IMMUNOTHERAPY
Overview
Keytruda Qlex is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several types of bladder cancer, which is the most common form of urothelial cancer. It is approved in combination with enfortumab vedotin for adults with locally advanced or metastatic urothelial carcinoma.
It is also approved as a single agent for adults with locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy, or whose disease has progressed during or after platinum-containing chemotherapy, including within 12 months of receiving platinum chemotherapy after surgery.
In addition, Keytruda Qlex is approved for adults with high-risk, non-muscle invasive bladder cancer (NMIBC) that is Bacillus Calmette-Guérin (BCG)-unresponsive, with carcinoma in situ (CIS) with or without papillary tumors, who are ineligible for or have chosen not to undergo cystectomy (surgical removal of the bladder).
Keytruda Qlex is also known by its drug name, pembrolizumab and berahyaluronidase alfa-pmph.
Keytruda Qlex is a type of immunotherapy. It works by blocking the PD-1 protein on immune cells, which helps the immune system recognize and attack bladder cancer cells. Berahyaluronidase alfa helps the medication absorb more efficiently when injected under the skin.
How do I take it?
Prescribing information states that Keytruda Qlex is given as a subcutaneous (under the skin) injection into the abdomen or thigh by a healthcare provider. It is typically administered once every three or six weeks, depending on the dosing schedule. Depending on the setting, it may be used alone or in combination with enfortumab vedotin. It should be administered exactly as prescribed by a healthcare provider.
Side effects
Common side effects of Keytruda Qlex include fatigue, nausea, musculoskeletal pain (pain in muscles, bones, or joints), rash, diarrhea, decreased appetite, cough, shortness of breath, constipation, abdominal pain, fever, itching, and hypothyroidism (low thyroid hormone levels).
When used in combination with enfortumab vedotin, side effects may also include rash, peripheral neuropathy (nerve damage causing pain or numbness), fatigue, itching, diarrhea, hair loss, weight loss, decreased appetite, dry eyes, nausea, constipation, altered taste, and urinary tract infections.
Rare but serious side effects may include immune-mediated reactions such as pneumonitis (lung inflammation), colitis (intestinal inflammation), hepatitis (liver inflammation), endocrinopathies (hormone gland problems), nephritis (kidney inflammation), severe skin reactions, and rejection of transplanted organs. Severe allergic reactions and complications following stem cell transplant may also occur. The drug may cause harm to an unborn baby and is not recommended during pregnancy.
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