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Sprycel

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Sprycel

Sprycel Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Sprycel (dasatinib) is a kinase inhibitor that blocks proteins that signal certain cancer cells to divide. It is 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. The generic name is dasatinib; Sprycel is not currently available as a generic. Side effects of Sprycel may include headaches, flu-like symptoms, skin rash, mouth sores, weakness, weight loss, muscle and joint discomfort, and gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea or constipation). Severe side effects of Sprycel may occur; rapid or irregular heartbeats, chest pain, GI bleeding (bloody vomit or bloody stools), mental status changes, severe weakness or headaches, shortness of breath, rapid weight gain or swelling (edema) are all reasons that medical care should be sought quickly. This drug interacts with many common medications so the treating physician needs a complete medical and current medication history before prescribing Sprycel to a patient.

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. 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 in clinical studies including 258 patients with newly diagnosed chronic phase CML and in 2182 patients with imatinib resistant or intolerant CML or Ph+ ALL.

In the newly diagnosed chronic phase CML trial with a minimum of 36 months follow up and median duration of therapy of 37 months, the median average daily dose was 99 mg.

In the imatinib resistant or intolerant CML or Ph+ ALL clinical trials, 1520 patients had a minimum of 2 years follow up and 662 patients with chronic phase CML had a minimum of 60 months follow up (starting dosage 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily). Among patients with chronic phase CML and resistance or intolerance to prior imatinib therapy, the median duration of treatment with SPRYCEL 100 mg once daily was 37 months (range 1-65 months). The median duration of treatment with SPRYCEL 140 mg once daily was 15 months (range 0.03-36 months) for accelerated phase CML, 3 months (range 0.03- 29 months) for myeloid blast phase CML, and 3 months (range 0.1-10 months) for lymphoid blast CML.

The majority of SPRYCEL-treated patients experienced adverse reactions at some time. In the newly diagnosed chronic phase CML trial, drug was discontinued for adverse reactions in 6% of SPRYCEL-treated patients with a minimum of 12 months follow up. After a minimum of 36 months follow up, the cumulative discontinuation rate was 9%. Among patients with resistance or intolerance to prior imatinib therapy, the rates of discontinuation for adverse reactions at 2 years were 15% in chronic phase CML for all dosages, 16% in accelerated phase CML, 15% in myeloid blast phase CML, 8% in lymphoid blast phase CML, and 8% in Ph+ ALL. In a dose-optimization trial in patients with resistance or intolerance to prior imatinib therapy and chronic phase CML with a minimum of 60 months follow up, the rate of discontinuation for adverse reactions was 18% in patients treated with 100 mg once daily.

The most frequently reported adverse reactions reported in ≥ 10% of patients in newly diagnosed chronic phase CML included myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarrhea, headache, musculoskeletal pain, rash, and nausea. Pleural effusions were reported in 50 patients (see Table 2).

The most frequently reported adverse reactions reported in ≥ 20% of patients with resistance or intolerance to prior imatinib therapy included myelosuppression, fluid retention events, diarrhea, headache, dyspnea, skin rash, fatigue, nausea, and hemorrhage.

The most frequently reported serious adverse reactions in patients with newly diagnosed chronic phase CML included pleural effusion (4%), hemorrhage (2%), congestive heart failure (1%), pulmonary hypertension (1%), and pyrexia (1%). The most frequently reported serious adverse reactions in patients with resistance or intolerance to prior imatinib therapy included pleural effusion (11%), gastrointestinal bleeding (4%), febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarrhea (3%), infection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%), and CNS hemorrhage (1%).

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 3 and 4 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 36 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 31 44 3 1
  Pleural effusion 19 < 1 2 0
  Superficial localized edema 13 37 0 < 1
  Generalized edema 3 7 0 0
  Congestive heart failure/ cardiac dysfunctiona 2 1 < 1 < 1
  Pericardial effusion 3 1 1 0
  Pulmonary hypertension 2 0 < 1 0
  Pulmonary edema 1 0 0 0
Diarrhea 21 22 1 1
Headache 13 11 0 0
Musculoskeletal pain 13 17 0 < 1
Rashb 13 18 0 2
Nausea 10 24 0 0
Fatigue 9 11 < 1 0
Myalgia 6 12 0 0
Hemorrhagec 7 7 1 1
  Gastrointestinal bleeding 2 1 1 0
  Other bleedingd 6 5 0 1
  CNS bleeding 0 < 1 0 < 1
Vomiting 5 11 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.
cAdverse reaction of special interest with < 10% frequency.
dIncludes conjunctival hemorrhage, ear hemorrhage, ecchymosis, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemoptysis, intra-abdominal hematoma, petechiae, scleral hemorrhage, uterine hemorrhage, and vaginal hemorrhage.

The cumulative rates of the majority of adverse reactions (all grades) in newly diagnosed patients with chronic phase CML were similar after 12 and 36 months minimum follow up including congestive heart failure/cardiac dysfunction (2% vs 2%), pericardial effusion (2% vs 3%), pulmonary edema ( < 1% vs 1%), gastrointestinal bleeding (2% vs 2%), diarrhea (18% vs 21%), and generalized edema (3% vs 3%). Cumulative adverse reaction rates (all grades) that increased between 12 months and 36 months minimum follow up included overall fluid retention (23% vs 31%), pleural effusion (12% vs 19%), and superficial edema (10% vs 13%). A total of 9 patients (3.5%) discontinued due to pleural effusion in the trial.

At 36 months, there were 17 deaths in the dasatinib-treated patients (6.6%) and 20 deaths in the imatinib-treated patients (7.7%); 1 in each group was judged by the investigator as related to study therapy.

Table 3: Adverse Reactions Reported in ≥ 10% of Patients with Chronic Phase CML Resistant or Intolerant to Prior Imatinib Therapy (minimum of 60 months follow up)

Preferred Term 100 mg Once Daily Chronic
(n=165)
All Grades Grade 3/4
Percent (%) of Patients
Fluid retention 42 5
  Superficial localized edema 21 0
  Pleural effusion 24 4
  Generalized edema 4 0
  Pericardial effusion 2 1
  Congestive heart failure/cardiac dysfunctiona 0 0
  Pulmonary edema 0 0
Headache 33 1
Diarrhea 28 2
Fatigue 26 4
Dyspnea 24 2
Musculoskeletal pain 22 2
Nausea 18 1
Skin rashb 18 2
Myalgia 13 0
Arthralgia 12 1
Infection (including bacterial, viral, fungal, and non-specified) 13 1
Abdominal pain 12 1
Hemorrhage 11 1
  Gastrointestinal bleeding 2 1
  CNS bleeding 0
Pruritus 10 1
Pain 10 1
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.

With a minimum follow up of 60 months (see Table 3), the cumulative rates of the majority of adverse reactions (all grades) in patients with chronic phase CML treated with a starting dose of 100 mg once daily were identical with a minimum follow up of 24 and 60 months including congestive heart failure/cardiac dysfunction, pericardial effusion, pulmonary edema, and gastrointestinal bleeding or similar for diarrhea (27% vs 28%), and generalized edema (3% vs 4%). Cumulative adverse reaction rates (all grades) that increased between 24 months and 60 months minimum follow up included: overall fluid retention (34% vs 42%), pleural effusion (18% vs 24%), and superficial edema (18% vs 21%). The cumulative rate of Grade 3 or 4 pleural effusion was 2% vs 4%, respectively.

Table 4: Adverse Reactions Reported in ≥ 10% of Patients with Advanced Phase CML Resistant or Intolerant to Prior Imatinib Therapy

Preferred Term Accelerated
(n=157)
Myeloid
(n=7
Lymphoid Blast
(n=33)
All Grades Grade 3/4 All Grades Grade 3/4 All Grades Grade 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 5 and 6). 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 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 transaminase 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 transaminase 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 5. There were no discontinuations of SPRYCEL therapy in this patient population due to biochemical laboratory parameters.

Table 5: CTC Grade 3/4 Laboratory Abnormalities in Patients with Newly Diagnosed Chronic Phase CML (minimum of 36 months follow up)

  SPRYCEL
(n=258)
Imatinib
(n=258)
Percent (%) of Patients
Hematology Parameters
  Neutropenia 24 21
  Thrombocytopenia 19 11
  Anemia 12 9
Biochemistry Parameters
  Hypophosphatemia   7 28
  Hypokalemia 0 2
  Hypocalcemia 3 2
  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 6.

Table 6: CTC Grade 3/4 Laboratory Abnormalities in Clinical Studies of CML: Resistance or Intolerance to Prior Imatinib Therapy

  Chronic Phase CML Advanced Phase CML
140 mg Once Daily
100 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. The most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (7%), febrile neutropenia (6%), infection (5%), pyrexia (4%), pneumonia (3%), diarrhea (3%), nausea (2%), vomiting (2%), and colitis (2%).

Additional Data From Clinical Trials

The following adverse reactions were reported in patients in the SPRYCEL 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; < 0.1% - protein losing gastroenteropathy, ileus.

General Disorders and Administration Site Conditions: 1%- < 10% - asthenia, pain, chest pain, chills; 0.1%- < 1% - malaise, temperature intolerance.

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

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

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

Blood and Lymphatic System Disorders: 1%- < 10% - pancytopenia; < 0.1% - aplasia pure red cell.

Musculoskeletal and Connective Tissue Disorders: 1%- < 10% - muscular weakness, musculoskeletal stiffness, muscle spasm; 0.1%- < 1% - rhabdomyolysis, tendonitis, muscle inflammation.

Investigations: 1%- < 10% - weight increased, weight decreased; 0.1%- < 1% - blood creatine phosphokinase 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% - anorexia, appetite disturbances, hyperuricemia; 0.1%- < 1% - hypoalbuminemia.

Cardiac Disorders: 1%- < 10% - arrhythmia (including tachycardia), palpitations; 0.1%- < 1% - angina pectoris, cardiomegaly, pericarditis, ventricular arrhythmia (including ventricular tachycardia); < 0.1% - cor pulmonale, myocarditis, acute coronary syndrome.

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

Vascular Disorders: 1%- < 10% - flushing, hypertension; 0.1%- < 1% - hypotension, thrombophlebitis; < 0.1% - livedo reticularis.

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

Reproductive System and Breast Disorders: 0.1%- < 1% - gynecomastia, menstruation irregular. Injury, Poisoning, and Procedural Complications: 1%- < 10% - contusion.

Ear and Labyrinth Disorders: 1%- < 10% - tinnitus; 0.1%- < 1% - vertigo.

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

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

Neoplasms Benign, Malignant, and Unspecified: 0.1%- < 1% - tumor lysis syndrome.

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

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

Vascular disorders: thrombosis/embolism (including pulmonary embolism, deep vein thrombosis)

Respiratory, thoracic, and mediastinal disorders: interstitial lung disease, pulmonary arterial hypertension

Read the entire FDA prescribing information for Sprycel (Dasatinib) »

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Sprycel - User Reviews

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