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TREANDA
Overview
What is TREANDA?
Bendamustine hydrochloride is an alkylating agent. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-, monohydrochloride. Its empirical molecular formula is CHClNO HCl, and the molecular weight is 394.7. Bendamustine hydrochloride contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent, and has the following structural formula:
TREANDA Injection (45 mg/0.5 mL or 180 mg/2 mL solution)
TREANDA (bendamustine HCl) Injection is intended for intravenous infusion only after dilution with either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP. It is supplied as a sterile clear colorless to yellow solution in a single-dose vial at the concentration of 90 mg/mL of bendamustine HCl. Each 0.5 mL vial contains 45 mg of bendamustine hydrochloride, 162 mg of Propylene Glycol, USP and 293 mg of N,N-Dimethylacetamide, EP. Each 2 mL vial contains 180 mg of bendamustine hydrochloride, 648 mg of Propylene Glycol, USP and 1172 mg of N,N-Dimethylacetamide, EP. An overfill of 0.2 mL is included in each vial.
TREANDA for Injection (25 mg/vial or 100 mg/vial lyophilized powder)
TREANDA (bendamustine HCl) for Injection is intended for intravenous infusion only after reconstitution with Sterile Water for Injection, USP, and after further dilution with either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP. It is supplied as a sterile non-pyrogenic white to off-white lyophilized powder in a single-dose vial. Each 25-mg vial contains 25 mg of bendamustine hydrochloride and 42.5 mg of mannitol, USP. Each 100-mg vial contains 100 mg of bendamustine hydrochloride and 170 mg of mannitol, USP. The pH of the reconstituted solution is 2.5 - 3.5.
What does TREANDA look like?
What are the available doses of TREANDA?
Injection:
For Injection
3
3
What should I talk to my health care provider before I take TREANDA?
How should I use TREANDA?
TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
TREANDA is available in two formulations, a solution (TREANDA Injection) and a lyophilized powder (TREANDA for Injection).
Do not use TREANDA Injection if you intend to use closed system transfer devices (CSTDs), adapters and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS) prior to dilution in the infusion bag
[see Dosage and Administration ()]
If using a syringe to withdraw and transfer TREANDA Injection from the vial into the infusion bag, only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer TREANDA Injection into the infusion bag.
TREANDA Injection and the reconstituted TREANDA for Injection have different concentrations of bendamustine hydrochloride. The concentration of bendamustine hydrochloride in the solution is 90 mg/mL and the concentration of bendamustine hydrochloride in the reconstituted solution of lyophilized powder is 5 mg/mL.
TREANDA Injection must be withdrawn and transferred for dilution in a biosafety cabinet (BSC) or containment isolator using a polypropylene syringe with a metal needle and a polypropylene hub.
If a CSTD or adapter that contains polycarbonate or ABS is used as supplemental protection prior to dilution, only use TREANDA for Injection, the lyophilized powder formulation .
What interacts with TREANDA?
Sorry No Records found
What are the warnings of TREANDA?
Sorry No Records found
What are the precautions of TREANDA?
Sorry No Records found
What are the side effects of TREANDA?
Sorry No records found
What should I look out for while using TREANDA?
TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.
What might happen if I take too much TREANDA?
The intravenous LD of bendamustine HCl is 240 mg/m in the mouse and rat. Toxicities included sedation, tremor, ataxia, convulsions and respiratory distress.
Across all clinical experience, the reported maximum single dose received was 280 mg/m. Three of four patients treated at this dose showed ECG changes considered dose-limiting at 7 and 21 days post-dosing. These changes included QT prolongation (one patient), sinus tachycardia (one patient), ST and T wave deviations (two patients) and left anterior fascicular block (one patient). Cardiac enzymes and ejection fractions remained normal in all patients.
No specific antidote for TREANDA overdose is known. Management of overdosage should include general supportive measures, including monitoring of hematologic parameters and ECGs.
How should I store and handle TREANDA?
Store at 20°C to 25ºC (68°F to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.]Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows:Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6523-04Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6523-06Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows:Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6523-04Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6523-06Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows:Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6523-04Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6523-06Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows:Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6523-04Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6523-06Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows:Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6523-04Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6523-06Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows:Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6523-04Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6523-06Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Bendamustine is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. Bendamustine is active against both quiescent and dividing cells. The exact mechanism of action of bendamustine remains unknown.
Non-Clinical Toxicology
TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. CellCept has not been administered concomitantly with azathioprine.
TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies (see Table 4). Three patients (2%) died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV).
In the event of treatment-related myelosuppression, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. In the clinical trials, blood counts were monitored every week initially. Hematologic nadirs were observed predominantly in the third week of therapy. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle. Prior to the initiation of the next cycle of therapy, the ANC should be ≥ 1 x 10/L and the platelet count should be ≥ 75 x 10/L.
The following serious adverse reactions have been associated with TREANDA in clinical trials and 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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