Dasatinib-Nativ (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

L01EA02 (Dasatinib)

Active Substance

Dasatinib (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antitumor drug. Protein kinase inhibitor

Pharmacotherapeutic Group

Antineoplastic agents; protein kinase inhibitors; BCR-ABL tyrosine kinase inhibitors

Pharmacological Action

Antitumor agent, protein tyrosine kinase inhibitor.

Dasatinib inhibits BCR-ABL tyrosine kinase and SRC family tyrosine kinases, as well as many other oncogenic kinases, including c-KIT, ephrin (EPH) receptor kinase, and PDGFβ receptor. Dasatinib binds to both active and inactive forms of the BCR-ABL enzyme and inhibits it at subnanomolar concentrations (0.6-0.8 nmol/ml).

In vitro, Dasatinib exhibits activity in cellular models of leukemia, both against imatinib-sensitive and imatinib-resistant cells. Dasatinib overcomes imatinib resistance associated with BCR-ABL overexpression, mutations in the BCR-ABL kinase domain, activation of alternative mechanisms inducing SRC family kinases (LYN, HCK), as well as with overexpression of the multidrug resistance gene.

Pharmacokinetics

Absorption after oral administration is rapid. The C_max of dasatinib is reached within 0.5-3 hours. AUC and elimination are dose-dependent in the dose range from 25 to 120 mg twice daily. When a single 100 mg dose of dasatinib is taken 30 minutes after a high-fat meal, the mean AUC increases by 14%; after a low-fat meal – by 21%. Food intake does not significantly affect absorption.

The apparent V_d of dasatinib is 2505 L, indicating significant distribution in the extravascular space. Dasatinib protein binding is 96%.

Dasatinib is metabolized primarily by the CYP3A4 isoenzyme. After oral administration of 100 mg of [¹⁴C]-dasatinib to healthy volunteers, 29% of the radioactivity in plasma was attributed to unchanged dasatinib. Based on plasma concentrations and in vitro activity, it can be assumed that metabolites do not play a major role in the pharmacological action of dasatinib.

It is eliminated mainly via the intestine, predominantly as metabolites. After a single oral dose of [¹⁴C]-dasatinib, 4% and 85% of the radioactivity is excreted by the kidneys and intestine, respectively, within 10 days. Unchanged Dasatinib accounts for 0.1% and 19% of the dose excreted by the kidneys and intestine, respectively, the remainder of the dose consists of metabolites.

The mean overall terminal T_1/2 of dasatinib in patients is 5-6 hours.

The pharmacokinetics of dasatinib were studied in 8 patients with moderate hepatic impairment after a single 50 mg dose and in 5 patients with severe hepatic impairment after a single 20 mg dose compared to the pharmacokinetics in healthy volunteers after a 70 mg dose. The C_max and AUC values for dasatinib were 47% and 8% lower, respectively, with moderate liver damage compared to values in healthy volunteers. In patients with severe hepatic impairment, the decrease in C_max and AUC values for dasatinib reached 43% and 28%, respectively.

Indications

Chronic myeloid leukemia in the chronic phase, accelerated phase, or lymphoid or myeloid blast crisis phase in cases of resistance or intolerance to previous therapy, including imatinib.

Acute lymphoblastic leukemia with positive Philadelphia chromosome in cases of resistance or intolerance to previous therapy.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
C91.0	Acute lymphoblastic leukemia [ALL]
C92.1	Chronic myeloid leukemia [CML], BCR/ABL-positive

ICD-11 code	Indication
2A20.0Z	Chronic myelogenous leukemia, BCR-ABL1-positive, unspecified
2B33.3	Lymphoid leukemia, not elsewhere classified
XH4XG8	Chronic myelogenous leukemia, NOS

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

The recommended initial dose for adult patients with chronic myeloid leukemia in chronic phase or Philadelphia chromosome-positive acute lymphoblastic leukemia is 100 mg taken once daily.

For adult patients with chronic myeloid leukemia in accelerated phase or blast crisis, the recommended initial dose is 140 mg taken once daily.

Administer tablets orally. Swallow whole with a full glass of water. Do not crush, break, or chew the tablets.

Take dasatinib either one hour before or two hours after a meal. Consistent administration relative to food intake is recommended to minimize variability in drug exposure.

Dose escalation beyond the initial starting dose may be considered in patients not achieving a desired hematologic or cytogenetic response and who do not experience grade 3 or higher adverse reactions.

Perform complete blood counts weekly for the first two months of therapy and then monthly thereafter, or more frequently if clinically indicated.

Manage adverse reactions, particularly myelosuppression, through temporary interruption of therapy and/or dose reduction.

For hematologic toxicity, interrupt treatment until the absolute neutrophil count is ≥1.0 x 10⁹/L and platelets are ≥50 x 10⁹/L, then resume at the original starting dose. If recurrence occurs, resume at a reduced dose upon recovery.

For non-hematologic toxicity, interrupt treatment until the event resolves or improves to Grade 1. Severe non-hematologic toxicity may require a dose reduction upon resumption of therapy.

In patients with moderate hepatic impairment, consider a dose reduction. The recommended starting dose in these patients should be reduced. Use with caution in patients with severe hepatic impairment; a further dose reduction is recommended.

Avoid concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin). If co-administration is unavoidable, consider a dasatinib dose reduction. Monitor patients closely for toxicity.

Avoid concomitant use of antacids and H2 blockers or proton pump inhibitors. If antacid therapy is needed, administer it at least two hours before or two hours after dasatinib.

Treatment duration is continuous. Continue treatment as long as the patient derives clinical benefit, as evidenced by hematologic and cytogenetic response, and in the absence of unacceptable toxicity.

Adverse Reactions

Most frequently (> 20%): fluid retention, diarrhea, headache, skin rash, nausea, hemorrhage, fatigue, dyspnea, myalgia, infectious complications, vomiting, cough, abdominal pain, fever, dasatinib-induced febrile neutropenia (5%).

Infections and infestations Very common – infections (including bacterial, viral, fungal), pneumonia (including bacterial, viral, and fungal), upper respiratory tract infections, herpes infections, enterocolitis, sepsis (including fatal).

From the hematopoietic system: Common – febrile neutropenia, pancytopenia; Rare – erythroblastopenia.

From the blood clotting system Very common – bleeding.

From the immune system Uncommon – hypersensitivity reactions (including erythema nodosum).

From the nervous system Very common – headache; Common – insomnia, depression, neuropathy (including peripheral neuropathy), dizziness, taste disturbance, drowsiness; Uncommon – anxiety, emotional lability, psychosis, decreased libido, cerebral hemorrhage, tremor, syncope, amnesia; Rare – convulsions, cerebrovascular accident (stroke), transient ischemic attack.

From the organ of vision Common – visual impairment, dry eyes; Uncommon – conjunctivitis.

From the organ of hearing Common – tinnitus; Uncommon – vertigo.

From the cardiovascular system Common – flushing, increased blood pressure, pericardial effusion, arrhythmia (including tachycardia), congestive heart failure/myocardial dysfunction, palpitations; Uncommon – QT interval prolongation on ECG, angina pectoris, cardiomegaly, decreased blood pressure, thrombophlebitis, pericarditis, ventricular arrhythmia (including ventricular tachycardia), myocardial infarction; Rare – cor pulmonale, myocarditis, acute coronary syndrome, livedo reticularis.

From the respiratory system Very common – pleural effusion, dyspnea, cough; Common – pulmonary infiltrates, pulmonary edema, pneumonitis, pulmonary hypertension; Uncommon – bronchial asthma, bronchospasm; Rare – acute respiratory distress syndrome.

From the digestive system Very common – diarrhea, nausea, vomiting, abdominal pain; Common – appetite disorder, inflammation of mucous membranes (including mucositis/stomatitis), gastrointestinal bleeding, dyspepsia, abdominal distension, constipation, gastritis, oral mucosal lesion, colitis (including neutropenic colitis), anorexia; Uncommon – dysphagia, ascites, anal fissures, upper GI ulcers, pancreatitis, esophagitis, cholestasis, cholecystitis, hepatitis.

From the skin and subcutaneous tissues Very common – skin rash; Common – pruritus, acne, alopecia, dry skin, hyperhidrosis, urticaria, dermatitis (including eczema); Uncommon – skin ulcers, bullous dermatosis, pigmentation disorders, nail disorders, photosensitivity, acute febrile neutrophilic dermatosis, panniculitis, palmar-plantar erythrodysesthesia syndrome.

From the musculoskeletal system Very common – musculoskeletal pain; Common – arthralgia, myositis, muscle weakness, musculoskeletal stiffness; Uncommon – increased blood CPK, rhabdomyolysis; Rare – tendonitis.

From the urinary system Uncommon – renal failure, frequent urination, proteinuria.

From the reproductive system Uncommon – gynecomastia, menstrual cycle disorders.

General disorders Very common – fluid retention, localized subcutaneous edema of various locations, tongue edema, lip edema, conjunctival edema, fatigue, fever; Common – asthenia, pain, chest pain, generalized edema, chills, hyperuricemia; Uncommon – malaise, intolerance to high and low temperatures, tumor lysis syndrome, hypoalbuminemia.

Contraindications

Pregnancy, lactation (breastfeeding); children and adolescents under 18 years of age; hypersensitivity to dasatinib.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Patients must use reliable methods of contraception during treatment and for at least 3 months after.

Special Precautions

Use with caution in hepatic insufficiency, when used concomitantly with anticoagulants and drugs affecting platelet function; with QT interval prolongation or risk of its prolongation (also when taking drugs that prolong the QT interval concomitantly); concomitantly with substrates of the CYP3A4 isoenzyme, concomitant use with inhibitors or inducers of the CYP3A4 isoenzyme with a narrow therapeutic range.

During treatment, a complete blood count should be performed weekly for the first 2 months of treatment, and then monthly or more frequently, as clinically indicated. Bone marrow suppression is usually reversible and resolves upon temporary discontinuation or dose reduction of dasatinib.

Most cases of bleeding during dasatinib use were associated with severe thrombocytopenia. Severe cerebral hemorrhage, including fatal, was reported in less than 1% of patients receiving Dasatinib; severe gastrointestinal bleeding was noted in 4% of patients. Other severe bleeding was reported in 2% of patients.

If shortness of breath or dry cough occurs, chest X-ray monitoring is necessary.

Effect on ability to drive vehicles and operate machinery

If the patient experiences treatment-related symptoms such as dizziness and visual disturbances affecting concentration and reaction speed, it is recommended to refrain from driving vehicles and engaging in potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Drug Interactions

Dasatinib is a substrate of the CYP3A4 isoenzyme. Inhibitors of the CYP3A4 isoenzyme (e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, telithromycin, grapefruit juice) may increase the plasma concentration of dasatinib, so their concomitant use with dasatinib should be avoided. Patients for whom systemic administration of a potent CYP3A4 isoenzyme inhibitor cannot be avoided should be closely monitored for timely detection of signs of toxicity.

Inducers of the CYP3A4 isoenzyme may decrease the plasma concentration of dasatinib. Concomitant use of potent inducers of the CYP3A4 isoenzyme with dasatinib should be avoided. Patients taking inducers of the CYP3A4 isoenzyme (e.g., dexamethasone, phenytoin, carbamazepine; rifampicin, phenobarbital, or St. John’s wort preparations) should be switched to drugs that do not have (or have minimal) ability to induce this isoenzyme.

Long-term suppression of gastric acid secretion by histamine H₂-receptor blockers and proton pump inhibitors (e.g., famotidine and omeprazole) may lead to decreased dasatinib concentrations. Concomitant use of these drugs and dasatinib is not recommended. Antacids can be used as an alternative.

Dasatinib is an inhibitor of the CYP3A4 isoenzyme, so its concomitant use with substrates of the CYP3A4 isoenzyme may enhance the effect of that substrate. Substrates of the CYP3A4 isoenzyme with a narrow therapeutic range, such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, and ergot alkaloids (ergotamine, dihydroergotamine) should be used with caution in patients receiving Dasatinib.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Dasatinib-Nativ [Pharmental Group, LLC (Russia)]
Film-coated tablets, 140 mg: 30 pcs.

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Dosage Form

Dasatinib-Nativ

Film-coated tablets, 140 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	140 mg

Excipients : lactose monohydrate – 189 mg, microcrystalline cellulose – 189 mg, hypromellose – 16.8 mg, croscarmellose sodium – 22.4 mg, magnesium stearate – 2.8 mg.

Film coating composition, 23 mg polyvinyl alcohol – 40%, macrogol – 20.2%, talc – 14.8%, sunset yellow FCF (E110) aluminum lake -13.91%, titanium dioxide – 10.14%, yellow iron oxide – 0.91%, indigo carmine (E132) aluminum lake – 0.04%

30 pcs. – polyethylene bottles (1) – cardboard packs.

Dasatinib-Nativ [Pharmental Group, LLC (Russia)]
Film-coated tablets, 100 mg: 30 pcs.

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Dosage Form

Dasatinib-Nativ

Film-coated tablets, 100 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	100 mg

Excipients : lactose monohydrate – 135 mg, microcrystalline cellulose – 135 mg, hypromellose – 12 mg, croscarmellose sodium – 16 mg, magnesium stearate – 2 mg.

Film coating composition, 16 mg polyvinyl alcohol – 40%, macrogol – 20.2%, talc – 14.8%, titanium dioxide – 11.98%, quinoline yellow (E104) aluminum lake -11.69%, sunset yellow FCF (E110) aluminum lake – 0.73%, yellow iron oxide – 0.58%, indigo carmine (E132) aluminum lake – 0.02%

30 pcs. – polyethylene bottles (1) – cardboard packs.

Dasatinib-Nativ [Pharmental Group, LLC (Russia)]
Film-coated tablets, 70 mg: 60 pcs.

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Dosage Form

Dasatinib-Nativ

Film-coated tablets, 70 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	70 mg

Excipients : lactose monohydrate – 94.5 mg, microcrystalline cellulose – 94.5 mg, hypromellose – 8.4 mg, croscarmellose sodium – 11.2 mg, magnesium stearate – 1.4 mg.

Film coating composition, 11 mg polyvinyl alcohol – 40%, macrogol – 20.2%, talc – 14.8%, titanium dioxide – 11.98%, quinoline yellow (E104) aluminum lake -11.69%, sunset yellow FCF (E110) aluminum lake – 0.73%, yellow iron oxide – 0.58%, indigo carmine (E132) aluminum lake – 0.02%

60 pcs. – polyethylene bottles (1) – cardboard packs.

Dasatinib-Nativ [Pharmental Group, LLC (Russia)]
Film-coated tablets, 20 mg: 60 pcs.

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Dosage Form

Dasatinib-Nativ

Film-coated tablets, 20 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	20 mg

Excipients : lactose monohydrate – 27 mg, microcrystalline cellulose – 27 mg, hypromellose – 2.4 mg, croscarmellose sodium – 3.2 mg, magnesium stearate – 0.4 mg.

Film coating composition, 4 mg polyvinyl alcohol – 40%, macrogol – 20.2%, talc – 14.8%, titanium dioxide – 11.98%, quinoline yellow (E104) aluminum lake -11.69%, sunset yellow FCF (E110) aluminum lake – 0.73%, yellow iron oxide – 0.58%, indigo carmine (E132) aluminum lake – 0.02%

60 pcs. – polyethylene bottles (1) – cardboard packs.

Dasatinib-Nativ [Pharmental Group, LLC (Russia)]
Film-coated tablets, 80 mg: 30 pcs.

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Dosage Form

Dasatinib-Nativ

Film-coated tablets, 80 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange, round, biconvex; the core is white or almost white on the cross-section.

	1 tab.
Dasatinib	80 mg

Excipients: lactose monohydrate – 108 mg, microcrystalline cellulose – 108 mg, hypromellose – 9.6 mg, croscarmellose sodium – 12.8 mg, magnesium stearate – 1.6 mg.

Film coating composition, 13 mg: polyvinyl alcohol – 40%, macrogol – 20.2%, talc – 14.8%, sunset yellow FCF (E110) aluminum lake – 13.91%, titanium dioxide – 10.14%, yellow iron oxide – 0.91%, indigo carmine (E132) aluminum lake – 0.04%.

30 pcs. – polyethylene bottles (1) – cardboard packs.

Dasatinib-Nativ [Pharmental Group, LLC (Russia)]
Film-coated tablets, 50 mg: 60 pcs.

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Dosage Form

Dasatinib-Nativ

Film-coated tablets, 50 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange, oval, biconvex; the core is white or almost white on the cross-section.

	1 tab.
Dasatinib	50 mg

Excipients: lactose monohydrate – 67.5 mg, microcrystalline cellulose – 67.5 mg, hypromellose – 6 mg, croscarmellose sodium – 8 mg, magnesium stearate – 1 mg.

Film coating composition, 8 mg: polyvinyl alcohol – 40%, macrogol – 20.2%, talc – 14.8%, sunset yellow FCF (E110) aluminum lake – 13.91%, titanium dioxide – 10.14%, yellow iron oxide – 0.91%, indigo carmine (E132) aluminum lake – 0.04%.

60 pcs. – polyethylene bottles (1) – cardboard packs.

Dasatinib [Amedart LLC (Russia)]
Film-coated tablets, 100 mg: 30 pcs.

Marketing Authorization Holder

Amedart LLC (Russia)

Dosage Form

Dasatinib

Film-coated tablets, 100 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Dasatinib	100 mg

Excipients: lactose monohydrate – 135 mg, microcrystalline cellulose 102 – 135 mg, croscarmellose sodium – 16 mg, hypromellose (hydroxypropylcellulose) – 12 mg, magnesium stearate – 2 mg.

Film coating composition Opadry^® AMB II white 88A180040 – 11 mg.

Composition of Opadry^® AMB II white 88A180040: polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3% – 11 mg.

30 pcs. – polyethylene jars (1) – cardboard packs.

Dasatinib [MBA-Group, LLC (Russia)]
Film-coated tablets, 20 mg: 30 or 60 pcs.
Film-coated tablets, 50 mg: 30 or 60 pcs.
Film-coated tablets, 70 mg: 30 or 60 pcs.
Film-coated tablets, 80 mg: 30 or 60 pcs.
Film-coated tablets, 100 mg: 30 pcs.
Film-coated tablets, 140 mg: 30 pcs.

Marketing Authorization Holder

MBA-Group, LLC (Russia)

Manufactured By

Amedart LLC (Russia)

Dosage Forms

	Dasatinib	Film-coated tablets, 20 mg: 30 or 60 pcs.
		Film-coated tablets, 50 mg: 30 or 60 pcs.
		Film-coated tablets, 70 mg: 30 or 60 pcs.
		Film-coated tablets, 80 mg: 30 or 60 pcs.
		Film-coated tablets, 100 mg: 30 pcs.
		Film-coated tablets, 140 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Dasatinib	20 mg

Excipients: lactose monohydrate, microcrystalline cellulose 102, croscarmellose sodium, hypromellose, magnesium stearate.

Film coating composition opadry AMB II white 88A180040, polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Dasatinib	50 mg

Excipients: lactose monohydrate, microcrystalline cellulose 102, croscarmellose sodium, hypromellose, magnesium stearate.

Film coating composition opadry AMB II white 88A180040, polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Dasatinib	70 mg

Excipients: lactose monohydrate, microcrystalline cellulose 102, croscarmellose sodium, hypromellose, magnesium stearate.

Film coating composition opadry AMB II white 88A180040, polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Dasatinib	80 mg

Excipients: lactose monohydrate, microcrystalline cellulose 102, croscarmellose sodium, hypromellose, magnesium stearate.

Film coating composition opadry AMB II white 88A180040, polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Dasatinib	100 mg

Excipients: lactose monohydrate, microcrystalline cellulose 102, croscarmellose sodium, hypromellose, magnesium stearate.

Film coating composition opadry AMB II white 88A180040, polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

30 pcs. – jars – cardboard packs.

Film-coated tablets white or almost white, oval, biconvex.

	1 tab.
Dasatinib	140 mg

Excipients: lactose monohydrate, microcrystalline cellulose 102, croscarmellose sodium, hypromellose, magnesium stearate.

Film coating composition opadry AMB II white 88A180040, polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type 1), sodium lauryl sulfate.

30 pcs. – jars (1) – cardboard packs.

Dasatinib [Ozon Medica, LLC (Russia)]
Film-coated tablets 20 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
Film-coated tablets 50 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
Film-coated tablets 70 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
Film-coated tablets 80 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
Film-coated tablets 100 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
Film-coated tablets 140 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.

Marketing Authorization Holder

Ozon Medica, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Dasatinib	Film-coated tablets 20 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
		Film-coated tablets 50 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
		Film-coated tablets 70 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
		Film-coated tablets 80 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
		Film-coated tablets 100 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.
		Film-coated tablets 140 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets round, biconvex, coated with a white or almost white film coating. The core is white or almost white on the cross-section.

	1 tab.
Dasatinib	20 mg

Excipients: lactose monohydrate (milk sugar) – 27 mg, microcrystalline cellulose (MCC-101) – 27 mg, croscarmellose sodium – 3.2 mg, hypromellose – 2.4 mg, magnesium stearate – 0.4 mg.

Coating composition: polyvinyl alcohol – 1.304 mg; macrogol 4000 – 0.616 mg; titanium dioxide – 0.48 mg.

10 pcs. – contour cell packaging (1) – cardboard packs (1).
10 pcs. – contour cell packaging (2) – cardboard packs (1).
10 pcs. – contour cell packaging (3) – cardboard packs (1).
10 pcs. – contour cell packaging (5) – cardboard packs (1).
10 pcs. – contour cell packaging (6) – cardboard packs (1).
10 pcs. – contour cell packaging (10) – cardboard packs (1).
30 pcs. – contour cell packaging (1) – cardboard packs (1).
30 pcs. – contour cell packaging (2) – cardboard packs (1).
30 pcs. – contour cell packaging (3) – cardboard packs (1).
30 pcs. – contour cell packaging (5) – cardboard packs (1).
30 pcs. – contour cell packaging (6) – cardboard packs (1).
30 pcs. – contour cell packaging (10) – cardboard packs (1).
10 pcs. – jars (1) – cardboard packs (1).
30 pcs. – jars (1) – cardboard packs (1).
50 pcs. – jars (1) – cardboard packs (1).
60 pcs. – jars (1) – cardboard packs (1).
100 pcs. – jars (1) – cardboard packs (1).

Film-coated tablets round, biconvex, coated with a white or almost white film coating. The core is white or almost white on the cross-section.

	1 tab.
Dasatinib	50 mg

Excipients: lactose monohydrate (milk sugar) – 67.5 mg, microcrystalline cellulose (MCC-101) – 67.5 mg, croscarmellose sodium – 8 mg, hypromellose – 6 mg, magnesium stearate – 1 mg.

Coating composition: polyvinyl alcohol – 3.26 mg; macrogol 4000 – 1.54 mg; titanium dioxide – 1.2 mg.

Film-coated tablets round, biconvex, coated with a white or almost white film coating. The core is white or almost white on the cross-section.

	1 tab.
Dasatinib	70 mg

Excipients: lactose monohydrate (milk sugar) – 94.5 mg, microcrystalline cellulose (MCC-101) – 94.5 mg, croscarmellose sodium – 11.2 mg, hypromellose – 8.4 mg, magnesium stearate – 1.4 mg.

Coating composition: polyvinyl alcohol – 4.564 mg; macrogol 4000 – 2.156 mg; titanium dioxide – 1.68 mg.

Film-coated tablets round, biconvex, coated with a white or almost white film coating. The core is white or almost white on the cross-section.

	1 tab.
Dasatinib	80 mg

Excipients: lactose monohydrate (milk sugar) – 108 mg, microcrystalline cellulose (MCC-101) – 108 mg, croscarmellose sodium – 12.8 mg, hypromellose – 9.6 mg, magnesium stearate – 1.6 mg.

Coating composition: polyvinyl alcohol – 5.216 mg; macrogol 4000 – 2.464 mg; titanium dioxide – 1.92 mg.

Film-coated tablets round, biconvex, coated with a white or almost white film coating. The core is white or almost white on the cross-section.

	1 tab.
Dasatinib	100 mg

Excipients: lactose monohydrate (milk sugar) – 135 mg, microcrystalline cellulose (MCC-101) – 135 mg, croscarmellose sodium – 16 mg, hypromellose – 12 mg, magnesium stearate – 2 mg.

Coating composition: polyvinyl alcohol – 6.52 mg; macrogol 4000 – 3.08 mg; titanium dioxide – 2.4 mg.

Film-coated tablets round, biconvex, coated with a white or almost white film coating. The core is white or almost white on the cross-section.

	1 tab.
Dasatinib	140 mg

Excipients: lactose monohydrate (milk sugar) – 189 mg, microcrystalline cellulose (MCC-101) – 189 mg, croscarmellose sodium – 22.4 mg, hypromellose – 16.8 mg, magnesium stearate – 2.8 mg.

Coating composition polyvinyl alcohol – 9.128 mg; macrogol-4000 – 4.312 mg; titanium dioxide – 3.36 mg.

Dasatinib [Oncotarget, LLC (Russia)]
Film-coated tablets, 20 mg: 60 pcs.
Film-coated tablets, 50 mg: 60 pcs.
Film-coated tablets, 70 mg: 60 pcs.
Film-coated tablets, 80 mg: 30 pcs.
Film-coated tablets, 100 mg: 30 pcs.
Film-coated tablets, 140 mg: 30 pcs.

Marketing Authorization Holder

Oncotarget, LLC (Russia)

Dosage Forms

	Dasatinib	Film-coated tablets, 20 mg: 60 pcs.
		Film-coated tablets, 50 mg: 60 pcs.
		Film-coated tablets, 70 mg: 60 pcs.
		Film-coated tablets, 80 mg: 30 pcs.
		Film-coated tablets, 100 mg: 30 pcs.
		Film-coated tablets, 140 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	20 mg

Excipients: lactose monohydrate – 27 mg, microcrystalline cellulose (type 101) – 27 mg, hypromellose – 2.4 mg, croscarmellose sodium – 3.2 mg, magnesium stearate – 0.4 mg.

Film coating composition: Opadry II orange: polyvinyl alcohol, macrogol, talc, sunset yellow FCF (E110), aluminum lake, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132), aluminum lake.

60 pcs. – polyethylene jars (1) – cardboard packs.

Film-coated tablets yellow, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	50 mg

Excipients: lactose monohydrate – 67.5 mg, microcrystalline cellulose (type 101) – 67.5 mg, hypromellose – 6 mg, croscarmellose sodium – 8 mg, magnesium stearate – 1 mg.

Film coating composition: Opadry II yellow: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), quinoline yellow (E104), aluminum lake, sunset yellow FCF (E110), aluminum lake, yellow iron oxide (E172), indigo carmine (E132), aluminum lake.

60 pcs. – polyethylene jars (1) – cardboard packs.

Film-coated tablets yellow, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	70 mg

Excipients: lactose monohydrate – 94.5 mg, microcrystalline cellulose (type 101) – 94.5 mg, hypromellose – 8.4 mg, croscarmellose sodium – 11.2 mg, magnesium stearate – 1.4 mg.

60 pcs. – polyethylene jars (1) – cardboard packs.

Film-coated tablets orange, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	80 mg

Excipients: lactose monohydrate – 108 mg, microcrystalline cellulose (type 101) – 108 mg, hypromellose – 9.6 mg, croscarmellose sodium – 12.8 mg, magnesium stearate – 1.6 mg.

30 pcs. – polyethylene jars (1) – cardboard packs.

Film-coated tablets yellow, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	100 mg

Excipients: lactose monohydrate – 135 mg, microcrystalline cellulose (type 101) – 135 mg, hypromellose – 12 mg, croscarmellose sodium – 16 mg, magnesium stearate – 2 mg.

30 pcs. – polyethylene jars (1) – cardboard packs.

Film-coated tablets orange, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Dasatinib	140 mg

Excipients: lactose monohydrate – 189 mg, microcrystalline cellulose (type 101) – 189 mg, hypromellose – 16.8 mg, croscarmellose sodium – 22.4 mg, magnesium stearate – 2.8 mg.

30 pcs. – polyethylene jars (1) – cardboard packs.

Medixlife (Author)

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