Nilotinib (Capsules) Instructions for Use
ATC Code
L01EA03 (Nilotinib)
Active Substance
Nilotinib (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
Nilotinib is an antitumor agent, a protein tyrosine kinase inhibitor. It effectively inhibits the tyrosine kinase activity of the Bcr-Abl oncoprotein in cell lines and primary Philadelphia chromosome-positive (Ph-positive) leukemic cells.
It has a high affinity for ATP-binding sites and thus exerts a pronounced inhibitory effect on the unbound form of the Bcr-Abl oncoprotein, and also demonstrates activity against imatinib-resistant 32/33 mutant forms of Bcr-Abl tyrosine kinase, with the exception of the T315I mutation. Nilotinib selectively inhibits proliferation and induces apoptosis of cell lines and Ph-positive leukemic cells in patients with chronic myeloid leukemia (CML).
Nilotinib has no or minimal effect on other known protein kinases (including kinases of the Src protein family), except for kinases with receptors for platelet-derived growth factors, Kit receptors, and ephrin receptors. Inhibition of this type of protein kinases occurs at nilotinib concentrations within the range of therapeutic oral doses recommended for the treatment of CML.
Pharmacokinetics
After oral administration, the absorption of nilotinib is about 30%. The mean Tmax in blood plasma is about 3 hours. In healthy volunteers, when taken simultaneously with food, the Cmax and AUC of nilotinib increased by 112% and 82%, respectively, compared with the use of nilotinib on an empty stomach. When taken 30 minutes or 2 hours after a meal, the bioavailability of nilotinib increased by 29% and 15%, respectively.
The blood-to-plasma ratio for nilotinib is 0.68. In vitro binding to plasma proteins is about 98%.
Css of nilotinib was reached by day 8 and was less dose-dependent than the systemic concentration, which increased with doses above 400 mg compared to a single dose. The daily Css of nilotinib in plasma was 35% higher when used at a dose of 400 mg twice daily than when used at a dose of 800 mg once daily. There was no significant increase in Css of nilotinib when the dose was increased from 400 mg twice daily to 600 mg twice daily. The increase in plasma concentration of nilotinib between the first dose and reaching Css was approximately 2 times when nilotinib was taken once daily and 3.8 times when taken twice daily.
In healthy volunteers, the main pathways of nilotinib metabolism are oxidation and hydroxylation. In blood plasma, Nilotinib circulates mainly unchanged. All metabolites of nilotinib have minimal pharmacological activity.
After a single dose of nilotinib in healthy volunteers, more than 90% of the dose was excreted within 7 days, mainly in the feces. 69% is excreted unchanged. T1/2 with multiple doses of the daily dose was approximately 17 hours.
Individual differences in pharmacokinetics among patients ranged from moderate to pronounced.
Indications
Treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase and accelerated phase in adult patients with intolerance or resistance to prior therapy, including imatinib.
ICD codes
| ICD-10 code | Indication |
| C92.1 | Chronic myeloid leukemia [CML], BCR/ABL-positive |
| ICD-11 code | Indication |
| 2A20.0Z | Chronic myelogenous leukemia, BCR-ABL1-positive, unspecified |
| 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. |
Capsules
It is taken orally. The recommended dose is 400 mg twice daily. Treatment is continued as long as the clinical effect persists.
If neutropenia and thrombocytopenia occur that are not related to leukemia, temporary discontinuation of the drug or a reduction in its dose is required, depending on the severity of these side effects.
If moderate or severe non-hematological side effects associated with nilotinib intake develop, therapy should be interrupted. After the side effects disappear, treatment can be resumed at a dose of 400 mg once daily. If necessary, the dose can be increased to 400 mg twice daily.
If the lipase level increases to 5 times the upper limit of normal (ULN) or bilirubin increases to more than 3 times the ULN, it is recommended to reduce the dose of nilotinib to 400 mg/day.
Adverse Reactions
From the hematopoietic system: very common – thrombocytopenia (27%), neutropenia (15%), anemia (13%); common – febrile neutropenia, pancytopenia; frequency unknown – thrombocythemia, leukocytosis.
From the central and peripheral nervous system: very common – headache (15%); common – dizziness, paresthesia, insomnia; uncommon – intracranial hemorrhage, migraine, tremor, hypesthesia, hyperesthesia, depression, anxiety; frequency unknown – cerebral edema, loss of consciousness, optic neuritis and peripheral neuropathy, confusion, disorientation.
From the digestive system: very common – nausea (19%), constipation (11%), diarrhea (11%); common – vomiting (9%), abdominal pain (5%), anorexia (5%), abdominal discomfort, dyspepsia, flatulence; uncommon – pancreatitis, gastrointestinal bleeding, melena, gastroesophageal reflux, stomatitis, dry mouth, increased or decreased appetite, hepatitis; frequency unknown – perforation of gastrointestinal ulcers, retroperitoneal hemorrhage, vomiting blood, gastric ulcer, ulcerative esophagitis, partial intestinal obstruction, hepatomegaly, jaundice.
Dermatological reactions: very common – rash (26%), pruritus (22%); common – alopecia (7%), eczema, urticaria, hyperhidrosis, dry skin; uncommon – exfoliative rash, ecchymoses; frequency unknown – erythema nodosum, skin ulcers, petechiae, increased photosensitivity.
From metabolism: common – hypomagnesemia, hyperkalemia, hyperglycemia; uncommon – hypokalemia, hyponatremia, hypocalcemia, hypophosphatemia, dehydration; frequency unknown – hypercalcemia, hyperphosphatemia.
From the endocrine system: uncommon – hyperthyroidism; frequency unknown – hypothyroidism, thyroiditis, diabetes mellitus.
From the sensory organs: common – vertigo; uncommon – intraocular hemorrhage, decreased visual acuity, periorbital edema, conjunctivitis, eye irritation, dry eye syndrome; frequency unknown – optic disc edema, diplopia, blurred vision, photophobia, eyelid swelling, blepharitis, eye pain, hearing loss, ear pain.
From the cardiovascular system: common – palpitations, QT interval prolongation on ECG, flushing, increased blood pressure; uncommon – heart failure, angina pectoris, atrial fibrillation, pericardial effusion, coronary artery disease, cardiomegaly, appearance of heart murmurs, bradycardia, hypertensive crisis, hematomas; frequency unknown – myocardial infarction, pericarditis, atrial flutter, extrasystole, hemorrhagic shock, decreased blood pressure, thrombosis.
From the respiratory system: common – dyspnea at rest and on exertion, cough, dysphonia; uncommon – pulmonary edema, pleural effusion, interstitial lung diseases, chest pain, pleurisy, epistaxis, pain in the pharynx and/or larynx, irritation of the pharyngeal mucosa; frequency unknown – pulmonary hypertension.
From the musculoskeletal system: common – myalgia (8%), arthralgia (6%), bone pain (6%), muscle spasms (6%); uncommon – muscle weakness; frequency unknown – arthritis, joint swelling.
From the urinary system: uncommon – dysuria, painful urge to urinate, nocturia, pollakiuria; frequency unknown – renal failure, hematuria, urinary incontinence.
From the reproductive system: uncommon – breast pain, erectile dysfunction, gynecomastia.
Infectious diseases: uncommon – pneumonia, urinary tract infections, pharyngitis, gastroenteritis; frequency unknown – sepsis, bronchitis, herpes infection (herpes simplex), candidiasis.
Other: very common – increased fatigue (16%); common – asthenia (6%), fluid retention and edema (5%), increased body temperature, night sweats; uncommon – chest pain, facial edema, leg edema, flu-like syndrome, chills, general malaise.
From laboratory parameters: very common – increased lipase activity; common – increased plasma activity of amylase, CPK, ALP, ALT, AST, GGT, bilirubin level, glucose level, decrease or increase in body weight; uncommon – increased plasma activity of LDH, creatinine level, urea, hypoglycemia; frequency unknown – increased troponin level, increased plasma level of conjugated bilirubin. Asymptomatic increase in serum lipase levels is possible; in some cases, this increase was accompanied by clinical symptoms such as abdominal pain, or developed against the background of pancreatitis.
Pleural and pericardial effusion, as well as other complications resulting from fluid retention, congestive heart failure, QTcF interval prolongation over 500 msec were observed in less than 1% of cases. Gastrointestinal bleeding and CNS hemorrhage were reported in 3% and 1% of cases, respectively.
Contraindications
Pregnancy; lactation (breastfeeding); children and adolescents under 18 years of age; hypersensitivity to nilotinib.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and during lactation (breastfeeding).
Use in Hepatic Impairment
Use with caution in hepatic insufficiency.
Use in Renal Impairment
Since the kidneys do not play a significant role in the excretion of nilotinib and its metabolites, no reduction in total clearance is expected when using nilotinib in patients with renal insufficiency.
Pediatric Use
Contraindicated in children and adolescents under 18 years of age.
Geriatric Use
In elderly patients, no dose adjustment is required.
Special Precautions
Use with caution in patients with a prolonged QTcF interval (QT interval corrected by Fridericia) on ECG (including in patients with hypokalemia or hypomagnesemia, with congenital long QTcF syndrome, receiving treatment with antiarrhythmic drugs or other drugs that prolong the QTcF interval, when using anthracyclines in a high cumulative dose), in hepatic insufficiency.
In elderly patients, no dose adjustment is required.
Since the kidneys do not play a significant role in the excretion of nilotinib and its metabolites, no reduction in total clearance is expected when using nilotinib in patients with renal insufficiency.
There are no data on the use of nilotinib in patients with serum creatinine levels 1.5 times the ULN, with ALT and/or AST activity exceeding 2.5 times (or more than 5 times if associated with the disease) the ULN and/or with a total bilirubin level more than 1.5 times the ULN, severe heart disease (including complete left bundle branch block, unstable angina, uncontrolled chronic heart failure, or recent myocardial infarction).
Drug Interactions
Nilotinib is metabolized mainly in the liver and is also a substrate for the excretion system of many drugs – P-glycoprotein. The absorption and subsequent elimination of nilotinib can be affected by drugs acting on the CYP3A4 isoenzyme and/or P-glycoprotein.
The bioavailability of nilotinib in healthy volunteers increased 3-fold with simultaneous use with the strong CYP3A4 isoenzyme inhibitor ketoconazole (simultaneous use of nilotinib with such drugs should be avoided, including ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin and telithromycin, as well as with grapefruit juice and other products that are known inhibitors of the CYP3A4 isoenzyme).
Inducers of the CYP3A4 isoenzyme may enhance the metabolism of nilotinib and reduce its plasma concentration. When taken simultaneously with drugs that are inducers of the CYP3A4 isoenzyme (including phenytoin, rifampicin, carbamazepine, phenobarbital and St. John’s wort), a decrease in the concentration of nilotinib is possible.
Nilotinib, being a competitive inhibitor of the CYP3A4, CYP2C8, CYP2C9 and CYP2D6 isoenzymes in vitro, can potentially increase the concentration of drugs eliminated with the participation of these enzymes. In addition, with a single use of nilotinib with midazolam in healthy volunteers, an increase in the concentration of midazolam by 30% was noted.
Caution should be exercised when using nilotinib together with drugs that cause QT interval prolongation (for example, with amiodarone, disopyramide, halofantrine, clarithromycin, haloperidol or methadone).
When taken simultaneously with food, an increase in the absorption of nilotinib is noted, leading to an increase in its plasma concentration.
If necessary, nilotinib can be used together with hematopoietic stimulants such as erythropoietins, G-CSF, as well as with hydroxycarbamide and anagrelide.
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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 200 mg: 28, 40, 112 or 120 pcs.
Marketing Authorization Holder
Amedart LLC (Russia)
Dosage Form
 |
Nilotinib | Capsules 200 mg: 28, 40, 112 or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #00, white, opaque; capsule contents – brownish-yellow powder.
| 1 cap. | |
| Nilotinib | 200 mg |
Excipients: lactose monohydrate – 49 mg, crospovidone – 10.47 mg, poloxamer 188 – 3.2 mg, colloidal silicon dioxide – 1.33 mg, magnesium stearate – 1.33 mg.
Capsule shell composition: titanium dioxide (E171) – 2%, gelatin – up to 100%.
28 pcs. – polyethylene jars (1) – cardboard packs.
40 pcs. – polyethylene jars (1) – cardboard packs.
112 pcs. – polyethylene jars (1) – cardboard packs.
120 pcs. – polyethylene jars (1) – cardboard packs.
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
MBA-Group, LLC (Russia)
Manufactured By
Amedart LLC (Russia)
Dosage Forms
|
Nilotinib | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 cap. | |
| Nilotinib | 150 mg |
112 pcs. – jars – cardboard packs (112 pcs.) – By prescription
120 pcs. – jars – cardboard packs (120 pcs.) – By prescription
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
40 pcs. – jars – cardboard packs (40 pcs.) – By prescription
Capsules
| 1 cap. | |
| Nilotinib | 200 mg |
112 pcs. – jars – cardboard packs (112 pcs.) – By prescription
120 pcs. – jars – cardboard packs (120 pcs.) – By prescription
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
40 pcs. – jars – cardboard packs (40 pcs.) – By prescription
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
Medical Leasing-Consulting, LLC (Russia)
Manufactured By
Institute Of Bioorganic Chemistry Of The National Academy Of Sciences Of Belarus, State Institution (Republic Of Belarus)
Dosage Forms
|
Nilotinib | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 cap. | |
| Nilotinib | 150 mg |
28 pcs. – bottles – cardboard boxes (28 pcs.) – By prescription
40 pcs. – bottles – cardboard boxes (40 pcs.) – By prescription
Capsules
| 1 cap. | |
| Nilotinib | 200 mg |
28 pcs. – bottles – cardboard boxes (28 pcs.) – By prescription
40 pcs. – bottles – cardboard boxes (40 pcs.) – By prescription
Capsules 150 mg: 28, 40, 112 or 120 pcs.
Marketing Authorization Holder
Nativa, LLC (Russia)
Dosage Form
|
Nilotinib | Capsules 150 mg: 28, 40, 112 or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules white in color, with a blue cap; hard, gelatin, size #1; capsule contents – white or white with a yellowish tint powder.
| 1 caps. | |
| Nilotinib hydrochloride monohydrate | 165.45 mg, |
| Equivalent to nilotinib content | 150 mg |
Excipients : mannitol – 117.05 mg, crospovidone – 12 mg, poloxamer – 2.5 mg, colloidal silicon dioxide – 1.5 mg, magnesium stearate – 1.5 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: indigo carmine – 0.13%, titanium dioxide – 1%, gelatin – up to 100%.
4 pcs. – blister packs (7) – cardboard packs.
4 pcs. – blister packs (28) – cardboard packs.
8 pcs. – blister packs (5) – cardboard packs.
8 pcs. – blister packs (15) – cardboard packs.
28 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
40 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
112 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
120 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
Capsules 200 mg: 28, 40, 112 or 120 pcs.
Marketing Authorization Holder
Nativa, LLC (Russia)
Dosage Form
|
Nilotinib | Capsules 200 mg: 28, 40, 112 or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules white in color, hard, gelatin, size #1; capsule contents – white or white with a yellowish tint powder.
| 1 caps. | |
| Nilotinib hydrochloride monohydrate | 220.6 mg, |
| Equivalent to nilotinib content | 200 mg |
Excipients : mannitol – 156 mg, crospovidone – 16 mg, poloxamer – 3.4 mg, colloidal silicon dioxide – 2 mg, magnesium stearate – 2 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide – 2%, gelatin – up to 100%.
4 pcs. – blister packs (7) – cardboard packs.
4 pcs. – blister packs (28) – cardboard packs.
8 pcs. – blister packs (5) – cardboard packs.
8 pcs. – blister packs (15) – cardboard packs.
28 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
40 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
112 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
120 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
Ozon Medica, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Nilotinib | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Nilotinib | 150 mg |
10 pcs. – blister packs – cardboard packs (10 pcs.) – Prescription only
10 pcs. – blister packs (12 pcs.) – cardboard packs (120 pcs.) – Prescription only
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – Prescription only
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
7 pcs. – blister packs – cardboard packs (7 pcs.) – Prescription only
7 pcs. – blister packs (12 pcs.) – cardboard packs (84 pcs.) – Prescription only
7 pcs. – blister packs (2 pcs.) – cardboard packs (14 pcs.) – Prescription only
7 pcs. – blister packs (3 pcs.) – cardboard packs (21 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
Capsules
| 1 caps. | |
| Nilotinib | 200 mg |
10 pcs. – blister packs – cardboard packs (10 pcs.) – Prescription only
10 pcs. – blister packs (12 pcs.) – cardboard packs (120 pcs.) – Prescription only
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – Prescription only
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
7 pcs. – blister packs – cardboard packs (7 pcs.) – Prescription only
7 pcs. – blister packs (12 pcs.) – cardboard packs (84 pcs.) – Prescription only
7 pcs. – blister packs (2 pcs.) – cardboard packs (14 pcs.) – Prescription only
7 pcs. – blister packs (3 pcs.) – cardboard packs (21 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
Pharmental Group, LLC (Russia)
Dosage Forms
|
Nilotinib | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Nilotinib | 150 mg |
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
Capsules
| 1 caps. | |
| Nilotinib | 200 mg |
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Forms
|
Nilotinib Canon | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Nilotinib (as hydrochloride monohydrate) | 150 mg |
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – Prescription only
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
14 pcs. – blister packs (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
15 pcs. – blister packs (2 pcs.) – cardboard packs (30 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
Capsules
| 1 caps. | |
| Nilotinib (as hydrochloride monohydrate) | 200 mg |
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – Prescription only
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
14 pcs. – blister packs (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
15 pcs. – blister packs (2 pcs.) – cardboard packs (30 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
Pharmasintez-Nord, JSC (Russia)
Dosage Forms
|
Nilotinib Pharmasyntez | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| Nilotinib | 150 mg |
10 pcs. – blister packs (12 pcs.) – boxes (120 pcs.) – Prescription only
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
7 pcs. – blister packs (16 pcs.) – boxes (112 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
8 pcs. – blister packs (15 pcs.) – boxes (120 pcs.) – Prescription only
8 pcs. – blister packs (5 pcs.) – cardboard packs (40 pcs.) – Prescription only
Capsules
| Nilotinib | 200 mg |
10 pcs. – blister packs (12 pcs.) – boxes (120 pcs.) – Prescription only
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
112 pcs. – jars – cardboard packs (112 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
7 pcs. – blister packs (16 pcs.) – boxes (112 pcs.) – Prescription only
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
8 pcs. – blister packs (15 pcs.) – boxes (120 pcs.) – Prescription only
8 pcs. – blister packs (5 pcs.) – cardboard packs (40 pcs.) – Prescription only
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
Binergia JSC (Russia)
Manufactured By
Nanopharma Development, LLC (Russia)
Dosage Forms
|
Nilotinib-Binergia | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Nilotinib (as hydrochloride monohydrate) | 150 mg |
8 pcs. – blister packs (15 pcs.) – cardboard packs (120 pcs.) – Prescription only
8 pcs. – blister packs (150 pcs.) – cardboard boxes (1200 pcs.) – In-Bulk
8 pcs. – blister packs (200 pcs.) – cardboard boxes (1600 pcs.) – In-Bulk
8 pcs. – blister packs (300 pcs.) – cardboard boxes (2400 pcs.) – In-Bulk
8 pcs. – blister packs (400 pcs.) – cardboard boxes (3200 pcs.) – In-Bulk
8 pcs. – blister packs (5 pcs.) – cardboard packs (40 pcs.) – Prescription only
8 pcs. – blister packs (500 pcs.) – cardboard boxes (4000 pcs.) – In-Bulk
8 pcs. – blister packs (600 pcs.) – cardboard boxes (4800 pcs.) – In-Bulk
Capsules
| 1 caps. | |
| Nilotinib (as hydrochloride monohydrate) | 200 mg |
8 pcs. – blister packs (15 pcs.) – cardboard packs (120 pcs.) – Prescription only
8 pcs. – blister packs (150 pcs.) – cardboard boxes (1200 pcs.) – In-Bulk
8 pcs. – blister packs (200 pcs.) – cardboard boxes (1600 pcs.) – In-Bulk
8 pcs. – blister packs (300 pcs.) – cardboard boxes (2400 pcs.) – In-Bulk
8 pcs. – blister packs (400 pcs.) – cardboard boxes (3200 pcs.) – In-Bulk
8 pcs. – blister packs (5 pcs.) – cardboard packs (40 pcs.) – Prescription only
8 pcs. – blister packs (500 pcs.) – cardboard boxes (4000 pcs.) – In-Bulk
8 pcs. – blister packs (600 pcs.) – cardboard boxes (4800 pcs.) – In-Bulk
Capsules 150 mg
Capsules 200 mg
Marketing Authorization Holder
Chemical Diversity Research Institute LLC (Russia)
Dosage Forms
|
Nilotinib-Khimrar | Capsules 150 mg |
| Capsules 200 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Nilotinib | 150 mg |
10 pcs. – blister packs – cardboard packs (10 pcs.) – Prescription only
120 pcs. – bottles – cardboard packs (120 pcs.) – Prescription only
Capsules
| 1 caps. | |
| Nilotinib | 200 mg |
10 pcs. – blister packs – cardboard packs (10 pcs.) – Prescription only
120 pcs. – bottles – cardboard packs (120 pcs.) – Prescription only
Capsules 150 mg: 28, 40, 45, 112, or 120 pcs.
Capsules 200 mg: 28, 40, 45, 112, or 120 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
|
Nilotinib-Promomed | Capsules 150 mg: 28, 40, 45, 112, or 120 pcs. |
| Capsules 200 mg: 28, 40, 45, 112, or 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size #0, yellow body, yellow cap, opaque, cylindrical in shape with hemispherical ends; capsule contents – a mixture of powder and granules from white to light yellow in color; the presence of lumps and rods that easily disintegrate when lightly pressed with a glass rod is allowed, may appear as a compacted mass in the shape of a cylinder.
| 1 caps. | |
| Nilotinib (as malate) | 150 mg |
Excipients : lactose monohydrate, crospovidone, poloxamer 188, colloidal silicon dioxide, sodium stearyl fumarate.
Capsule body and cap titanium dioxide (E171), iron oxide yellow dye (E172), gelatin.
4 pcs. – blister pack (7) – cardboard packs.
4 pcs. – blister pack (10) – cardboard packs.
8 pcs. – blister pack (5) – cardboard packs.
8 pcs. – blister pack (15) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
112 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin size #00, white body, white cap, opaque, cylindrical in shape with hemispherical ends; capsule contents – a mixture of powder and granules from white to light yellow in color; the presence of lumps and rods that easily disintegrate when lightly pressed with a glass rod is allowed, may appear as a compacted mass in the shape of a cylinder.
| 1 caps. | |
| Nilotinib (as malate) | 200 mg |
Excipients : lactose monohydrate, crospovidone, poloxamer 188, colloidal silicon dioxide, sodium stearyl fumarate.
Capsule body and cap titanium dioxide (E171), gelatin.
4 pcs. – blister pack (7) – cardboard packs.
4 pcs. – blister pack (10) – cardboard packs.
8 pcs. – blister pack (5) – cardboard packs.
8 pcs. – blister pack (15) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
112 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
![Nilotinib [Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Nilotinib [Capsules] 2")