For US audiences only
Non-US residents
US Patient Site
Full Prescribing Information
Other approved uses of ADCETRIS
NOW APPROVED FOR
pcALCL or CD30-EXPRESSING MF
ADULT PATIENTS AFTER PRIOR SYSTEMIC THERAPY
NOW APPROVED FOR
pcALCL or
CD30-EXPRESSING MF
ADULT PATIENTS AFTER
PRIOR SYSTEMIC THERAPY
ADCETRIS® (brentuximab vedotin) is approved to treat adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (treatment that reaches and affects the entire body).1
Other approved uses of ADCETRIS
IMPORTANT SAFETY INFORMATION,
BOXED WARNING AND INDICATIONS
IMPORTANT SAFETY INFORMATION
What is the most important serious safety information I should know about ADCETRIS® (brentuximab vedotin) for injection?
  • PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): A rare but serious infection of the brain that can lead to death and can occur in ADCETRIS-treated patients. Cases occurred at different times from the start of ADCETRIS therapy, some within 3 months after the first dose. Possible causes other than ADCETRIS-treatment include previous therapies and diseases that may weaken your immune system.
  • ADCETRIS should not be taken with bleomycin because of possible side effects in the lungs.

What are the other possible serious side effects of ADCETRIS?
  • Nerve damage: Peripheral neuropathy (nerve damage) that 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 your ADCETRIS dose depending on the severity of your symptoms.
  • Allergic and infusion reactions: Allergic reactions, including severe forms, during infusion or up to 24 hours after administration of ADCETRIS. Patients who had a reaction with earlier doses should receive premedication with later doses, which may include acetaminophen, an antihistamine, and a corticosteroid.
  • Blood problems: Low number of white blood cells lasting a week or more, with or without fever. Low number of platelets (which help the blood clot) and low number of red blood cells. 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 ADCETRIS therapy, or give you a medicine called growth factor with future doses of ADCETRIS.
  • Infections: Serious infections that occur when your immune system is weakened, such as pneumonia, bacteremia, and sepsis or septic shock (including deaths).
  • Tumor lysis syndrome (TLS): You will be closely monitored for TLS if you have a tumor that grows quickly or have many tumor cells throughout your body.
  • Patients with severe kidney disease may have more side effects and deaths compared to patients with normal kidney function and should avoid use of ADCETRIS.
  • Patients with moderate or severe liver disease may have more side effects and deaths compared to patients with normal liver function and should avoid use of ADCETRIS.
  • Liver injury: Liver problems (including deaths) have been reported after the first dose of ADCETRIS and after ADCETRIS 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 your ADCETRIS therapy if you have liver problems.
  • Lung problems: Lung problems, including deaths, have been reported. If you have symptoms, your doctor may hold your ADCETRIS therapy until they improve.
  • Skin problems: Rare but serious skin conditions (including deaths) called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If either occurs, your doctor will stop ADCETRIS and treat you for symptoms.
  • Gastrointestinal (GI) problems: Problems related to the pancreas, stomach, intestine, and colon, including deaths, have been reported. Lymphoma that involves the stomach or intestine may increase the risk of GI perforation (hole in the stomach or intestine).
  • Fetal harm: ADCETRIS can harm a fetus (unborn baby). Women should not become pregnant while taking ADCETRIS and for at least 6 months after the last dose of ADCETRIS.

What were the most common side effects in clinical trials?
In 393 patients treated with ADCETRIS in four clinical trials, the most common side effects were tingling or numbness in the hands or feet, feeling tired, nausea, diarrhea, a low number of white blood cells, infection in the upper respiratory tract, and fever.

What should I tell my doctor before I start treatment with ADCETRIS® (brentuximab vedotin) for injection?
  • Tell your doctor about all of your medical conditions. ADCETRIS should be avoided if you have severe kidney disease or moderate or severe liver disease.
  • Tell your doctor about any medicine you are taking (including over-the-counter drugs, vitamins, and herbal supplements) because it is possible for ADCETRIS to interact with certain types of drugs.
  • Tell your doctor if you are pregnant or plan to become pregnant. You should not take ADCETRIS while pregnant or breastfeeding.
  • Women should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.
  • Men with female partners should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.

Contact your doctor if you experience any of the following:
  • Symptoms of nerve damage: Tingling, burning, or numbness in the hands or feet. Changes in sense of touch or trouble moving the hands or feet.
  • Symptoms of infection: Fever of 100.5°F or higher, chills, cough, or pain upon urination.
  • Symptoms of infusion reaction: Fever, chills, rash, or breathing problems within 24 hours of infusion.
  • Symptoms of liver injury: Fatigue, anorexia, upper stomach pain, dark urine, yellowing of the skin and eyes (jaundice).
  • Symptoms of PML: Changes in mood or usual behavior. Confusion, thinking problems, or loss of memory. Changes in vision, speech, or walking. Decreased strength or weakness on one side of the body.
  • Symptoms of lung problems: New or worsening cough or shortness of breath.
  • Symptoms of acute pancreatitis: Severe abdominal pain.
  • Symptoms of GI problems: Severe stomach pain, chills, fever, nausea, vomiting, or diarrhea.
  • Pregnancy: Pregnant or breastfeeding women should not receive ADCETRIS. ADCETRIS can harm a fetus (unborn baby).
  • Any other side effects that are bothersome or do not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.
INDICATION
ADCETRIS® (brentuximab vedotin) is approved to treat adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (treatment that reaches and affects the entire body).1
For additional Important Safety Information, including BOXED WARNING, please see the full Prescribing Information for ADCETRIS.
Reference
1. ADCETRIS [Prescribing Information]. Bothell, WA: Seattle Genetics, Inc.; November 2017.
Learn about other approved uses of ADCETRIS
I am a healthcare provider in the US
I am a patient in the US
I am a healthcare provider in Canada
I am a healthcare provider outside of US/Canada
You are now leaving AdcetrisUpdate.com
Do you wish to continue?
Continue
Stay on page
I am a healthcare provider
In Canada
Outside of US/Canada