Glossary of terms
- Patient advocacy groups help patients, their families, and their caregivers navigate the cancer landscape. These groups work to ensure cancer patients receive appropriate and timely care, education, and financial assistance, when needed.1
- The most common leukemia in adults. It’s a type of cancer in which immature lymphocytes (white blood cells) are found in the blood and bone marrow and/or in the lymph nodes. The cancer (leukemia) cells start in the bone marrow but then go into the blood.2
- Follicular lymphoma (FL) is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma.3
- A small bean-shaped structure that is part of the body’s immune system. Lymph nodes filter substances that travel through the lymphatic fluid, and they contain lymphocytes (white blood cells) that help the body fight infection and disease.4
- The tissues and organs that produce, store, and carry white blood cells that fight infections and other diseases. This system includes the bone marrow, spleen, thymus, lymph nodes, and lymphatic vessels (a network of thin tubes that carry lymph and white blood cells).5
- Any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss.6
- A drug used alone or with other anticancer drugs to treat certain types of chronic lymphocytic leukemia (CLL).7
- The percentage of all patients whose cancer shrinks or disappears after a given treatment.8
- A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.9
- The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.10
- A disease or condition that does not respond to treatment.11
- The return of a disease or the signs and symptoms of a disease after a period of improvement.12
Relapsed CLL is the term for CLL that responded to therapy but, after six or more months, stops responding. Refractory CLL does not result in a remission (but may be stable) or CLL that gets worse within six months of the last treatment.13
- Relapsed FL is the term for FL that responded to therapy but, after six or more months, stops responding. Refractory FL does not result in a remission (but may be stable) or FL that gets worse within six months of the last treatment.14
- Relapsed SLL is the term for SLL that responded to therapy but, after six or more months, stops responding. Refractory SLL does not result in a remission (but may be stable) or SLL that gets worse within six months of the last treatment.15
- In medicine, an improvement or reaction related to treatment.16
- A slow-growing type of lymphoma in which too many immature lymphocytes (white blood cells) are found mostly in the lymph nodes. This causes the lymph nodes to become larger than normal. The disease is most often seen in people older than 50 years. SLL is a type of non-Hodgkin lymphoma.17
- A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical trial.18
- The normal cells, molecules, and blood vessels that surround and feed a tumor cell. A tumor can change its microenvironment, and the microenvironment can affect how a tumor grows and spreads.19
What is the most important information about COPIKTRA?
COPIKTRA can cause serious side effects, including:
- Infections. Infections are common during COPIKTRA treatment and can be serious and can lead to death. Tell your healthcare provider right away if you have a fever, chills, or other signs of an infection during treatment with COPIKTRA.
- Diarrhea or inflammation of your intestine. Diarrhea or inflammation of your intestine (colitis) is common during COPIKTRA treatment and can be serious and can lead to death. Your healthcare provider may prescribe an antidiarrhea medicine for your diarrhea. Tell your healthcare provider right away if you have any new or worsening diarrhea, stool with mucus or blood, or if you have severe stomach-area (abdominal) pain. Your healthcare provider should prescribe medicine to help your diarrhea and check you at least weekly. If your diarrhea is severe or anti-diarrhea medicines did not work, you may need treatment with a steroid medicine.
- Skin reactions. Rashes are common with COPIKTRA treatment. COPIKTRA can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening skin rash, or other skin reactions during treatment with COPIKTRA, including:
- painful sores or ulcers on your skin, lips, or in your mouth
- severe rash with blisters or peeling skin
- rash with itching
- rash with fever
- Inflammation of the lungs. COPIKTRA can cause inflammation of your lungs which can be serious and can lead to death. Tell your healthcare provider right away if you get new or worsening cough or difficulty breathing. Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with COPIKTRA. Your healthcare provider may treat you with a steroid medicine if you develop inflammation of the lungs that is not due to an infection.
If you have any of the above serious side effects during treatment with COPIKTRA, your healthcare provider may stop your treatment for a period of time, change your dose of COPIKTRA, or completely stop your treatment with COPIKTRA.
COPIKTRA may cause other serious side effects, including:
Elevated liver enzymes. COPIKTRA may cause abnormalities in liver blood tests. Your healthcare provider should do blood tests during your treatment with COPIKTRA to check for liver problems. Tell your healthcare provider right away if you get any symptoms of liver problems, including yellowing of your skin or the white part of your eyes (jaundice), pain in the abdominal region, bruising or bleeding more easily than normal.
Low white blood cell count (neutropenia). Neutropenia is common with COPIKTRA treatment and can sometimes be serious. Your healthcare provider should check your blood counts regularly during treatment with COPIKTRA. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with COPIKTRA.
Common side effects of COPIKTRA include:
- upper respiratory infection
- bone and muscle pain
- low red blood cell count
These are not all the possible side effects of COPIKTRA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 and to Secura Bio at 1-844-9SECURA (1-844-973-2872).
Before taking COPIKTRA, tell your healthcare provider about all your medical conditions, including if you:
- have intestinal problems
- have lung or breathing problems
- have an infection
- are pregnant or plan to become pregnant. COPIKTRA can harm your unborn baby.
- Your healthcare provider should do a pregnancy test to see if you are pregnant before you start treatment with COPIKTRA.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with COPIKTRA and for at least 1 month after the last dose of COPIKTRA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with COPIKTRA.
- Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with COPIKTRA and for at least 1 month after the last dose of COPIKTRA.
- are breastfeeding or plan to breastfeed. It is not known if COPIKTRA passes into breast milk. Do not breastfeed during treatment and for at least 1 month after the last dose of COPIKTRA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. COPIKTRA and certain other medicines may affect each other.