Bortezomib for Injection

Bortezomib for Injection

Multiple Myeloma (bortezomib) is indicated for the treatment of patients with multiple myeloma. Mantle Cell Lymphoma bortezomib is indicated for the treatment of patients with mantle cell lymphoma.

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Details

Bortezomib for injection

Description

A white or similar white mass or powder.

 

Indications

Product Name:Bortezomib for injection

Nombre del Producto: Bortezomib para inyección

Specification: 3.5mg

Package: 1vial/box

Standard: State Standard


Dosage and administration

The recommended starting dose of bortezomib is 1.3 mg/m² . bortezomib may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL.

bortezomib retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with bortezomib and who have relapsed at least 6 months after completing prior bortezomib treatment. Treatment may be started at the last tolerated dose.

When administered intravenously, bortezomib is administered as a 3 to 5 second bolus intravenous injection. bortezomib is for intravenous or subcutaneous use only. bortezomib should not be administered by any other route.

 

Side Effect 

>10%

Asthenia (61-65%),Nausea (61-65%),Diarrhea (51-55%),Anorexia (41-45%),Constipation (41-45%),Thrombocytopenia (41-45%),Peripheral neuropathy (IV: 16-41%; SC: 6-24%),Pyrexia (36-40%),Vomiting (36-40%),Anemia (31-35%),Arthralgia (26-30%),Headache (26-30%),Insomnia (26-30%),Limb pain (26-30%),Dizziness (21-25%),Dyspnea (21-25%),Edema (21-25%),Neutropenia (21-25%),Paresthesia (21-25%),Rash (21-25%),Cough (15-20%),Dehydration (15-20%),URI (15-20%),Rigors, grade 4 toxicity (10-15%)

Frequency Not Defined

Hypotension,Anxiety,Pain,Pruritis,Abdominal pain,Dyspepsia,Back pain,Bone pain,Myalgia,Muscle spasms,Herpes zoster,Pneumonia,Blurred vision

 

Contraindications

Hypersensitivity to any component or boron or mannitol; intrathecal administration

 

Precautions

Fatal events with inadvertent intrathecal administration reported

Syncope history

Dehydration

Use caution in hepatic impairment (reduce starting dose); monitor hepatic enzymes during treatment

Diabetes mellitus

Heart disease

High tumor load (risk of tumor lysis syndrome)

Acute respiratory syndromes have occurred; monitor closely for new or worsening symptoms

Risks of: CHF; severe lung disease (eg, ARDS, pneumonitis)

Closely monitor patients with high tumor burden

Acute diffuse infiltrative pulmonary disease, PRES (formerly RPLS)

Monitor complete blood counts regularly throughout treatment

Hypotension (antihypertensive dosages may need modification)

Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement

Consider MRI imaging for onset of visual or neurological symptoms; discontinue therapy if suspected

Worsening of and development of cardiac failure reported; closely monitor patients with existing heart disease or risk factors for heart disease

Women should avoid becoming pregnant while on therapy; advise pregnant women of potential embryo-fetal harm

Associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle

.

Pharmacology

Mechanism of Action

Reversible inhibitor of chymotrypsin-like activity at the 26-S proteasome, which in turn causes cell cycle arrest and apoptosis

Absorption

Pleak plasma level: 509 ng/mL

Distribution

Protein bound: 83%

Vd: 498-1884 L/m²

Metabolism

Hepatic P450 enzyme CYP3A4 (major); also CYP1A2, 2C9, 2C19, 2D6 (minor)

Enzymes inhibited: CYP2C19

Elimination

Half-Life: 9-15 hr (single dose IV); 40-193 (multiple 1 mg/m² doseing); 76-108 hr (multiple 1.3 mg/m² dosing)


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We are considered as one of the leading manufacturers and suppliers of bortezomib for injection. With the aid of our technologically advanced manufacturing section, we are able to offer customers bortezomib for injection products which are tested on various quality parameters in order to supply flawless range at the customers' end.

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