Pembrolizumab: Uses and precautions when using

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Article known by Pharmacist Nguyen Le Trang - Clinical Pharmacist - Faculty of Pharmacy - Vinmec Times City International Hospital
Pembrolizumab is known for its anti-cancer effects, monoclonal antibodies. Knowing about the drug is always necessary for any patient, because this will help the treatment become effective and reduce the risks.

1. Learn about pembrolizumab

Pembrolizumab drug formulation is a solution for intravenous infusion: Keytruda 100 mg/4 ml. A group of drugs with anti-cancer effects, a group of monoclonal antibodies.
Mechanism of action Pembrolizumab is an anti-PD-1 monoclonal antibody. The role of PD-1 is to inhibit T-cell regulation involved in the immune response. Pembrolizumab inhibits PD-1 activity by binding to the PD-1 receptor on T cells to block PD-1 and PDL1/PDL2 binding on cancer cells, thereby inducing an immune response against cancer cells again.

2. Indications when using pembrolizumab

According to the principle, pembrolizumab is indicated in the following cases:
advanced (unresectable or metastatic) melanoma or as adjunctive therapy for patients with melanoma with lymph node metastasis, after treatment completely cut off. Single-dose monotherapy in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression (TPS ≥ 1%) without EGFR mutation or ALK-positive, and stage III in patients without indication for surgery or chemotherapy. In combination with pemetrexed and carboplatin, first-line treatment of metastatic non-small cell lung cancer (NSCLC). Monotherapy in metastatic non-small cell lung cancer in adults whose tumors express PD-L1 (TPS ≥ 1%) and have received at least one prior platinum-containing chemotherapy regimen. Metastatic small cell lung cancer after progression to platinum-containing regimens and at least one other prior step of chemotherapy. In combination with platinum or fluorouracil group in the initial treatment of patients with metastatic or unresectable, recurrent head and neck cancer, squamous cell. As monotherapy in the initial treatment of recurrent, metastatic, or unresectable, squamous cell head and neck cancers that express PD-L1 (CPS ≥1). Monotherapy in recurrent or metastatic head and neck squamous cell carcinoma following platinum-containing regimens. Treatment of classic hodgkin lymphoma in refractory adults. Locally advanced or metastatic urothelial carcinoma in adults previously treated with platinum-containing chemotherapy. Locally advanced or metastatic urothelial carcinoma in adults not eligible for cisplatin-containing chemotherapy. Hepatocellular carcinoma in a patient previously treated with sorafenib. Renal cell carcinoma, advanced adenocarcinoma, in combination with axitinib. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction with PD-L1-expressing tumor (CPS 1), disease progression while on or after 2 or more previous steps of treatment containing fluoropyrimidine and platinum. Combination chemotherapy in locally advanced or metastatic triple negative cancer with PDL1 (CPS ≥10).

Indications off-label, cervical cancer (recurrence or metastasis), high MSI cancer (unresectable or metastatic), mediastinal large B-cell lymphoma (recurrent or refractory), squamous cell carcinoma (locally advanced or metastatic), advanced Merkel cell carcinoma. Patients should be cautious about previous adverse reactions to ipilimumab, taking immunosuppressive drugs, autoimmune disease.

3. Undesirable and very common effects when using pembrolizumab

Possible side effects when taking the drug are diarrhea, nausea, rash, itching, joint pain, fatigue. Among them are anemia, infusion-related reactions, thyroid dysfunction, decreased appetite, taste disturbances, headache, dizziness, dry eyes, pneumonia, shortness of breath, cough, colitis, myositis, musculoskeletal pain, increased liver enzymes, increased creatinine.
More rare reactions may be immune thrombocytopenic purpura, hemolytic anemia, myasthenia gravis, small bowel perforation, TEN.
When using pembrolizumab you need to pay attention, dilute in glucose 5%, NaCl 0.9% IV infusion in 30 minutes.
NSCLC not previously treated with chemotherapy, classic Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, or stomach cancer: 200mg every 3 weeks. NSCLC previously treated with chemotherapy or for melanoma: 2 mg/kg every 3 weeks. Advanced Merkel cell carcinoma: 2 mg/kg every 3 weeks. Other indications: 200 mg every 3 weeks.
Attention when using PD-L1 status assessment before starting treatment. Check thyroid, liver, and kidney function every 3 cycles. Treat until disease progression or unacceptable toxicity or within 24 months. Immune-related adverse reactions such as pneumonia, colon, liver, kidney, endocrine disease, serious skin reactions... can be reversible and managed by temporarily discontinuing pembrolizumab, using corticosteroids. . After improvement to ≤ grade 1, the corticosteroid dose should be tapered gradually and continued for at least 1 month. Permanently discontinue pembrolizumab treatment when: Toxicity grade 4, except for endocrine diseases controlled by hormone replacement, cannot reduce the corticosteroid dose ≤ 10 mg prednisone or its equivalent daily for 12 weeks. Irreversible toxicity grade 0 - 1 within 12 weeks of last dose, any second event with grade ≥ 3. Infusion-related reactions, rarely serious, often tremor, chills, pruritus, flushing, fever, hypotension. Prophylaxis with paracetamol and antihistamines may be considered.
For pregnant and lactating women there are currently no data. The drug also does not require dose adjustment in patients with renal impairment.

Once you understand what the drug pembrolizumab is, you can somewhat know how to use it to ensure safety and limit risks. However, it should be noted that, before using any medicine, you should consult your doctor, pharmacist and follow the instructions. It is strictly forbidden to arbitrarily use drugs, because this can potentially pose many health risks.

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