くすりのしおり

Internal
Revised: 2/2017

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 :
ZELBORAF Tablet 240mg
 Active ingredient:
Vemurafenib
 Dosage form:
faintly reddish white to orange white tablet, major axis: approx. 19.1 mm, minor axis: approx. 9.7 mm, thickness: approx. 7.4 mm
 Print on wrapping:
ゼルボラフ 240 mg

Effects of this medicine

This medicine suppresses growth of cancer cells by inhibiting activation of BRAF protein required for the growth of cancer cells.
It is usually used to treat unresectable malignant melanoma with BRAF gene mutations.

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 liver dysfunction.
    If you have a risk of QT prolongation or a history of QT prolongation.
  • If you are 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, take 4 tablets (960 mg as the active ingredient) at a time, twice a day. The dosage may be decreased according to the symptoms. Strictly follow the instructions.
  • In order to avoid influence of food, you should take this medicine on an empty stomach (do not take this medicine between approximately 1 hour before and 2 hours after meals).
  • If you miss a dose, take the missed dose as soon as possible. If the next dose is within 4 hours, skip the missed dose and continue 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

  • Squamous cell cancer (bumps or ulcers on the skin covered with erosion or scabs) may occur. If you notice any abnormality of the skin, visit a medical institution immediately.
  • Since QT interval prolongation may occur, electrocardiography and blood tests are performed regularly before and during use of this medicine.
  • Since liver failure, liver dysfunction or jaundice may occur, liver function test is performed regularly during use of this medicine.
  • Since acute kidney disorder may occur, kidney function test is performed regularly before and during use of this medicine.
  • Since photosensitivity (rash or blister on parts of the skin exposed to sunlight, or exaggerated sunburn, itching or skin pigmentation by exposure to sunlight) may occur, avoid exposure to sunlight and ultraviolet rays by wearing hats or clothing, etc., or by using highly effective sunscreens when you are outside.
  • Since eye disorder, such as inflammation of the uvea (foggy vision, reduced visual acuity, floaters, sensitive to light, eye pain, or bloodshot eyes) may occur, visit a medical institution immediately if you notice any abnormality of the eyes.
  • If you may possibly become pregnant, use birth control.
  • If you are breastfeeding, stop breastfeeding.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include joint pain, rash (eczema and papules), musculoskeletal pain, alopecia, fatigue and photosensitivity. 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.
  • bumps or ulcers on the skin covered with erosion or scabs [squamous cell cancer]
  • new malignant tumor [malignant tumor (secondary cancer)]
  • itching, hives, rash, hoarseness, shortness of breath, breathing difficulty, palpitation, general malaise, hot flush, chills, lightheadedness, sweating, fever, swelling around eyes and lips, impaired mind, decreased judgment, decreased consciousness [anaphylaxis, sensitivity]
  • general malaise, loss of appetite, high fever, fever, joint pain, erythema with edema on the center, red rash, general erythema and soft blisters, scab, desquamated skin, eyelid redness, bloodshot eyes, erosion of conjunctiva, lip or oral erosions, severe stomatitis, pubic pain [mucocutaneous ocular syndrome(Stevens-Johnson syndrome), toxic epidermal necrolysis(TEN), erythema multiforme, erythroderma (exfoliative dermatitis, etc.)]
  • chills, lightheadedness, excessive sweating, fever, decreased consciousness, impaired mind, breathing difficulty, itching, rash, numbness, decreased judgment [drug-induced hypersensitivity syndrome]
  • palpitation, loss of consciousness [QT interval prolongation]
  • nausea, vomiting, loss of appetite, shivering of hands as if a bird is flapping its wings, general malaise, yellow discoloration of the skin and the white of eyes, itching, dark-colored urine [liver failure, liver dysfunction, jaundice]
  • swollen face/limbs, easy fatigability, loss of appetite, urinary retention, decreased urinary volume [Acute kidney disorder]
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 the reach of children. Store away from direct sunlight and moisture in PTP-package. Store at room temperature (1-30℃).
  • Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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