Patient information: uses, side effects, how to take - Unloxcyt

What is the most important information I should know about UNLOXCYT?

UNLOXCYT is a medicine that may treat a type of skin cancer by working with your immune system. UNLOXCYT 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.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems.

cough

chest pain
shortness of breath

Intestinal problems.

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness

Liver problems.

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)

dark urine (tea colored)
bleeding or bruising more easily than normal

Hormone gland problems.

headache that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual

urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems:

decrease in your amount urine
blood in your urine

swelling of your ankles
loss of appetite

Skin problems.

rash
itching
fever or flu-like symptoms
skin blistering or peeling

painful sores or ulcers in mouth or nose, throat, or genital area
swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with UNLOXCYT. Call or see your healthcare provider right way for any new or worsening signs or symptoms which may include:

chest pain, irregular heartbeat, shortness of breath or swelling of ankles
confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
persistent or severe muscle pain or weakness, muscle cramps
low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

nausea
chills or shaking
itching or rash
flushing
shortness of breath or wheezing

dizziness
feel like passing out
fever
back or neck pain

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.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). 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 is UNLOXCYT?

UNLOXCYT 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.

Before you receive UNLOXCYT, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant, including corneal transplant.
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.
are pregnant or plan to become pregnant. UNLOXCYT can harm your unborn baby.

Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment with UNLOXCYT.
You should use an effective method of birth control during your treatment and for 4 months after the last dose of UNLOXCYT. Talk to your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with UNLOXCYT.

are breastfeeding or plan to breastfeed. It is not known if UNLOXCYT passes into your breast milk. Do not breastfeed during treatment and for 4 months after the last dose of UNLOXCYT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive UNLOXCYT?

Your healthcare provider will give you UNLOXCYT into your vein through an intravenous (IV) line over 60 minutes.
UNLOXCYT is usually given every 3 weeks.
Your healthcare provider will decide how many treatments you will need.
Your healthcare provider will do blood tests to check you for side effects.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of UNLOXCYT?

UNLOXCYT can cause serious side effects.

See “What is the most important information I should know about 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.

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

General Information about the safe and effective use of UNLOXCYT.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about UNLOXCYT, talk with your healthcare provider. You can ask your healthcare provider for information about UNLOXCYT that is written for healthcare professionals.

What are the ingredients of UNLOXCYT?

Active Ingredient: cosibelimab-ipdl

Inactive ingredients: acetic acid, mannitol, polysorbate 80, sodium acetate, sodium chloride, and Water for Injection.

Manufactured by:

Sun Pharmaceutical Industries, Inc. Princeton, NJ 08540

U.S. License No 2275, Product of Korea

UNLOXCYT is a registered trademark of Sun Pharmaceutical Industries, Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 08/2026

Unloxcyt (Cosibelimab): Uses, Side Effects and Dosage