General Information
Manufacturer: Merck
Medical Name: Pembrolizumab
Purpose: Keytruda is a prescription medicine used to treat:
- a kind of lung cancer called non–small cell lung cancer (NSCLC)
- a kind of skin cancer called melanoma.
- a kind of cancer called head and neck squamous cell cancer (HNSCC).
- a kind of bladder and urinary tract cancer called urothelial cancer.
- a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor.
- a kind of cancer called colon or rectal cancer.
- a kind of stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- a kind of cancer called esophageal or certain gastroesophageal junction (GEJ) carcinomas that cannot be cured by surgery or a combination of chemotherapy and radiation therapy.
- a kind of cancer called cervical cancer.
- a kind of kidney cancer called renal cell carcinoma (RCC).
- a kind of uterine cancer called advanced endometrial carcinoma.
- a kind of skin cancer called cutaneous squamous cell carcinoma (cSCC). It may be used when your skin cancer has returned or spread, and cannot be cured by surgery or radiation.
- a kind of cancer called triple-negative breast cancer (TNBC).
Possible Side Effects
| Side Effect | Likelihood |
|---|---|
| Fatigue | 48-57% |
| Nausea | 44-67% |
| Alopecia (hair loss) | 34% |
| Constipation | 28-40% |
| Diarrhea | 28-36% |
| Stomatitis (mouth sores) | 27% |
| Rash | 26-34% |
| Vomiting | 26-34% |
| Weight loss | 24% |
| Cough | 23% |
| Decreased appetite | 21-44% |
| Pyrexia (fever) | 21-33% |
| Musculoskeletal pain | 20-48% |
| Headache | 20% |
| Diarrhea | 1-2% |
Serious but Less Common Side Effects
- Pneumonitis: Inflammation of the lungs
- Colitis: Inflammation of the colon
- Hepatitis: Inflammation of the liver
- Nephritis: Inflammation of the kidneys
- Hypophysitis: Inflammation of the pituitary gland
- Thyroid disease: Inflammation of the thyroid gland
- Type 1 diabetes: Affects blood sugar levels
- Neurological problems: Can cause weakness, confusion, or seizures
- Infusion-related reactions: Symptoms can include fever, chills, and difficulty breathing
- Cardiovascular problems: Can cause an irregular heartbeat or high blood pressure
- Skin problems: Including severe rashes and blistering
- Eye problems: Can cause vision changes or pain
- Graft-versus-host-disease: Can occur in patients who have received a stem cell transplant
- Heart muscle inflammation (myocarditis): A rare but serious side effect
Preconditions and Warnings
Absolute - Do Not Use Keytruda
- Severe Hypersensitivity: Patients who have had a severe or life-threatening allergic reaction to pembrolizumab or any of its ingredients should not receive Keytruda.
- Pregnancy and Breastfeeding: Keytruda can cause fetal harm and is not recommended during pregnancy. Women of childbearing potential must use effective contraception during treatment and for four months after the last dose. Breastfeeding is also not recommended during this time.
- Certain Transplant Histories/Plans
- Solid Organ Transplants: Patients with a history of solid organ transplants may be at increased risk of organ rejection.
- Allogeneic Stem Cell Transplants
High Risk
- Autoimmune Diseases: Because Keytruda works by activating the immune system, it may worsen symptoms of existing autoimmune disorders such as lupus, Crohn's disease, ulcerative colitis, rheumatoid arthritis, or psoriasis.
- Nervous System Conditions: Conditions like myasthenia gravis or Guillain-Barré syndrome may be worsened by Keytruda therapy.
- Prior Radiation Treatment: A history of radiation treatment in the chest area can increase the risk of lung problems (pneumonitis).
- Multiple Myeloma: The use of PD-1 or PD-L1 blocking antibodies (like Keytruda) in combination with thalidomide analogues and dexamethasone is not recommended outside of controlled clinical trials due to an increased risk of death.
- Severe Immune-Mediated Side Effects