Approved Use & Safety Info
Approved Use
Important Safety Information
Approved Use
JEMPERLI is a prescription medicine used to treat adults with a kind of cancer called rectal cancer. JEMPERLI may be used alone to treat rectal cancer that:
- is Stage II or III and has spread to nearby tissues (locally advanced) but not to other parts of the body, and
- is shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
- This use is approved based on clinical complete response (defined as no signs of cancer) maintained for 12 months. The risk of the cancer returning over time is unknown, and researchers will continue to gather more information. Studies are ongoing to confirm the clinical benefit of JEMPERLI for this use.
It is not known if JEMPERLI is safe and effective in children.
Important Safety Information
JEMPERLI is a medicine that may treat certain cancers by working with your immune system. JEMPERLI 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 (HCP) right away if you develop any new or worsening signs or symptoms, including:
Lung problems. Signs and symptoms may include cough, shortness of breath, or chest pain.
Intestinal problems. Signs and symptoms may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.
Liver problems. Signs and symptoms may include 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), or bleeding or bruising more easily than usual.
Hormone gland problems. Signs and symptoms may include headaches 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. Signs and symptoms may include change in the amount or color of your urine, blood in your urine, swelling in your ankles, or loss of appetite.
Skin problems. Signs and symptoms may include rash; itching; skin blistering or peeling; swollen lymph nodes; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms.
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 JEMPERLI. Call or see your HCP right away for any new or worsening signs or symptoms. Signs and symptoms may include chest pain, irregular heartbeat, shortness of breath, swelling of ankles; persistent or severe muscle pain or weakness, muscle cramps; 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, drooping eyelids, sensitivity to light, eye pain, changes in eyesight; 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, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.
Rejection of a transplanted organ or tissue. Your HCP 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 JEMPERLI. Your HCP will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your HCP will check you for these problems during treatment with JEMPERLI and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your HCP may also need to delay or completely stop treatment with JEMPERLI.
Before receiving JEMPERLI, tell your HCP about all of your medical conditions, including immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; received an organ or tissue 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.
If you are pregnant or plan to become pregnant, tell your HCP. JEMPERLI can harm your unborn baby. If you are able to become pregnant, your HCP will give you a pregnancy test before you start treatment. Use an effective birth control method during treatment and for 4 months after your last dose of JEMPERLI. Tell your HCP right away if you become pregnant or think you may be pregnant during treatment with JEMPERLI.
If you are breastfeeding or plan to breastfeed, tell your HCP. It is not known if JEMPERLI passes into your milk. Do not feed with your own milk during treatment with JEMPERLI and for 4 months after your last dose.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of JEMPERLI in people with MSI-H or dMMR locally advanced rectal cancer (LARC) when used alone include tiredness, rash, diarrhea, itchy skin (pruritus).
These are not all of the possible side effects of JEMPERLI. Call your doctor for medical advice about side effects.
Please see full Prescribing Information, including Medication Guide for patients.
