Keytruda Qlex (Subcutaneous)
Berahyaluronidase alfa and pembrolizumab is a combination medicine used to treat certain types and stages of cancers of the skin, lung and the lining of the chest (mesothelioma), head and neck, bladder, urinary tract, colon, rectum, stomach, esophagus, cervix, liver, bile duct, gallbladder, kidney, uterus, or breast.
Berahyaluronidase alfa and pembrolizumab may be used alone or in combination with other cancer treatments.
Berahyaluronidase alfa and pembrolizumab is often given when the cancer has spread to other parts of the body, cannot be treated with surgery or radiation, or when other cancer treatments did not work or have stopped working.
Your doctor will make sure you have the correct tumor type to be treated with berahyaluronidase alfa and pembrolizumab.
Berahyaluronidase alfa and pembrolizumab may also be used for purposes not listed in this medication guide.
uses
What is Keytruda Qlex (Subcutaneous) used for?
- Breast Cancer
- Renal Cell Carcinoma
- Endometrial Carcinoma
- Malignant Melanoma
- Breast Cancer -- Male
- Squamous Cell Carcinoma
- Neoplasia -- Estrogen Dependent
- Non-Small Cell Lung Cancer
- Colorectal Cancer
- Bladder Cancer
- Solid Tumors
- Melanoma -- Metastatic
- Esophageal Carcinoma
- Gastric Cancer
- Malignant Pleural Mesothelioma
- Cervical Cancer
- Head and Neck Cancer
- Hepatocellular Carcinoma
- Urothelial Carcinoma
- Merkel Cell Carcinoma
- Cholangiocarcinoma of biliary tract
warnings
What is the most important information I should know about Keytruda Qlex (Subcutaneous)?
You should not be treated with berahyaluronidase alfa and pembrolizumab if you are allergic to berahyaluronidase alfa or hyaluronidase.
Tell your doctor if you have or have ever had:
- an autoimmune disorder such as Crohn's disease, ulcerative colitis, or lupus;
- to receive or plan to receive a stem cell transplant that uses donor stem cells;
- to receive an organ or tissue transplant, including corneal transplant;
- radiation to your chest; or
- a nerve-muscle disorder, such as myasthenia gravis or Guillain-Barré syndrome.
May harm an unborn baby. Do not use if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while using berahyaluronidase alfa and pembrolizumab and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine, and for at least 4 months after your last dose.
Side Effects
What are the side effects of Keytruda Qlex (Subcutaneous)?
Get emergency medical help if you have signs of an allergic reaction (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 medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Berahyaluronidase alfa and pembrolizumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, adrenal glands, or other parts of your body, even after your treatment has ended.
Call your doctor at once if you have:
- lung problems--cough, shortness of breath, chest pain;
- intestinal problems--diarrhea, bloody or tarry stools, severe stomach pain;
- liver problems--loss of appetite, severe nausea and vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- signs of a hormonal disorder--unusual headaches, vision problems, feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss;
- kidney problems--swelling, urinating less, feeling tired or short of breath;
- eye problems--double vision, blurred vision, increased sensitivity to light, eye pain, vision changes;
- low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;
- signs of organ transplant rejection--feeling sick or uneasy, with pain or swelling near your transplanted organ;
- skin problems--skin rash, itching, blistering or peeling of the skin, fever, flu-like symptoms, swollen glands, ulcers in your mouth, nose, throat, or genitals;
- irregular heartbeats;
- confusion, drowsiness, memory problems;
- neck stiffness, problems with balance, numbness or tingling in your arms or legs; or
- severe muscle pain or weakness, muscle cramps, bruising.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- nausea, vomiting, diarrhea, constipation, stomach pain, loss of appetite;
- itching, skin rash;
- pain, headache, bone pain, joint or muscle pain;
- cough, shortness of breath;
- fever, tiredness; or
- abnormal blood tests.
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.
Pregnancy & Breastfeeding
Can I take Keytruda Qlex (Subcutaneous) if I’m pregnant or breastfeeding?
May harm an unborn baby. Do not use if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while using berahyaluronidase alfa and pembrolizumab and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine, and for at least 4 months after your last dose.
Interactions
What drugs and food should I avoid while taking Keytruda Qlex (Subcutaneous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Keytruda Qlex (Subcutaneous)?
Use Keytruda Qlex (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor will perform tests to make sure berahyaluronidase alfa and pembrolizumab is the right treatment for you.
Berahyaluronidase alfa and pembrolizumab is injected under the skin, usually once every 3 or 6 weeks. A healthcare provider will give you this injection.
Your doctor will determine your treatment schedule and how long you will receive this medicine.
You may be given other medications to treat serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.
You may need frequent medical tests and your cancer treatments may be delayed based on the results.
Call your doctor for instructions if you miss an appointment for your berahyaluronidase alfa and pembrolizumab injection.
Overdose Signs
What happens if I overdose on Keytruda Qlex (Subcutaneous)?
In a medical setting an overdose would be treated quickly.