Pembrolizumab

Keytruda®

IgG4 antibody, binds to the PD-1 receptor on T cells and inhibits interaction with the ligands PD-L1 and PD-L2 on cancer cells.

10/2015 (non-resectable, metastatic melanoma), 02/2019 (adjuvant).

Non-resectable or metastatic melanoma.

As monotherapy for adjuvant treatment of completely resected melanoma in stages IIB, C and III.

Differential blood count, biochemical panel (sodium, potassium, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, ASAT, ALAT, gamma-GT, alkaline phosphatase, LDH, pancreatic amylase, total protein, CRP, CK), glucose, cortisol, TSH, fT4, high-sensitivity troponin T, troponin I, NT-pro BNP, S-100, pregnancy test, ECG, echocardiography (if cardiovascular risk is present)

Before each administration: differential blood count, biochemical panel (sodium, potassium, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, ASAT, ALAT, gamma-GT, alkaline phosphatase, LDH, pancreatic amylase, total protein, CRP, CK), glucose; every 2 months: TSH, fT4

IV infusion over 30 minutes 200 mg every 3 weeks (additional FDA and EMA approval 400 mg every 6 weeks over 60 minutes)

Until disease progression or the occurrence of unacceptable toxicity; adjuvant for a maximum of 12 months or until recurrence.

Refer to medical literature, guidelines, and study results.

• Women: negative pregnancy test, dual contraception up to 120 days after the last infusion, offer reproductive counselling
• Men: adequate contraception up to 120 days after the last infusion, offer reproductive counselling
• No live vaccines 30 days before starting and during therapy