Sunitinib (Capsules) Instructions for Use
ATC Code
L01EX01 (Sunitinib)
Active Substance
Sunitinib (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antitumor drug. Protein kinase inhibitor
Pharmacotherapeutic Group
Antineoplastic agents; protein kinase inhibitors; other protein kinase inhibitors
Pharmacological Action
Antitumor agent, inhibitor of protein tyrosine kinases. It is capable of simultaneously inhibiting receptors of various tyrosine kinases (RTKs) involved in tumor growth, pathological angiogenesis, and metastasis.
It exhibits inhibitory activity against many kinases (>80 kinases), and is a potent inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 receptor (FLT), colony-stimulating factor receptor (CSF-1R), and glial cell line-derived neurotrophic factor receptor (RET). The activity of the main metabolite was similar to that of sunitinib.
Sunitinib inhibited the phosphorylation of many RTKs (PDGFRβ, VEGFR2, and KIT) in tumor xenografts expressing target RTKs in vivo and demonstrated tumor growth suppression or regression and/or metastasis suppression in experimental models of various tumors. Sunitinib has been shown to inhibit the growth of tumor cells expressing deregulated target RTKs (PDGFR, RET, or KIT) in vitro and PDGFRβ- and VEGFR2-dependent angiogenesis in vivo.
Pharmacokinetics
When taken orally, Sunitinib is well absorbed from the gastrointestinal tract. The time to reach Cmax is 6-12 hours. Food intake does not affect the bioavailability of sunitinib.
The binding of sunitinib and its metabolite to plasma proteins is 95% and 90%, respectively, with no apparent concentration dependence within the range of 100-4000 ng/ml.
Vd is 2230 L, demonstrating distribution into tissues.
Sunitinib is metabolized mainly by the CYP3A4 isoenzyme, resulting in the formation of the main active metabolite. The proportion of the active metabolite is 23-37% of the AUC value.
Css of sunitinib and its main active metabolite are reached in 10-14 days. By day 14, the total plasma concentration of sunitinib and its main active metabolite is 62.9-101 ng/ml. With multiple daily administration or repeated cycles with different dosing regimens, no significant changes in the pharmacokinetics of sunitinib and its main active metabolite were found.
Sunitinib is excreted mainly in feces – 61%. Approximately 16% of the dose is excreted by the kidneys as unchanged substance and its metabolites. The total oral clearance reached 34-62 L/h.
T1/2 of sunitinib and its main active metabolite is 40-60 hours and 80-110 hours, respectively. With repeated daily administration, there is a 3-4-fold accumulation of sunitinib and a 7-10-fold accumulation of its main metabolite.
Available data show that the apparent clearance of sunitinib in women may be 30% lower than in men; however, this difference does not require adjustment of the initial dose of sunitinib.
Indications
Gastrointestinal stromal tumors in case of no effect from imatinib therapy due to resistance or intolerance; advanced and/or metastatic renal cell carcinoma in patients who have not received prior specific treatment; advanced and/or metastatic renal cell carcinoma in case of no effect from cytokine therapy; unresectable or metastatic well-differentiated neuroendocrine tumors of the pancreas in adults with disease progression.
ICD codes
| ICD-10 code | Indication |
| C16 | Malignant neoplasm of stomach |
| C17 | Malignant neoplasm of small intestine |
| C25 | Malignant neoplasm of pancreas |
| C64 | Malignant neoplasm of kidney, except renal pelvis |
| ICD-11 code | Indication |
| 2B72.Z | Malignant neoplasms of stomach, unspecified |
| 2B80.0Z | Malignant tumors of duodenum, unspecified |
| 2B80.Z | Malignant neoplasm of small intestine, unspecified |
| 2C10.Z | Malignant neoplasm of pancreas, unspecified |
| 2C90.Y | Other specified malignant neoplasm of kidney, except renal pelvis |
| 2C90.Z | Unspecified malignant neoplasm of kidney, except renal pelvis |
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. |
Take orally once daily with or without food.
The recommended dose for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is 50 mg once daily for 4 weeks, followed by a 2-week treatment-free period. This constitutes one complete 6-week cycle.
For pancreatic neuroendocrine tumors (pNET), the recommended dose is 37.5 mg taken once daily continuously without a scheduled treatment-free period.
Do not crush or open capsules. Swallow whole with a sufficient amount of water.
Dose adjustments are required based on individual safety and tolerability. The daily dose may be increased or decreased in 12.5 mg increments.
For severe adverse reactions, temporarily interrupt therapy until symptoms resolve or improve to Grade 1 severity. Subsequently, resume treatment at a reduced dose.
Reduce the dose to 37.5 mg daily for GIST and RCC, or to 25 mg daily for pNET, if further dose reduction is necessary.
For patients with severe hepatic impairment (Child-Pugh Class C), a reduced dose is recommended. Monitor closely.
Concomitant use with strong CYP3A4 inhibitors requires a dose reduction. Avoid co-administration with strong CYP3A4 inducers.
Adverse Reactions
Most common (>20%): fatigue, gastrointestinal disorders (including diarrhea, nausea, stomatitis, dyspepsia, vomiting, taste disturbance, anorexia), skin pigmentation changes, rash, palmar-plantar erythrodysesthesia syndrome, dry skin, hair color changes, mucosal inflammation, asthenia. In patients with solid tumors, the most common therapy-related adverse reactions were fatigue, hypertension, and neutropenia up to grade 3, increased lipase levels up to grade 4.
From the digestive system very common – taste perversion, diarrhea, nausea, vomiting, stomatitis, mucositis, dyspepsia, abdominal pain, anorexia, constipation, glossodynia (neuralgia of the tongue), flatulence, dry mouth; common – mouth pain, gastroesophageal reflux; uncommon – pancreatitis; rare – gastrointestinal perforations.
Dermatological reactions very common – skin discoloration, palmar-plantar syndrome (erythrodysesthesia), rash (erythematous, maculopapular, papular, pityriasis-like, generalized, psoriasis-like), blisters, hair color changes, dry skin, erythema; common – alopecia, skin peeling, skin itching, exfoliative dermatitis.
From the musculoskeletal system common – limb pain, arthralgia, myalgia; in rare cases (mostly in the presence of risk factors) – myopathy and/or rhabdomyolysis with or without acute renal failure, with rare fatal outcomes.
From the nervous system very common – headache; common – dizziness, paresthesia, insomnia or increased somnolence, depression; in isolated cases – taste sensitivity disorders, including ageusia.
From the cardiovascular system very common – increased blood pressure; common – decreased left ventricular ejection fraction (LVEF), venous thromboembolism (pulmonary embolism, deep vein thrombosis); uncommon – heart failure, congestive heart failure, left ventricular dysfunction; rare – QT interval prolongation, torsades de pointes type atrial fibrillation and flutter; in isolated cases – cardiomyopathy up to fatal outcome.
From the urinary system common – chromaturia (change in urine color); in isolated cases – proteinuria, nephrotic syndrome; there are reports of cases of renal function impairment/renal failure, some of which were fatal.
From the respiratory system very common – epistaxis; common – dyspnea, laryngopharyngeal pain; cases of pulmonary embolism, sometimes fatal, have been reported.
From the endocrine system rare – hyperthyroidism progressing to hypothyroidism.
From the hematopoietic system: rare cases of thrombotic microangiopathy have been reported. In such cases, it is recommended to temporarily suspend sunitinib administration; after resolution of symptoms, the drug may be resumed at the discretion of the treating physician.
Allergic reactions: hypersensitivity reactions, including angioedema, have been reported.
Infections and infestations: in isolated cases – serious infections (with or without neutropenia), some of which were fatal.
Other: very common – asthenia, increased fatigue, increased serum lipase activity; common – lacrimation, weight loss, influenza, fever, chills, peripheral edema, periorbital edema, dehydration, increased serum creatine phosphokinase (CPK) activity and amylase activity; uncommon – tumor bleeding, flu-like syndrome. Cases of seizures have been described in patients with brain metastases or with reversible posterior leukoencephalopathy syndrome.
Contraindications
Pregnancy; lactation (breastfeeding); childhood; hypersensitivity to sunitinib.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and lactation (breastfeeding).
During sunitinib therapy and for at least three months after its discontinuation, reliable methods of contraception must be used.
Based on the results of preclinical studies, it can be concluded that sunitinib therapy may adversely affect fertility in men and women.
Special Precautions
Use with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmic drugs, or in patients with relevant heart disease, bradycardia, or electrolyte imbalances, as well as in renal or hepatic insufficiency.
Caution is required and the dose of sunitinib should be reduced when used concomitantly with strong inhibitors of CYP3A4 isoenzymes, which may increase the plasma concentration of sunitinib.
A complete analysis of hematological parameters should be performed at the beginning of each treatment cycle.
There have been reports of bleeding, sometimes fatal, including gastrointestinal bleeding, respiratory tract bleeding, tumor bleeding, urinary tract bleeding, and cerebral hemorrhage. These events can occur unexpectedly, and in the case of tumor foci in the lungs, they can manifest as severe or life-threatening hemoptysis or pulmonary hemorrhage. Periodic medical examination and blood tests are necessary for early detection of the first signs of bleeding and application of necessary therapeutic measures. With concomitant anticoagulant therapy, blood coagulation parameters should be monitored.
If it is necessary to use sunitinib in patients with cardiovascular diseases within the last 12 months (including myocardial infarction, severe/unstable angina, coronary or peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, pulmonary embolism), the risk/benefit ratio should be carefully assessed.
During therapy, periodic examination should be performed to detect clinical signs and symptoms of congestive heart failure. LVEF is recommended to be assessed before starting therapy and periodically during treatment.
If clinical signs of congestive heart failure appear, sunitinib treatment should be discontinued. In the absence of clinical signs of congestive heart failure, but with LVEF values <50% or a decrease in this indicator >20% compared to baseline (before starting therapy), it is recommended to reduce the dose of sunitinib or discontinue administration.
At concentrations approximately twice the therapeutic levels, Sunitinib contributes to the prolongation of the QTcF interval. The clinical significance of this effect is unclear and depends on the risk factors and susceptibility of the individual patient. Sunitinib should be used with caution in patients with a history of QT interval prolongation, taking antiarrhythmic drugs, or in patients with relevant heart disease, bradycardia, electrolyte imbalances. Caution is required and the dose of sunitinib should be reduced when used concomitantly with strong CYP3A4 inhibitors, which may increase the plasma concentration of sunitinib. ECG monitoring is recommended before starting therapy and during sunitinib treatment.
Patients should be examined for the occurrence of arterial hypertension using standard blood pressure control methods. In patients with severe arterial hypertension that is not amenable to treatment, temporary discontinuation of sunitinib therapy is recommended. Therapy is resumed as soon as arterial hypertension is controlled.
Baseline testing of thyroid function laboratory parameters is recommended in patients with hypothyroidism or hyperthyroidism. Treatment of patients with hypothyroidism should be carried out in accordance with standard medical practice before starting sunitinib therapy. Monitoring of all patients during sunitinib therapy for the development of thyroid dysfunction is recommended. Patients with signs and/or symptoms of thyroid dysfunction should undergo laboratory monitoring.
Since nausea and vomiting may occur with the use of sunitinib, prophylactic administration of antiemetic drugs should be considered. If diarrhea occurs, antidiarrheal agents are prescribed.
During treatment with sunitinib, serum lipase and amylase activity should be checked periodically. If symptoms of pancreatitis are present or appear, regular medical monitoring is necessary.
Patients with brain metastases, a history of seizures, and/or signs/symptoms of reversible posterior leukoencephalopathy, such as hypertension, headache, lethargy, impaired mental activity, vision loss, including cortical blindness, should be monitored by standard methods, including blood pressure control. If these symptoms appear during therapy, temporary discontinuation of sunitinib is recommended. After the symptoms disappear, treatment may be resumed at the discretion of the treating physician.
If thrombotic microangiopathy occurs, temporary discontinuation of sunitinib treatment is recommended. After the symptoms disappear, treatment may be resumed on the recommendation of the treating physician.
Examination of renal function before starting treatment, as well as monitoring of renal function parameters during sunitinib therapy, is recommended. The safety of sunitinib in patients with moderate or severe proteinuria has not been evaluated. In patients with nephrotic syndrome, sunitinib treatment should be discontinued.
Effect on ability to drive vehicles and operate machinery
Patients should be warned about the possibility of dizziness during treatment, which may affect the ability to drive a car and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Drug Interactions
With concomitant use of a single dose of sunitinib with the CYP3A4 inhibitor ketoconazole, an increase in Cmax and AUC of the complex of sunitinib and its main active metabolite by 49% and 51%, respectively, was possible in healthy volunteers.
With concomitant use of sunitinib with other CYP3A4 inhibitors (including ritonavir, itraconazole, erythromycin, clarithromycin, or grapefruit juice), an increase in the concentration of sunitinib is possible.
Concomitant use of sunitinib with CYP3A4 inhibitors should be avoided, or an alternative drug with minimal ability to inhibit CYP3A4 should be chosen. If this is not possible, the daily dose of sunitinib should be reduced by 12.5 mg. In this case, the daily dose should be at least 37.5 mg.
With concomitant use of a single dose of sunitinib with the CYP3A4 inducer rifampin, Cmax and AUC decreased by 23% and 46%, respectively, in healthy volunteers.
With concomitant use of sunitinib with other CYP3A4 inducers (including dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital, or St. John’s wort), a decrease in the concentration of sunitinib is possible.
Concomitant use of sunitinib with CYP3A4 inducers should be avoided, or an alternative drug with minimal ability to induce CYP3A4 should be chosen. If this is not possible, the dose of sunitinib should be increased by 12.5 mg, monitoring the patient’s tolerance to the drug. In this case, the daily dose should not exceed 87.5 mg/day for gastrointestinal stromal tumors and metastatic renal cell carcinoma and up to 62.5 mg/day for pancreatic neuroendocrine tumors.
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 12.5 mg
Capsules 25 mg
Capsules 37.5 mg
Capsules 50 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
 |
Sunitinib | Capsules 12.5 mg |
| Capsules 25 mg | ||
| Capsules 37.5 mg | ||
| Capsules 50 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Sunitinib | 12.5 mg |
30 pcs. – bottles – cardboard boxes (30 pcs.) – By prescription
Capsules
| 1 caps. | |
| Sunitinib | 25 mg |
30 pcs. – bottles – cardboard boxes (30 pcs.) – By prescription
Capsules
| 1 caps. | |
| Sunitinib | 37.5 mg |
30 pcs. – bottles – cardboard boxes (30 pcs.) – By prescription
Capsules
| 1 caps. | |
| Sunitinib | 50 mg |
30 pcs. – bottles – cardboard boxes (30 pcs.) – By prescription
Capsules 12.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100 or 140 pcs.
Capsules 25 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100 or 140 pcs.
Capsules 50 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100 or 140 pcs.
Marketing Authorization Holder
Ozon Medica, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Sunitinib | Capsules 12.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100 or 140 pcs. |
| Capsules 25 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100 or 140 pcs. | ||
| Capsules 50 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100 or 140 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #4, white body, yellow cap, opaque; capsule contents – a mixture of powder and granules from yellow to orange; compaction of the capsule contents into lumps is allowed, easily destroyed when pressed with a glass rod.
| 1 caps. | |
| Sunitinib malate | 16.7 mg |
| Equivalent to sunitinib content | 12.5 mg |
Excipients: mannitol – 80 mg, croscarmellose sodium – 6.6 mg, povidone K25 – 5.6 mg, magnesium stearate – 1.1 mg.
Capsule body composition titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition sunset yellow dye – 0.0059%, quinoline yellow – 0.75%, titanium dioxide – 2%, gelatin – up to 100%.
7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
14 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin, size #4, yellow body, orange cap, opaque; capsule contents – a mixture of powder and granules from yellow to orange; compaction of the capsule contents into lumps is allowed, easily destroyed when pressed with a glass rod.
| 1 caps. | |
| Sunitinib malate | 33.4 mg |
| Equivalent to sunitinib content | 25 mg |
Excipients: mannitol – 39.7 mg, croscarmellose sodium – 5 mg, povidone K25 – 4.2 mg, magnesium stearate – 1.2 mg.
Capsule body composition sunset yellow dye – 0.0059%, quinoline yellow – 0.75%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition sunset yellow dye – 0.14%, titanium dioxide – 2%, gelatin – up to 100%.
7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
14 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin, size #2, yellow body and cap, opaque; capsule contents – a mixture of powder and granules from yellow to orange; compaction of the capsule contents into lumps is allowed, easily destroyed when pressed with a glass rod.
| 1 caps. | |
| Sunitinib malate | 66.8 mg |
| Equivalent to sunitinib content | 50 mg |
Excipients: mannitol – 79.4 mg, croscarmellose sodium – 10 mg, povidone K25 – 8.4 mg, magnesium stearate – 2.4 mg.
Capsule body composition sunset yellow dye – 0.0059%, quinoline yellow – 0.75%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition sunset yellow dye – 0.0059%, quinoline yellow – 0.75%, titanium dioxide – 2%, gelatin – up to 100%.
7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
14 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Capsules 12.5 mg: 28 or 30 pcs.
Capsules 25 mg: 28 or 30 pcs.
Capsules 50 mg: 28 or 30 pcs.
Marketing Authorization Holder
Oncotarget, LLC (Russia)
Manufactured By
Oncotarget, LLC (Russia)
Dosage Forms
|
Sunitinib | Capsules 12.5 mg: 28 or 30 pcs. |
| Capsules 25 mg: 28 or 30 pcs. | ||
| Capsules 50 mg: 28 or 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #4, yellow body, yellow cap.
| 1 caps. | |
| Sunitinib malate | 16.7 mg |
| Equivalent to sunitinib content | 12.5 mg |
Excipients: mannitol – 80 mg, croscarmellose sodium – 6.6 mg, povidone K-30 – 5.6 mg, magnesium stearate – 1.1 mg.
Capsule body composition titanium dioxide – 1%, iron oxide yellow – 0.5%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 1%, iron oxide yellow – 0.5%, gelatin – up to 100%.
7 pcs. – contour cell packs (4) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Capsules hard gelatin, size #3, orange body, orange cap.
| 1 caps. | |
| Sunitinib malate | 33.4 mg |
| Equivalent to sunitinib content | 25 mg |
Excipients: mannitol – 39.7 mg, croscarmellose sodium – 5 mg, povidone K-30 – 4.2 mg, magnesium stearate – 1.2 mg.
Capsule body composition titanium dioxide – 1.333%, iron oxide red – 0.09%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 1.333%, iron oxide red – 0.09%, gelatin – up to 100%.
7 pcs. – contour cell packs (4) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Capsules hard gelatin, size #2, white or almost white body, white or almost white cap.
| 1 caps. | |
| Sunitinib malate | 66.8 mg |
| Equivalent to sunitinib content | 50 mg |
Excipients: mannitol – 79.3 mg, croscarmellose sodium – 10 mg, povidone K-30 – 8.4 mg, magnesium stearate – 2.5 mg.
Capsule body composition titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 2%, gelatin – up to 100%.
7 pcs. – contour cell packs (4) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Capsules 12.5 mg: 28 pcs.
Capsules 25 mg: 28 pcs.
Capsules 50 mg: 28 pcs.
Marketing Authorization Holder
R-Pharm JSC (Russia)
Manufactured By
Ortat, JSC (Russia)
Packaging and Quality Control Release
ORTAT, JSC (Russia)
Or
R-OPRA, LLC (Russia)
Dosage Forms
|
Sunitinib | Capsules 12.5 mg: 28 pcs. |
| Capsules 25 mg: 28 pcs. | ||
| Capsules 50 mg: 28 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard, gelatin, size #3, with yellow body and cap; capsule contents – a mixture of powder and granules from yellow to orange.
| 1 caps. | |
| Sunitinib (as malate) | 12.5 mg |
Excipients: mannitol, croscarmellose sodium, povidone K25, magnesium stearate.
Capsule body composition titanium dioxide, quinoline yellow (E104), gelatin.
Capsule cap composition titanium dioxide, quinoline yellow (E104), gelatin.
28 pcs. – jars (1) – cardboard packs.
Capsules hard, gelatin, size #1, with brown body and cap; capsule contents – a mixture of powder and granules from yellow to orange.
| 1 caps. | |
| Sunitinib (as malate) | 25 mg |
Excipients: mannitol, croscarmellose sodium, povidone K25, magnesium stearate.
Capsule body composition titanium dioxide, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), gelatin.
Capsule cap composition titanium dioxide, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), gelatin.
28 pcs. – jars (1) – cardboard packs.
Capsules hard, gelatin, size #0, with pink body and cap; capsule contents – a mixture of powder and granules from yellow to orange.
| 1 caps. | |
| Sunitinib (as malate) | 50 mg |
Excipients: mannitol, croscarmellose sodium, povidone K25, magnesium stearate.
Capsule body composition titanium dioxide, iron oxide red (E172), gelatin.
Capsule cap composition titanium dioxide, iron oxide red (E172), gelatin.
28 pcs. – jars (1) – cardboard packs.
Capsules 12.5 mg
Capsules 25 mg
Capsules 50 mg
Marketing Authorization Holder
Pharmental Group, LLC (Russia)
Dosage Forms
|
Sunitinib | Capsules 12.5 mg |
| Capsules 25 mg | ||
| Capsules 50 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Sunitinib | 12.5 mg |
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
Capsules
| 1 caps. | |
| Sunitinib | 25 mg |
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
Capsules
| 1 caps. | |
| Sunitinib | 50 mg |
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
Capsules 25 mg
Capsules 50 mg
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Forms
|
Sunitinib Canon | Capsules 25 mg |
| Capsules 50 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Sunitinib | 25 mg |
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – By prescription
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
Capsules
| 1 caps. | |
| Sunitinib | 50 mg |
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – By prescription
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
Capsules 12.5 mg: 28 pcs.
Capsules 25 mg: 28 pcs.
Capsules 50 mg: 28 pcs.
Marketing Authorization Holder
Amedart LLC (Russia)
Dosage Forms
|
Sunitinib-Amedart | Capsules 12.5 mg: 28 pcs. |
| Capsules 25 mg: 28 pcs. | ||
| Capsules 50 mg: 28 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #3, opaque, cylindrical in shape, consisting of an orange body and an orange cap; capsule contents – granules from yellow to orange in color.
| 1 cap. | |
| Sunitinib (in the form of sunitinib malate) | 12.5 mg |
Excipients: mannitol, povidone, croscarmellose sodium, magnesium stearate.
Capsule shell: gelatin, titanium dioxide, yellow iron oxide, red iron oxide.
28 pcs. – polyethylene jars (1) – cardboard packs.
Capsules hard gelatin, size #4, opaque, cylindrical in shape, consisting of an orange body and an orange cap; capsule contents – granules from yellow to orange in color.
| 1 cap. | |
| Sunitinib (in the form of sunitinib malate) | 25 mg |
Excipients: mannitol, povidone, croscarmellose sodium, magnesium stearate.
Capsule shell: gelatin, titanium dioxide, yellow iron oxide, red iron oxide.
28 pcs. – polyethylene jars (1) – cardboard packs.
Capsules hard gelatin, size #1, opaque, cylindrical in shape, consisting of an orange body and an orange cap; capsule contents – granules from yellow to orange in color.
| 1 cap. | |
| Sunitinib (in the form of sunitinib malate) | 50 mg |
Excipients: mannitol, povidone, croscarmellose sodium, magnesium stearate.
Capsule shell: gelatin, titanium dioxide, yellow iron oxide, red iron oxide.
28 pcs. – polyethylene jars (1) – cardboard packs.
Capsules 12.5 mg: 28 pcs.
Capsules 25 mg: 28 pcs.
Capsules 50 mg: 28 pcs.
Marketing Authorization Holder
Chemical Diversity Research Institute LLC (Russia)
Dosage Forms
|
Sunitinib-Khimrar | Capsules 12.5 mg: 28 pcs. |
| Capsules 25 mg: 28 pcs. | ||
| Capsules 50 mg: 28 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin #4 with a brown body and a brown cap; contents – powder from yellow to orange in color.
| 1 cap. | |
| Sunitinib | 12.5 mg |
Capsule contents: mannitol, croscarmellose sodium, povidone K30, magnesium stearate, colloidal silicon dioxide.
Hard gelatin capsule: titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), gelatin.
7 pcs. – contour cell packaging (4) – cardboard packs with an insert.
Capsules hard gelatin #3 with a brown body and a light brown cap; contents – powder from yellow to orange in color.
| 1 cap. | |
| Sunitinib | 25 mg |
Excipients:
Capsule contents: mannitol, croscarmellose sodium, povidone K30, magnesium stearate, colloidal silicon dioxide.
Hard gelatin capsule: titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), gelatin.
7 pcs. – contour cell packaging (4) – cardboard packs with an insert.
Capsules hard gelatin #2 with a light brown body and a light brown cap; contents – powder from yellow to orange in color.
| 1 cap. | |
| Sunitinib | 50 mg |
Excipients:
Capsule contents: mannitol, croscarmellose sodium, povidone K30, magnesium stearate, colloidal silicon dioxide.
Hard gelatin capsule: titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), gelatin.
7 pcs. – contour cell packaging (4) – cardboard packs with an insert.
Capsules 12.5 mg: 7, 28 or 30 pcs.
Marketing Authorization Holder
Pharmental Group, LLC (Russia)
Dosage Form
|
Sunitinib-Native | Capsules 12.5 mg: 7, 28 or 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin # 4, with a yellow body and a yellow cap.
| 1 cap. | |
| Sunitinib malate | 16.7 mg, |
| Sunitinib | 12.5 mg |
Excipients: mannitol – 80 mg, croscarmellose sodium – 6.6 mg, povidone K30 – 5.6 mg, magnesium stearate – 1.1 mg.
Capsule shell composition: titanium dioxide – 1 mg, yellow iron oxide – 0.5 mg, gelatin up to 100%.
Capsule cap composition: titanium dioxide – 1 mg, yellow iron oxide – 0.5 mg, gelatin up to 100%.
7 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Capsules 25 mg: 7, 28 or 30 pcs.
Marketing Authorization Holder
Pharmental Group, LLC (Russia)
Dosage Form
|
Sunitinib-Native | Capsules 25 mg: 7, 28 or 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin # 3, with an orange body and an orange cap.
| 1 cap. | |
| Sunitinib malate | 33.4 mg, |
| Equivalent to sunitinib content | 25 mg |
Excipients: mannitol – 39.7 mg, croscarmellose sodium – 5 mg, povidone K30 – 4.2 mg, magnesium stearate – 1.2 mg.
Capsule shell composition: titanium dioxide – 1.3333 mg, yellow iron oxide – 0.7 mg, red iron oxide – 0.09 mg, gelatin up to 100%.
Capsule cap composition: titanium dioxide – 1.3333 mg, yellow iron oxide – 0.7 mg, red iron oxide – 0.9 mg, gelatin up to 100%.
7 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Capsules 50 mg: 7, 28 or 30 pcs.
Marketing Authorization Holder
Pharmental Group, LLC (Russia)
Dosage Form
|
Sunitinib-Native | Capsules 50 mg: 7, 28 or 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin # 2, with a red-brown body and a red-brown cap. Capsule contents powder or granules from yellow to orange in color.
| 1 cap. | |
| Sunitinib malate | 66.8 mg, |
| Equivalent to sunitinib content | 50 mg |
Excipients: mannitol – 79.3 mg, croscarmellose sodium – 10 mg, povidone K30 – 8.4 mg, magnesium stearate – 2.5 mg.
Capsule shell composition: titanium dioxide – 0.5 mg, red iron oxide – 1.5 mg, gelatin up to 100%.
Capsule cap composition: titanium dioxide – 0.5 mg, red iron oxide – 1.5 mg, gelatin up to 100%.
7 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Capsules 12.5 mg: 14, 28, 30, or 40 pcs.
Capsules 25 mg: 14, 28, 30, or 40 pcs.
Capsules 50 mg: 14, 28, 30, or 40 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
|
Sunitinib-Promomed | Capsules 12.5 mg: 14, 28, 30, or 40 pcs. |
| Capsules 25 mg: 14, 28, 30, or 40 pcs. | ||
| Capsules 50 mg: 14, 28, 30, or 40 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, #4, yellow body, yellow cap; opaque, cylindrical in shape with hemispherical ends; capsule contents – a mixture of powder and granules of orange color.
| 1 cap. | |
| Sunitinib malate | 16.7 mg |
| Equivalent to sunitinib content | 12.5 mg |
Excipients: mannitol – 80 mg, croscarmellose sodium – 6.6 mg, povidone – 5.6 mg, magnesium stearate – 1.1 mg.
Capsule body composition: titanium dioxide (E171) – 1%, yellow iron oxide (E172) – 0.5%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide (E171) – 1%, yellow iron oxide (E172) – 0.5%, gelatin – up to 100%.
7 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – polyethylene jars (1) – cardboard packs.
28 pcs. – polyethylene jars (1) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
Capsules hard gelatin, #3, white body, white cap; opaque, cylindrical in shape with hemispherical ends; capsule contents – a mixture of powder and granules of orange color.
| 1 cap. | |
| Sunitinib malate | 33.4 mg |
| Equivalent to sunitinib content | 25 mg |
Excipients: mannitol – 39.7 mg, croscarmellose sodium – 5 mg, povidone – 4.2 mg, magnesium stearate – 1.2 mg.
Capsule body composition: titanium dioxide (E171) – 2%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide (E171) – 2%, gelatin – up to 100%.
7 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – polyethylene jars (1) – cardboard packs.
28 pcs. – polyethylene jars (1) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
Capsules hard gelatin, #2, blue body, blue cap; opaque, cylindrical in shape with hemispherical ends; capsule contents – a mixture of powder and granules of orange color.
| 1 cap. | |
| Sunitinib malate | 66.8 mg |
| Equivalent to sunitinib content | 50 mg |
Excipients: mannitol – 79.3 mg, croscarmellose sodium – 10 mg, povidone – 8.4 mg, magnesium stearate – 2.5 mg.
Capsule body composition: titanium dioxide (E171) – 2%, patent blue V (E131) – 0.274%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide (E171) – 2%, patent blue V (E131) – 0.274%, gelatin – up to 100%.
7 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – polyethylene jars (1) – cardboard packs.
28 pcs. – polyethylene jars (1) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
![Sunitinib [Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Sunitinib [Capsules] 2")