Abecma
- Generic Name: idecabtagene vicleucel suspension
- Brand Name: Abecma
- Drug Class: CAR-T Cell Therapies
Abecma (Idecabtagene Vicleucel Suspension) side effects drug center
- Related Drugs
- cytokine release syndrome (CRS),
- infections,
- fatigue,
- musculoskeletal pain,
- hypogammaglobulinemia,
- diarrhea,
- upper respiratory tract infection,
- nausea,
- viral infections,
- encephalopathy,
- fluid retention (edema),
- fever,
- cough,
- headache,
- decreased appetite,
- low white blood cells (neutropenia, leukopenia, lymphopenia),
- low platelets (thrombocytopenia), and
- anemia
- headaches, dizziness, drowsiness;
- problems with thinking or memory;
- trouble speaking or understanding what is said to you;
- tremors, anxiety, sleep problems;
- seizure;
- right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well; or
- low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.
- cytokine release syndrome (confusion, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired);
- headache, dizziness;
- problems with speech;
- low blood cell counts;
- fever, chills, tiredness, or other signs of infection;
- decreased appetite, severe nausea or diarrhea;
- pain in your bones, joints, or muscles;
- swelling anywhere in your body; or
- cold symptoms such as stuffy nose, sneezing, sore throat, cough.
- Cytokine Release Syndrome [see WARNINGS AND PRECAUTIONS]
- Neurologic Toxicities [see WARNINGS AND PRECAUTIONS]
- Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Infections [see WARNINGS AND PRECAUTIONS]
- Prolonged Cytopenias [see WARNINGS AND PRECAUTIONS]
- Hypogammaglobulinemia [see WARNINGS AND PRECAUTIONS]
- Blood and lymphatic system disorders: coagulopathya (9%)
- Cardiac disorders: atrial fibrillation (4.7%), cardiomyopathyb (1.6%)
- Gastrointestinal disorders: gastrointestinal hemorrhagec (3.1%)
- Immune system disorders: hemophagocytic lymphohistiocytosis (3.1%)
- Infections and infestations: fungal infections (8%), sepsisd (9%)
- Nervous system disorders: aphasiae (7%), ataxiaf (3.1%), paresisg (2.4%), seizure (1.6%)
- Psychiatric disorders: deliriumh (6%)
- Respiratory, thoracic, and mediastinal disorders: hypoxia (2.4%), pulmonary edema (2.4%)
- Vascular disorders: thrombosisi (3.1%)
What Is Abecma?
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy used to treat adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
What Are Side Effects of Abecma?
Side effects of Abecma include:
Dosage for Abecma
Dosing of Abecma is based on the number of chimeric antigen receptor (CAR)-positive T cells. The recommended dose range of Abecma is 300 to 460×106 CAR-positive T cells.
Abecma In Children
The safety and efficacy of Abecma in patients under 18 years of age have not been established.
What Drugs, Substances, or Supplements Interact with Abecma?
Abecma may interact with other medicines.
Tell your doctor all medications and supplements you use.
Abecma During Pregnancy and Breastfeeding
Abecma is not recommended for use during pregnancy; it may harm a fetus. Pregnancy status of females with reproductive potential should be verified prior to starting treatment with Abecma. Pregnancy after Abecma infusion should be discussed with the treating physician. It is unknown if Abecma passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Abecma (idecabtagene vicleucel), Suspension for Intravenous Infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
A serious side effect of idecabtagene vicleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.
Also tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems: problems with speech, problems with thinking or memory, confusion, or a seizure.
Also call your doctor at once if you have:
Common side effects may include:
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.
Read the entire detailed patient monograph for Abecma (Idecabtagene Vicleucel Suspension)
SIDE EFFECTS
The following adverse reactions are described elsewhere in the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data described in this section reflect the exposure to ABECMA in the KarMMa study, in which 127 patients with relapsed/refractory multiple myeloma received ABECMA across a dose range of 150 to 518 x 106 CAR-positive T cells [see Clinical Studies]. Patients with a history of CNS disease (such as seizure or cerebrovascular ischemia) or requiring ongoing treatment with chronic immunosuppression were excluded. The median duration of follow-up was 11.4 months. The median age of the study population was 61 years (range: 33 to 78 years); 35% were 65 years or older, and 60% were men. The Eastern Cooperative Oncology Group (ECOG) performance status at baseline was 0 in 45%, 1 in 53%, and 2 in 2% of patients. Seven percent of the patients treated with ABECMA had creatinine clearance <45 ml/min. For details about the study population, see Clinical Studies.
The most common (greater than or equal to 10%) Grade 3 or 4 nonlaboratory adverse reactions were febrile neutropenia (16%) and infections - pathogen unspecified (15%).
The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) included CRS, infections - pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.
Serious adverse reactions occurred in 67% of patients. The most common nonlaboratory (greater than or equal to 5%) serious adverse reactions included CRS (18%), general physical health deterioration (10%), pneumonia (12%), infections-pathogen unspecified (19%), viral infections (9%), sepsis (7%), and febrile neutropenia (6%). Fatal adverse reactions occurred in 6%.
Table 3 summarizes the adverse reactions that occurred in at least 10% of patients treated with ABECMA. Table 4 describes the most common Grade 3 or 4 laboratory abnormalities.
Table 3: Adverse Reactions Observed in at Least 10% of Patients Treated with ABECMA in the KarMMa Study
| System Organ Class Preferred Term |
Target Dose of ABECMA (CAR-Positive T Cells) | |
| Any Grade | Grade 3 or Higher | |
| [150 to 450 x 106] (N=127) % |
[150 to 450 x 106] (N=127) % |
|
| Blood and lymphatic system disorders | ||
| Febrile neutropenia | 16 | 16 |
| Cardiac disorders | ||
| Tachycardiaa | 19 | 0 |
| Gastrointestinal disorders | ||
| Diarrhea | 35 | 1.6 |
| Nausea | 29 | 0 |
| Constipation | 16 | 0 |
| Vomiting | 15 | 0 |
| Oral painb | 12 | 0 |
| General disorders and administration site conditions | ||
| Fatiguec | 45 | 3.1 |
| Pyrexia | 25 | 1.6 |
| General physical health deterioration | 11 | 10 |
| Edemad | 25 | 0 |
| Chills | 11 | 0 |
| Immune system disorders | ||
| Cytokine release syndrome | 85 | 9 |
| Hypogammaglobulinemiae | 41 | 0.8 |
| Infections and infestationsf | ||
| Infections - Pathogen unspecified | 51 | 15 |
| Viral infections | 27 | 9 |
| Bacterial infections | 15 | 3.9 |
| Pneumoniag | 17 | 9 |
| Upper respiratory tract infectionh | 34 | 1.6 |
| Investigations | ||
| Weight decreased | 13 | 1.6 |
| Metabolism and nutrition disorders | ||
| Decreased appetitei | 22 | 0.8 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal painj | 45 | 3.1 |
| Motor dysfunctionk | 11 | 0 |
| Nervous system disorders | ||
| Encephalopathyl | 26 | 6 |
| Headachem | 23 | 0 |
| Dizzinessn | 17 | 0.8 |
| Neuropathy peripheralo | 17 | 0.8 |
| Tremorp | 10 | 0 |
| Psychiatric disorders | ||
| Insomniaq | 13 | 0 |
| Anxietyr | 12 | 0.8 |
| Renal and urinary disorders | ||
| Renal failures | 10 | 2.4 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cought | 23 | 0 |
| Dyspneau | 13 | 2.4 |
| Skin and subcutaneous tissue disorder | ||
| Rashv | 14 | 0.8 |
| Xerosisw | 11 | 0 |
| Vascular disorders | ||
| Hypotensionx | 17 | 0 |
| Hypertension | 11 | 3.1 |
| CAR=chimeric antigen receptor. a Tachycardia includes sinus tachycardia, tachycardia. b Oral pain includes oral pain, oropharyngeal pain, toothache. c Fatigue includes asthenia, fatigue, malaise. d Edema includes edema, face edema, fluid overload, fluid retention, generalized edema, peripheral edema, peripheral swelling, scrotal swelling, swelling. e Hypogammaglobulinemia includes patients with adverse events (21%) of blood immunoglobulin G decreased, hypogammaglobulinemia, hypoglobulinemia; and/or patients with laboratory IgG levels below 500 mg/dL following ABECMA infusion (25%). f Infections and infestations System Organ Class Adverse Events are grouped by pathogen type and selected clinical syndromes. g Pneumonia includes bronchopulmonary aspergillosis, lung infection, pneumonia, pneumonia aspiration, pneumonia cytomegaloviral, pneumonia pneumococcal, pneumonia pseudomonal. Pneumonias may also be included under pathogen categories. h Upper respiratory tract infection includes laryngitis, nasopharyngitis, pharyngeal erythema, pharyngitis, respiratory tract congestion, respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract infection, upper respiratory tract infection bacterial. Upper respiratory tract infections may also be included under pathogen categories. i Decreased appetite includes decreased appetite, hypophagia. j Musculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, spinal pain. k Motor dysfunction includes dysphonia, eyelid ptosis, hypotonia, motor dysfunction, muscle spasms, muscular weakness, restless legs syndrome. lEncephalopathy includes amnesia, bradyphrenia, cognitive disorder, confusional state, depressed level of consciousness,disturbance in attention, dyscalculia, dysgraphia, encephalopathy, lethargy, memory impairment, mental status changes,metabolic encephalopathy, somnolence, toxic encephalopathy. m Headache includes headache, head discomfort, sinus headache. n Dizziness includes dizziness, presyncope, syncope, vertigo. oNeuropathy peripheral includes carpal tunnel syndrome, hypoesthesia, hypoesthesia oral, neuralgia, neuropathyperipheral, paresthesia, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, sciatica. p Tremor includes asterixis, tremor. q Insomnia includes insomnia, sleep deficit, sleep disorder. r Anxiety includes anxiety, feeling jittery, nervousness. s Renal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal impairment. t Cough includes cough, productive cough, upper-airway cough syndrome. uDyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure. v Rash includes acne, dermatitis, dermatitis bullous, erythema, rash, rash macular, rash papular, urticaria. w Xerosis includes dry eye, dry mouth, dry skin, lip dry, xerosis. x Hypotension includes hypotension, orthostatic hypotension. |
||
Other clinically important adverse reactions that occurred in less than 10% of patients treated with ABECMA include the following:
a Coagulopathy includes activated partial thromboplastin time prolonged, anticoagulation drug level above therapeutic, disseminated intravascular coagulation, international normalized ratio increased.
b Cardiomyopathy includes stress cardiomyopathy, ventricular hypertrophy.
c Gastrointestinal hemorrhage includes gastrointestinal hemorrhage, hemorrhoidal hemorrhage, melena.
d Sepsis includes bacteremia, enterococcal bacteremia, Escherichia bacteremia, sepsis, septic shock, Serratia bacteremia, streptococcal bacteremia.
e Aphasia includes aphasia, dysarthria.
f Ataxia includes ataxia, gait disturbance, Romberg test positive.
g Paresis includes cranial nerve disorder, hemiparesis.
h Delirium includes delirium, disorientation, hallucination.
i Thrombosis includes deep vein thrombosis, jugular vein thrombosis, portal vein thrombosis, pulmonary embolism.
Laboratory Abnormalities
Table 4 presents the most common Grade 3 or 4 laboratory abnormalities, based on laboratory data, occurring in at least 10% of patients.
Table 4: Grade 3 or 4a Laboratory Abnormalities Worsening from Baseline in at Least 10% of Patients Treated with ABECMA in the KarMMa Study
| Laboratory Abnormality | Dose=[150 to 450 x 106 CAR-Positive T cells] (N=127) % |
| Grade 3 or 4 (%) | |
| Neutropenia | 96 |
| Leukopenia | 96 |
| Lymphopenia | 92 |
| Thrombocytopenia | 63 |
| Anemia | 63 |
| Hypophosphatemia | 45 |
| Hyponatremia | 10 |
| aPTT Increased (seconds) | 10 |
| aNCI CTCAE=Common Terminology Criteria for Adverse Events version 4.03. aPTT=activated partial thromboplastin time; CAR=chimeric antigen receptor; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute. Laboratory tests were graded according to NCI CTCAE Version 4.03. Laboratory abnormalities are sorted by decreasing frequency in the 150 to 450 x 106 column. |
|
Other clinically important Grade 3 or 4 laboratory abnormalities (based on laboratory data) that occurred in less than 10% of patients treated with ABECMA include the following: alanine aminotransferase increased, aspartate aminotransferase increased, hypoalbuminemia, alkaline phosphatase increased, hyperglycemia, hypokalemia, bilirubin increased, hypofibrinogenemia, and hypocalcemia.
Immunogenicity
ABECMA has the potential to induce anti-product antibodies. In clinical studies, humoral immunogenicity of ABECMA was measured by determination of anti-CAR antibody in serum pre- and post-administration. In the KarMMa study, 3% of patients (4/127) tested positive for pre-infusion anti-CAR antibodies and treatment-induced anti-CAR antibodies were detected in 47% (60/127) of the patients. There is no evidence that the presence of pre-existing or post-infusion anti-CAR antibodies impact the cellular expansion, safety, or effectiveness of ABECMA. 21
DRUG INTERACTIONS
Drug/Laboratory Test Interactions
HIV and the lentivirus used to make ABECMA have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received ABECMA.
Read the entire FDA prescribing information for Abecma (Idecabtagene Vicleucel Suspension)
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