Keytruda(pembrolizumab)注射剂

【Function and Indications】

Keytruda (pembrolizumab) injection is one of the drugs approved by the US FDA for accelerated approval in September 2014. It is the first PD-1 blocking drug for the treatment of melanoma.

【Model and Specification】
Injection, 50 mg sterile lyophilized powder.

【Usage and Dosage】
The recommended dose of Keytruda (pembrolizumab) injection is 2 mg/kg, intravenous infusion for 30 minutes, given every 3 weeks until disease progression or unacceptable toxicity.

【Clinical Research】
Pembrolizumab is a new humanized monoclonal antibody that enhances human immunity and eliminates advanced melanoma by acting on programmed cell death 1 (PD-1).

According to Phase I clinical data, 24% of melanoma patients had a reduction in tumor size after treatment.

Merck is conducting Phase II and Phase III clinical studies on advanced melanoma to provide further research support for the drug.

【Precautions】
Withhold KEYTRUDA for any of the following:
● Grade 2 pneumonitis
● Grade 2 or 3 colitis
● Symptomatic hypophysitis
● Grade 2 nephritis
● Grade 3 hyperthyroidism
● Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times the upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN.
● Any other severe or Grade 3 treatment-related adverse events
Resume KEYTRUDA in patients whose adverse reactions recover to Grade 0-1.

Permanently discontinue KEYTRUDA for any of the following:
●Any life-threatening adverse event
●Grade 3 or 4 pneumonitis
●Grade 3 or 4 nephritis
●AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
o Patients with liver metastases who initiate treatment have Grade 2 AST or ALT if AST or ALT increases by greater than or equal to 50% relative to baseline and persists for at least 1 week
●Grade 3 or 4 infusion-related reactions
●Inability to reduce corticosteroid dose to 10 mg or less per day of prednisone or equivalent within 12 weeks
●Persistent Grade 2 or 3 adverse reactions that do not recover to Grade 0-1 within 12 weeks after the last dose of KEYTRUDA
●Recurrence of any severe or Grade 3 treatment-related adverse event

[Adverse Reactions and Contraindications]
Common adverse reactions include fatigue, cough, itching, rash, decreased appetite, constipation, arthralgia, and diarrhea.

[Pregnant women use]
This product may enter the baby through breast milk. If breastfeeding women need to use this product, please stop breastfeeding.

[Manufacturer]
Onyx Pharmaceuticals.

Postscript: Keytruda (pembrolizumab), also known as “K drug” in the industry, is the most widely used drug among PD-1 blockers and can be used in combination with the most anti-tumor drugs. It is effective for many cancers, such as breast cancer, melanoma, lung cancer, liver cancer, intestinal cancer, gastric cancer, etc., and the effects of K drug are still being discovered. I believe that in the near future, humans will finally be able to defeat cancer!