ADCETRIS is indicated for use in patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as consolidation treatment after an autologous hematopoietic stem cell transplantation.
Important Safety Information
Progressive multifocal leukoencephalopathy (PML): A rare but serious infection of the brain that can lead to death and can occur in patients receiving ADCETRIS® (brentuximab vedotin).
What other therapies should I not be on with ADCETRIS?
You should not receive ADCETRIS if you are taking bleomycin because of possible side effects in the lungs.
Warnings and Precautions
Peripheral neuropathy: ADCETRIS treatment causes peripheral neuropathy that mostly involves numbness or tingling in the hands or feet. Some patients have had weakness in their arms or legs. These symptoms increase with more doses of ADCETRIS. Your doctor should check regularly for symptoms and change or stop your ADCETRIS dose if necessary.
Anaphylaxis and infusion reactions: Some patients have had allergic reactions during an ADCETRIS infusion. Some patients had more severe forms of this reaction. Your doctor will watch you closely during infusion. If an infusion reaction occurs, the infusion should be stopped and any symptoms treated. If a severe reaction occurs, the infusion should be stopped immediately and permanently and any symptoms treated.
Hematologic toxicities: Severe neutropenia (low number of white blood cells) that lasts a week or more, Grade 3 or 4 thrombocytopenia (low number of platelets, which help the blood clot), and anemia (low number of red blood cells) can occur with ADCETRIS. Neutropenia with fever has been reported with ADCETRIS. Your doctor will check your blood counts before each dose. If your white blood cell count gets too low (Grade 3 or 4 neutropenia), your doctor may check your blood count more often. He or she will watch you closely for a fever. If you develop Grade 3 or 4 neutropenia, 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.
Serious infections and opportunistic infections: Infections that occur when your immune system is weakened, such as pneumonia, bacteremia, and sepsis or septic shock (including deaths), have been reported in patients treated with ADCETRIS. Your doctor will watch you closely for infections.
Tumor lysis syndrome: If you have a tumor that grows quickly or if there are many tumor cells throughout your body, your doctor will watch you closely for symptoms.
Increased toxicity in the presence of severe renal impairment: Patients with severe kidney disease may have more side effects and deaths compared to patients with normal kidney function. Use of ADCETRIS should be avoided in patients with severe kidney disease.
Increased toxicity in the presence of moderate or severe hepatic impairment: Patients with moderate or severe liver disease may have more side effects and deaths compared to patients with normal liver function. Use of ADCETRIS should be avoided in patients with moderate or severe liver disease.
Hepatotoxicity: Liver problems (including deaths) have been reported in patients after the first dose of ADCETRIS and after ADCETRIS is stopped and restarted. Having liver problems, raised liver enzymes, and some medicines may increase the risk. Your doctor will perform tests to check your liver function and may delay your next infusion, lower your dose or stop your ADCETRIS therapy if you have liver problems.
Progressive multifocal leukoencephalopathy (PML): This rare but serious infection of the brain can lead to death and has been reported in ADCETRIS-treated patients. Cases occurred at different times from the start of ADCETRIS therapy, and some occurred within 3 months. In addition to ADCETRIS therapy, other possible causes include previous therapies and diseases that may weaken your immune system. Your doctor may delay your next infusion and perform tests if he or she thinks you might have PML. Your doctor will stop your ADCETRIS therapy if PML is confirmed.
Pulmonary toxicity: Lung problems, including deaths, have been reported in patients treated with ADCETRIS. If you have new or worsening signs of lung problems, such as cough or shortness of breath, tell your doctor. If you have symptoms, your doctor may hold your ADCETRIS therapy until your symptoms improve.
Serious dermatologic reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), rare but serious skin conditions (including deaths), have been reported with ADCETRIS. If either occurs, your doctor will stop ADCETRIS and treat you for symptoms.
Embryo-fetal toxicity: ADCETRIS can harm an unborn baby. Women should not become pregnant while taking ADCETRIS. If you are pregnant or if you become pregnant while on therapy, tell your doctor right away.
ADCETRIS was studied in a trial with 329 patients with classical HL at high risk of relapse or progression after autologous hematopoietic stem cell transplantation. The most common side effects in patients who received ADCETRIS (167 patients) were a low number of white blood cells, tingling or numbness in the hands or feet, a low number of platelets (which help the blood clot), a low number of red blood cells, an infection in the upper respiratory tract, feeling tired, trouble moving the hands or feet, nausea, cough, and diarrhea.
It is possible for ADCETRIS to interact with certain types of drugs. Make sure you tell your doctor everything you are taking.
Use in Specific Populations:
The amount of the drug part of ADCETRIS (MMAE) and side effects are higher in patients with moderate or severe liver or severe kidney disease. Use of ADCETRIS should be avoided in these patients.
Any suspected side effects should be reported to Seattle Genetics, Inc., at 855.473.2436 or the FDA at 800.FDA.1088 or www.fda.gov/medwatch.