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Important information about LIBTAYO

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

LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO 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:
1 Lung problems: cough, shortness of breath, chest pain
Lung problems
  • Cough
  • Shortness of breath
  • Chest pain
2 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
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
3 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
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
4 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
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
5 Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite
Kidney problems
  • Decrease in your amount of urine
  • Blood in your urine
  • Swelling of your ankles
  • Loss of appetite
6 Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, swollen lymph nodes
Skin problems
  • Rash
  • Itching
  • Skin blistering or peeling
  • Painful sores or ulcers in mouth or nose, throat, or genital area
  • Fever or flu-like symptoms
  • Swollen lymph nodes
7 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 LIBTAYO® (cemiplimab-rwlc): 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
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 LIBTAYO. Call or see your healthcare provider right away 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
8 Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, facial swelling.
Infusion reactions that can sometimes be severe or life-threatening

Signs and symptoms of infusion reactions may include:

  • Nausea
  • Vomiting
  • Chills or shaking
  • Itching or rash
  • Flushing
  • Shortness of breath or wheezing
  • Dizziness
  • Feel like passing out
  • Fever
  • Back or neck pain
  • Facial swelling
9 Rejection of a transplanted organ: Tell your doctor if you have had an organ transplant. Your doctor 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 LIBTAYO. Your healthcare provider will monitor you for these complications.
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 LIBTAYO. 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 LIBTAYO. Your healthcare provider may treat you with a corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.

Before you receive LIBTAYO, 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
  • Have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • Have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • Are pregnant or plan to become pregnant. LIBTAYO 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 LIBTAYO
    • You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of LIBTAYO. 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 LIBTAYO
  • are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO

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

Once you have been prescribed LIBTAYO, you have access to a wide variety of resources and support.