TREANDA Bendamustine Hydrochloride 25 mg/5mL Injection, Powder, Lyophilized, For Solution

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressive: Describes something that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

absolute neutrophil count: A blood test number showing how many infection-fighting neutrophil white blood cells you have.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

ANC: A blood test number showing how many infection-fighting neutrophil white blood cells you have.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

cytotoxic: Describing a substance that kills cells, especially fast-growing ones such as cancer cells.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extravasation: The accidental leaking of an injected medicine out of the vein into the surrounding tissue, which can cause pain, swelling, or tissue damage.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

herpes zoster: The medical name for shingles, a painful rash caused by reactivation of the virus that causes chickenpox.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypertensive crisis: A dangerous, sudden rise in blood pressure to very high levels.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

lymphopenia: A low level of lymphocytes, a type of white blood cell that is important for immune defense.

lyophilized: Freeze-dried into a powder that is mixed with liquid before it is given.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myelosuppression: A slowing of the bone marrow's job of making blood cells, which can lower red cells, white cells, or platelets.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

neutrophil: A type of white blood cell that is one of the body's main defenders against infection.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

opportunistic infection: An infection caused by germs that usually don't make healthy people sick, but can take hold when the body's defenses are weak.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pyrexia: A raised body temperature; a fever.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reactivation: When a germ that has been quiet in the body for a long time becomes active again and causes an infection.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

refractory: Describing a disease that does not respond to, or improve with, treatment.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

spermatogenesis: The making of sperm in the male body.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

tuberculosis: A serious infection, usually of the lungs, caused by tuberculosis bacteria and spread through the air.

tumor lysis syndrome: A serious condition where many cancer cells break apart quickly, releasing their contents and upsetting the body's balance of salts and waste products.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.