Abecma (idecabtagene vicleucel)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For autologous use only. For IV use only.

*Do NOT use a leukodepleting filter.

*Administer a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine before infusion of idecabtagene vicleucel. Confirm the availability of idecabtagene vicleucel prior to starting the lymphodepleting chemotherapy regimen. Administer idecabtagene vicleucel 2 days after completion of lymphodepleting chemotherapy.

*Confirm the patient's identity prior to infusion. Check that the patient's identity matches patient identifiers on the idecabtagene vicleucel cassette(s) and infusion bag(s). Do not infuse idecabtagene vicleucel if the information on the patient-specific label(s) does not match the intended patient.

*Premedicate with acetaminophen and an H1-antihistamine approximately 30 to 60 minutes before infusion.

*Avoid prophylactic use of dexamethasone or other systemic corticosteroids as such use may interfere with the activity of idecabtagene vicleucel.

*Confirm availability of tocilizumab prior to infusion.

*Dosing of idecabtagene vicleucel is based on the number of chimeric antigen receptor (CAR)-positive T cells. The recommended dose range is 300 to 510 x 106 CAR-positive T cells.

*Monitor patients at least daily for 7 days following idecabtagene vicleucel infusion for signs and symptoms ofCRS and neurologic toxicities.

*Instruct patients to remain within proximity of a healthcare facility for at least 2 weeks followinginfusion.

*Advise patients to avoid driving for at least 2 weeks following infusion.

*See Full Prescribing Information for detailed instructions on preparation and administration, and management of severe adverse reactions.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common nonlaboratory adverse reactions (>=20%) include pyrexia, CRS, hypogammaglobulinemia, infections (pathogen unspecified), musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea, and viral infections.

The most common Grade 3 or 4 laboratory adverse reactions (incidence >=50%) include decreased leukocyte count, neutrophil count, lymphocyte count, platelet count, and hemoglobin.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The safety and efficacy of idecabtagene vicleucel in patients under 18 years of age have not been established.

There are no available data with idecabtagene vicleucel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with idecabtagene vicleucel to assess whether it can cause fetal harm when administered to a pregnant woman.

It is not known if idecabtagene vicleucel has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia. Therefore, idecabtagene vicleucel is not recommended for women who are pregnant, and pregnancy after idecabtagene vicleucel infusion should be discussed with the treating physician. Assess immunoglobulin levels in newborns of mothers treated with idecabtagene vicleucel.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

There is no information regarding the presence of idecabtagene vicleucel in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for idecabtagene vicleucel and any potential adverse effects on the breastfed infant from idecabtagene vicleucel or from the underlying maternal condition.

In the clinical trial of idecabtagene vicleucel, 141 (40%) of the 349 patients in the KarMMa study were 65 years of age or older and 16/349 (4.6%) patients were 75 years of age or older. In the KarMMa study, all 5 cases of Grade 3 neurotoxicity occurred in patients >=65 years of age (66 to 74 years). No clinically important differences in effectiveness of idecabtagene vicleucel were observed between these patients and patients younger than 65 years of age.