くすりのしおり

Injection
Revised: 7/2019

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 :
KEYTRUDA Injection 100mg
 Active ingredient:
Pembrolizumab(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine blocks the interaction between a receptor called PD-1 on T lymphocytes (immune cells) and its ligands (PD-L1 and PD-L2) on cancer cells, which results in T-cell activation and subsequent suppression of tumor progression.
It is usually used to treat malignant melanoma, unresectable advanced/recurrent non-small cell lung cancer, recurrent or refractory classical Hodgkin's lymphoma, unresectable urothelial cancer progressing after cancer chemotherapy and advanced/recurrent solid tumor with microsatellite instability-high (MSI-High) progressing after cancer chemotherapy (only when it is difficult to treat with standard treatment).

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 are currently or you were previously diagnosed as autoimmune disease and/or interstitial lung disease.
    If you have previously received organ or hematopoietic stem cell transplantation.
    If you are currently or you were previously infected with tuberculosis.
  • 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))
  • For malignant melanoma: In general, for adults, inject by intravenous infusion over 30 minutes once every 3 weeks. The maximum duration of medication is 12 months for postoperative adjuvant chemotherapy.
    For unresectable advanced/recurrent non-small cell lung cancer, recurrent or refractory classical Hodgkin's lymphoma, unresectable urothelial cancer progressing after cancer chemotherapy and advanced/recurrent solid tumor with MSI-High progressing after cancer chemotherapy (only when it is difficult to treat with standard treatment): In general, for adults, inject by intravenous infusion over 30 minutes once every 3 weeks.
  • Ask your doctor about the treatment span.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include itch, malaise, fatigue, rash, diarrhea, asthenia, nausea, arthralgia, anemia, decreased appetite, alopecia and fever. 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, breathing difficulty [interstitial lung disease]
  • vomiting, abdominal pain, diarrhea, muddy stool [colitis, enteritis, severe diarrhea]
  • eyelid/eye redness, lip/intraoral erosion, rash, blister [muco-cutaneo-ocular syndrome, erythema multiform]
  • intensely itchy blister [pemphigoid]
  • paralyzed motion, numbness of limbs, numbness of fingertip, difficulty in walking [neuropathy]
  • general malaise, yellowing of the skin and the white of eyes, itching, fever, right upper abdominal pain [liver dysfunction, hepatitis, sclerosing cholangitis]
  • sweat tendency, palpitation, general malaise, intolerance to cold [thyroid dysfunction]
  • general malaise, foggy head and loss of consciousness, blood pressure drop [pituitary dysfunction]
  • general malaise, decreased consciousness, hypotension [adrenal dysfunction]
  • general malaise, thirst, increased urine output, decreased consciousness [type 1 diabetes mellitus]
  • edema, headache, decreased urine output [renal disorder]
  • nausea, vomit, severe gastric/abdominal pain, back pain [pancreatitis]
  • lassitude, muscle pain, breathing difficulty, reddish brown urine [myositis, rhabdomyolysis]
  • heavy eyelids, drooping of upper eyelid, double vision, muscle fatigue [myasthenia gravis]
  • general malaise, fever, nausea, breathing difficulty [myocarditis]
  • fever, headache, decreased consciousness [encephalitis, meningitis]
  • anemia, fever, bleeding tendency [serious blood disorder]
  • fever, pressured feeling and pain in the left upper abdomen, lymph node swelling [hemophagocytic syndrome]
  • prolonged low grade fever/cough, general malaise, weight loss [tuberculosis]
  • respiratory distress, consciousness disorder, swelling of eyelid/lip/tongue [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.

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