くすりのしおり

Injection
Revised: 8/2018

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 :
OPDIVO intravenous infusion 20mg
 Active ingredient:
Nivolumab (genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine inhibits binding of cancer cell to T-cell (immune cell) via PD-1 receptor and promotes T-cell activation. It consequently enhances immune response to cancer and shows antitumor effect.
It is usually used to treat malignant melanoma, unresectable advanced and/or recurrent non-small cell lung cancer, unresectable or metastatic renal cell carcinoma, relapsed or refractory classical Hodgkin's lymphoma, recurrent or metastatic head and neck cancer, unresectable advanced or recurrent gastric cancer progressing after cancer chemotherapy, and unresectable advanced and/or recurrent malignant pleural mesothelioma progressing 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 autoimmune disorder or its history, or interstitial pulmonary disease or its history, or a history of organ transplantation (including hematopoietic stem cell transplantation).
  • 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))
  • Non-small cell lung cancer, classical Hodgkin's lymphoma, head and neck cancer, gastric cancer, malignant pleural mesothelioma: In general, for adults, administer by intravenous infusion once every 2 weeks.
    Malignant melanoma, renal cell carcinoma: In general, for adults, administer by intravenous infusion once every 2 weeks. However, in the case of the adjuvant therapy in the malignant melanoma, the treatment duration is up to 12 months. In general, for adults, administer by intravenous infusion in combination with ipilimumab 4 times every 3 weeks, then followed by intravenous infusion once every 2 weeks.
  • In general, administer by intravenous infusion for at least 30 minutes at a time.
  • Ask your doctor about your dosing schedule.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include fatigue, itch, nausea, decreased appetite, rash, diarrhea, fever, hypothyroidism, arthralgia, 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.
  • fever, dry cough, respiratory distress [interstitial pulmonary disease]
  • muscle weakness, droopy eyelid, respiratory distress, swallowing disorder, muscle pain, palpitation, chest pain [myasthenia gravis, myocarditis, myositis, rhabdomyolysis]
  • persistent diarrhea, abdominal pain, bloody stool [colitis, severe diarrhea]
  • dry mouth, nausea, vomiting, general malaise, polyuria [type 1 diabetes]
  • nose bleeding, gum bleeding, subcutaneous bleeding [immune thrombocytopenic purpura]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes, upper stomachache, pain particularly in the upper right abdomen, itch [liver dysfunction, hepatitis, sclerosing cholangitis]
  • general malaise, edema, sweating, decreased body weight [disturbed thyroid function]
  • paralysis, paralysis of the lower part of the body, numbness of limbs, pain in limbs [nervous disorder]
  • decreased urine output, facial edema, swelling in the eyelid, headache [renal disorder]
  • general malaise, decreased consciousness, vomiting, loss of appetite, hypotension [adrenal disorder]
  • fever, headache, vomiting [encephalitis]
  • generalized red spot and breakable blister, red rash, red spot with swelling in the center, fever [severe skin disorder]
  • edema, feeling hot, local pain [venous thromboembolism]
  • respiratory distress, consciousness disorder, swelling of eyelids/lips/tongue, fever [infusion reaction]
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

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.