| Views: 63 |
| Date: 19 Jan 2012 |
|
|
|
Definition of medical terminology for Food.
Definition of medical terminology for Progressive Multifocal Leukoencephalopathy.
Definition of medical terminology for Brain.
Definition of medical terminology for Infection.
Definition of medical terminology for Lymphoma.
Definition of medical terminology for Nature.
Definition of medical terminology for Risk.
computer aided software engineering
Definition of medical terminology for Lymphoma.
Definition of medical terminology for Lymphoma.
An immunoglobulin, a specialized immune protein, produced because of the introduction of an antigen into the body, and which possesses the remarkable ability to combine with the very antigen that triggered its production.
An immunoglobulin, a specialized immune protein, produced because of the introduction of an antigen into the body, and which possesses the remarkable ability to combine with the very antigen that triggered its production.
Definition of medical terminology for Lymphoma.
Definition of medical terminology for Patients.
Definition of medical terminology for Bleomycin.
Definition of medical terminology for Risk.
Definition of medical terminology for Signs and Symptoms.
Definition of medical terminology for Mood.
Definition of medical terminology for Body Build.
Definition of medical terminology for Patients.
Definition of medical terminology for Signs and Symptoms.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Diagnosis.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Recommendations.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Patients.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Progressive Multifocal Leukoencephalopathy.
Definition of medical terminology for Brain.
Definition of medical terminology for Infection.
Definition of medical terminology for Signs and Symptoms.
Definition of medical terminology for Mood.
Definition of medical terminology for Patients.
Definition of medical terminology for Signs and Symptoms.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Patients.
Definition of medical terminology for Bleomycin.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Patients.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Patients.
FDA Safety Information and Adverse Event Reporting Program
polyacrylimide gel electrophoresis
Definition of medical terminology for Healthcare.
Definition of medical terminology for Bleomycin.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Infection.
Definition of medical terminology for Progressive Multifocal Leukoencephalopathy.
Definition of medical terminology for Death.
Definition of medical terminology for Patients.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Disease.
Definition of medical terminology for Immunosuppression (Physiology).
Definition of medical terminology for Healthcare.
Definition of medical terminology for Patients.
Definition of medical terminology for Mood.
The use of special eye exercises to address eye defects, such as strabismus.
Definition of medical terminology for Healthcare.
Definition of medical terminology for Diagnosis.
Definition of medical terminology for Patient.
Definition of medical terminology for Nervous System.
Definition of medical terminology for Abnormalities.
Definition of medical terminology for Evaluation.
Definition of medical terminology for Brain.
Definition of medical terminology for Magnetic.
Definition of medical terminology for Lumbar Puncture.
Definition of medical terminology for Puncture.
A psychology term for processes used to gain understanding of complex emotional or behavioral issues.
Definition of medical terminology for Polymerase Chain Reaction.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Brain.
Definition of medical terminology for Healthcare.
computer aided software engineering
Definition of medical terminology for Diagnosis.
Definition of medical terminology for Healthcare.
FDA Safety Information and Adverse Event Reporting Program
polyacrylimide gel electrophoresis
Definition of medical terminology for Patients.
Definition of medical terminology for Lymphoma.
Definition of medical terminology for Radiation.
Definition of medical terminology for Patient.
Definition of medical terminology for Speech.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Death.
Definition of medical terminology for Symptoms and General Pathology.
Definition of medical terminology for Radiation.
In blood transfusion and transplantation, a situation in which the donor and recipient are the same person.
Definition of medical terminology for STEM.
Definition of medical terminology for Emergency.
Definition of medical terminology for Writing.
Definition of medical terminology for Magnetic.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Patient.
Definition of medical terminology for Large Cell Lymphoma.
Definition of medical terminology for Lymphoma.
Definition of medical terminology for Radiation.
1. Information gathered at the beginning of a study from which variations found in the study are measured.
Definition of medical terminology for Normal Distribution.
Definition of medical terminology for Patient.
Definition of medical terminology for Memory.
A biological system that enables us to know where our bodies are in the environment and to maintain a desired position.
Definition of medical terminology for Brain.
Definition of medical terminology for Brain.
A microorganism smaller than a bacteria, which cannot grow or reproduce apart from a living cell.
Definition of medical terminology for Dacarbazine.
Definition of medical terminology for Dacarbazine.
Definition of medical terminology for Patients.
adriamycin, bleomycin, vinblatime, dacarbazine
adriamycin, bleomycin, vinblatime, dacarbazine
Definition of medical terminology for Literature.
Definition of medical terminology for Group 1 Elements.
Definition of medical terminology for Patients.
Definition of medical terminology for Dyspnea.
Definition of medical terminology for Patients.
Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label. At the time of Adcetris` approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.
Facts about Adcetris (brentuximab vedotin)
Used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma
An antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30
Since FDA approval in August 2011, approximately 2,000 patients worldwide have received treatment with Adcetris
In addition, a new Contraindication warning against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity has been added to the drug label (see Data Summary below).
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 . Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed.
FDA recommends that healthcare professionals refer to the current Adcetris drug label for the latest prescribing recommendations (also see Additional Information for Healthcare Professionals below). Patients should contact their healthcare professional if they have any questions or concerns about Adcetris.
Additional Information for Patients
Cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with Adcetris.
Signs and symptoms of PML may include:
Changes in mood or usual behavior
Confusion, thinking problems, loss of memory
Changes in vision, speech, or walking
Decreased strength or weakness on one side of the body
Patients who develop any signs and symptoms suggestive of PML should notify their healthcare professional immediately.
Patients who are receiving Adcetris in combination with bleomycin should talk to their healthcare professional about stopping this combination of medications.
Patients should talk to their healthcare professional if they have any questions or concerns about Adcetris.
Patients should report serious side effects from the use of Adcetris to the FDA MedWatch program, using the information at the bottom of the page in the "Contact Us" box.
Additional Information for Healthcare Professionals
Concomitant use of Adcetris and bleomycin is contraindicated due to pulmonary toxicity.
John Cunningham (JC) virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has been reported in Adcetris-treated patients.
The factors leading to reactivation of latent JC virus are not fully understood. In addition to Adcetris therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression .
Healthcare professionals should instruct patients to report changes in mood or usual behavior, confusion, problems thinking, loss of memory, changes in walking or talking, decreased strength or weakness on one side of the body, or changes in vision .
Healthcare professionals should consider a possible diagnosis of PML in any patient currently receiving or who has received Adcetris in the past, and who presents with new signs or symptoms of central nervous system abnormalities.
Evaluation of PML may include consultation with a neurologist and performance of a brain magnetic resonance imaging (MRI) and/or lumbar puncture with analysis of cerebrospinal fluid by polymerase chain reaction for JC virus and/or brain biopsy.
Healthcare professionals should hold Adcetris dosing for any suspected case of PML and discontinue Adcetris dosing if a diagnosis of PML is confirmed.
Healthcare professionals should report adverse events involving Adcetris to the FDA MedWatch program, using the information at the bottom of the page in the "Contact Us" box.
Data Summary
Progressive multifocal leukoencephalopathy (PML)
To date, three patients have developed PML while receiving treatment with Adcetris.
A 48 year old man with Hodgkin lymphoma (HL) was diagnosed with PML after receiving Adcetris. The patient`s medical history included prior treatment with multiple chemotherapeutic agents and targeted radiation therapy. After the third dose of Adcetris, the patient presented with left-sided weakness and slurred speech. Cerebrospinal fluid was positive for John Cunningham (JC) virus. The patient`s condition deteriorated rapidly resulting in death within four weeks of onset of symptoms .
A 50 year old man with HL was diagnosed with PML after receiving Adcetris. The patient`s medical history included prior treatment with multiple chemotherapeutic agents, targeted radiation therapy, and autologous stem cell transplant. After eight cycles of Adcetris, he presented to the local emergency room with complaints of changes in speech, difficulty writing with his right hand, and right lower extremity weakness. In addition, he had poor coordination, poor balance, and left-sided sensory deficits. Although magnetic resonance imaging (MRI) was inconclusive and cerebrospinal fluid analyses were negative for JC virus early in the course of the neurologic work-up, an immunostain of a spinal cord lesion biopsy was positive for JC virus. The patient`s neurological condition continues to worsen, and most recently he lost motor function of his lower extremities and deep tendon reflexes of his legs. He also has tremulousness of his hands and hypoactive arm reflexes.
A 38 year old female patient with a history of Stage IV cutaneous anaplastic large cell lymphoma (ALCL) was diagnosed with PML after receiving Adcetris. The patient`s medical history included prior treatment with multiple chemotherapeutic agents and targeted radiation therapy. Prior to treatment with Adcetris, a baseline neurological examination was normal . After the second dose, the patient complained of inability to read, inability to find words to express herself, memory lapses, and slight loss of balance. A brain MRI revealed a demyelinating process and a brain biopsy was positive for JC virus. Treatment with Adcetris was discontinued.
Pulmonary toxicity
A clinical trial compared the combination of Adcetris plus Adriamycin (doxorubicin), bleomycin, vinblastine, and dacarbazine (ABVD) to the combination of Adcetris plus Adriamycin (doxorubicin), vinblastine, and dacarbazine (AVD) as front-line therapy for HL. An excessive number of patients in the Adcetris plus ABVD treatment group experienced non-infectious pulmonary toxicity. The frequency of pulmonary toxicity in the Adcetris plus ABVD group was approximately 40%, compared to a frequency of 10-25% most commonly reported in the literature with bleomycin-based regimens (not containing Adcetris). No pulmonary toxicity has been observed thus far in the Adcetris plus AVD treatment group . Patients have reported cough and dyspnea. Signs of interstitial infiltration have been observed on radiographs and computed tomographic imaging of the chest. Patients have responded to corticosteroid therapy.
Source :
DrugsFreeList.com
Tags:
Adcetris, bleomycin, multifocal leukoencephalopathy
|
