Drug name:
Laracel
Medicinal class:
anticancer
Drug form:
20, 70, 100 mg tablets
Mechanism of action:
tyrosine kinase inhibitor
Indications:
• Treatment of adults with newly diagnosed Philadelphia chromosome positive CML in chronic phase
• Treatment of adults with Philadelphia chromosome positive CML in chronic, progressive and blast phases with intolerance or resistance to previous treatment.
• Treatment of adults with Philadelphia chromosome-positive ALL who are intolerant or resistant to previous therapy
• Treatment of children over one year of age with newly diagnosed Philadelphia chromosome positive CML in chronic phase
Treatment of children over one year old with CML with positive Philadelphia chromosome in chronic phase with intolerance or resistance to previous treatment.
Treatment of children over one year of age with newly diagnosed Philadelphia chromosome positive ALL along with chemotherapy
Use in pregnancy and breastfeeding
Classification of use in pregnancy
category D
Side effects have been observed in animal reproduction studies. Administering drugs to pregnant women may cause harm. Dasatinib has been reported to pass through the placenta; The plasma and amniotic concentrations of the drug in the fetus are comparable with the plasma concentrations of the drug in the mother. With the use of dasatinib during pregnancy, unwanted effects on the fetus have been reported, although there are also reports of no side effects after contact with the drug.
It is recommended that men and women taking this medicine use safe methods of contraception during treatment. It is also recommended that pregnant women avoid contact with crushed or broken tablets.
• Fertility – Based on data from animal studies, dasatinib may cause damage to reproductive tissues in both men and women.
• Breastfeeding – So far, no information is available regarding the secretion of this drug in breast milk, the effects of the drug on the infant or its effects on milk production. Due to the possibility of serious side effects in infants, breastfeeding is not recommended during the treatment period with this drug and for 2 weeks after the final dose.
Pay attention to these points regarding the correct way of consumption
• Based on the response to the treatment, the doctor may prescribe a higher or lower dose or even stop the treatment for a short time. For higher or lower doses, a combination of different tablet doses may be required.
• Take the pills at a certain time of the day.
• Swallow the tablets whole, avoid crushing, halving or chewing them. Tablets should not be dispersed in water, because the amount of drug received by patients is less than if the tablet is swallowed whole.
• This medicine can be taken with food or on an empty stomach and it should always be taken in the morning or in the evening. In case of digestive discomfort, take it with food or a large glass full of water.
• Avoid taking dasatinib with grapefruit or grapefruit juice at the same time.
• Dasatinib tablets are unlikely to break. But in case of breakage, the people around the patient should use gloves when handling the medicine.
• Take dasatanib daily until the doctor orders to stop using it. Make sure to take the medicine within the prescribed time.
• In case of accidental consumption of large amounts of this medicine, call your doctor immediately. In such cases, medical attention may be required.
• If you forget to take a dose of medicine, do not double the amount of medicine. Take the next dose according to your regular schedule.
Drug interactions
• Acetaminophen may enhance the hepatotoxic effect of dasatinib. Dasatinib may increase the serum concentration of acetaminophen. Adjust the treatment.
• Drugs with anti-platelet properties (such as P2Y12 inhibitors, NSAIDs, SSRIs) – Dasatinib may enhance the anticoagulant effect of these drugs. Treatment monitoring is essential.
• Antacids may reduce dasatinib absorption. Adjust the treatment.
• Anticoagulants – Dasatinib may enhance the anticoagulant effect of anticoagulants. Treatment monitoring is essential.
• Aripiprazole – dasatinib may increase the serum concentration of aripiprazole. The increase in pharmacological effects of aripiprazole should be monitored. Based on the concomitant treatment or use, aripiprazole dose adjustment may be required. Treatment monitoring is essential.
• BCG – dasatinib may reduce the therapeutic effect of BCG. Avoid taking them at the same time.
• Bosentan – may decrease the serum concentration of dasatinib. Treatment monitoring is essential.
• Ceritinib, ivaceftor, loliconazole, simprevir – may increase the serum concentration of dasatinib. Treatment monitoring is essential.
• Cardiac glycosides – Dasatinib may reduce the absorption of cardiac glycosides. This may only affect digoxin tablets and not digitoxin. Treatment monitoring is essential.
• Clozapine – dasatinib may enhance the side effect/toxicity of clozapine. Especially the risk of agranulocytosis may increase. Avoid taking them at the same time.
• Coccidividin-dasatinib skin test may reduce the diagnostic effect of this skin test. Treatment monitoring is essential.
• Conivaptan, fusidic acid (systemic) – may increase the serum concentration of dasatinib. Avoid taking them at the same time.
• CYP3A4 inducers (strong) such as doxamethasone, phenytoin, carbamazepine, phenobarbital – may decrease the serum concentration of dasatinib. If possible, avoid using them together. If the combination of drugs is necessary, increasing the dose of dasatinib should be considered and the clinical response and toxicity should be closely monitored. Adjust the treatment.
• CYP3A4 inhibitors (moderate) – may reduce the metabolism of dasatinib. Treatment monitoring is essential.
• CYP3A4 (strong) inhibitors (such as ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin) may decrease the metabolism of dasatinib. Adjust the treatment.
• CYP3A4 substrates – dasatinib may increase the serum concentration of these drugs. Treatment monitoring is essential.
• Dabrafenib may decrease the serum concentration of dasatinib. If possible, alternative drugs to dasatinib should be used. If it is necessary to use drugs together, the clinical effects (especially the therapeutic effects) of the substrate should be carefully monitored. Adjust the treatment.
• Defrazirox, ciltuximab, tocilizumab – may decrease the serum concentration of dasatinib. Treatment monitoring is essential.
• Denosumab – side effects/toxicity of dasatinib may increase. Especially, it may increase the risk of serious infections. Treatment monitoring is essential.
• Dipirone – side effects/toxicity of dasatinib may increase. In particular, it may increase the risk of agranulocytosis and pancytopenia. Avoid taking them at the same time.
• Echinacea – may reduce the therapeutic effect of dasatinib. Adjust the treatment.
H2-receptor antagonists may reduce the absorption of dasatinib. If some gastric acid-reducing therapy is required, antacids (taken 2 hours before or after dasatinib administration) can be used instead of H2-receptor antagonists. Avoid taking them at the same time.
• Highest risk QTc prolonging drugs – Dasatinib may increase the QTc prolonging effect of these drugs. Avoid using them at the same time if possible. Their combined use should be accompanied by careful monitoring of symptoms of QT interval prolongation or other heart rhythm changes. Adjust the treatment.
• Leflunomide – dasatinib may increase the side effect/toxicity of leflunomide. Especially the risk of hematological toxicity such as pancytopenia, agranulocytosis or thrombocytopenia may increase. Do not use the loading dose of leflunomide in patients treated with dasatinib. Patients treated with dasatinib and leflunomide should be monitored at least monthly for bone marrow suppression. Adjust the treatment.
• Lomitapide – dasatinib may increase the serum concentration of lomitapide. Adjust the treatment.
• Mifepristone – may increase the serum concentration of dasatinib. Reduce dasatinib doses and monitor for increased concentrations/toxicity during treatment and 2 weeks after mifepristone therapy. Avoid simultaneous use of cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus. Adjust the treatment.
Mifepristone may increase the QTc prolongation effect of dasatinib. Avoid using them at the same time if possible. Adjust the treatment.
• Mitotane – may decrease the serum concentration of dasatinib. In patients treated with mitotane, dasatinib doses may need to be adjusted. Adjust the treatment.
• Intermediate risk QTc prolonging drugs – dasatinib may increase the QTc prolonging effect of these drugs. Treatment monitoring is essential.
• Natalizumab – dasatinib may enhance the side effect/toxicity of natalizumab. Especially the risk of simultaneous infection may increase. Avoid using them together.• Pimecrolimus, tacrolimus (topical) – side effects/toxicity of dasatinib may increase. Avoid taking them at the same time.
• Pimozide – dasatinib may increase the serum concentration of pimozide. Avoid taking them at the same time.
• Proton pump inhibitors may decrease the serum concentration of dasatinib. If some gastric acid-reducing therapy is needed, antacids (taken 2 hours before or after dasatinib administration) can be used instead of proton pump inhibitors. Avoid taking them at the same time.
• Reflumilast – may increase the immunosuppressive effect of dasatinib. Adjust the treatment.
• Cipulocel-T – Dasatinib may reduce the therapeutic effect of Cipulocel-T. Treatment monitoring is essential.
• Stiripentol – may increase the serum concentration of dasatinib. Adjust the treatment.
• Tofacitinib – dasatinib may enhance the immunosuppressive effect of tofacitinib. Avoid taking them at the same time.
• Trastuzumab may increase the neutropenic effect of dasatinib. Treatment monitoring is essential.
• Vaccines (inactive) – dasatinib may reduce the therapeutic effect of vaccines (inactive). Treatment monitoring is essential.
• Vaccines (live) – Dasatinib may increase the side effect/toxicity of vaccines (live). Vaccination infections may occur. Dasatinib may reduce the therapeutic effect of (live) vaccines. Avoid the simultaneous use of dasatinib with live organism vaccines; Live attenuated vaccines should not be used for at least 3 months after dasatinib administration. Avoid taking them at the same time.
Precautions
• Bone marrow suppression – dose-dependent severe bone marrow suppression (thrombocytopenia, neutropenia, anemia) is associated with treatment (usually reversible); In severe bone marrow suppression, dose adjustment or temporary discontinuation of treatment may be required; In patients with advanced CML and Ph+ ALL, bone marrow suppression is more common. Monitor blood cell counts weekly for the first 2 months of treatment and then monthly (or if clinically needed).
• Bleeding – fatal intracranial bleeding and gastrointestinal bleeding have been reported in connection with dasatinib use; Severe bleeding (including central nervous system and gastrointestinal) may occur due to thrombocytopenia. In addition to thrombocytopenia, dasatinib may also cause platelet dysfunction.
• Fluid retention – severe fluid retention/edema (eg, pleural effusions, pericardial effusions, pulmonary edema) has been reported with dasatinib treatment. Patients with symptoms of fluid retention (such as new or aggravated shortness of breath with activity or at rest, chest pain caused by pleural membrane, dry cough) should be evaluated by chest radiography or other diagnostic imaging. Symptom control may include diuretic therapy or short-term steroid therapy; Patients with pleural effusions may require thoracentesis or oxygen. Discontinuation of treatment or dose reduction may be required in patients with severe fluid retention.
• Cardiovascular side effects – cardiomyopathy, diastolic dysfunction, congestive heart failure, left ventricular dysfunction and myocardial infarction (MI) have been reported. The signs and symptoms of cardiac dysfunction should be monitored.
• Increased pulmonary artery blood pressure – with the use of this drug, the occurrence of this complication has been reported, sometimes after 12 months from the start of treatment. Assess underlying cardiopulmonary disease before starting and then during treatment; Evaluate and rule out alternative etiologies in patients with pulmonary arterial hypertension (PAH) symptoms (eg, dyspnea, fatigue, hypoxia, fluid retention). In case of severe symptoms, the treatment should be interrupted. Permanent discontinuation of treatment should be done if PAH is definitively diagnosed.
• Monitoring – complete and differential blood cell count (weekly for 2 months, then monthly or if clinically needed), bone marrow biopsy, liver function tests, electrolytes including calcium, phosphorus, magnesium, fluid retention, symptoms or Monitor for signs of cardiac dysfunction and electrocardiogram (ECG) (if there is a risk of QTc prolongation); Chest X-ray is recommended for signs of pleural effusion (such as cough, shortness of breath).
Thyroid function tests – History of levothyroxine therapy: Determine baseline thyroid stimulating hormone (TSH) levels, then monitor every 4 weeks until stable levels and dose of levothyroxine are achieved, and every 2 months thereafter. Without a history of thyroid hormone replacement: TSH should be done at first, then monthly for 4 months and then every 2 to 3 months.
• High-risk drug – proper precautions for transportation and disposal of this drug should be considered.
• Driving and working with machines – if you experience side effects such as confusion and blurred vision, be careful while driving and working with machines.
• Larasel contains lactose:
In case of intolerance to some sugars, consult your doctor before taking this medicine.
prohibited usage
Hypersensitivity to dasatinib or any of the components of this drug.
Was this helpful?
0 / 0
