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Sprycel

Side Effects
Interactions

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 Sprycel (dasatinib) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs That May Increase Dasatinib Plasma Concentrations

CYP3A4 Inhibitors

Dasatinib is a CYP3A4 substrate. In a trial of 18 patients with solid tumors, 20-mg SPRYCEL once daily coadministered with 200 mg of ketoconazole twice daily increased the dasatinib Cmax and AUC by four- and five-fold, respectively. Concomitant use of SPRYCEL and drugs that inhibit CYP3A4 may increase exposure to dasatinib and should be avoided. In patients receiving treatment with SPRYCEL, close monitoring for toxicity and a SPRYCEL dose reduction should be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided [see DOSAGE AND ADMINISTRATION].

Drugs That May Decrease Dasatinib Plasma Concentrations

CYP3A4 Inducers

When a single morning dose of SPRYCEL was administered following 8 days of continuous evening administration of 600 mg of rifampin, a potent CYP3A4 inducer, the mean Cmax and AUC of dasatinib were decreased by 81% and 82%, respectively. Alternative agents with less enzyme induction potential should be considered. If SPRYCEL must be administered with a CYP3A4 inducer, a dose increase in SPRYCEL should be considered [see DOSAGE AND ADMINISTRATION].

Antacids

Nonclinical data demonstrate that the solubility of dasatinib is pH dependent. In a trial of 24 healthy subjects, administration of 30 mL of aluminum hydroxide/magnesium hydroxide 2 hours prior to a single 50-mg dose of SPRYCEL was associated with no relevant change in dasatinib AUC; however, the dasatinib Cmax increased 26%. When 30 mL of aluminum hydroxide/magnesium hydroxide was administered to the same subjects concomitantly with a 50-mg dose of SPRYCEL, a 55% reduction in dasatinib AUC and a 58% reduction in Cmax were observed. Simultaneous administration of SPRYCEL with antacids should be avoided. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of SPRYCEL.

H2 Antagonists/Proton Pump Inhibitors

Long-term suppression of gastric acid secretion by H2 antagonists or proton pump inhibitors (eg, famotidine and omeprazole) is likely to reduce dasatinib exposure. In a trial of 24 healthy subjects, administration of a single 50-mg dose of SPRYCEL 10 hours following famotidine reduced the AUC and Cmax of dasatinib by 61% and 63%, respectively. In a trial of 14 healthy subjects, administration of a single 100-mg dose of SPRYCEL 22 hours following a 40-mg omeprazole dose at steady state reduced the AUC and Cmax of dasatinib by 43% and 42%, respectively. The concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended. The use of antacids (at least 2 hours prior to or 2 hours after the dose of SPRYCEL) should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving SPRYCEL therapy.

Drugs That May Have Their Plasma Concentration Altered By Dasatinib

CYP3A4 Substrates

Single-dose data from a trial of 54 healthy subjects indicate that the mean Cmax and AUC of simvastatin, a CYP3A4 substrate, were increased by 37% and 20%, respectively, when simvastatin was administered in combination with a single 100-mg dose of SPRYCEL. Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or ergot alkaloids (ergotamine, dihydroergotamine) should be administered with caution in patients receiving SPRYCEL.

Read the Sprycel Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/1/2013
This monograph has been modified to include the generic and brand name in many instances.

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