: <0.1% – abortion.

Reproductive System and Breast Disorders: 0.1%–<1% – gynecomastia, menstrual disorder.

Injury, Poisoning, and Procedural Complications: 1%–<10% – contusion.

Ear and Labyrinth Disorders: 1%–<10% – tinnitus; 0.1%–<1% – vertigo, hearing loss.

Hepatobiliary Disorders: 0.1%–<1% – cholestasis, cholecystitis, hepatitis.

Renal and Urinary Disorders: 0.1%–<1% – urinary frequency, renal failure, proteinuria; <0.1% – renal impairment.

Immune System Disorders: 0.1%–<1% – hypersensitivity (including erythema nodosum).

Endocrine Disorders: 0.1%–<1% – hypothyroidism; <0.1% – hyperthyroidism, thyroiditis.

4.2Postmarketing Experience

The following additional adverse reactions have been identified during post approval use of SPRYCEL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections: hepatitis B virus reactivation

Cardiac disorders: atrial fibrillation/atrial flutter

Respiratory, thoracic, and mediastinal disorders: interstitial lung disease, chylothorax

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome

Renal and urinary disorders: nephrotic syndrome

Blood and lymphatic system disorders: thrombotic microangiopathy

Hepatobiliary disorders: hepatotoxicity

5OVERDOSAGE

Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases. The highest overdosage of 280 mg per day for 1 week was reported in two patients and both developed severe myelosuppression and bleeding. Since SPRYCEL is associated with severe myelosuppression

Acute overdose in animals was associated with cardiotoxicity. Evidence of cardiotoxicity included ventricular necrosis and valvular/ventricular/atrial hemorrhage at single doses ≥100 mg/kg (600 mg/m

6DESCRIPTION

SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C

Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol.

SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.

7REFERENCES

8HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

SPRYCEL

Storage

SPRYCEL tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Handling and Disposal

SPRYCEL is an antineoplastic product. Follow special handling and disposal procedures.

Personnel who are pregnant should avoid exposure to crushed or broken tablets.

SPRYCEL tablets consist of a core tablet, surrounded by a film coating to prevent exposure of healthcare professionals to the active substance. The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimize the risk of dermal exposure.

9PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

10PATIENT INFORMATION SPRYCEL^®(Spry-sell) (dasatinib) tablets

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: February 2023

11SPRYCEL 20 mg tablets Representative Packaging

See

60 Tablets NDC 0003-0527-11