What is the most important information I should know about penpulimab-kcqx?

Penpulimab-kcqx is a medicine that may treat non-keratinizing nasopharyngeal cancer by working with your immune system. Penpulimab-kcqx 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

• shortness of breath

• chest pain

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

• dark urine (tea colored)

• severe nausea or vomiting

• bleeding or bruising more easily than normal

• pain on the right side of your stomach-area (abdomen)

Hormone gland problems

• headaches that will not go away or unusual headaches

• urinating more often than usual

• eye sensitivity to light

• hair loss

• eye problems

• feeling cold

• rapid heartbeat

• constipation

• increased sweating

• your voice gets deeper

• extreme tiredness

• dizziness or fainting

• weight gain or weight loss

• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

• feeling more hungry or thirsty than usual

Kidney problems

• decrease in your amount of urine

• swelling of your ankles

• blood in your urine

• loss of appetite

Skin problems

• rash

• painful sores or ulcers in your mouth or nose, throat, or genital area

• itching

• fever or flu-like symptoms

• skin blistering or peeling

• 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 penpulimab-kcqx. 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, 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:

• chills or shaking

• dizziness

• itching or rash

• feeling like passing out

• flushing

• fever

• shortness of breath or wheezing

• back pain

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue 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 penpulimab-kcqx. Your healthcare provider will monitor you for these complications.

What are the possible side effects of penpulimab-kcqx?

Penpulimab-kcqx can cause serious side effects. See “What is the most important information I should know about penpulimab-kcqx?”

The most common side effects of penpulimab-kcqx when used in combination with either cisplatin or carboplatin and gemcitabine include:

• nausea

• decreased appetite

• feeling tired

• vomiting

• decreased weight

• rash

• low thyroid hormone levels

• cough

• fever

• constipation

• COVID-19 infection