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Brentuximab vedotin

(bren-tuk-suh-mab veh-doe-tun)

Trade/other name(s): Adcetris

Why would this drug be used?

This drug is used to treat Hodgkin lymphoma (Hodgkin disease) and a type of non-Hodgkin lymphoma known as anaplastic large cell lymphoma (ALCL), when other treatments have been tried and are no longer working. This drug is also being studied for use in other types of cancer.

How does this drug work?

Brentuximab vedotin is a type of drug known as an antibody-drug conjugate. It has 2 parts. The first is a monoclonal antibody (a man-made version of an immune system protein) that specifically attaches to the CD30 antigen, a protein found on the surface of certain lymphoma cells. The second part is a chemotherapy drug known as monomethyl auristatin E (MMAE), which is thought to work by interfering with microtubules, part of the internal scaffolding needed by cells when they are dividing into 2 cells.

The antibody acts like a homing signal, bringing the chemotherapy drug to the lymphoma cells, where it enters the cells and causes them to die when they try to divide.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any type of kidney disease or liver disease, such as hepatitis or cirrhosis. Both the kidneys and the liver remove this drug from the body. If kidney or liver disease causes more of the drug to stay in the body, it might lead to more side effects.
  • If you have any other medical conditions such as heart disease, congestive heart failure, diabetes, gout, or infections. Your doctor may need to monitor you more closely during treatment.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug might cause problems if either the male or female is taking it at the time of conception or during pregnancy. Men and women who will be taking this drug should talk with their doctor about birth control, including what kinds of birth control can be used with this medicine. This drug should be used during pregnancy only if the potential benefit is thought to justify the potential risk to the fetus.
  • If you are breast-feeding. Although no studies have been done, this drug might pass into breast milk and affect the baby. Breast-feeding is not recommended during treatment with this drug.
  • If you think you might want to have children in the future. This drug may affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Brentuximab vedotin can interact with a number of drugs and supplements, so it is important to check with your health care team before taking any new medicines.

The following drugs and supplements can lower the levels of brentuximab vedotin in the blood and might make it less effective:

  • Anti-seizure drugs, such as carbamazepine (Tegretol), phenobarbital (Solfoton), and phenytoin (Dilantin)
  • Drugs to treat tuberculosis (TB), such as rifampin (Rifadin, Rimactane; also in Rifamate and Rifater), rifabutin (Mycobutin), and rifapentine (Prifin)
  • The steroid drug dexamethasone (Decadron)
  • St. John's wort (herbal dietary supplement)

Some drugs and supplements could cause brentuximab vedotin to build up in your blood, which might worsen side effects and other problems:

  • Some antibiotics, such as erythromycin, clarithromycin (Biaxin), telithromycin (Ketek), and similar drugs
  • Anti-fungal medicines such as ketoconazole (Nizoral), itraconazole (Sporanox), and voriconazole (Vfend)
  • Some anti-depressant drugs, such as nefazodone (Serzone)
  • Anti-HIV drugs such as indinavir (Crixivan), ritonavir (Kaletra), nelfinavir (Viracept), atazanavir (Reyataz), saquinavir (Invirase), and others

If you need to take any of these drugs, your doctor may need to watch you closely for possible side effects. Do not start or stop taking any of these medicines while on brentuximab vedotin without talking with the prescribing doctor(s) about all of the medicines you take, including brentuximab vedotin.

Other medicines or supplements may affect blood levels of brentuximab vedotin. Make sure your doctor is aware of all drugs and supplements you are taking.

This drug should not be given along with the chemotherapy drug bleomycin. Bleomycin can cause lung damage in some people who get it, and brentuximab vedotin increases the risk of this side effect.

Check with your doctor, nurse, or pharmacist about any other medicines, herbs, and supplements you are taking, and whether alcohol can cause problems with this medicine.

Interactions with foods

Grapefruit and grapefruit juice might affect the amount of brentuximab vedotin in the body. Check with your doctor, nurse, or pharmacist about whether you should avoid these, and whether any other specific foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

This drug is given as an infusion into a vein (IV), usually over about 30 minutes. It is given once every 3 weeks, unless it is no longer working or the side effects become too severe, for up to a maximum of 16 doses. The dose given is based on your body weight.

The next dose may need to be delayed and/or the dose reduced if you have side effects such as nerve damage (peripheral neuropathy) or low white blood cell counts. The drug may need to be stopped permanently if you have more serious side effects.

Precautions

This drug may interact with a number of other drugs or supplements in the body. (See "Interactions" above.) Be sure your doctor knows about all of the drugs and supplements you are taking. Do not start or stop taking any drug without talking to your doctor about all of them.

This drug can damage nerves (called neuropathy), which can cause numbness, tingling, burning sensations, weakness, sensitivity to hot and cold, or even pain in the hands or feet. This can be more of a problem in someone who had diabetes or neuropathy before treatment is started. Tell your doctor if you notice any of these symptoms, as your next treatment dose may need to be delayed and/or reduced. Neuropathy may get better over time, but in some people the symptoms may not go away.

This drug may cause allergic reactions in some people while the drug is being given. Mild reactions usually consist of fever and chills. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), fainting, headache, feeling warm or flushed, fever or chills, hives, itching, shortness of breath, changes in heart rate, pain the back or abdomen, or swelling of the face, tongue, or throat. Tell your doctor or nurse right away if you notice any of these symptoms during or after being given the drug.

Your doctor will probably test your blood throughout your treatment, looking for effects of the drug on blood counts or on blood chemistry levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it completely. Be sure to keep all your appointments for lab tests and doctor visits.

Serious (sometimes life-threatening) infections may occur in patients taking this drug because of low white blood cell counts. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5° or higher), chills, pain when passing urine, a new cough, diarrhea, or bringing up sputum. Do not get any immunizations (vaccinations), either during or after treatment with this drug, without your doctor's OK.

This drug may lower your red blood cell count. If this occurs, it is usually a few months after starting treatment. A low red blood cell count (known as anemia) can cause shortness of breath, or make you feel weak or tired all the time. Your doctor may give you medicines to help prevent or treat this condition, or you may need to get blood transfusions.

This drug may lower your platelet count in the weeks after it is given, which can increase your risk of bleeding. Talk with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

This drug may rapidly kill many tumor cells within the first few days of treatment. When the cells die, their contents spill into the blood, changing the levels of certain chemicals. This is known as tumor lysis syndrome, and it can lead to serious kidney damage and heart problems. It is more likely to occur if you have a very large number of cancer cells in the body. If your doctor feels you might be at risk, he or she will give you medicines and/or fluids to help prevent this. If you notice pain in the back or sides of your chest, or see blood in your urine, let your doctor or nurse know right away.

This drug may rarely cause a fast-spreading rash and blistering or peeling of the skin (usually on the hands), sometimes along with swelling or sores in the mouth. This condition, known as Stevens-Johnson syndrome, can be severe or even life-threatening. Tell your doctor or nurse right away if you notice any new rashes, blistering or peeling of the skin, or mouth sores or swelling.

Use of this drug has been linked to a rare brain disease known as progressive multifocal leukoencephalopathy (PML). This disease is caused by a virus and occurs in people with poor immune function. It can lead to seizures, headache, high blood pressure, confusion or change in mental status, loss of vision, and even death. Call your doctor or nurse right away if you have any of these symptoms.

Possible side effects

Most of the following side effects probably will not occur. Your doctor or nurse will want to discuss specific care instructions with you. They can help you understand these side effects and help you deal with them.

Common

  • Decreased white blood cell count with increased risk of infection*
  • Numbness, tingling, burning, or pain in the hands or feet (neuropathy)*
  • Feeling tired
  • Upper respiratory infection
  • Fever
  • Nausea or vomiting
  • Diarrhea
  • Low red blood cell count (anemia)*
  • Decreased platelet count with increased risk of bleeding*
  • Rash
  • Cough
  • Abdominal (belly) pain

Less common

  • Skin itching
  • Headache
  • Constipation
  • Shortness of breath
  • Feeling dizzy
  • Chills
  • Hair loss
  • Swollen lymph nodes
  • Swelling in the hands or feet
  • Loss of appetite
  • Weight loss
  • Trouble sleeping
  • Night sweats
  • Feeling anxious
  • Dry skin
  • Mouth or throat pain
  • Joint or muscle pain
  • Back pain

Rare

  • Allergic reaction during the infusion*
  • Severe skin reactions*
  • Tumor lysis syndrome*
  • Brain disorder (progressive multifocal leukoencephalopathy)*
  • Blood clot in the lungs
  • Inflammation in the lungs
  • Inflammation in the kidneys
  • Serious blood infection
  • Abnormal heart rhythm
  • Urinary tract infection

*See the Precautions section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2011

Disclaimer: This information may not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 08/24/2011
Last Revised: 01/18/2012