ADCETRIS® (brentuximab vedotin) dose modifications in relapsed classical Hodgkin lymphoma (HL)

How is ADCETRIS given?

ADCETRIS is given as an intravenous infusion. Each infusion takes about 30 minutes and is given every 3 weeks. You will get your ADCETRIS infusion at a doctor’s office or clinic.

The dose of ADCETRIS is calculated based on your weight. If you have mild liver disease, your doctor may give you a smaller dose of ADCETRIS. People with moderate or severe liver disease or severe kidney disease should avoid using ADCETRIS.

How long will I keep taking ADCETRIS?

  • ADCETRIS may be given until disease progresses, relapses, or there are side effects that outweigh the potential benefits of therapy
    • In the relapsed classical HL study, people received ADCETRIS for up to 1 year (The average length of therapy was 27 weeks)
    • If you continue to respond well and tolerate ADCETRIS therapy, you may continue therapy beyond 1 year
  • Work with your doctor to decide what your therapy plan is and be sure to always discuss changes in therapy strategy if they occur

If ADCETRIS is working for you, continue therapy as long as side effects remain manageable.

Why might my doctor change or stop my ADCETRIS therapy?

Side effects sometimes cause people to stop therapy earlier than planned. Your doctor might need to delay giving you your next dose or give you a smaller dose of ADCETRIS until your symptoms improve.

In cases where side effects are severe or do not improve, you might need to stop taking ADCETRIS completely. It is important to tell your healthcare team as soon as possible about any symptoms that develop.

Download a Peripheral Neuropathy Symptom Tracker here to help monitor your symptoms.

In 2 studies of 160 people treated with ADCETRIS, 21% of people stopped therapy with ADCETRIS because of side effects. Side effects that led to stopping therapy in 2 or more people in these 2 studies were peripheral sensory neuropathy (8%) and peripheral motor neuropathy (3%). Side effects that led to dose delays in more than 5% of people in these 2 studies were low white blood cell count (14%) and peripheral sensory neuropathy (11%).

When you should call your doctor

Contact your doctor if any other side effects are bothersome or do not go away.

Any suspected side effects should be reported to Seattle Genetics, Inc. at 1.855.473.2436, or the FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

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

ADCETRIS and peripheral neuropathy (PN)

What do I need to know about ADCETRIS and PN?

In the study of ADCETRIS in people with relapsed classical HL, people experienced mild to severe PN:

Peripheral Sensory Neuropathy

peripheral sensory neuropathy
Mild or Moderate
44% of people experienced mild or moderate peripheral sensory neuropathy
This means a feeling of numbness, tingling, prickling, discomfort, burning, or coldness in the skin of the hands or feet. While mild symptoms do not interfere with daily activities, moderate symptoms may limit instrumental daily activities like preparing meals, shopping, and using the telephone.
Severe
8% of people had severe peripheral sensory neuropathy
This means symptoms that made certain daily activities difficult. Severe symptoms may limit selfcare activities such as bathing, dressing, feeding self, and taking medications.

Peripheral Motor Neuropathy

peripheral motor neuropathy
Mild or Moderate
12% of people experienced mild or moderate peripheral motor neuropathy
This means weakness in the hands, feet, arms, or legs that may interfere with instrumental daily activities in moderate cases.
Severe
4% of people had severe peripheral motor neuropathy
This means symptoms that made activities such as walking difficult enough that they might require assistance. (eg, a cane)

What are the symptoms of PN?

You can help your doctor by reporting signs of PN if they occur. Your doctor should check regularly for these signs.

The symptoms of PN include

  • Hypoesthesia—Numbness or decreased sense of touch
  • Hyperesthesia—Increased sense of touch
  • Paresthesia—Sense of prickling, tingling, or creeping on the skin with no clear cause
  • Discomfort
  • A burning sensation
  • Neuropathic pain—Nerve pain
  • Weakness

Working with your doctor to manage side effect symptoms when they appear may help you maintain therapy consistent with your treatment plan

  • Your doctor may be able to manage your PN by delaying doses or by giving you less ADCETRIS with each therapy
  • If your symptoms do not get better or get worse, you may need to stop taking ADCETRIS
  • Call your doctor if you have any of the symptoms listed above

Download a Peripheral Neuropathy Symptom Tracker here to help monitor your symptoms.

PN with ADCETRIS is likely to worsen with continued doses, so your doctor may adjust or stop therapy

During therapy it is important to watch for small changes in feeling or function that might be symptoms of PN. Tell your healthcare team about these right away.

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

ADCETRIS and neutropenia

What do I need to know about ADCETRIS and neutropenia?

Therapy with ADCETRIS has been shown to cause a side effect called neutropenia. Neutropenia means a decreased number of neutrophils in the blood. ADCETRIS can result in severe neutropenia that may last a week or more. Neutropenia can make it harder for the body to fight infection.

Your healthcare team will do regular blood tests to monitor for neutropenia before every dose and will monitor even more often in severe cases. If you experience neutropenia, you should watch for symptoms such as fever, signs of illness, or unusual pain or redness around skin wounds, as this could be a sign of a potentially life-threatening infection.

In the relapsed classical HL study with 102 people, 54% experienced neutropenia. Neutropenia led to dose delays in 14% of the 160 people in the combined studies. Your doctor may delay or reduce your next dose of ADCETRIS or stop therapy, depending on the severity of your neutropenia symptoms. There are also types of therapy that can be given to help raise a person’s neutrophil count.

NEUTROPENIA IN THE STUDY OF ADCETRIS IN RELAPSED CLASSICAL HL

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.