Cosibelimab (Intravenous)
Cosibelimab is used in adults to treat certain cancers of the skin.
Cosibelimab is often used when the cancer has spread to other parts of the body (metastatic), or cannot be treated with other cancer drugs, radiation, or surgery.
Your doctor will make sure you have the correct tumor type to be treated with cosibelimab.
Cosibelimab may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Cosibelimab (Intravenous)?
Tell your doctor if you have or have ever had:
- to receive or plan to receive a stem cell transplant that uses donor stem cells;
- to receive an organ transplant (including corneal transplant);
- radiation to your chest;
- an autoimmune disorder such as lupus, ulcerative colitis, or Crohn's disease; or
- nerve-muscle disorder such as myasthenia gravis or Guillain-Barré syndrome.
You may need to have a negative pregnancy test before starting this treatment.
May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using cosibelimab and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine, and for at least 4 months after your last dose.
Side Effects
What are the side effects of Cosibelimab (Intravenous)?
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Cosibelimab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, skin, thyroid, or adrenal glands.
Call your doctor at once if you have:
- fever or flu-like symptoms, severe nausea or vomiting, swollen glands;
- severe headache, feeling light-headed or very tired, drowsiness;
- severe muscle cramps, pain or weakness, neck pain or stiffness, swelling, numbness or tingling in your arms or legs, hoarse or deepened voice, hair loss, increased sweating, feeling cold;
- new or worsening skin rash, itching, blistering, or ulcers;
- chest pain, rapid or irregular heartbeats, new or worsening cough, feeling short of breath, bleeding, bruising, anemia (low red blood cells);
- appetite changes including loss of appetite or increased hunger or thirst, weight gain, or weight loss;
- vision changes, confusion, mood or behavior changes, memory problems, balance problems;
- severe pain in your upper stomach (that may spread to your back), jaundice (yellowing of skin or eyes), or dark urine;
- diarrhea, constipation, bloody or tarry stools, decreased or increased urination, or blood in your urine; or
- (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- nausea, constipation, diarrhea;
- abnormal blood tests;
- bone or muscle pain;
- rash, itching, or swelling;
- infection;
- pain and burning when you urinate; or
- headache, feeling weak or tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Cosibelimab (Intravenous) if I’m pregnant or breastfeeding?
You may need to have a negative pregnancy test before starting this treatment.
May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using cosibelimab and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine, and for at least 4 months after your last dose.
Interactions
What drugs and food should I avoid while taking Cosibelimab (Intravenous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Cosibelimab (Intravenous)?
Use Cosibelimab (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor will perform tests to make sure cosibelimab is the right treatment for you.
Cosibelimab is given as an infusion into a vein, usually once every 3 weeks. A healthcare provider will give you this injection.
After receiving an infusion, you will be watched closely to make sure you do not have an allergic reaction.
Your doctor will need to check your progress on a regular basis.
You will need frequent medical tests, and your next dose may be delayed based on the results.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
Call your doctor for instructions if you miss an appointment for your cosibelimab injection.
Overdose Signs
What happens if I overdose on Cosibelimab (Intravenous)?
In a medical setting an overdose would be treated quickly.