Brentuximab vedotin

Brentuximab vedotin is a prescription medication used to treat certain types of lymphoma. 

This medication belongs to a group of drugs called antibody-drug conjugates. It attaches to and enters cancer cells and kills them.

Brentuximab vedotin comes in an injectable form to be given directly into a vein and infused over 30 minutes by a healthcare provider. It is usually injected once every 3 weeks.

Common side effects include tiredness, nausea, and diarrhea.

Brentuximab vedotin is a prescription medication used to treat stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.

This medication is also approved to treat patients with Hodgkin's lymphoma:

• who did not respond to a stem cell transplant (a procedure that replaces diseased bone marrow with healthy bone marrow), or
• patients who are not a candidate for stem cell transplant and did not respond to at least two treatment periods of chemotherapy 

Brentuximab vedotin is also used to treat systemic anaplastic large cell lymphoma (sALCL; a type of non-Hodgkin lymphoma) who did not respond to a previous chemotherapy regimen. 

Brentuximab vedotin is also used to treat primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have tried a certain type of therapy.

Brentuximab vedotin may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Brentuximab vedotin may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Brentuximab vedotin may be found in some form under the following brand names:

• Adcetris

Common side effects include:

• tiredness
• nausea
• diarrhea
• low white blood cell counts
• anemia
• tingling sensation

This is not a complete list of brentuximab vedotin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• clarithromycin (Biaxin)
• indinavir (Crixivan)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• nefazodone, nelfinavir (Viracept)
• rifampin (Rifadin, in Rifamate, in Rifater, Rimactane)
• ritonavir (Norvir)
• bleomycin

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have occurred with the use of brentuximab vedotin.

• Nerve damage. This nerve damage mostly involves numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor). Symptoms increase with more doses. Your doctor may change or stop brentuximab vedotin depending on the severity of your symptoms.
• Infection in the brain. Brentuximab vedotin may increase the risk that you will develop progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented or cured and that usually causes death or severe disability). Tell your doctor if you have or have ever had a condition that affects your immune system. Tell your doctor and pharmacist if you are taking any medications that suppress the immune system. If you experience any of the following symptoms, stop receiving brentuximab vedotin and call your doctor immediately: decreased strength or weakness on one side of the body; difficulty walking; loss of coordination; headache; confusion; difficulty thinking clearly; memory loss; changes in mood or usual behavior; difficulty speaking; or vision problems.
• Infections. These may include pneumonia, bacteremia, and sepsis. Tell your doctor if you notice a fever, chills, cough, or other signs of infection. 
• Blood problems: Brentuximab vedotin may lead to a decrease in the number of blood counts. Brentuximab vedotin may lead to low numbers of red blood cells, low numbers of white blood cells. Your doctor will give you a medicine called growth factor with your first dose if you are receiving brentuximab vedotin in combination with chemotherapy for the treatment of advanced cHL. Your blood counts will be checked before each dose, more often if necessary. You will be monitored for fever. If your white blood cell count is too low, your doctor may delay your next infusion, lower your dose, stop your brentuximab vedotin therapy, or give you growth factor with future doses of brentuximab vedotin.
• Serious allergic reactions. Brentuximab vedotin may cause serious allergic reactions, which usually occur during the infusion of the medication or within 24 hours of receiving a dose. You may receive certain medications before your infusion to prevent an allergic reaction if you had a reaction to a previous treatment. Your doctor will watch you carefully while you are receiving brentuximab vedotin. If you experience any of the following symptoms, tell your doctor immediately: fever, chills, rash, hives, itching, or difficulty breathing.
• Liver injury: Liver problems (including deaths) have been reported after the first dose of brentuximab vedotin  and after brentuximab vedotin was stopped and restarted. Your liver function will be monitored. Having liver problems, raised liver enzymes, and some medicines may increase the risk. Your doctor may delay your next infusion, lower your dose, or stop brentuximab vedotin if you have liver problems.
• Skin problems. Although rare, skin conditions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), may occur. These conditions are serious. If either occurs, your doctor will stop brentuximab vedotin and treat you for symptoms. 
• Harm to your unborn baby. It is recommended women do not become pregnant while taking this medication and for at least 6 months after the last dose of brentuximab vedotin. 

Do not take brentuximab vedotin if you are:

• allergic to this medication
• are also taking bleomycin

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before receiving brentuximab vedotin, tell your doctor and pharmacist if you:

• are allergic to brentuximab vedotin, any other medications, or any of the ingredients in brentuximab vedotin. 
• have liver problems
• have kidney problems
• are receiving bleomycin. Your doctor will probably tell you not to use brentuximab if you are receiving this medication.
• are pregnant, plan to become pregnant, or are breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

This medication can cause harm to your unborn baby. As a result, it is recommended women use effective birth control while taking brentuximab vedotin. 

It is recommended women do not become pregnant while taking this medication and for at least 6 months after the last dose of brentuximab vedotin.

Men with female partners should use effective birth control while taking this medication and for at least 6 months after the final dose of brentuximab vedotin.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if brentuximab vedotin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. You should not do both. 

Brentuximab vedotin comes as a powder to be mixed with fluid and injected over 30 minutes intravenously (into a vein) by a healthcare professional.

It is usually injected once every 3 weeks. This treatment period is called a cycle, and the cycle may be repeated up to 16 times.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

The recommended dose range is 1.2 mg/kg to 1.8 mg/kg (up to a maximum of 180 mg) infused over 30 minutes every 3 weeks. 

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to brentuximab vedotin injection.

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

JC virus infection resulting in PML and death can occur in patients receiving this medication.