【Drug Name】

Name:Cabozantinib Tablets/Capsules

Product Name: CABODX

【Specification】20/60/80mg

 【Indications】

 CABODX is a prescription medicine used to treat:

• people with kidney cancer (renal cell carcinoma). CABODX may be used:

○ alone to treat people with renal cell carcinoma (RCC) that has spread (advanced RCC).

○ in combination with nivolumab when your cancer has spread (advanced RCC), and you have not already had treatment for your advanced RCC.

• people with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

  It is not known if CABODX is safe and effective in children. 

【Recommended Dosage】

• Take CABODX exactly as your healthcare provider tells you to take it.

• Do not take CABODX with food. Take CABODX at least 1 hour before or at least 2 hours  after eating.  

• Swallow CABODX tablets whole.

• Do not crush CABODX tablets.  

• If you miss a dose and your next scheduled dose is in:  

○ less than 12 hours, take your next dose at the normal time. Do not make up the missed dose.  

○ 12 hours or more, take the missed dose as soon as you remember. Take your next dose at the  normal time. 

【Side Effects】

CABODX may cause serious side effects, including:

• bleeding (hemorrhage). CABODX can cause severe bleeding that may lead to death. Tell your  healthcare provider right away if you get any signs of bleeding during treatment with CABODX,  including:  

 o coughing up blood or blood clots           o red or black (looks like tar) stools

  o menstrual bleeding that is heavier than normal  coffee-grounds

  o any unusual or heavy bleeding               o vomiting blood or if your vomit looks like

• a tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you get tenderness 

 or pain in your stomach-area (abdomen) that is severe or that does not go away.

• blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you get:  

o swelling or pain in your arms or legs        o sudden confusion, trouble speaking or

o shortness of breath understanding           o feel lightheaded or faint 

o sudden trouble seeing in one or both eyes               o sweating more than usual

o sudden trouble walking                 o numbness or weakness of your face, arm or  leg, especially on one side of your body  

o dizziness, loss of balance or coordination                o a sudden severe headache  

• high blood pressure (hypertension). Hypertension is common with CABODX and sometimes  can be severe. Your healthcare provider will check your blood pressure before starting CABODX  

  and regularly during treatment with CABODX. If needed, your healthcare provider may prescribe  medicine to treat your high blood pressure. Tell your healthcare provider if you develop severe  

  headaches, nose bleeds, tiredness or confusion, vision changes, chest pain, trouble breathing,  irregular heartbeat, or blood in your urine.

• diarrhea. Diarrhea is common with CABODX and can be severe. If needed, your healthcare  provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away, if  you

    have frequent loose, watery bowel movements.

• a skin problem called hand-foot skin reaction. Hand-foot skin reactions are common and can be  severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, 

   or  blisters on the palms of your hands or soles of your feet.

• liver problems. Liver problems may happen during treatment with CABODX. When  CABODX is taken in combination with nivolumab, severe changes in liver function tests may  happen more often

  than if you take CABODX alone. Your healthcare provider will do blood tests  to check your liver function before and during treatment with CABODX. Tell your healthcare  provider right away if you 

  develop symptoms of liver problems including: yellowing of your skin or the  whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area  (abdomen), dark urine,

  bleeding or bruising more easily than normal.

• adrenal gland problems. Your healthcare provider will monitor you for this problem. Your healthcare  provider may prescribe hormone replacement therapy or corticosteroid medicines if needed. 

  Tell your healthcare provider right away if you develop any of the following signs or symptoms: extreme  tiredness, dizziness or fainting, weakness, nausea, or vomiting.  

• protein in your urine and possible kidney problems. Symptoms may include swelling in your  hands, arms, legs, or feet. Your healthcare provider will check you for this problem during 

   treatment  with CABODX.

• severe jaw bone problems (osteonecrosis). Your healthcare provider should examine your mouth  before you start and during treatment with CABODX. Tell your dentist that you are taking

   CABODX. It is important for you to practice good mouth care during treatment with  CABODX. Tell your healthcare provider right away if you develop any symptoms of jaw  problems, including:

   jaw pain, toothache, or sores on your gums.  

• wound healing problems. Wound healing problems have happened in some people who take  CABODX. Tell your healthcare provider if you plan to have any surgery before or during  treatment

  with CABODX.

 o You should stop taking CABODX at least 3 weeks before planned surgery.  

 o Your healthcare provider should tell you when you may start taking CABODX again after  surgery.

• Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible  posterior leukoencephalopathy syndrome can happen during treatment with CABODX. 

  Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.Your healthcare provider may change your dose, temporarily stop, 

   or permanently stop treatment with  CABODX if you have certain side effects.  

The most common side effects of CABODX include:

 • tiredness           • decreased appetite              

 • nausea              • vomiting 

 • weight loss        • constipation            

 • difficulty speaking  

  The most common side effects of CABODX when used in combination with nivolumab include:

 • tiredness           • mouth sores            • rash                • low thyroid hormone levels  (hypothyroidism)  

 • pain in muscles, bones, and joints      • decreased appetite                              • nausea  

 • changes in the way things taste          • stomach-area (abdominal) pain           • cough  

 • upper respiratory tract infection  

 CABODX may cause fertility problems in females and males, which may affect your ability to have  children. Talk to your healthcare provider if you have concerns about fertility.  These are not all of

 the possible side effects of CABODX. Call your doctor for medical advice about  side effects. 

【Storage】

• Store CABODX at room temperature between 68°F to 86°F (20°C to 30°C).

Keep CABODX and all medicines out of reach of children.