[Posted 01/13/2012] ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug brentuximab vedotin (Adcetris). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label.
In addition, a new Contraindication warning was added against use of brentuximab with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity.
The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.
BACKGROUND: Brentuximab vedotin is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of brentuximab's approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.
RECOMMENDATION: Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold brentuximab dosing if PML is suspected and discontinue brentuximab if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communication for additional information.. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Brentuximab vedotin injection is used to treat patients with Hodgkin's lymphoma who did not respond to a stem cell transplant (procedure that replaces diseased bone marrow with healthy bone marrow) or at least two treatment periods of chemotherapy. Brentuximab vedotin injection is also used to treat systemic anaplastic large cell lymphoma (sALCL; a type of non-Hodgkin lymphoma) who did not respond to another treatment period of chemotherapy. Brentuximab vedotin injection is in a class of medications called antibody-drug conjugates. It works by killing cancer cells.
Brentuximab vedotin injection comes as a powder to be mixed with fluid and injected over 30 minutes intravenously (into a vein) by a doctor or nurse in a medical office or hospital. It is usually injected once every 3 weeks. This treatment period is called a cycle, and the cycle may be repeated up to 16 times.
Brentuximab vedotin injection may cause serious allergic reactions which usually occur during the infusion of the medication or within 24 hours of receiving a dose. You may receive certain medications before your infusion to prevent an allergic reaction if you had a reaction with previous treatment. Your doctor will watch you carefully while you are receiving brentuximab vedotin. If you experience any of the following symptoms, tell your doctor immediately: fever, chills, rash, hives, itching, or difficulty breathing.
Your doctor may need to delay your treatment, adjust your dose, or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with brentuximab vedotin injection.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
stomach pain
constipation
decreased appetite
weight loss
tiredness
dizziness
difficulty falling asleep or staying asleep
anxiety
hair loss
night sweats
joint, muscle, back, arm, or leg pain
muscle spasms
unusual bleeding or bruising
numbness, burning, or tingling in the hands, arms, feet, or legs
muscle weakness
peeling or blistering skin
hives
rash
itching
nausea
vomiting
diarrhea
decreased urination
swelling of the hands, feet, ankles, or lower legs
difficult, painful, or frequent urination
fever, chills, cough, or other signs of infection
headache
loss of coordination
memory loss
vision problems
difficulty speaking
Brentuximab vedotin injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
fever, chills, cough, or other signs of infection
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to brentuximab vedotin injection.
Ask your pharmacist any questions you have about brentuximab vedotin injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 02/15/2012
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.