Cabanib60 mg

Renal Cell Carcinoma: Cabanib 60 mg is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).Hepatocellular Carcinoma: Cabanib 60 mg is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib.

Cytotoxic Chemotherapy

In vitro biochemical and/or cellular assays have shown that Cabanib 60 mg inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

Recommended Dosage for Renal Cell Carcinoma: The recommended dosage of Cabanib 60 mg is 60 mg once daily without food until the patient no longer experiences clinical benefit or experiences unacceptable toxicity.Recommended Dosage for Hepatocellular Carcinoma: The recommended dosage of Cabanib 60 mg is 60 mg once daily without food until disease progression or unacceptable toxicity. Or, as directed by the registered physicians. Stop treatment with Cabanib 60 mg at least 28 days prior to scheduled surgery, including dental surgery. Do not substitute Cabanib 60 mg tablets with Cabanib 60 mg capsules. Do not administer Cabanib 60 mg with food. Administer at least 1 hour before or at least 2 hours after eating. Swallow Cabanib 60 mg tablets whole. Do not crush Cabanib 60 mg tablets. Do not take a missed dose within 12 hours of the next dose. Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450. Pediatric Use: The safety and effectiveness of Cabanib 60 mg in pediatric patients have not been established.

Stop treatment with Cabanib 60 mg at least 28 days prior to scheduled surgery, including dental surgery Do not substitute Cabanib 60 mg tablets with Cabanib 60 mg capsules. Do not administer Cabanib 60 mg with food. Administer at least 1 hour before or at least 2 hours after eating Swallow Cabanib 60 mg tablets whole. Do not crush Cabanib 60 mg tablets. Do not take a missed dose within 12 hours of the next dose. Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450

Strong CYP3A4 Inhibitors: Coadministration of a Cabanib 60 mg capsule formulation with a strong CYP3A4 inhibitor increased the exposure of Cabanib 60 mg, which may increase the risk of exposure-related adverse reactions. Avoid coadministration of Cabanib 60 mg with strong CYP3A4 inhibitors. Reduce the dosage of Cabanib 60 mg if coadministration with strong CYP3A4 inhibitors cannot be avoided. Avoid grapefruit or grapefruit juice which may also increase exposure of Cabanib 60 mg.Strong CYP3A Inducers: Coadministration of a Cabanib 60 mg capsule formulation with a strong CYP3A4 inducer decreased the exposure of Cabanib 60 mg, which may reduce efficacy. Avoid coadministration of Cabanib 60 mg with strong CYP3A4 inducers. Increase the dosage of Cabanib 60 mg if coadministration with strong CYP3A4 inducers cannot be avoided. Avoid St. John's Wort which may also decrease exposure of Cabanib 60 mg.

It is contraindicated in patients with known hypersensitivity to Cabanib 60 mg or any other components of this product.

Hemorrhage Perforations and Fistulas Thrombotic Events Hypertension and Hypertensive Crisis Diarrhea Palmar-plantar Erythrodysesthesia Proteinuria Osteonecrosis of the Jaw Wound Complications Reversible Posterior Leukoencephalopathy Syndrome

Based on findings from animal studies and its mechanism of action, Cabanib 60 mg can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of Cabanib 60 mg or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Cabanib 60 mg and for 4 months after the final dose.

Hemorrhage: Severe and fatal hemorrhages occurred with Cabanib 60 mg. Discontinue Cabanib 60 mg for Grade 3 or 4 hemorrhage. Do not administer Cabanib 60 mg to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of Cabanib 60 mg-treated patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of Cabanib 60 mg-treated patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue Cabanib 60 mg in patients who experience a fistula that cannot be appropriately managed or a GI perforation.Thrombotic Events: Cabanib 60 mg increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism occurred in 2% of Cabanib 60 mg-treated patients. Fatal thrombotic events occurred in Cabanib 60 mg-treated patients. Discontinue Cabanib 60 mg in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.Hypertension and Hypertensive Crisis: Cabanib 60 mg can cause hypertension, including hypertensive crisis. Do not initiate Cabanib 60 mg in patients with uncontrolled hypertension. Monitor blood pressure regularly during Cabanib 60 mg treatment. Withhold Cabanib 60 mg for hypertension that is not adequately controlled with medical management; when controlled, resume Cabanib 60 mg at a reduced dose. Discontinue Cabanib 60 mg for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.Diarrhea: Diarrhea occurred in 63% of patients treated with Cabanib 60 mg. Withhold Cabanib 60 mg until improvement to Grade 1 and resume Cabanib 60 mg at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.Palmar-Plantar Erythrodysesthesia: Palmar-plantar erythrodysesthesia (PPE) occurred in 44% of patients treated with Cabanib 60 mg. Withhold Cabanib 60 mg until improvement to Grade 1 and resume Cabanib 60 mg at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.Proteinuria: Proteinuria was observed in 7% of patients receiving Cabanib 60 mg. Monitor urine protein regularly during Cabanib 60 mg treatment. Discontinue Cabanib 60 mg in patients who develop nephrotic syndrome.Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) occurred in <1% of patients treated with Cabanib 60 mg. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to initiation of Cabanib 60 mg and periodically during Cabanib 60 mg. Advise patients regarding good oral hygiene practices. Withhold Cabanib 60 mg for at least 28 days prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold Cabanib 60 mg for development of ONJ until complete resolution.Wound Complications: Wound complications have been reported with Cabanib 60 mg. Stop Cabanib 60 mg at least 28 days prior to scheduled surgery. Resume Cabanib 60 mg after surgery based on clinical judgment of adequate wound healing. Withhold Cabanib 60 mg in patients with dehiscence or wound healing complications requiring medical intervention. Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with Cabanib 60 mg. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue Cabanib 60 mg in patients who develop RPLS.Embryo-Fetal Toxicity: Based on data from animal studies and its mechanism of action, Cabanib 60 mg can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Cabanib 60 mg and for 4 months after the last dose.

One case of overdosage was reported following administration of another formulation of Cabanib 60 mg; a patient inadvertently took twice the intended dose for 9 days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.

Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.

Pediatric Use: The safety and effectiveness of Cabanib 60 mg in pediatric patients have not been established. Geriatric Use: No overall differences in safety or effectiveness were observed between these patients and younger patients. Renal Impairment: No dosage adjustment is recommended in patients with mild or moderate renal impairment.

Tyrosine Kinase Inhibitor

In vitro biochemical and/or cellular assays have shown that Cabanib 60 mg inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.Absorption: Median time to peak Cabanib 60 mg concentrations (Tmax) ranged from 3 to 4 hours post-dose. A 19% increase in the Cmax of Cabanib 60 mg compared to a Cabanib 60 mg capsule formulation was observed following a single 140 mg dose. A less than 10% difference in the AUC was observed between Cabanib 60 mg and a Cabanib 60 mg capsule formulation.Distribution: The oral volume of distribution (Vz/F) of Cabanib 60 mg is approximately 319 L. Cabanib 60 mg is highly protein-bound in human plasma (≥99.7%).Elimination: The predicted terminal half-life is approximately 99 hours and the clearance (CL/F) at steady state is estimated to be 2.2 L/hr.Metabolism: Cabanib 60 mg is a substrate of CYP3A4 in vitro.Excretion: Approximately 81% of the total administered radioactivity was recovered within a 48-day collection period following a single dose of radiolabeled 14 C- Cabanib 60 mg in healthy subjects. Approximately 54% was recovered in feces and 27% in urine. Unchanged Cabanib 60 mg accounted for 43% of the total radioactivity in feces and was not detectable in urine following a 72-hour collection.

Pregnancy: Cabanib 60 mg can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Lactation: There is no information regarding the presence of Cabanib 60 mg or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Cabanib 60 mg and for 4 months after the final dose.Contraception: Cabanib 60 mg can cause fetal harm when administered to a pregnant woman.Females: Females of reproductive potential should be advised to use effective contraception during treatment with Cabanib 60 mg and for 4 months after the final dose.Infertility: Females and Males: Based on findings in animals, Cabanib 60 mg may impair fertility in females and males of reproductive potential.