Cabozandr Cabozantinib capsule

I. Drug Name

Generic Name: Cabozantinib Capsules

Brand Names: Cometriq, Cabometyx, Cabozandr

Dosage Form: Capsules

Specification: 20 mg per capsule; 90 capsules per box

Manufacturer: INDAR Pharmaceuticals Pvt Ltd

II. Indications and Usage

This product is a multi-targeted tyrosine kinase inhibitor indicated for the treatment of:

1.  Advanced Renal Cell Carcinoma (RCC): Indicated for first-line treatment (in combination with nivolumab) or as a monotherapy for patients with advanced RCC who have previously received anti-angiogenic therapy.

2.  Hepatocellular Carcinoma (HCC): Indicated for patients with advanced HCC who have previously received sorafenib therapy.

3.  Differentiated Thyroid Carcinoma (DTC): Indicated for the treatment of patients with locally advanced or metastatic DTC that has progressed following prior therapy and is refractory to radioactive iodine.

4.  Medullary Thyroid Carcinoma (MTC): Indicated for the treatment of progressive, metastatic MTC.

III. Dosage and Administration

Recommended Dosage (varies by indication):

RCC (Monotherapy): 60 mg orally once daily.

RCC (in combination with nivolumab): 40 mg orally once daily.

HCC: 60 mg orally once daily.

DTC: 60 mg orally once daily.

MTC: 140 mg orally once daily (Cometriq capsules).

Administration: Take on an empty stomach; specifically, do not consume food for at least 2 hours before and at least 1 hour after taking the medication. Swallow the capsule/tablet whole; do not crush or break it.

Dosage Adjustment: Detailed dosage adjustment guidelines are provided for adverse reactions (e.g., palmar-plantar erythrodysesthesia, hypertension, proteinuria, etc.), typically involving suspension of treatment followed by a dose reduction to 40 mg or 20 mg.

IV. Contraindications

Patients with a known hypersensitivity to cabozantinib or to any of the excipients.

V. Warnings and Precautions

1.  Perforations and Fistulas: Monitor for signs and symptoms of gastrointestinal perforation or fistula formation (e.g., abdominal pain, fever). Permanently discontinue the drug in patients who develop a Grade 4 fistula or gastrointestinal perforation. 2.  Hemorrhage: Severe hemorrhage may occur. Do not use in patients with a history of severe hemorrhage or recent hemoptysis or cerebral hemorrhage. Permanently discontinue the drug in the event of severe hemorrhage.

3.  Thromboembolic Events: Monitor for signs of myocardial ischemia, stroke, portal vein thrombosis, etc.

4.  Hypertension and Hypertensive Crisis: Control blood pressure prior to treatment, and monitor at least weekly during treatment. Temporarily suspend the drug in cases of severe hypertension; resume at a reduced dose once controlled. Permanently discontinue the drug in the event of a hypertensive crisis.

5.  Diarrhea: May be severe and persistent, leading to dehydration and electrolyte imbalances. Initiate standard anti-diarrheal treatment early, and adjust the dosage as necessary.

6.  Hand-Foot Skin Reaction: Very common and may be severe. Early intervention (moisturizing, callus removal, wearing soft footwear) is required, and the dosage should be adjusted based on severity.

7.  Proteinuria: Monitor for urinary protein regularly. Permanently discontinue the drug in the event of nephrotic syndrome.

8.  Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Rare but severe; permanently discontinue the drug.

9.  Impaired Wound Healing: Discontinue the drug at least 3 weeks prior to elective surgery; resume treatment post-operatively based on the status of wound healing.

10. Osteonecrosis of the Jaw: Conduct a dental examination prior to initiating treatment, and avoid invasive dental procedures during treatment.

VI. Adverse Reactions

Very Common (>30%): Diarrhea, hand-foot skin reaction, fatigue, nausea, decreased appetite, hypertension, weight loss, vomiting, constipation, dysphonia.

Common Severe Adverse Reactions: Hemorrhage, diarrhea, perforation, fistula, hypertension, PPES (Palmar-Plantar Erythrodysesthesia Syndrome), proteinuria.

VII. Drug Interactions

Strong CYP3A4 Inducers (e.g., rifampin, phenytoin): Co-administration should be avoided, as it significantly reduces cabozantinib plasma concentrations, thereby compromising efficacy.

Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin): Co-administration may increase cabozantinib exposure; monitor closely for adverse reactions and consider a dosage reduction. VIII. Use in Specific Populations

Hepatic Impairment: A dose reduction is required for patients with moderate hepatic impairment. Use is not recommended for patients with severe hepatic impairment.

Renal Impairment: No dose adjustment is required for patients with mild to moderate renal impairment. Use with caution in patients with severe renal impairment.

Pediatric Use: Safety and efficacy have not been established.

Pregnant and Lactating Women: This drug is associated with fetal toxicity; therefore, it is contraindicated in pregnant women. Lactating women should either discontinue breastfeeding or discontinue the medication.

IX. Pharmacological Actions

Pharmacological Class: Multi-targeted tyrosine kinase inhibitor.

Mechanism of Action: Inhibits various tyrosine kinases—including MET, VEGFR2, RET, AXL, and KIT—that are implicated in tumor growth, angiogenesis, metastasis, and drug resistance.

X. Storage

Store at room temperature (20°C–25°C); protect from moisture.

Keep out of the reach of children.

Important Notice:

This package insert is not a substitute for professional medical advice. Before using Cabozantinib, patients must undergo a comprehensive assessment by a specialist physician and strictly adhere to the detailed dosing instructions provided by their doctor or pharmacist. Regular monitoring and follow-up are mandatory throughout the course of treatment. Product Specifications

Product Name: Indar Cabozantinib Capsules 20mg × 90 Capsules/Box (Cabozandr Cabozantinib Capsule)

Common Name: Cabozantinib

Active Ingredient: Cabozantinib

Dosage Form: Capsules

Specification: 20mg × 90 capsules/box

Manufacturer: Indar Pharmaceutical Pvt. Ltd.

Indications: Cabozantinib has a broad range of indications, primarily including:

(1) Advanced renal cell carcinoma (kidney cancer) in patients who have previously received anti-angiogenic therapy;

(2) Medullary thyroid carcinoma that is not amenable to surgical resection;

(3) Hepatocellular carcinoma (liver cancer) in patients who have developed resistance to Sorafenib (Nexavar);

(4) Advanced prostate cancer in patients with bone metastases.

Usage and Dosage:

(1) The recommended dosage is 140 mg daily (consisting of one 80 mg capsule and three 20 mg capsules);

(2) Do not take with food;

(3) Do not consume food for at least 2 hours—specifically, for at least 1 hour before taking the medication and for at least 1 hour after taking it;

(4) In the event of adverse reactions, dose reduction or temporary interruption of treatment may be considered.