Cabozanib Tablet

Cabozantinib is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). Cabozantinib is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Perforations and Fistulas: Monitor for symptoms. Discontinue Cabozantinib for Grade 4 fistula or perforation. Hemorrhage: Do not administer Cabozantinib if recent history of hemorrhage. Thrombotic Events: Discontinue Cabozantinib for myocardial infarction or serious arterial or venous thromboembolic events. Impaired Wound Healing: Withhold Cabozantinib for at least 3 weeks before elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Cabozantinib after resolution of wound healing complications has not been established. Hypertension and hypertensive crisis: Monitor blood pressure regularly. Interrupt for hypertension that is not adequately controlled with anti- hypertensive therapy. Discontinue Cabozantinib for hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. Cardiac Failure: Monitor patients for signs and symptoms of cardiac failure throughout treatment. Osteonecrosis of the Jaw (ONJ): Withhold Cabozantinib for at least 3 weeks prior to invasive dental procedure and for development of ONJ. Diarrhea: May be severe. Interrupt Cabozantinib immediately until diarrhea resolves or decreases to Grade 1. Recommend standard antidiarrheal treatments. Palmar-Plantar Erythrodysesthesia (PPE): Interrupt Cabozantinib until PPE resolves or decreases to Grade 1. Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Cabozantinib. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Hypocalcemia: Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold Cabozantinib and resume at reduced dose upon recovery or permanently discontinue Cabozantinib depending on severity. Perforations and Fistulas Gastrointestinal (GI) perforations and fistulas, including fatal cases, were reported in 3% and 1% of Cabozantinib-treated patients (N=214), respectively. Non-GI fistulas including tracheal/esophageal, including fatal cases, were reported in 4% of Cabozantinib-treated patients. Monitor patients for symptoms of perforations and fistulas, including abscess and sepsis. Discontinue Cabozantinib in patients who experience a Grade 4 fistula or a GI perforation. Hemorrhage Severe and fatal hemorrhage occurred with Cabozantinib. The incidence of Grade ≥ 3 hemorrhagic events was higher in Cabozantinib-treated patients compared with placebo (3% vs. 1%). Discontinue Cabozantinib for Grade 3 or 4 hemorrhage. Do not administer Cabozantinib to patients with a recent history of hemorrhage, including hemoptysis, hematemesis, or melena. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Perforations and Fistula Hemorrhage Thromboembolic Events Impaired Wound Healing Hypertension and Hypertensive Crisis Cardiac Failure Osteonecrosis of the Jaw Diarrhea Palmar-Plantar Erythrodysesthesia Proteinuria Reversible Posterior Leukoencephalopathy Syndrome Hypocalcemia The most common adverse reactions (≥ 25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia (PPE), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥ 25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia. Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Cabozantinib was evaluated in 330 patients with progressive metastatic medullary thyroid cancer randomized to receive 140 mg Cabozantinib (n = 214) or placebo (n = 109) administered daily until disease progression or intolerable toxicity in a randomized, doubleblind, controlled trial (Study 1). The data described below reflect a median exposure to Cabozantinib for 204 days. The population exposed to Cabozantinib was 70% male, 90% white, and had a median age of 55 years. Fatal adverse reactions occurred in 6% of patients receiving Cabozantinib and resulted from hemorrhage, pneumonia, septicemia, fistulas, cardiac arrest, respiratory failure, and unspecified death. Fatal adverse reactions occurred in 5% of patients receiving placebo and resulted from septicemia, pneumonia, and general deterioration. The Cabozantinib dose was reduced in 79% of patients receiving Cabozantinib and in 9% of patients receiving placebo. The median number of dosing delays was one in patients receiving Cabozantinib and in no patients receiving placebo. Adverse reactions led to study treatment discontinuation in 16% of patients receiving Cabozantinib. The most frequent adverse reactions leading to permanent discontinuation of Cabozantinib were: hypocalcemia, increased lipase, PPE, diarrhea, fatigue, hypertension, nausea, pancreatitis, tracheal fistula formation and vomiting. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.