Adcetris is used to treat certain types of lymphoma. It is used when the cancer cells have a protein called CD30 on their surface (CD30-positive). 

Adcetris works by targeting the CD30 protein to interfere with the growth and spread of cancer cells in the body.

Adcetris is used in combination with other cancer medicines to treat adults and pediatric patients with Hodgkin lymphoma that has not been treated before.

Adcetris is used in adult patients with Hodgkin lymphoma who have had an autologous stem cell transplant or who have received other cancer medicines and the cancer has come back or is likely to come back, or has not responded.

Adcetris is used combination with other cancer medicines to treat adults patients with anaplastic large cell lymphoma that has not been treated before, or has not responded to, or has come back after treatment with other cancer medicines.

Adcetris is also used to treat mycosis fungoides.

You should not receive Adcetris if you are also receiving another cancer medicine called bleomycin.

Adcetris may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement.

Adcetris is given as an infusion into a vein. A healthcare provider will give you this injection.

Adcetris is usually given once every 2 to 3 weeks. Follow your doctor's dosing instructions very carefully.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Brentuximab vedotin can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Brentuximab vedotin doses are based on weight. Your dose needs may change if you gain or lose weight.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Usual Adult Dose for Hodgkin's Disease:

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Comments:
-The dose for patients weighing more than 100 kg should be calculated based on a weight of 100 kg.
-In patients with previously untreated Stage III or IV cHL who are treated with this drug plus doxorubicin/ vinblastine/dacarbazine (AVD), administer G-CSF beginning with Cycle 1.

Uses:
-For previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
-For adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
-For adults with cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
-For adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
-For adults with pcALCL or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy

Usual Adult Dose for Mycosis Fungoides:

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Comments:
-The dose for patients weighing more than 100 kg should be calculated based on a weight of 100 kg.
-In patients with previously untreated Stage III or IV cHL who are treated with this drug plus doxorubicin/ vinblastine/dacarbazine (AVD), administer G-CSF beginning with Cycle 1.

Uses:
-For previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
-For adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
-For adults with cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
-For adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
-For adults with pcALCL or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy

Usual Adult Dose for Lymphoma:

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Comments:
-The dose for patients weighing more than 100 kg should be calculated based on a weight of 100 kg.
-In patients with previously untreated Stage III or IV cHL who are treated with this drug plus doxorubicin/ vinblastine/dacarbazine (AVD), administer G-CSF beginning with Cycle 1.

Uses:
-For previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
-For adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
-For adults with cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
-For adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
-For adults with pcALCL or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy

Usual Pediatric Dose for Hodgkin's Disease:

Previously Untreated High Risk Classical Hodgkin Lymphoma: 1.8 mg/kg IV over 30 minutes (maximum 180 mg) every 3 weeks for a maximum of 5 doses

Use: Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide

You should not be treated with Adcetris if you are allergic to brentuximab vedotin, or:

• if you are also receiving another cancer medicine called bleomycin.

To make sure Adcetris is safe for you, tell your doctor if you have ever had:

• diabetes;

• liver disease;

• kidney disease; or

• peripheral vascular disease such as Raynaud's syndrome.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Brentuximab vedotin can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 6 months after your last dose of Adcetris. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine.

You should not breast-feed while you are using Adcetris.

Call your doctor if you miss an appointment for your Adcetris injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Brentuximab vedotin can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Adcetris (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Some side effects may occur during the injection or within 24 hours afterward. Tell your caregiver right away if you feel dizzy, nauseated, chilled or feverish, or if you have itching or trouble breathing.

Brentuximab vedotin may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor if you have any of these other serious side effects, even if they occur several months after you receive Adcetris:

• numbness, weakness, burning pain, tingly feeling, or loss of feeling in your arms or legs;

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

• pain or burning when you urinate;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• signs of tumor cell breakdown - confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth;

• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes); or

• stomach problems - severe constipation, new or worsening stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Adcetris side effects may include:

• numbness or tingling;

• fever;

• low blood cell counts;

• nausea, vomiting, diarrhea, constipation; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with brentuximab vedotin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.