May 27, 2016
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Sprycel

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Sprycel




Sprycel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/4/2015

Sprycel (dasatinib) is a kinase inhibitor that blocks proteins that signal certain cancer cells to divide used to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (resistant to prior or failed therapy) and chronic, accelerated, or myeloid or lymphoid blast phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib. Side effects of Sprycel include headaches, flu-like symptoms, skin rash, mouth sores, weakness, weight loss, tired feeling, muscle and joint discomfort, nausea, vomiting, diarrhea or constipation. See a doctor if you experience severe side effects of Sprycel including rapid or irregular heartbeats, chest pain, bloody vomit or bloody stools, mental status changes, severe weakness or headaches, shortness of breath, rapid weight gain, or swelling (edema).

Sprycel tablets are available as 20, 50, 70, 80, 100, and 140 mg film-coated tablets. Doses are highly variable and are determined by the disease type, and a physician experienced in treating malignancies refractory to other drug treatments; high doses are 140 mg once per day. The dose, even when adjusted, is still usually only once per day; tablets should be swallowed whole and not chewed. Crushed tablets are capable of causing skin rashes and the drug can be adsorbed; gloves should be used when disposing crushed tablets. Sprycel interacts with many common medications so the treating physician needs a complete medical and current medication history before prescribing Sprycel to a patient. Women who are pregnant should avoid any contact with this medication; women who are breastfeeding should not come in contact with this drug.

Our Sprycel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sprycel in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking dasatinib and call your doctor right away if you have any symptoms of pulmonary arterial hypertension (PAH), such as:

  • feeling tired or short of breath (even with mild exertion);
  • swelling in your feet or lower legs;
  • rapid weight gain;
  • blue-colored lips and skin; and
  • feeling light-headed or fainting.

Stop using dasatinib and call your doctor at once if you have any of these other serious side effects:

  • pale skin, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

  • headache;
  • tired feeling;
  • nausea, diarrhea; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sprycel (Dasatinib)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sprycel Overview - Patient Information: Side Effects

SIDE EFFECTS: Upset stomach, nausea, vomiting, diarrhea, headache, tiredness, muscle pain, body aches, and loss of appetite may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dry cough, swelling (especially of lower legs/the area around eyes), sudden/unexplained weight gain, increasing trouble breathing (shortness of breath, dyspnea).

Tell your doctor immediately if any of these rare but very serious side effects occur: black/bloody stools, dark urine, stomach/abdominal pain, vomit that looks like coffee grounds, yellowing eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/slow/irregular heartbeat, chest pain, confusion, weakness on one side of the body.

This medication may cause very serious blood disorders (low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sprycel (Dasatinib)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sprycel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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 at all doses tested in clinical studies including 324 patients with newly diagnosed chronic phase CML and in 2388 patients with imatinib resistant or intolerant chronic or advanced phase CML or Ph+ ALL. The median duration of therapy in 2712 SPRYCEL-treated patients was 19.2 months (range 0-93.2 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 patients with chronic phase CML was 29 months (range 0-92.9 months).

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

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

In the randomized trial in patients with newly diagnosed chronic phase CML, drug was discontinued for adverse reactions in 16% of SPRYCEL-treated 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 SPRYCEL-treated patients with chronic phase CML, drug-related adverse events leading to discontinuation were reported in 329 (20.3%) patients; among the 1094 SPRYCEL-treated patients with advanced phase CML or Ph+ ALL, drug-related adverse events leading to discontinuation were reported in 191 (17.5%) patients.

Adverse reactions reported in ≥ 10% of 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 2.

Adverse reactions reported in ≥ 10% of 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 4.

Drug-related serious adverse events (SAEs) were reported for 16.7% of SPRYCEL-treated 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 SAEs were reported for 26.1% of patients treated at the recommended dose of 100 mg once daily in the randomized dose-optimization trial of patients with chronic phase CML resistant or intolerant to prior imatinib therapy. Serious adverse reactions reported in ≥ 5% of patients included pleural effusion (10%).

Chronic Myeloid Leukemia (CML)

Adverse reactions (excluding laboratory abnormalities) that were reported in at least 10% of patients are shown in Table 2 for newly diagnosed patients with chronic phase CML and Tables 4 and 6 for CML patients with resistance or intolerance to prior imatinib therapy.

Table 2: Adverse Reactions Reported in ≥ 10% of Patients with Newly Diagnosed Chronic Phase CML (minimum of 60 months follow-up)

Preferred Term All Grades Grade 3/4
SPRYCEL
(n=258)
Imatinib
(n=258)
SPRYCEL
(n=258)
Imatinib
(n=258)
Percent (%) of Patients
Fluid retention 38 45 5 1
  Pleural effusion 28 1 3 0
  Superficial localized edema 14 38 0 < 1
  Pulmonary hypertension 5 < 1 1 0
  Generalized edema 4 7 0 0
  Pericardial effusion 4 1 1 0
  Congestive heart failure/ cardiac dysfunctiona 2 1 < 1 < 1
  Pulmonary edema 1 0 0 0
Diarrhea 22 23 1 1
Musculoskeletal pain 14 17 0 < 1
Rashb 14 18 0 2
Headache 14 11 0 0
Abdominal pain 11 8 0 1
Fatigue 11 12 < 1 0
Nausea 10 25 0 0
Myalgia 7 12 0 0
Arthralgia 7 10 0 < 1
Hemorrhagec 8 8 1 1
  Gastrointestinal bleeding 2 2 1 0
  Other bleedingd 6 6 0 < 1
  CNS bleeding < 1 < 1 0 < 1
Vomiting 5 12 0 0
Muscle spasms 5 21 0 < 1
a Includes cardiac failure acute, cardiac failure congestive, cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and left ventricular dysfunction.
bIncludes erythema, erythema multiforme, rash, rash generalized, rash macular, rash papular, rash pustular, skin exfoliation, and rash vesicular.
c Adverse reaction of special interest with < 10% frequency.
d Includes conjunctival hemorrhage, ear hemorrhage, ecchymosis, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemoptysis, intra-abdominal hematoma, petechiae, scleral hemorrhage, uterine hemorrhage, and vaginal hemorrhage.

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 3.

Table 3: Adverse Reactions Reported in ≥ 10% of Patients with Newly Diagnosed Chronic Phase CML in the SPRYCEL Treated Arm (n=258)

Preferred Term Minimum of 1 Year Follow-up Minimum of 5 Years Follow-up
All Grades Grade 3/4 All Grades Grade 3/4
Percent (%) of Patients
Fluid Retention 19 1 38 5
  Pleural effusion 10 0 28 3
  Superficial localized edema 9 0 14 0
  Pulmonary hypertension 1 0 5 1
  Generalized edema 2 0 4 0
  Pericardial effusion 1 < 1 4 1
  Congestive heart failure/cardiac dysfunctiona 2 < 1 2 < 1
  Pulmonary edema < 1 0 1 0
Diarrhea 17 < 1 22 1
Musculoskeletal pain 11 0 14 0
Rashb 11 0 14 0
Headache 12 0 14 0
Abdominal pain 7 0 11 0
Fatigue 8 < 1 11 < 1
Nausea 8 0 10 0
a Includes cardiac failure acute, cardiac failure congestive, cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and left ventricular dysfunction.
b Includes erythema, erythema multiforme, rash, rash generalized, rash macular, rash papular, rash pustular, skin exfoliation, and rash vesicular.

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.

Table 4: Adverse Reactions Reported in ≥ 10% of Patients with Chronic Phase CML Resistant or Intolerant to Prior Imatinib Therapy (minimum of 84 months follow-up)

Preferred Term All Grades Grade 3/4
Percent (%) of Patients
Fluid retention 48 7
  Superficial localized edema 22 0
  Pleural effusion 28 5
  Generalized edema 4 0
  Pericardial effusion 3 1
  Pulmonary hypertension 2 1
Headache 33 1
Diarrhea 28 2
Fatigue 26 4
Dyspnea 24 2
Musculoskeletal pain 22 2
Nausea 18 1
Skin rasha 18 2
Myalgia 13 0
Arthralgia 13 1
Infection (including bacterial, viral, fungal, and non-specified) 13 1
Abdominal pain 12 1
Hemorrhage 12 1
  Gastrointestinal bleeding 2 1
Pruritus 12 1
Pain 11 1
Constipation 10 1
a Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalized erythema, genital rash, heat rash, milia, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, skin exfoliation, skin irritation, urticaria vesiculosa, and rash vesicular.

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 5.

Table 5: Selected Adverse Reactions Reported in Dose Optimization Trial (Imatinib Intolerant or Resistant Chronic Phase CML)a

Preferred Term Minimum of 2 Years Follow-up Minimum of 5 Years Follow-up Minimum of 7 Years Follow-up
All Grades Grade 3/4 All Grades Grade 3/4 All Grades Grade 3/4
Percent (%) of Patients
Diarrhea 27 2 28 2 28 2
Fluid Retention 34 4 42 6 48 7
  Superficial edema 18 0 21 0 22 0
  Pleural effusion 18 2 24 4 28 5
  Generalized edema 3 0 4 0 4 0
  Pericardial effusion 2 1 2 1 3 1
  Pulmonary hypertension 0 0 0 0 2 1
Hemorrhage 11 1 11 1 12 1
  Gastrointestinal bleeding 2 1 2 1 2 1
aRandomized dose-optimization trial results reported in the recommended starting dose of 100 mg once daily (n=165) population.

Table 6: Adverse Reactions Reported in ≥ 10% of Patients with Advanced Phase CML Resistant or Intolerant to Prior Imatinib Therapy

Preferred Term Accelerated (n=157) Myeloid Blast (n=74) Lymphoid Blast (n=33)
All Grade Grades 3/4 All Grade Grades 3/4 All Grade Grades 3/4
Percent (%) of Patients
Fluid retention 35 8 34 7 21 6
  Superficial localized edema 18 1 14 0 3 0
  Pleural effusion 21 7 20 7 21 6
  Generalized edema 1 0 3 0 0 0
  Pericardial effusion 3 1 0 0 0 0
  Congestive heart failure/cardiac dysfunctiona 0 0 4 0 0 0
  Pulmonary edema 1 0 4 3 0 0
Headache 27 1 18 1 15 3
Diarrhea 31 3 20 5 18 0
Fatigue 19 2 20 1 9 3
Dyspnea 20 3 15 3 3 3
Musculoskeletal pain 11 0 8 1 0 0
Nausea 19 1 23 1 21 3
Skin rashb 15 0 16 1 21 0
Arthralgia 10 0 5 1 0 0
Infection (including bacterial, viral, fungal, and non-specified) 10 6 14 7 9 0
Hemorrhage 26 8 19 9 24 9
  Gastrointestinal bleeding 8 6 9 7 9 3
  CNS bleeding 1 1 0 0 3 3
Vomiting 11 1 12 0 15 0
Pyrexia 11 2 18 3 6 0
Febrile neutropenia 4 4 12 12 12 12
a Includes ventricular dysfunction, cardiac failure, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and ventricular failure.
bIncludes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalized erythema, genital rash, heat rash, milia, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, skin exfoliation, skin irritation, urticaria vesiculosa, and rash vesicular.

Laboratory 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 7 and 8). 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 patients in a randomized trial of patients with newly diagnosed chronic phase CML and 5% of patients with resistance or intolerance to prior imatinib therapy [see WARNINGS AND PRECAUTIONS].

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 the course of SPRYCEL therapy often had recovery with oral calcium supplementation.

Laboratory abnormalities reported in patients with newly diagnosed chronic phase CML are shown in Table 7. There were no discontinuations of SPRYCEL therapy in this patient population due to biochemical laboratory parameters.

Table 7: CTC Grade 3/4 Laboratory Abnormalities in Patients with Newly Diagnosed Chronic Phase CML (minimum of 60 months follow-up)

  SPRYCEL
(n=258)
Imatinib
(n=258)
Percent (%) of Patients
Hematology Parameters
  Neutropenia 29 24
  Thrombocytopenia 22 14
  Anemia 13 9
Biochemistry Parameters
  Hypophosphatemia 7 31
  Hypokalemia 0 3
  Hypocalcemia 4 3
  Elevated SGPT (ALT) < 1 2
  Elevated SGOT (AST) < 1 1
  Elevated Bilirubin 1 0
  Elevated Creatinine 1 1
CTC grades: neutropenia (Grade 3 ≥ 0.5- < 1.0 109/L, Grade 4 < 0.5 109/L); thrombocytopenia (Grade 3 ≥ 25- < 50 109/L, Grade 4 < 25 109/L); anemia (hemoglobin Grade 3 ≥ 65- < 80 g/L, Grade 4 < 65 g/L); elevated creatinine (Grade 3 > 3-6 upper limit of normal range (ULN), Grade 4 > 6 ULN); elevated bilirubin (Grade 3 > 3-10 ULN, Grade 4 > 10 ULN); elevated SGOT or SGPT (Grade 3 > 5-20 ULN, Grade 4 > 20 ULN); hypocalcemia (Grade 3 < 7.0-6.0 mg/dL, Grade 4 < 6.0 mg/dL); hypophosphatemia (Grade 3 < 2.0-1.0 mg/dL, Grade 4 < 1.0 mg/dL); hypokalemia (Grade 3 < 3.0-2.5 mmol/L, Grade 4 < 2.5 mmol/L).

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 8.

Table 8: CTC Grade 3/4 Laboratory Abnormalities in Clinical Studies of CML: Resistance or Intolerance to Prior Imatinib Therapy

  Chronic Phase CML 100 mg Once Daily Advanced Phase CML 140 mg Once Daily
(n=165) Accelerated Phase
(n=157)
Myeloid Blast Phase
(n=74)
Lymphoid Blast Phase
(n=33)
Percent (%) of Patients
Hematology Parameters*
  Neutropenia 36 58 77 79
  Thrombocytopenia 24 63 78 85
  Anemia 13 47 74 52
Biochemistry Parameters
  Hypophosphatemia 10 13 12 18
  Hypokalemia 2 7 11 15
  Hypocalcemia < 1 4 9 12
  Elevated SGPT (ALT) 0 2 5 3
  Elevated SGOT (AST) < 1 0 4 3
  Elevated Bilirubin < 1 1 3 6
  Elevated Creatinine 0 2 8 0
CTC grades: neutropenia (Grade 3 ≥ 0.5- < 1.0 109/L, Grade 4 < 0.5 109/L); thrombocytopenia (Grade 3 ≥ 25- < 50 109/L, Grade 4 < 25 109/L); anemia (hemoglobin Grade 3 ≥ 65- < 80 g/L, Grade 4 < 65 g/L); elevated creatinine (Grade 3 > 3-6 upper limit of normal range (ULN), Grade 4 > 6 ULN); elevated bilirubin (Grade 3 > 3-10 ULN, Grade 4 > 10 ULN); elevated SGOT or SGPT (Grade 3 > 5-20 ULN, Grade 4 > 20 ULN); hypocalcemia (Grade 3 < 7.0-6.0 mg/dL, Grade 4 < 6.0 mg/dL); hypophosphatemia (Grade 3 < 2.0-1.0 mg/dL, Grade 4 < 1.0 mg/dL); hypokalemia (Grade 3 < 3.0-2.5 mmol/L, Grade 4 < 2.5 mmol/L).
* Hematology parameters for 100 mg once-daily dosing in chronic phase CML reflects 60 month minimum follow-up.

Among chronic phase CML patients 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%).

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

A total of 135 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%).

Additional Pooled Data From Clinical Trials

The following additional adverse reactions were reported in patients in SPRYCEL CML and Ph+ ALL clinical studies at a frequency of ≥ 10%, 1%- < 10%, 0.1%- < 1%, or < 0.1%. These events are included on the basis of 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; < 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.

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, photophobia, lacrimation increased.

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.

Postmarketing 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.

Cardiac disorders: atrial fibrillation/atrial flutter

Respiratory, thoracic, and mediastinal disorders: interstitial lung disease Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome

Read the entire FDA prescribing information for Sprycel (Dasatinib)

Sprycel - User Reviews

Sprycel User Reviews

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Here is a collection of user reviews for the medication Sprycel sorted by most helpful. Patient Discussions FAQs

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