FDA approved
for advanced CSCC
UNLOXCYT™ is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. This may also be referred to as advanced cutaneous squamous cell carcinoma (aCSCC).
Advanced CSCC—a serious form of skin cancer—occurs when cutaneous squamous cell carcinoma grows beyond the area where it started on the skin. It may spread into nearby tissues (laCSCC) or to other parts of the body (mCSCC).
What Is UNLOXCYT?
Helpful information for your journey
If you or your loved one has been diagnosed with advanced CSCC, you may be feeling overwhelmed. But you are not alone. Your doctor can help you find the right treatment option.
UNLOXCYT is a type of immunotherapy that helps your immune system find and attack cancer cells. Learn more by reading through the information below. Talk to your doctor to see if UNLOXCYT may be right for you.
How well does it work?
UNLOXCYT was proven to work in patients with metastatic and locally advanced CSCC. In some patients, the cancer shrank, and in others, it could no longer be seen.
How long did it work?
Most patients who responded to treatment continued to respond for 12 months or more.
What about side effects?
As with any treatment, some patients who took UNLOXCYT experienced side effects, but they were usually mild to moderate. See a list of the most common side effects here.
Understanding PD-L1 and the Immune System
Every day, your immune system protects you from various health threats, including cancer. Some immune cells, like T cells, specialize in recognizing and attacking cancer cells. But cancer often finds ways to hide. One of the tricks it uses is making a protein called PD-L1, which attaches to immune cell proteins called PD-1 and B7.1. This sends a “stop” signal to the T cells, so they stop attacking the cancer, allowing it to grow.
How UNLOXCYT Works
UNLOXCYT is a type of medicine called an immunotherapy. It works by binding to PD-L1—the protein that helps cancer cells hide—and releasing the brakes on your immune system. This means your T cells can find and attack cancer cells again. UNLOXCYT may also help the immune system more directly by helping other immune cells, called natural killer cells, recognize and kill the cancer cells.
UNLOXCYT also allows another protein called PD-L2 to keep working. This helps prevent your immune system from going too far when it is activated, which can sometimes be a reason why you may experience certain types of immune-related side effects.
Starting UNLOXCYT
What to expect during treatment
IV infusion
You’ll receive UNLOXCYT at an infusion center or clinic under the care of a healthcare professional.
Every 3 weeks
You’ll get treatment every 3 weeks. Your doctor will also check your progress and watch for side effects at these appointments.
For 60 minutes
A typical infusion takes about 60 minutes. Your doctor may also provide medicine beforehand to help manage side effects.
Before treatment:
Your doctor will want to know about your health and medical history. Make sure to tell your doctor if you:
Have ever had an organ or stem cell transplant
Have an autoimmune condition
Have had surgery or radiation treatment in the past few months
Take any medicines, vitamins, or supplements
Are pregnant, planning to become pregnant, breastfeeding or plan to breastfeed*
This isn’t the full list of topics to bring up with your doctor, but it can help them understand what’s best for you.
During treatment:
Your healthcare team will:
Monitor you for any side effects during and after the infusion
Adjust the infusion rate if needed (for example, by slowing down, pausing, or stopping the infusion)
Provide additional medications as needed to help manage side effects
Do blood tests to check for liver, kidney, or thyroid side effects
Your healthcare provider will decide how long you should continue treatment with UNLOXCYT based on how you respond and how well you tolerate it.
*Do not breastfeed during treatment and for 4 months after the last dose of UNLOXCYT.
Talking to your doctor about UNLOXCYT
Tips for discussion
The right conversations can help you and your doctor decide on the best approach for your care. These questions can help you feel informed and confident as you talk with your healthcare team.
Please choose the option that best represents you or your loved one:
I'm ready to ask my doctor about UNLOXCYT
Important topics and questions to discuss with your doctor
- How does UNLOXCYT work to treat my type of skin cancer?
- Is UNLOXCYT different from other treatments I’ve received or heard about?
- What are the most common or serious side effects, and how will I know if they happen?
- If I have other health conditions, can I still take UNLOXCYT?
- Could UNLOXCYT affect my ability to become pregnant or breastfeed?
- How will we know if UNLOXCYT is working for me?
I’ve already been prescribed UNLOXCYT
Important topics and questions to discuss with your doctor
- What should I expect during my infusion and how long will each one last?
- How often will I need to come in for treatment, and how many doses might I receive?
- What side effects should I watch for, and how do I know when an immediate phone call is necessary?
- How will you check my health during treatment—will I have regular blood tests or other exams?
- What should I do if I miss an infusion appointment?
- Are there any medicines, vitamins, or supplements I should avoid while taking UNLOXCYT?
- How will we know if UNLOXCYT is working for me?
Support & Resources
Start your treatment journey
What’s next?
Your doctor can enroll you in UNLOXCYT SupportTM to help make starting and continuing treatment easier.
Once we receive your prescription, you will be assigned to a Patient Access Liaison (PAL) from UNLOXCYT SUPPORT. Your PAL is available to answer questions or if you need more information about your insurance coverage and receiving UNLOXCYT.
Help with paying for UNLOXCYT
The dedicated support team reviews your insurance coverage, estimates your out-of-pocket costs, and looks for options that may help lower the cost of treatment.
For more information, download the UNLOXCYT Support Brochure.
Learn more about available resources, financial assistance, and what to expect during treatment.
Download
For a quick overview, download the UNLOXCYT Patient Flashcard.
Learn how treatment works, common side effects, and where to find ongoing support.
Download
Stay connected and supported with UNLOXCYTTM
Sign up to receive information about UNLOXCYT and access resources to help you feel confident and supported throughout you or your loved one's treatment.
*Required fields
What is UNLOXCYT?
UNLOXCYT (cosibelimab-ipdl) is a prescription medicine used to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC). UNLOXCYT may be used to treat CSCC that has spread or cannot be cured by surgery or radiation.
It is not known if UNLOXCYT is safe and effective in children.
Important Safety Information
What is the most important information I should know about UNLOXCYT injection?
UNLOXCYT works with your immune system. It can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
What signs and symptoms of immune system problems can happen with UNLOXCYT?
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms including: lung problems, intestinal, liver, hormone gland, kidney and skin problems.
Problems can also happen in other organs and tissues. Call or see your healthcare provider right away if you have any new or worsening signs or symptoms which may include chest pain, irregular heartbeat, shortness of breath, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, eye problems, or bruising.
What problems can occur during infusion?
Infusion reactions can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include nausea, dizziness, chills or shaking, feeling like passing out, itching or rash, fever, flushing, back or neck pain, shortness of breath or wheezing.
What if I have a transplanted organ or bone marrow transplant?
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had. There may be complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells. These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with UNLOXCYT. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with UNLOXCYT. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with UNLOXCYT if you have severe side effects.
What are the possible side effects of UNLOXCYT?
The most common side effects of UNLOXCYT include tiredness or weakness, muscle or bone pain, rash, diarrhea, low thyroid hormone levels (hypothyroidism), constipation, nausea, headache, itchy skin, swelling, infection, and urinary tract infection. These are not all the possible side effects of UNLOXCYT.
Can I take UNLOXCYT while pregnant or breastfeeding?
UNLOXCYT can cause fetal harm. Females of reproductive potential should use effective contraception. Breastfeeding should be avoided. Discuss with your healthcare provider.
How will I receive UNLOXCYT?
Your healthcare provider will give you UNLOXCYT into your vein through an intravenous (IV) line over 60 minutes, usually every three weeks. Your healthcare provider will decide how many treatments you will need and will do blood tests to check you for side effects.
Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with UNLOXCYT if you have severe side effects.
You are encouraged to report side effects of UNLOXCYT to FDA: visit www.fda.gov/medwatch; or call 1-800-FDA-1088. You are also encouraged to report SUSPECTED ADVERSE REACTIONS or any side effects or ADEs (adverse drug events) to our Drug Safety Department at 1-800-406-7984 or DrugSafety.USoperations@sunpharma.com (preferred) with as much information as available.
What is UNLOXCYT?
UNLOXCYT (cosibelimab-ipdl) is a prescription medicine used to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC). UNLOXCYT may be used to treat CSCC that has spread or cannot be cured by surgery or radiation.
It is not known if UNLOXCYT is safe and effective in children.
Important Safety Information
What is the most important information I should know about UNLOXCYT injection?
UNLOXCYT works with your immune system. It can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
What signs and symptoms of immune system problems can happen with UNLOXCYT?
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms including: lung problems, intestinal, liver, hormone gland, kidney and skin problems.
Problems can also happen in other organs and tissues. Call or see your healthcare provider right away if you have any new or worsening signs or symptoms which may include chest pain, irregular heartbeat, shortness of breath, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, eye problems, or bruising.
What problems can occur during infusion?
Infusion reactions can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include nausea, dizziness, chills or shaking, feeling like passing out, itching or rash, fever, flushing, back or neck pain, shortness of breath or wheezing.
What if I have a transplanted organ or bone marrow transplant?
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had. There may be complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells. These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with UNLOXCYT. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with UNLOXCYT. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with UNLOXCYT if you have severe side effects.
What are the possible side effects of UNLOXCYT?
The most common side effects of UNLOXCYT include tiredness or weakness, muscle or bone pain, rash, diarrhea, low thyroid hormone levels (hypothyroidism), constipation, nausea, headache, itchy skin, swelling, infection, and urinary tract infection. These are not all the possible side effects of UNLOXCYT.
Can I take UNLOXCYT while pregnant or breastfeeding?
UNLOXCYT can cause fetal harm. Females of reproductive potential should use effective contraception. Breastfeeding should be avoided. Discuss with your healthcare provider.
How will I receive UNLOXCYT?
Your healthcare provider will give you UNLOXCYT into your vein through an intravenous (IV) line over 60 minutes, usually every three weeks. Your healthcare provider will decide how many treatments you will need and will do blood tests to check you for side effects.
Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with UNLOXCYT if you have severe side effects.
You are encouraged to report side effects of UNLOXCYT to FDA: visit www.fda.gov/medwatch; or call 1-800-FDA-1088. You are also encouraged to report SUSPECTED ADVERSE REACTIONS or any side effects or ADEs (adverse drug events) to our Drug Safety Department at 1-800-406-7984 or DrugSafety.USoperations@sunpharma.com (preferred) with as much information as available.
© 2025 Sun Pharmaceutical Industries, Inc. All rights reserved.
UNLOXCYT and UNLOXCYT SUPPORT are trademarks of Checkpoint Therapeutics, Inc.
PM-US-ULX-0033 12/25