Pembrolizumab/berahyaluronidase Alfa-pmph (By injection)

Berahyaluronidase Alfa-pmph (ber-a-hye-al-ur-ON-i-dase AL-fa - pmph), Pembrolizumab (pem-broe-LIZ-ue-mab)

Treats cancer, including bile duct, gallbladder, bladder, breast, colon, esophagus, lung (including the lining of the lungs and chest wall), rectum, skin, kidney, lung, liver, stomach, cervix, uterus, and head and neck cancer. Also treats solid tumors, Merkel cell carcinoma, and tumor mutational burden-high cancer.

Brand Name(s):

Keytruda Qlex

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. You should not receive it if you had an allergic reaction to pembrolizumab, berahyaluronidase alfa-pmph, or if you are pregnant or breastfeeding.

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is usually given in the stomach or thigh for at least 1 or 2 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control while you are receiving this medicine and for at least 4 months after your last dose.
• Do not breastfeed while you are receiving this medicine and for 4 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, diabetes, lung disease, immune system problems (including Crohn disease, ulcerative colitis, lupus), thyroid problems, nervous system problems (including Guillain-Barré syndrome, myasthenia gravis), or brain or spinal cord cancer. Tell your doctor if you have received an organ transplant (including kidney or liver transplant) or other transplant (including cornea transplant).
• This medicine may cause the following problems:
  • Lung or breathing problem (including pneumonitis)
  • Colitis (swelling of the colon), which might damage your digestive system
  • Liver problem, including hepatitis (inflammation of the liver)
  • Adrenal, pituitary, or thyroid gland problems
  • Changes in blood sugar levels
  • Kidney problems, including nephritis
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis
  • Increased risk of possible organ transplant rejection
  • Infusion reactions, which could be severe
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Bloody or black, tarry stools, diarrhea, severe stomach pain
• Bloody or cloudy urine, lower back or side pain, swelling of your face, feet, or lower legs
• Blurred vision, trouble seeing, eye pain, or other vision changes
• Cough, chest pain or tightness, trouble breathing, fast, slow, or pounding heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, shaking, rash, itchy skin
• Increased hunger or thirst, dry mouth, sweating, changes in how much or how often you urinate
• Joint, muscle, or bone pain
• Lightheadedness, dizziness, fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Unusual bleeding, bruising, or weakness
• Unusual headaches, tiredness, weight changes, feeling cold, voice changes

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Hair loss
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 11/4/2025