Glossary

A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

A

Albumin [al-byoo-min]   

The main protein found in blood that helps maintain fluid balance in the body.

Anemia [uh-nee-mee-uh]   

Having a lower level of red blood cells than normal. This may cause a person to be tired and weak.

C

Chemotherapy treatment

This is a type of treatment that uses drugs to stop cancer cells from growing. Chemotherapy does this by either killing cells or by preventing them from continuing to divide.

Complete response (CR)

When all signs of cancer disappear. Disappearance of all signs of cancer does not mean the cancer is cured.

D

DNA

The molecules inside cells that hold genetic information.

Duration of response

The length of time in which the tumor responded to treatment as shown by decreased size or disappearance.

E

Epithelioid [eh-pih-thee-lee-oyd]   

Resembling epithelium, which are cells bound together in a sheet to form the outer layer of skin or lining of body cavities. Epithelioid sarcoma often starts as a slow-growing, firm lump in the body’s deep soft tissue or skin. It may be found in areas like the arms, hands, fingers, legs, head, or neck.

H

Hyperglycemia [hai-per-glai-see-mee-uh]   

Having a higher level of blood glucose (a type of sugar in the blood) than normal. While it is more likely to happen in a patient who has diabetes, a patient without diabetes may also experience hyperglycemia.

Hypokalemia [hai-po-kuh-lee-mee-uh]   

Having a lower level of potassium in the body than normal. Potassium helps carry electrical signals in your body. Low levels may cause a person to be weak or have muscle cramps.

I

Intravenous infusion [in-truh-vee-nus in-fyoo-zhun]   

A method of getting fluids, including medication, directly into the body’s bloodstream.

K

Kinase [kie-nays]   

A special type of protein that speeds up chemical reactions in the body and affects different cell processes. Some kinases are linked to cancer, and certain cancer treatments target this protein.

M

Malignant [muh-lig-nunt]   

Refers to cancer cells. Malignant cells can invade nearby tissue and spread to other parts of the body.

Median

The middle number in a group of numbers that are listed from lowest to highest.

Metastatic [meh-tuh-sta-tuhk]   

Describes cancer that has spread from where it started (for example, the lungs) to other parts of the body (for example, the brain).

mTOR [em-tor]   

Stands for mechanistic target of rapamycin. A protein that supports different cell functions, like cell division and survival. This protein may be more active in certain kinds of cancer. Because of this, a medicine that blocks mTOR may cause cancer cells to die.

mTOR inhibitor [em-tor in-hih-bit-tur]   

This type of cancer treatment blocks a protein known as mTOR, which is involved with cell division. It may help prevent cancer cells from growing. It also may stop new blood vessels from forming, which tumors need to grow.

Mucositis [myoo-kuh-sai-tuhs]   

Inflammation of the digestive system lining, including the mouth and throat.

Mutation [myoo-tay-shn]   

A change in a cell's DNA sequencing.

N

Nanoparticle technology [na-noe-paar-tuh-kl tek-naa-luh-jee]   

A type of technology that uses extremely tiny particles, smaller than 100 nanometers (one-billionth of a meter), to deliver medications to certain parts of the body in a precise way.

O

Overall response rate (ORR)

An outcome to assess the efficacy of a cancer treatment in clinical trials. ORR is the percent of patients who had tumors shrink by 30% or more, or had all signs of the cancer disappear while receiving treatment.

P

Partial response (PR)

An outcome to assess the efficacy of a cancer treatment in clinical trials. When the tumor size decreases by 30% or more in response to treatment but does not completely go away.

PEComa [pek-o-muh]   

Also called perivascular epithelioid cell tumors. These are very rare tumors that start in the soft tissues of the stomach, intestines, lungs, female reproductive organs, and/or urinary organs.

Perivascular [peh-rih-vas-cue-llr]   

Describes the space and cells around blood vessels. A perivascular tumor is a type of soft tissue tumor that begins in cells surrounding blood vessels. They can form anywhere in the body.

Pneumonitis [noo-muh-nai-tuhs]   

Inflammation in the lungs.

Protein

The molecules in the body made up of building blocks, which are called amino acids. Proteins are critical and are the basis of many parts of the body, including the skin and hair, as well as certain substances like antibodies.

R

Rapamycin [ra-puh-mie-sin]   

This is another name for sirolimus. This is a drug that is now known as sirolimus. It blocks a protein, mTOR, that is involved with cell division.

S

Sarcoma [saar-koe-muh]   

A rare type of cancer that forms in the bone or soft tissues. This can include cartilage, fat, muscles, blood vessels, and other connective tissues.

Sirolimus [sih-rah-lih-mus]   

This is a drug that blocks a protein, mTOR, that is involved with cell division. It is also known as rapamycin.

Stomatitis [stoh-muh-ty-tis]   

A type of mucositis that occurs when the inside of the mouth has sores or is inflamed.

T

Targeted cancer drug

A type of cancer treatment that blocks cancer from progressing by targeting specific molecules that help cancer grow and spread.

Thrombocytopenia [thraam-buh-sai-tuh-pee-nee-uh]   

Having a lower level of platelets in the blood than normal. This may cause a person to easily bruise or bleed when injured.

INDICATION

FYARRO® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat adults with malignant perivascular epithelioid cell tumors (PEComa) that have spread to other parts of the body (metastatic) or cannot be removed by surgery (locally advanced, unresectable). It is not known if FYARRO is safe and effective in people with severe liver problems or in children.

IMPORTANT SAFETY INFORMATION

Do not use FYARRO if you have had a severe allergic reaction to sirolimus or other medications that work similarly to sirolimus (eg, everolimus, temsirolimus), or human albumin.

FYARRO can cause the following serious side effects; depending on the severity, your doctor may decide to decrease your dose or stop treatment with FYARRO:

  • Mouth ulcers and sores are common during treatment with FYARRO and can be severe. If you develop pain, discomfort, or open sores in your mouth, tell your doctor.
  • Decreased blood cell counts (red blood cells, platelets, and white blood cells). Your doctor should do blood tests before you start and during treatment with FYARRO.
  • Infections. FYARRO can make you more susceptible to infections. Tell your doctor right away if you develop a fever, chills, or do not feel well.
  • Low potassium, which can affect your heart rhythm if severe. Your doctor should do blood tests to check your potassium levels before you start and during treatment with FYARRO.
  • Increased blood sugar levels in blood. Your doctor should do blood tests before you start and during treatment with FYARRO. Diabetic patients should monitor their blood sugar more frequently.
  • Lung inflammation. If you develop a persistent cough, chest pain, or shortness of breath, tell your doctor right away.
  • Bleeding, which can lead to death. If you develop bleeding, tell your doctor right away.
  • Allergic reactions, which can be severe and life-threatening. Tell your doctor or get medical help right away if you develop swelling of your face, lips, tongue, or throat; a rash, itching, or flushing of your skin; hives; difficulty breathing or swallowing; chest pain; or dizziness.
  • Harm to an unborn baby. Tell your doctor right away if you become pregnant or think you might be pregnant during treatment with FYARRO. Exposure to FYARRO during pregnancy or within 12 weeks before becoming pregnant can cause harm to your baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with FYARRO. Birth control should be used while receiving FYARRO and for 12 weeks after your last dose of FYARRO. Men with a female partner should use effective birth control during treatment and for 12 weeks after the last dose of FYARRO.
  • Infertility in woman and men. FYARRO may affect your ability to become pregnant if you are female, or your ability to father a child if you are male.
  • Vaccinations may be less effective while being treated with FYARRO. In addition, you should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with FYARRO.

Before taking FYARRO, tell your doctor if you are breast feeding. It is not known if FYARRO could pass into breast milk and harm your baby. You should not breast feed during treatment with FYARRO and for 2 weeks after the last dose. Tell your doctor about all your medical conditions and the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using FYARRO with certain other medicines can cause serious side effects. Tell your doctor before you start taking any new medicine. You should not drink grapefruit juice or eat grapefruit during your treatment with FYARRO. It may make the amount of FYARRO in your blood increase to a harmful level.

The most common side effects with FYARRO include the following: mouth ulcers or sores; feeling weak or tired; rash; infection; nausea; swelling of arms, hands, feet, ankles, face, or other parts of the body; diarrhea; body pain; decreased weight and appetite; cough; vomiting; and altered taste.

These are not all the possible side effects of FYARRO. Tell your doctor if you have any side effect that bothers you or does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.

INDICATION

FYARRO® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat adults with malignant perivascular epithelioid cell tumors (PEComa) that have spread to other parts of the body (metastatic) or cannot be removed by surgery (locally advanced, unresectable). It is not known if FYARRO is safe and effective in people with severe liver problems or in children.

INDICATION
IMPORTANT SAFETY INFORMATION

Do not use FYARRO if you have had a severe allergic reaction to sirolimus or other medications that work similarly to sirolimus (eg, everolimus, temsirolimus), or human albumin.

FYARRO can cause the following serious side effects; depending on the severity, your doctor may decide to decrease your dose or stop treatment with FYARRO:

  • Mouth ulcers and sores are common during treatment with FYARRO and can be severe. If you develop pain, discomfort, or open sores in your mouth, tell your doctor.
  • Decreased blood cell counts (red blood cells, platelets, and white blood cells). Your doctor should do blood tests before you start and during treatment with FYARRO.
  • Infections. FYARRO can make you more susceptible to infections. Tell your doctor right away if you develop a fever, chills, or do not feel well.
  • Low potassium, which can affect your heart rhythm if severe. Your doctor should do blood tests to check your potassium levels before you start and during treatment with FYARRO.
  • Increased blood sugar levels in blood. Your doctor should do blood tests before you start and during treatment with FYARRO. Diabetic patients should monitor their blood sugar more frequently.
  • Lung inflammation. If you develop a persistent cough, chest pain, or shortness of breath, tell your doctor right away.
  • Bleeding, which can lead to death. If you develop bleeding, tell your doctor right away.
  • Allergic reactions, which can be severe and life-threatening. Tell your doctor or get medical help right away if you develop swelling of your face, lips, tongue, or throat; a rash, itching, or flushing of your skin; hives; difficulty breathing or swallowing; chest pain; or dizziness.
  • Harm to an unborn baby. Tell your doctor right away if you become pregnant or think you might be pregnant during treatment with FYARRO. Exposure to FYARRO during pregnancy or within 12 weeks before becoming pregnant can cause harm to your baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with FYARRO. Birth control should be used while receiving FYARRO and for 12 weeks after your last dose of FYARRO. Men with a female partner should use effective birth control during treatment and for 12 weeks after the last dose of FYARRO.
  • Infertility in woman and men. FYARRO may affect your ability to become pregnant if you are female, or your ability to father a child if you are male.
  • Vaccinations may be less effective while being treated with FYARRO. In addition, you should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with FYARRO.

Before taking FYARRO, tell your doctor if you are breast feeding. It is not known if FYARRO could pass into breast milk and harm your baby. You should not breast feed during treatment with FYARRO and for 2 weeks after the last dose. Tell your doctor about all your medical conditions and the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using FYARRO with certain other medicines can cause serious side effects. Tell your doctor before you start taking any new medicine. You should not drink grapefruit juice or eat grapefruit during your treatment with FYARRO. It may make the amount of FYARRO in your blood increase to a harmful level.

The most common side effects with FYARRO include the following: mouth ulcers or sores; feeling weak or tired; rash; infection; nausea; swelling of arms, hands, feet, ankles, face, or other parts of the body; diarrhea; body pain; decreased weight and appetite; cough; vomiting; and altered taste.

These are not all the possible side effects of FYARRO. Tell your doctor if you have any side effect that bothers you or does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATION

FYARRO® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat adults with malignant perivascular epithelioid cell tumors (PEComa) that have spread to other parts of the body (metastatic) or cannot be removed by surgery (locally advanced, unresectable). It is not known if FYARRO is safe and effective in people with severe liver problems or in children.