ADCETRIS® (brentuximab vedotin) treatment in relapsed systemic anaplastic large cell lymphoma (sALCL)

ADCETRIS is indicated for treatment of people with sALCL after failure of at least 1 prior combination of chemotherapy medicines. The effectiveness of ADCETRIS in sALCL is based on studies in which people’s tumors became smaller. The sALCL study was not designed to show whether or not ADCETRIS can help people live longer or feel better.



If systemic anaplastic large cell lymphoma comes back, what are my options?

Coping with cancer that comes back after therapy can be difficult. Fortunately, today there may be different therapy options that can help. ADCETRIS was approved in 2011 specifically for treating relapsed systemic anaplastic large cell lymphoma (sALCL).

By now, your treatment may have consisted of many steps, including chemotherapy, radiation, and perhaps even a stem cell transplant (SCT). It’s okay to feel concerned about starting another therapy. The good news is that ADCETRIS was studied in and approved for people with sALCL who have experienced at least one multiagent chemotherapy that did not work.

About systemic anaplastic large cell lymphoma (sALCL)

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.

PROPERTIES OF sALCL TUMORS

Anaplastic large cell lymphoma is a type of lymphoma characterized by hallmark cells with a unique kidney-shaped nucleus. The term anaplastic refers to this irregular shape. sALCL specifically affects the lymph nodes and internal organs.

Initial treatment is not always successful in sALCL

Many patients with sALCL will go into remission with initial chemotherapy. However, for some people, initial treatment (or frontline therapy) may not work to control tumor growth. In this case the disease is called refractory. Another possibility is that their disease responds to treatment but then relapses, or returns. After relapse, it is still possible to respond to other types of treatment.

The different kinds of progressive treatment options are referred to as lines of therapy. The first line is the option selected based on evidence that it is most likely to succeed in the majority of patients. The next option selected is called second-line, and so on.

A stem cell transplant is an option for many patients

For second-line treatment, some people may receive more rounds of chemotherapy. After this, some people may undergo an autologous stem cell transplant (auto-SCT). In auto-SCT, blood-forming stem cells are taken from your own marrow, treated, and then returned to you. In other cases, an allogeneic SCT (allo-SCT) may be possible. In allo-SCT, the bone marrow of a person is replenished with matched donor cells. Allo-SCT can be more complex and may not be an option for everyone.

Before considering a transplant, you should work closely with your doctor to fully understand the benefits and risks of the procedure, how it fits into your treatment plan, and which therapy options are available in the event of relapse.

ADCETRIS is FDA approved to treat relapsed sALCL

ADCETRIS is used after at least 1 previous treatment when a combination of chemotherapy medicines did not work. The effectiveness of ADCETRIS in sALCL is based on studies in which people’s tumors became smaller. The sALCL study was not designed to show whether or not ADCETRIS can help people live longer or feel better.

Please see Important Safety Information, including BOXED WARNING, and read full Prescribing Information.

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Important Safety Information
Important Safety Information

Indications

ADCETRIS is approved in the following settings:

  • Relapsed classical Hodgkin lymphoma (HL): Classical HL after a stem cell transplant (SCT) fails or after 2 multiagent chemotherapy regimens fail and SCT is not an option
  • Consolidation therapy in HL: Classical HL at high risk of coming back or becoming worse after SCT
  • Relapsed systemic anaplastic large cell lymphoma (sALCL): sALCL after a multiagent chemotherapy regimen fails

The effectiveness of ADCETRIS in sALCL is based on studies in which patients’ tumors became smaller. The sALCL study was not designed to show whether or not ADCETRIS could help patients live longer or feel better.

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. 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).
  • Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to avoid pregnancy during, and for at least 6 months after final 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?

  • 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-10881-800-FDA-1088.

Please see Important Safety Information, including BOXED WARNING, and read full Prescribing Information.

Important Safety Information
Important Safety Information

Indications

ADCETRIS is approved in the following settings:

  • Relapsed classical Hodgkin lymphoma (HL): Classical HL after a stem cell transplant (SCT) fails or after 2 multiagent chemotherapy regimens fail and SCT is not an option
  • Consolidation therapy in HL: Classical HL at high risk of coming back or becoming worse after SCT
  • Relapsed systemic anaplastic large cell lymphoma (sALCL): sALCL after a multiagent chemotherapy regimen fails

The effectiveness of ADCETRIS in sALCL is based on studies in which patients’ tumors became smaller. The sALCL study was not designed to show whether or not ADCETRIS could help patients live longer or feel better.

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. 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).
  • Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to avoid pregnancy during, and for at least 6 months after final 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?

  • 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-10881-800-FDA-1088.