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Treatment Name: Brentuximab Vedotin (Adcetris®)

Brentuximab Vedotin (Adcetris®) is a Chemotherapy Regimen for Lymphoma, T-Cell

How does brentuximab vedotin (Adcetris®) work?
Brentuximab vedotin is an antibody that targets a protein on the surface of cancerous T-lymphocytes. Once brentuximab binds to the lymphoma cell surface, it then enters the inside of the cancer cell. Once inside the cell, the antibody releases a drug called MMAE, which stops the cell from growing and dividing. Brentuximab has activity on T-lymphocytes that have a protein known as “CD30” on their cell surface.

One example of a T-cell lymphoma includes a subtype known as anaplastic large cell lymphoma (ALCL).

Goals of therapy:
Brentuximab vedotin is given to shrink lymph nodes, alleviate symptoms of lymphoma, and achieve disease remission. If remission is achieved, some patients may receive a bone marrow transplant with the goal of cure.

Schedule

  • Brentuximab vedotin is an intravenous (I.V.) infusion usually given over 30 minutes on Day 1 of each cycle
  • Patients weighing more than 220 lbs. should have their dose of brentuximab calculated based upon a maximum weight of 220 lbs.

Estimated total infusion time for this treatment:

  • Up to 1 hour for each dose of brentuximab
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

Brentuximab vedotin is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, brentuximab vedotin may be given in the hospital if someone is too sick.

Brentuximab vedotin is repeated every 21 days. This is known as one Cycle. Each cycle is repeated for up to 16 doses unless the drug stops working, intolerable side effects occur, or until a bone marrow transplant can be given.

Click here for common brentuximab vedotin starting dose.

Side Effects

In clinical studies, the most commonly reported brentuximab vedotin (Adcetris®) side effects are shown here:

  • Tingling or numbness in fingers and toes (41%)
  • Nausea (40%)
  • Fatigue (38%)
  • Fever (34%)
  • Diarrhea (29%)
  • Rash (24%)
  • Constipation (22%)
  • Low white blood cells [neutropenia] (21%)
  • Headache (19%)
  • Itching (19%)
  • Cough (17%)
  • Shortness of breath (17%)
  • Upper respiratory tract infection [e.g. sinus infection] (17%)
  • Vomiting (17%)
  • Decreased appetite (16%)
  • Dizziness (16%)
  • Trouble sleeping (16%)
  • Muscle pain (16%)
  • Hair loss (14%)
  • Chills (14%)
  • Muscle spasms (14%)
  • Increased bleed risk [low platelets; thrombocytopenia] (14%)
  • Weight loss (14%)
  • Fluid retention [edema] (12%)
  • Pain in arms or legs (12%)
  • High blood potassium level (9%)

On average, 20 - 24% of patients discontinue treatment due to unacceptable side effects, most commonly due to changes in feeling in fingers or toes which is sometimes referred to as “sensory neuropathy”.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue DiarrheaDiarrheaConstipationConstipationPainPainHair LossHair LossBleedingBleeding

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each treatment and periodically in-between treatments. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), uric acid, blood phosphorous, LDH, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment then after approximately every 2 to 3 cycles until stable. Imaging may include: computerized tomography (CT) scans may be done as often as at cycles 2, 4, 7, 10, 13, and 16 (depending upon provider and insurance coverage) or positron emission tomography (PET) scans as often as at cycles 4 and 7.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue brentuximab vedotin as planned, decrease the dose, delay or switch therapy.

After all 16 cycles are received, continued imaging with CT scans may be recommended every 12 weeks to monitor response.

ChemoExperts Tips

  • Infusion reactions are rare, but can occur. The most common infusion related reactions are chills, nausea, trouble breathing, itching, fever, and cough. If infusion reactions are experienced, pre-medications can be given before future doses of brentuximab vedotin
  • Tell your doctor if you have numbness, tingling, burning, or weakness in hands or feet as this may require a decrease in brentuximab vedotin dose or delaying future doses
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for T-cell lymphoma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications.

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Brentuximab Vedotin (Adcetris®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Brentuximab Vedotin (Adcetris®). Depending upon your income, they may be able to help cover the cost of:

  • Bren­tuxi­mab Vedotin

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Brentuximab Vedotin (Adcetris®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Brentuximab Vedotin (Adcetris®)

Individual Drug Label Information

Bren­tuxi­mab Vedotin (Adcetris®)

  • Brentuximab vedotin is an intravenous (I.V.) infusion 
  • FDA Black Box Warning: A rare viral infection known as JC virus, has been diagnosed in some patients who received treatment with Brentuximab.  Patients themselves or family and friends should immediately report the following symptoms to the doctor: confusion, trouble speaking, loss of memory, changes in vision, difficulty walking, or weakness on one side of the body
  • Dosage adjustments may be required for liver dysfunction, low white blood cell counts, or nerve pain 
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions  
  • May interact with grapefruit and grapefruit juice causing increased blood levels of MMAE, the drug attached to brentuximab vedotin. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment 
  • Avoid therapy with St. Johns Wort as it will decrease blood levels of MMAE. This could decrease the effectiveness of brentuximab vedotin 
General Brentuximab Vedotin Side Effects 
  • Nerve pain such as numbness, tingling, burning, or weakness in hands or feet, also known as peripheral sensory neuropathy, may increase after each dose. It is usually reversible if treatment is stopped or the dose is decreased
  • Neutropenia, or low white blood cell counts, may occur which increases your risk of an infection.  Tell your doctor if you have a fever of 100.5° F or higher or any other concern for infection such as cough, chills, sore throat, or painful urination
  • Rash is common after treatment.  A severe rash such as Stevens-Johnson Syndrome may occur and requires immediate medical attention 
  • Click on the brentuximab vedotin (Adcetris) package insert for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaHair LossHair LossFatigue Fatigue

See DailyMed package insert.

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References

1) Pro B, Advani R, Brice P, et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012;30:2190-2196.

2) Horwitz SM, Advani RH, Bartlett NL, et al. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood 2014;123:3095-3100.

Created: March 16, 2017 Updated: October 17, 2018

What is Lymphoma, T-Cell?

A disease of lymphocytes called T-lymphocytes, or "T-cells" that are found most commonly in the skin, spleen, blood, bone marrow, and/or lymph nodes. Peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) are the two main types of T-cell lymphoma; however, there are many different subtypes of PTCL and CTCL and all are very rare.

The exact cause of T-cell lymphomas is not known, but certain viral infections such as the Epstein-Barr Virus (EBV) and human T-cell leukemia virus have been associated with development of T-cell lymphomas. The stage of T-cell lymphoma can vary at diagnosis and throughout treatment. Stages of T-cell lymphoma include stage I, II, III, and IV. The effectiveness of the treatment may depend upon the stage and specific subtype at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common brentuximab vedotin starting dose

  • Brentuximab vedotin 1.8 mg/kg (max 180 mg) intravenous infusion (I.V.) over 30 minutes on Day 1 of each cycle

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.