In relapsed classical Hodgkin lymphoma, ADCETRIS® (brentuximab vedotin) injection for intravenous infusion is indicated for use:

  • After failure of a stem cell transplant
  • For patients who are unable to receive a transplant after failure with at least 2 previous treatments with combinations of chemotherapy medicines

About Classical Hodgkin Lymphoma

Lymphoma is a general term that describes blood cancers that form in the lymphatic system. They occur when a type of white blood cell, called a lymphocyte, grows abnormally. Cancerous lymphocytes can travel to many parts of the body, such as the lymph nodes, spleen, bone marrow, or blood, and can build up to form tumors.

Classical Hodgkin lymphoma is one of several lymphoma subtypes. Classical Hodgkin lymphoma tumors are characterized by a specific type of abnormal lymphocyte, called a Reed-Sternberg cell, that is typically recognized upon diagnosis.

CD30 is a protein found on cancer cells in Classical Hodgkin Lymphoma (HL)

Classical Hodgkin lymphoma tumors are made up of dense groups of normal cells packed around cancerous Reed-Sternberg cells. A protein called CD30 is found on the surface of most Reed-Sternberg cells but is not commonly found on healthy cells. ADCETRIS® (brentuximab vedotin) is designed to target cells with CD30.

Many patients with classical Hodgkin lymphoma will go into remission with initial chemotherapy and radiation. However, for some patients, initial treatment fails to control tumor growth, in which case the disease is said to be "refractory." Another possibility is that disease responds to treatment but then returns, a scenario known as "relapse." After relapse, it is still possible to have a response with other types of treatment. Some patients may receive more rounds of chemotherapy. Some patients may undergo a stem cell transplant, a process in which healthy cells are given to a patient after high doses of chemotherapy in an attempt to eliminate the lymphoma.

Indications

  • In classical Hodgkin lymphoma (HL), ADCETRIS is indicated for use in patients with classical HL at high risk of relapse or progression as consolidation treatment after stem cell transplantation.
  • ADCETRIS is indicated for the treatment of patients with classical HL after failure of a stem cell transplant, or for patients with classical HL who are unable to receive a stem cell transplant and have previously failed at least 2 treatments with combinations of chemotherapy medicines.
  • In systemic anaplastic large cell lymphoma (sALCL), ADCETRIS is indicated for use after failure with at least 1 previous treatment with a combination of chemotherapy medicines.

The effectiveness of ADCETRIS in sALCL is based on studies in which patients’ tumors became smaller. Currently, it is not known whether or not ADCETRIS helps patients feel better or live longer.

Important Safety Information

What is the Most Important Serious Safety Information I Should Know About ADCETRIS (brentuximab vedotin)?

  • 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. 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: Stomach and intestine problems, 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?

ADCETRIS was studied by itself in 160 patients in two clinical trials in patients with relapsed classical HL and relapsed sALCL. Across both trials, the most common side effects were a low number of white blood cells, tingling or numbness in the hands or feet, feeling tired, nausea, a low number of red blood cells, an infection in the upper respiratory tract, diarrhea, fever, rash, a low number of platelets (which help the blood clot), cough, and vomiting.

ADCETRIS was studied in a trial with 329 patients with classical HL at high risk of relapse or progression after 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.

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 or other liver problems.
  • 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° 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 pancreatitis: Severe abdominal pain.
  • Symptoms of lung problems: New or worsening cough or shortness of breath.
  • Symptoms of GI problems: Severe stomach pain, chills, fever, nausea, vomiting, or diarrhea.
  • Pregnancy: Pregnant or breastfeeding women should not receive ADCETRIS.
  • 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.


For additional Important Safety Information, including BOXED WARNING, please see the full Prescribing Information for ADCETRIS.