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Besponsa
Overview
What is Besponsa?
Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab.
Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification.
BESPONSA (inotuzumab ozogamicin) for Injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0.
What does Besponsa look like?
What are the available doses of Besponsa?
For injection: 0.9 mg lyophilized powder in a single-dose vial for reconstitution and further dilution. ()
What should I talk to my health care provider before I take Besponsa?
Lactation: Advise not to breastfeed. ()
How should I use Besponsa?
BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Table 1 shows the recommended dosing regimens.
What interacts with Besponsa?
Sorry No Records found
What are the warnings of Besponsa?
Sorry No Records found
What are the precautions of Besponsa?
Sorry No Records found
What are the side effects of Besponsa?
Sorry No records found
What should I look out for while using Besponsa?
None.
What might happen if I take too much Besponsa?
Sorry No Records found
How should I store and handle Besponsa?
Refrigerate (2–8°C; 36–46°F) BESPONSA vials and store in the original carton to protect from light. Do not freeze.BESPONSA is a cytotoxic drug. Follow applicable special handling and disposal procedures. Refrigerate (2–8°C; 36–46°F) BESPONSA vials and store in the original carton to protect from light. Do not freeze.BESPONSA is a cytotoxic drug. Follow applicable special handling and disposal procedures. Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].Gabapentin Capsules, USP are supplied as follows:100 mg capsules:Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder;300 mg capsules:Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 55700-542-90400 mg capsules:Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate (ADC). Inotuzumab recognizes human CD22. The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of inotuzumab ozogamicin is due to the binding of the ADC to CD22-expressing tumor cells, followed by internalization of the ADC-CD22 complex, and the intracellular release of N-acetyl-gamma-calicheamicin dimethylhydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Non-Clinical Toxicology
None.In the INO-VATE ALL trial, hepatotoxicity, including severe, life-threatening, and sometimes fatal hepatic VOD was observed in 23/164 patients (14%) in the BESPONSA arm during or following treatment or following a HSCT after completion of treatment. VOD was reported up to 56 days after the last dose during treatment or during follow-up without an intervening HSCT. The median time from subsequent HSCT to onset of VOD was 15 days (range: 3–57 days). In the BESPONSA arm, among the 79 patients who proceeded to a subsequent HSCT, VOD was reported in 18/79 patients (23%), and among all 164 patients treated, VOD was reported in 5/164 patients (3%) during study therapy or in follow-up without an intervening HSCT.
The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents (e.g., busulfan in combination with other alkylating agents) and last total bilirubin level greater than or equal to the ULN before HSCT are significantly associated with an increased risk of VOD. Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. Patients who have experienced prior VOD or have serious ongoing hepatic liver disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis) are at an increased risk for worsening of liver disease, including developing VOD, following treatment with BESPONSA.
Monitor closely for signs and symptoms of VOD; these may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. Due to the risk of VOD, for patients proceeding to HSCT, the recommended duration of treatment with BESPONSA is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles . For patients who proceed to HSCT, monitor liver tests closely during the first month post-HSCT, then less frequently thereafter, according to standard medical practice.
In the INO-VATE ALL trial, increases in liver tests were reported. Grade 3/4 AST, ALT, and total bilirubin abnormal liver tests occurred in 7/160 (4%), 7/161 (4%), and 8/161 patients (5%), respectively.
In all patients, monitor liver tests, including ALT, AST, total bilirubin, and alkaline phosphatase, prior to and following each dose of BESPONSA. Elevations of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA .
The following adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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