A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Keytruda is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Keytruda is used alone or in combination with other medicines to treat certain types of cancer such as: • melanoma; • non-small cell lung cancer (NSCLC); • head and neck squamous cell cancer (HNSCC); • classical Hodgkin lymphoma (cHL); • primary mediastinal B-cell lymphoma (PMBCL); • urothelial carcinoma; • microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors; • microsatellite instability-high (MSI-H) or mismatch repair deficient colorectal cancer; • gastric cancer; • esophageal cancer; • cervical cancer; • hepatocellular carcinoma; • Merkel cell carcinoma; • renal cell carcinoma; • endometrial carcinoma; • tumor mutational burden-high (TMB-H) cancer; • cutaneous squamous cell carcinoma; or • triple-negative breast cancer. Keytruda is often given when the cancer has spread to other parts of the body, or cannot be treated with surgery or radiation, or when other cancer treatments did not work or have stopped working. For some types of cancer, pembrolizumab is given only if your tumor tests positive for PD-L1, or if the tumor has been tested for a specific genetic marker (including EGFR, ALK, HER2/neu, or TMB).
Keytruda is given as an infusion into a vein, usually once every 3 weeks or every 6 weeks. A healthcare provider will give you this injection. Your doctor will perform a blood test to make sure Keytruda is the right treatment for your condition. This medicine must be given slowly, and the infusion can take at least 30 minutes to complete. You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits.
Keytruda contains the active ingredient pembrolizumab.
Keytruda can change the way your immune system works, which may cause certain side effects that can lead to serious medical problems. Keytruda can cause side effects in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed. You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Call your doctor at once if you have: skin problems, vision problems, fever, swollen glands, neck stiffness, chest pain, cough, shortness of breath, muscle or joint pain, pale skin, weakness, diarrhea, severe stomach pain, blood in your stools, bruising or bleeding, dark urine, yellowing of the skin or eyes, a hormonal disorder (frequent headaches, feeling light-headed, rapid heartbeats, a deeper voice, increased thirst or urination, feeling cold, weight gain or loss), or a change in the amount or color of your urine.
Get emergency medical help if you have signs of an allergic reaction to Keytruda: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, itchy, hot, sweaty, chilled, or have trouble breathing. Pembrolizumab affects your immune system, and can cause side effects in many different parts of your body. Some side effects may need to be treated with other medicine. Call your doctor at once if you have: • sores in your mouth, throat, or nose, or on your genital area; • eye pain or vision problems; • numbness, tingling, burning pain, redness, rash, or blisters on your hands or feet; • severe muscle weakness, severe or ongoing muscle or joint pain; • fever, swollen glands, neck stiffness; • diarrhea or increased stools, severe stomach pain, bloody or tarry stools; • a change in the amount or color of your urine; • liver problems - loss of appetite, right-sided stomach pain, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); • low levels of sodium in the body - confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady; or • signs of a hormonal disorder - frequent or unusual headaches, feeling light-headed, rapid heartbeats, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, muscle pain, sweating, feeling cold, weight changes. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. Common Keytruda side effects (some are more likely with combination chemotherapy) may include: • nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation; • low sodium levels, abnormal liver function or thyroid function tests; • fever, feeling weak or tired; • cough, hoarse voice, feeling short of breath; • itching, rash, or hair loss; • increased blood pressure; • pain in your muscles, bones, or joints; or • soreness in or around your mouth, nose, eyes, throat, or vagina. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.