Cosibelimab-ipdl (Unloxcyt™)

Your immune system works by making antibodies, which are proteins that attach to antigens found on the surface of a cell. The antibody “calls” your immune system to attack the cell it is attached to, causing your immune system to kill the cell. Monoclonal antibodies are created in a lab to attach to the antigens found on certain types of cancer cells. These antibodies can work in different ways, including stimulating (revving up) the immune system to kill the cell or by blocking cell growth and other functions needed for cell growth.

Cosibelimab-ipdl is a type of monoclonal antibody therapy that targets and blocks PD-L1, a protein found on some cancer cells, from interacting with PD-1 on immune cells. By blocking PD-L1, the immune system can attack and kill the cancer cells, slowing or stopping cancer growth.

How to Take Cosibelimab-ipdl (Unloxcyt™)

Cosibelimab-ipdl is given intravenously (IV, into a vein). Your dose and how often you receive the medication will be determined by your provider. Most often, you will receive this medication over 1 hour every 3 weeks.

Tell your care team about all your medical conditions, including those that are autoimmune in nature (Crohn’s disease, Lupus, rheumatoid arthritis, etc.) as these can get worse with immunotherapy. You should also tell your provider if you have had or plan on having a solid organ transplant, an allogeneic hematopoietic stem cell transplantation (HSCT), or any other surgery or condition that would lead to prolonged or lifelong use of immunosuppression.

Tell your provider if you have had radiation therapy to your chest area or if you have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

Make sure your care team is aware of all medications (including prescription and over-the-counter), supplements, and vitamins you are taking. Steroids should be avoided while on immunotherapy unless directed by your care team.

Possible Side Effects of Cosibelimab-ipdl

There are a number of things you can do to manage the side effects of cosibelimab-ipdl. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Immune Reactions

This medication stimulates your immune system. Your immune system can attack normal organs and tissues in your body, leading to serious or life-threatening complications. It is important to notify your healthcare provider right away if you develop any of the following symptoms:

• Diarrhea/Gastrointestinal (GI) problems (colitis, inflammation of the bowel, pancreatitis, gastritis): Abdominal (belly) pain, diarrhea, cramping, mucus or blood in the stool, dark or tar-like stools, fever. Diarrhea means different things to different people. Any increase in your normal bowel patterns can be defined as diarrhea and should be reported to your healthcare team.
• Skin reactions: Report rash (with or without itching), sores in your mouth, blistering or peeling skin, as these can become severe and may need treatment with corticosteroids. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Let your oncology care team know right away of any rash that develops. 
• Lung problems (pneumonitis, inflammation of the lung): New or worsening cough, shortness of breath, trouble breathing, or chest pain.
• Liver problems (hepatitis, inflammation of the liver): Yellowing of the skin or eyes, your urine appears dark or brown, pain in your abdomen, bleeding or bruising more easily than normal, or severe nausea and vomiting. Your care team will monitor for these changes using blood tests called liver function tests.
• Brain and/or nerve problems: Report any headache, drooping of eyelids, double vision, trouble swallowing, weakness of arms, legs, or face, or numbness or tingling in the hands or feet to your healthcare team.
• Hormone abnormalities: Immune reactions can affect the pituitary, thyroid, pancreas, and adrenal glands, resulting in inflammation of these glands, which can affect their production of certain hormones. Some hormone levels can be monitored with blood work. It is important that you report any changes in how you are feeling to your care team. Symptoms of these hormonal changes can include: headaches, nausea, vomiting, constipation, rapid heart rate, increased sweating, extreme fatigue, weakness, changes in your voice, changes in memory and concentration, increased hunger or thirst, increased urination, weight gain, hair loss, dizziness, feeling cold all the time, and changes in mood or behavior (including irritability, forgetfulness, and decreased sex drive).
• Eye problems: Report any changes in vision, blurry or double vision, and eye pain or redness to your healthcare team.
• Kidney problems (kidney inflammation or failure): Decreased urine output, blood in the urine, swelling in the ankles, loss of appetite.
• Heart problems: Inflammation in the heart muscle can happen in rare cases. If you develop any of these symptoms, report them to your provider right away: chest pain, shortness of breath, trouble breathing when lying down or waking up gasping for air, heart palpitations (feeling like your heart is racing), swelling in your feet or legs, lightheadedness or fainting.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Low White Blood Cell Count (Leukopenia or Lymphocytopenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever, or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with has any vaccinations.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (sodium, potassium, calcium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Muscle or Joint Pain/Aches

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Important but Less Common Side Effects

• Infusion-Related Side Effects: The infusion can cause a reaction that may lead to chills, fever, low blood pressure, dizziness, feeling like you are going to pass out, and difficulty breathing. Let your nurse know right away if you are experiencing any changes in how you are feeling.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control for women is necessary during treatment and for at least 4 months after your last treatment, even if your menstrual cycle stops. Men should talk with their provider about birth control during and after treatment. You may want to consider sperm banking or egg harvesting if you may wish to have a child in the future. Discuss these options with your oncology team. You should not breastfeed while taking this medication and for 4 months after the last dose.