Our Therapies

KEYTRUDA QLEX™ Infusion Therapy

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About KEYTRUDA QLEX™ Injection Therapy

KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) is a fixed-combination biologic given as a subcutaneous injection rather than an intravenous infusion. Pembrolizumab is a PD-1 blocking antibody: rather than attacking cancer cells directly, it blocks the PD-1 pathway that many tumors use to switch off the immune response, which helps your own T cells recognize and attack the cancer. Berahyaluronidase alfa is an enzyme that temporarily increases dispersion under the skin, allowing the full dose of pembrolizumab to be delivered as an injection.

KEYTRUDA QLEX™ is injected into the thigh or abdomen, avoiding the area around the navel. There are two dosing options: 395 mg pembrolizumab with 4,800 units berahyaluronidase alfa given over about one minute every three weeks, or 790 mg with 9,600 units given over about two minutes every six weeks. Depending on your diagnosis, it may be given on its own or alongside chemotherapy or an oral targeted therapy such as axitinib. When KEYTRUDA QLEX™ is given on the same day as chemotherapy, it is administered first. KEYTRUDA QLEX™ and intravenous pembrolizumab are not interchangeable and cannot be substituted for one another, though patients already receiving IV pembrolizumab can switch to KEYTRUDA QLEX™ at their next scheduled dose. Your oncologist sets the regimen and how long treatment continues. At Violet Health, our clinical team handles scheduling, insurance coordination, and monitoring for each visit.

Conditions treated by this therapy

KEYTRUDA QLEX™ is FDA-approved across most of the solid tumor indications approved for intravenous KEYTRUDA®, in adults and in patients 12 years and older who weigh more than 40 kg. Your care team may consider this therapy if you have:

Melanoma, either unresectable or metastatic, or as adjuvant treatment of stage IIB, IIC, or III disease after complete resection
Non-small cell lung cancer (NSCLC), including first-line metastatic disease with chemotherapy and PD-L1 positive disease as a single agent
Head and neck squamous cell carcinoma, including resectable locally advanced disease before and after surgery, and metastatic or recurrent disease
Urothelial (bladder) cancer, including locally advanced or metastatic disease, and muscle-invasive disease with enfortumab vedotin
MSI-H or dMMR solid tumors, including advanced colorectal cancer, after prior treatment
Gastric and esophageal cancers, biliary tract cancer with gemcitabine and cisplatin, and hepatocellular carcinoma secondary to hepatitis B after prior systemic therapy
Cervical cancer, endometrial carcinoma, and platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma
Triple-negative breast cancer, including high-risk early-stage disease before and after surgery and locally recurrent or metastatic disease
Renal cell carcinoma, first-line with axitinib or as adjuvant therapy after nephrectomy
Merkel cell carcinoma and cutaneous squamous cell carcinoma

Some indications require an FDA-approved test to confirm PD-L1 expression or MSI-H or dMMR status. Not every intravenous KEYTRUDA® indication is approved for the subcutaneous formulation, so your oncologist will confirm whether KEYTRUDA QLEX™ is right for your diagnosis before treatment begins.

KEYTRUDA QLEX™ Price

The cost of prescription medications can vary depending on your insurance coverage. If you're concerned about the price of your medication:

Contact your insurance provider to understand your coverage
Ask your doctor or pharmacist about lower-cost alternatives
Check with the drug manufacturer about financial assistance programs
Explore patient assistance options if you're uninsured or underinsured

Remember, many resources exist to help patients access necessary medications. Don't hesitate to ask for help if you're struggling with medication costs. No patient should go without necessary treatment due to financial limitations. If you have questions about financial assistance opportunities, contact a member of our Violet Health team.

What to Expect During KEYTRUDA QLEX™ Injection Therapy

When you arrive at our Violet Health location, you'll settle into a private, welcoming space designed with your comfort and peace of mind in mind. Because KEYTRUDA QLEX™ is given as an injection rather than an infusion, there is no IV line and no infusion pump. Before and during your visit, our experienced team will:

Review your current health status and any symptoms you've noticed
Check your vital signs and review recent lab work, including thyroid, liver, and kidney function, before treatment begins
Choose and prepare your injection site in the thigh or abdomen, rotating sites between visits
Administer your KEYTRUDA QLEX™ injection over about one minute (every three weeks) or two minutes (every six weeks)
Monitor you afterward for any administration-related or hypersensitivity reactions
Protect your privacy and comfort throughout the visit

The injection itself takes one to two minutes, substantially less time than the 30-minute intravenous infusion of KEYTRUDA®, though you should still plan for time at check-in, assessment, and post-treatment monitoring. Most patients come in every three weeks, though your oncologist may choose the every-six-week dose, which means fewer visits. When KEYTRUDA QLEX™ is given on the same day as chemotherapy, it is administered first and your visit will be longer. If your regimen includes an oral medication such as axitinib, you'll continue taking that at home between visits. KEYTRUDA QLEX™ must be given by a healthcare provider and is never self-administered at home.

KEYTRUDA QLEX™ Side Effects

As with any medication, KEYTRUDA QLEX™ may cause side effects. Being informed helps you know what to watch for and when to contact your healthcare team. Common Side Effects:

Fatigue or weakness
Nausea
Muscle, bone, and joint pain
Injection site reactions, including redness, swelling, or discomfort in the thigh or abdomen
Itching (pruritus) and rash
Diarrhea, vomiting, or constipation
Decreased appetite and weight loss
Cough and shortness of breath
Underactive thyroid (hypothyroidism) or overactive thyroid (hyperthyroidism)
Hair loss, mouth sores, and numbness or tingling in the hands and feet, when given with chemotherapy
Changes in blood counts, including low white cells, low platelets, and anemia, particularly when given with chemotherapy
Changes in liver enzymes, kidney function, blood sugar, and electrolyte levels

KEYTRUDA QLEX™ can cause your immune system to attack healthy organs and tissues. These immune-mediated reactions can become severe or life-threatening, can affect any organ system, and may occur during treatment or after it has ended. Please alert our clinical staff or seek medical attention immediately if you experience any of the following:

Lung inflammation (pneumonitis), including new or worsening cough, chest pain, or shortness of breath
Intestinal inflammation (colitis), including diarrhea, stool changes, severe abdominal pain, or blood or mucus in the stool
Liver problems (hepatitis), including yellowing of the skin or eyes, dark urine, severe nausea, or pain on the right side of the abdomen
Hormone gland problems affecting the thyroid, adrenal glands, or pituitary gland, including headaches, extreme tiredness, weight changes, dizziness or fainting, constipation, hair loss, or feeling cold
New or worsening type 1 diabetes, including increased thirst or hunger, frequent urination, and unexplained weight loss
Kidney problems (nephritis), including changes in the amount or color of your urine or swelling in the ankles
Serious skin reactions, including rash, blistering or peeling skin, painful sores or ulcers in the mouth, nose, throat, or genital area, fever or flu-like symptoms, and swollen lymph nodes
Administration-related and hypersensitivity reactions, including chills or shaking, itching or rash, flushing, wheezing, dizziness, feeling faint, fever, and low blood pressure
Other immune-mediated problems affecting the heart, nerves, eyes, muscles, or pancreas, including irregular or rapid heartbeat, muscle pain or weakness, eye problems or vision changes, and numbness and tingling

Allergy to hyaluronidase: KEYTRUDA QLEX™ should not be used if you have a known hypersensitivity to berahyaluronidase alfa, hyaluronidase, or any of the other ingredients. Tell your care team about any prior reaction to a hyaluronidase-containing medicine.

Not interchangeable with IV KEYTRUDA®: KEYTRUDA QLEX™ has different dosing and administration instructions and must never be given intravenously or substituted for intravenous pembrolizumab.

Stem cell transplant: Tell your care team if you have had, or are planning to have, an allogeneic stem cell transplant. Serious complications, including graft-versus-host disease, can occur in patients treated with a PD-1 blocking antibody before or after transplant.

Multiple myeloma: PD-1 blocking antibodies are not recommended with a thalidomide analogue and dexamethasone outside of a clinical trial, because of an increased risk of death.

Pregnancy warning: KEYTRUDA QLEX™ may harm an unborn baby. Tell your care team if you are pregnant or plan to become pregnant. Use effective birth control during treatment and for four months after your last dose, and do not breastfeed during treatment or for four months after your last dose.

KEYTRUDA QLEX™ Injection Therapy at Violet Health

Your comfort during KEYTRUDA QLEX™ injection therapy at Violet Health is our priority. Our patients enjoy walk-up parking, complimentary entertainment and snacks, and a team of highly trained providers during each treatment. Plus, Violet Health's evening and weekend hours and convenient city and rural locations make it easier to schedule your appointments.