Question 1

What is Dasatinib used for?

Accepted Answer

1 INDICATIONS AND USAGE Dasatinib tablets are 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. Dasatinib tablets are indic

Question 2

How does Dasatinib work?

Accepted Answer

11 DESCRIPTION Dasatinib tablets are a kinase inhibitor.

Question 3

What is the active ingredient in Dasatinib?

Accepted Answer

Dasatinibum (Dasatinibum)

Question 4

What pharmaceutical form is Dasatinib available in?

Accepted Answer

Dasatinib: Tabletki powlekane 20 mg (doustna)

Question 5

Is Dasatinib OTC or prescription only?

Accepted Answer

Dasatinib requires a doctor's prescription.

Question 6

What are the side effects of Dasatinib?

Accepted Answer

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Myelosuppression [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] .﻿​​​‍​​‍​​​​‍​​‍‍﻿ • Bleeding-related events [see Warnings and Precautions (5.2) ] . • Fluid retention [see Warnings and Precautions (5.3) ] . • Cardiovascular toxicity [see Warnings and Precautions (5.4) ] . • Pulmonary arterial hypertension [see Warnings and Pre

Question 7

Who should NOT take Dasatinib?

Accepted Answer

4 CONTRAINDICATIONS None. None. (4)

Question 8

Does Dasatinib interact with other medications?

Accepted Answer

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Dose reduction may be necessary.﻿​​​‍​​‍​​​​‍​​‍‍﻿ ( 2.3 , 7.1 ) Strong CYP3A4 Inducers: Dose increase may be necessary. ( 2.3 , 7.1 ) Antacids: Avoid simultaneous administration. ( 7.1 ) H 2 Antagonists and Proton Pump Inhibitors: Avoid coadministration. ( 7.1 ) 7.1 Effect of Other Drugs on Dasatinib Strong CYP3A4 Inhibitors The coadministration with strong CYP3A inhibitors may increase dasatinib concentrations [ see Clinical Pharmacology (12.3) ] .

Question 9

Can Dasatinib be used during pregnancy?

Accepted Answer

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed.﻿​​​‍​​‍​​​​‍​​‍‍﻿ ( 8.2 ) 8.1 Pregnancy Risk Summary Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman. Adverse pharmacologic effects including hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to dasatinib. Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and

Question 10

What precautions should be taken with Dasatinib?

Accepted Answer

The film-coated 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 minimise the risk of dermal exposure.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Question 11

Who manufactures Dasatinib?

Accepted Answer

Accord Healthcare S.L.U. (Holandia)

Question 12

What ATC class does Dasatinib belong to?

Accepted Answer

Dasatinib: ATC L01EA02. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Dasatinib

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