くすりのしおり

Internal
Revised: 7/2021

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
CABOMETYX Tablets 60mg
 Active ingredient:
Cabozantinib malate
 Dosage form:
yellow oval tablet, major axis: approx. 11.3 mm, minor axis: approx. 6.3 mm, thickness: approx. 5.0 mm
 Print on wrapping:
(Face)nothing mentioned, (Back) 60mg, カボメティクス, XL60

Effects of this medicine

This medicine suppresses tumor growth by inhibiting phosphoenzyme of several proteins.
It is usually used to treat unresectable and/or metastatic renal cell carcinoma, or unresectable hepatocellular carcinoma which has progressed after cancer chemotherapy.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have: hypertension, intra-abdominal inflammation in gastrointestinal tract, etc., tumor infiltration in gastrointestinal tract, thromboembolism and a history of it, brain metastasis, lung metastasis, unhealed wound after surgery or liver dysfunction.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults, 1 tablet (60 mg of cabozantinib) at a time, once a day, on an empty stomach. The dosage may be decreased according to the condition. In any case, strictly follow the instructions.
  • Avoid taking this medicine from 1 hour before meal to 2 hours after meal in order to avoid the influence of food.
  • If you take 60 mg of this medicine, use 60 mg tablet. Do not use 20 mg tablet.
  • If you miss a dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Measurements of blood pressure, urinary tests, liver function tests, pancreatic enzyme tests and blood tests are regularly conducted before and during the treatment with this medicine.
  • Delay in wound healing may occur. If you are scheduled for surgery, this medicine may be discontinued before surgery.
  • Osteonecrosis of the jaw may occur.
    Most of the adverse reaction occurs in association with dental treatment such as tooth extraction. Receive an adequate explanation for the following points from your doctor or pharmacist.
    - Maintain your oral hygiene by brushing your teeth.
    - Receive dental checkup regularly.
    - Inform your dentist that you are taking this medicine when you receive dental treatment.
    - Avoid any treatments such as tooth extraction as much as possible during treatment with this medicine.
    If abnormalities in teeth or jaw occur, see a dentist or oral surgeon immediately.
  • If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine and for a certain period of time after you discontinue this medicine.
  • Avoid taking any food containing St. John's wort (a kind of herb) with this medicine, because the effect of this medicine may be affected.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, loss of appetite, nausea, stomatitis, vomiting, abdominal pain, rash, fatigue, taste abnormality, weight loss, hypothyroidism, dysphonia, mucosal inflammation and asthenia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • severe abdominal pain, nausea, vomiting, vomiting of blood, melena, red and swollen skin with leakage of pus and intestinal juice [gastrointestinal perforation, fistula]
  • abdominal pain, vomiting of blood, melena, black stool, headache, nausea, vomiting, consciousness disorder, hemiplegia [bleeding (gastrointestinal bleeding, cerebral bleeding, etc.)]
  • local pain, tenderness, erythema, edema, feeling hot, distention of superficial vein, skin discoloration, headache, transient consciousness disorder, paralysis of limbs on one side, speech difficulties [thromboembolism (pulmonary embolism, deep-vein thrombosis, ischemic stroke, etc.)]
  • headache, stiff shoulder, dizziness, palpitation, shortness of breath, facial flushing, general malaise, blurred vision, decreased consciousness, nausea, nasal bleeding [hypertension, high blood pressure crisis]
  • headache, decreased consciousness, convulsion, vision disturbance [reversible posterior leukoencephalopathy syndrome]
  • sore mouth, swollen mouth, redness, feeling of loose teeth, loose teeth, numbness of jaw, heavy feeling in the jaw, fever, loss of appetite [osteonecrosis of the jaw]
  • severe pain in the upper abdomen/lower back, fever, nausea, vomiting, loss of appetite [pancreatitis]
  • decreased urine output, edema, general malaise [renal disorder]
  • general malaise, loss of appetite, nausea, vomiting, yellowing of the skin and the white of eyes, consciousness disturbance [liver failure, liver dysfunction, hepatic encephalopathy]
  • fever, chills, sore throat, nasal bleeding, gum bleeding, bruise, bleeding tendency, dull headache, palpitation, shortness of breath, malaise, dizziness, headache, tinnitus [myelosuppression]
  • chest pain, pressured feeling, chest tightness, cold sweat, palpitation, dizziness, syncope, respiratory distress, general edema [ischemic heart disease, arrhythmia, cardiac failure]
  • pain of the limb muscle, stiffness, numbness, lassitude, general malaise, reddish brown urine [rhabdomyolysis]
  • fever, dry cough, respiratory distress, headache, general malaise [interstitial lung disease]
  • numbness of limbs, abnormal sensation of pain, etc., deformation/pigmentation of nails, skin redness of the limbs, edema, pigmentation, keratosis, cracked skin, blister [hand-foot syndrome]
  • slow wound recovery [delayed wound healing]
  • frequent watery stools, lower abdominal pain, general malaise, fever [severe diarrhea]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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