PEMBROLIZUMAB
Background and Date of Approval
Pembrolizumab is an immunotherapy medication containing the active constituent pembrolizumab. It is used to treat skin, lung, bladder, stomach, liver, gallbladder, cervix, kidney, colon, rectum, esophagus, breast, and uterus cancers. It is used to treat head and neck cancer and classical Hodgkin lymphoma, a type of blood cancer. Cancer is a disorder in which cells multiply uncontrolled and abnormally. Pembrolizumab can lead to durable responses and improved survival in some patients with advanced cancer and may improve overall survival in patients with several types of advanced cancer. However, not all patients respond to treatment, and some patients may experience side effects. Pembrolizumab is not recommended for adolescents and children under 18 years of age, except for children aged three years and older with classical Hodgkin lymphoma. Pembrolizumab is administered intravenously, usually in a hospital or clinic setting. Treatment is typically given every three to four weeks, and the number of treatment cycles depends on the type of cancer, the stage of cancer, and the patient's response to the medication. Pembrolizumab received U.S. Food and Drug Administration approval on August 5, 2016, to treat head and neck squamous cell carcinoma. The decision to use pembrolizumab depends on several factors, including the type and stage of cancer, the patient's overall health, and other treatments the patient has received. Patients considering treatment should discuss the potential risks and benefits with their healthcare provider.
Uses
It was first approved for treating head and neck advanced squamous cell carcinoma. Afterward, it is used to treat several other types of cancer, including non-small cell lung cancer, classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer, head and neck squamous cell carcinoma, melanoma, cervical cancer, and primary mediastinal large B-cell lymphoma.
How is it administered?
Pembrolizumab is a medication that is administered by a healthcare professional, typically in a hospital or clinic setting. The medication is given as an intravenous (IV) injection by healthcare professional. The dosage and frequency will depend on the type and stage of the cancer, as well as the patient's overall health and response to the medication. The medication is typically given every three to four weeks, and the number of treatment cycles varies with the type and staging of cancer and the patient's response to the drug. During the infusion, the patient will be monitored by a healthcare professional for any potential side effects or reactions to the medication. The infusion usually takes around 30 minutes to 1 hour to complete, and the patient can usually go home afterward.
Side Effects
Some of the more serious side effects that have been reported with pembrolizumab include pneumonitis (inflammation of the lungs), hepatitis (inflammation of the liver), colitis (inflammation of the colon), hypothyroidism or hyperthyroidism (changes in thyroid function), adrenal insufficiency (decreased adrenal function), and type 1 diabetes (autoimmune destruction of insulin-producing cells). In addition to the more serious side effects, pembrolizumab can also cause common side effects such as fatigue, nausea, loss of appetite, diarrhea or constipation, skin rash or itching, headache, muscle or joint pain, cough or shortness of breath, fever or chills, and low blood cell counts. These side effects can vary in severity and frequency among patients.
Warnings
Pembrolizumab can cause immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions. These adverse reactions can be serious or life-threatening and may occur even after discontinuing it. It is associated with the risk of infusion reactions, including fever, chills, rash, hypotension, wheezing, and shortness of breath. These reactions can be severe and require immediate medical attention. It can also cause fetal harm if administered during pregnancy. Pembrolizumab also carries the risk of immune-mediated colitis (inflammation of intestine), which can cause severe diarrhea, abdominal pain, and gastrointestinal perforation. in some cases hepatitis (liver inflammation). Patients should report any symptoms of colitis to their healthcare provider immediately.
Precautions
Patients receiving pembrolizumab should take several precautions to ensure safe and effective treatment. First and foremost, they should inform their healthcare provider of any current medications, medical conditions, or allergies before starting treatment with pembrolizumab. This will help the healthcare provider determine if pembrolizumab is safe for the patient and adjust the treatment plan as needed. Pembrolizumab may interact with other drugs, including immunosuppressive agents, such as corticosteroids, which may reduce the effectiveness of pembrolizumab, so patients should avoid taking these medications together. Patients receiving it should also avoid live vaccines during treatment, as the drug may affect their effectiveness. Women of reproductive potential should use effective contraception during treatment and four months after the last dose of pembrolizumab. Patients should also seek immediate medical attention if they experience signs or symptoms of a serious infusion reaction, such as fever, chills, rash, hypotension, wheezing, or shortness of breath.
Word of Advice
When receiving treatment with Pembrolizumab or any other medication, it is important to follow your healthcare provider’s instructions carefully. Attend all scheduled medical appointments so your healthcare team can monitor your progress, assess for possible side effects, and make adjustments to your treatment plan when necessary.
Women should avoid becoming pregnant and should not breastfeed during treatment unless specifically advised otherwise by their healthcare provider. Report any new or unusual symptoms or side effects to your doctor as soon as possible so they can be evaluated and managed appropriately.
Maintaining a healthy lifestyle during Pembrolizumab treatment is also important. This includes following a balanced diet, getting adequate rest, and engaging in physical activity as recommended by your healthcare provider. Finally, remain patient and try to maintain a positive outlook throughout treatment, as this can help you stay motivated and focused on your recovery.
References
Merck Sharp & Dohme (UK) Limited, European Medicines Agency (emc), [ Revised on Nov 2022], [ Accessed on 30th March 2023], https://www.ema.europa.eu/en/documents/procedural-steps-after/keytruda-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf Merck, U.S. Food and Drug Administration, Highlights of Prescribing Information: Pembrolizumab, [Last revised 2023], [Accessed on 30th March 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s128lbl.pdf Merck & Co., Inc, ASCO (American Society of Clinical Oncology) - Information on pembrolizumab {Last Revised June 2022], [Accessed on 30th March 2023], https://www.nccn.org/search-result?indexCatalogue=nccn-search-index&searchQuery=pembrolizunab Goodman and Gilman's, The Pharmacological Basis of Therapeutics, 13th Edition, 2018, 1026
Frequently Asked Questions
How is the effectiveness of pembrolizumab measured?
The effectiveness of pembrolizumab is measured by imaging tests, such as CT (computed tomography) scans or MRIs (magnetic resonance imaging), to monitor the tumor's size and growth. A reduction in tumor size or stabilization is considered a positive response to treatment.
Can pembrolizumab cause depression or anxiety?
Depression and anxiety have been reported as rare side effects of pembrolizumab. Patients should inform their healthcare provider if they experience new or worsening mental health symptoms while taking pembrolizumab.
What are the Potential Side Effects of Pembrolizumab?
The potential side effects of pembrolizumab include fatigue, nausea, loss of appetite, skin rash or itching, headache, muscle or joint pain, cough or shortness of breath, and low blood cell counts. Immune-mediated side effects may also occur, such as inflammation of the lungs, liver, or colon, changes in thyroid function, decreased adrenal function, or autoimmune destruction of insulin-producing cells.
How can Side Effects be Managed?
Side effects may be managed through dose adjustment, supportive care, or medication. In some cases, treatment with it may need to be stopped if side effects are severe or life-threatening.
Can patients continue to work or perform daily activities while taking pembrolizumab?
Many patients are able to continue working and performing daily activities while taking pembrolizumab. However, some patients may experience side effects that affect their ability to work or perform daily activities, such as fatigue or nausea.
Can pembrolizumab cure cancer?
Pembrolizumab can lead to long-lasting remissions in some patients, but it is not a cure for cancer. Patients should discuss their treatment plan and expected outcomes with their healthcare provider.
Can pembrolizumab be used in combination with other cancer treatments?
Yes, pembrolizumab can be combined with other cancer treatments such as chemotherapy, radiation therapy, and targeted therapy. Combining pembrolizumab with other cancer treatments may provide better outcomes than either treatment alone.
In How Much Time Will the Drug Show Effect?
The time it takes for pembrolizumab to show its effect can vary depending on the type and stage of the cancer being treated. In some cases, patients may see a response within a few weeks of starting treatment, while in other cases, it may take several months.
Can patients receive vaccinations while taking pembrolizumab?
Patients should discuss their vaccination schedule with their healthcare provider while taking pembrolizumab. Live vaccines, such as the measles, mumps, and rubella (MMR) vaccine, should not be given while taking pembrolizumab, as it can affect the vaccine's effectiveness. Inactivated vaccines, such as the flu vaccine, can be given but may be less effective while taking pembrolizumab.