Caboz

Caboz20 mg

Capsule

Cabozantinib

Beacon Pharmaceuticals Ltd.

Product Code : 2625
MRP 1044.00
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Medicine overview

Indications of Caboz 20 mg

Renal Cell Carcinoma: Caboz 20 mg is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).Hepatocellular Carcinoma: Caboz 20 mg is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib.

Theropeutic Class

Cytotoxic Chemotherapy

Pharmacology

In vitro biochemical and/or cellular assays have shown that Caboz 20 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.

Dosage of Caboz 20 mg

Recommended Dosage for Renal Cell Carcinoma: The recommended dosage of Caboz 20 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 Caboz 20 mg is 60 mg once daily without food until disease progression or unacceptable toxicity. Or, as directed by the registered physicians. Stop treatment with Caboz 20 mg at least 28 days prior to scheduled surgery, including dental surgery. Do not substitute Caboz 20 mg tablets with Caboz 20 mg capsules. Do not administer Caboz 20 mg with food. Administer at least 1 hour before or at least 2 hours after eating. Swallow Caboz 20 mg tablets whole. Do not crush Caboz 20 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 Caboz 20 mg in pediatric patients have not been established.

Administration of Caboz 20 mg

Stop treatment with Caboz 20 mg at least 28 days prior to scheduled surgery, including dental surgery Do not substitute Caboz 20 mg tablets with Caboz 20 mg capsules. Do not administer Caboz 20 mg with food. Administer at least 1 hour before or at least 2 hours after eating Swallow Caboz 20 mg tablets whole. Do not crush Caboz 20 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

Interaction of Caboz 20 mg

Strong CYP3A4 Inhibitors: Coadministration of a Caboz 20 mg capsule formulation with a strong CYP3A4 inhibitor increased the exposure of Caboz 20 mg, which may increase the risk of exposure-related adverse reactions. Avoid coadministration of Caboz 20 mg with strong CYP3A4 inhibitors. Reduce the dosage of Caboz 20 mg if coadministration with strong CYP3A4 inhibitors cannot be avoided. Avoid grapefruit or grapefruit juice which may also increase exposure of Caboz 20 mg.Strong CYP3A Inducers: Coadministration of a Caboz 20 mg capsule formulation with a strong CYP3A4 inducer decreased the exposure of Caboz 20 mg, which may reduce efficacy. Avoid coadministration of Caboz 20 mg with strong CYP3A4 inducers. Increase the dosage of Caboz 20 mg if coadministration with strong CYP3A4 inducers cannot be avoided. Avoid St. John's Wort which may also decrease exposure of Caboz 20 mg.

Contraindications

It is contraindicated in patients with known hypersensitivity to Caboz 20 mg or any other components of this product.

Side Effects of Caboz 20 mg

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

Pregnancy & Lactation

Based on findings from animal studies and its mechanism of action, Caboz 20 mg can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of Caboz 20 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 Caboz 20 mg and for 4 months after the final dose.

Precautions & Warnings

Hemorrhage: Severe and fatal hemorrhages occurred with Caboz 20 mg. Discontinue Caboz 20 mg for Grade 3 or 4 hemorrhage. Do not administer Caboz 20 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 Caboz 20 mg-treated patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of Caboz 20 mg-treated patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue Caboz 20 mg in patients who experience a fistula that cannot be appropriately managed or a GI perforation.Thrombotic Events: Caboz 20 mg increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism occurred in 2% of Caboz 20 mg-treated patients. Fatal thrombotic events occurred in Caboz 20 mg-treated patients. Discontinue Caboz 20 mg in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.Hypertension and Hypertensive Crisis: Caboz 20 mg can cause hypertension, including hypertensive crisis. Do not initiate Caboz 20 mg in patients with uncontrolled hypertension. Monitor blood pressure regularly during Caboz 20 mg treatment. Withhold Caboz 20 mg for hypertension that is not adequately controlled with medical management; when controlled, resume Caboz 20 mg at a reduced dose. Discontinue Caboz 20 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 Caboz 20 mg. Withhold Caboz 20 mg until improvement to Grade 1 and resume Caboz 20 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 Caboz 20 mg. Withhold Caboz 20 mg until improvement to Grade 1 and resume Caboz 20 mg at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.Proteinuria: Proteinuria was observed in 7% of patients receiving Caboz 20 mg. Monitor urine protein regularly during Caboz 20 mg treatment. Discontinue Caboz 20 mg in patients who develop nephrotic syndrome.Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) occurred in <1% of patients treated with Caboz 20 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 Caboz 20 mg and periodically during Caboz 20 mg. Advise patients regarding good oral hygiene practices. Withhold Caboz 20 mg for at least 28 days prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold Caboz 20 mg for development of ONJ until complete resolution.Wound Complications: Wound complications have been reported with Caboz 20 mg. Stop Caboz 20 mg at least 28 days prior to scheduled surgery. Resume Caboz 20 mg after surgery based on clinical judgment of adequate wound healing. Withhold Caboz 20 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 Caboz 20 mg. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue Caboz 20 mg in patients who develop RPLS.Embryo-Fetal Toxicity: Based on data from animal studies and its mechanism of action, Caboz 20 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 Caboz 20 mg and for 4 months after the last dose.

Overdose Effects of Caboz 20 mg

One case of overdosage was reported following administration of another formulation of Caboz 20 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.

Storage Conditions

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

Use In Special Populations

Pediatric Use: The safety and effectiveness of Caboz 20 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.

Drug Classes

Tyrosine Kinase Inhibitor

Mode Of Action

In vitro biochemical and/or cellular assays have shown that Caboz 20 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 Caboz 20 mg concentrations (Tmax) ranged from 3 to 4 hours post-dose. A 19% increase in the Cmax of Caboz 20 mg compared to a Caboz 20 mg capsule formulation was observed following a single 140 mg dose. A less than 10% difference in the AUC was observed between Caboz 20 mg and a Caboz 20 mg capsule formulation.Distribution: The oral volume of distribution (Vz/F) of Caboz 20 mg is approximately 319 L. Caboz 20 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: Caboz 20 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- Caboz 20 mg in healthy subjects. Approximately 54% was recovered in feces and 27% in urine. Unchanged Caboz 20 mg accounted for 43% of the total radioactivity in feces and was not detectable in urine following a 72-hour collection.

Pregnancy

Pregnancy: Caboz 20 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 Caboz 20 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 Caboz 20 mg and for 4 months after the final dose.Contraception: Caboz 20 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 Caboz 20 mg and for 4 months after the final dose.Infertility: Females and Males: Based on findings in animals, Caboz 20 mg may impair fertility in females and males of reproductive potential.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.