Velcade

Velcade

bortezomib

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
As monotherapy or in combination w/ pegylated liposomal doxorubicin or dexamethasone for adult patients w/ progressive multiple myeloma who have received at least 1 prior therapy & who have already undergone or are unsuitable for haematopoietic stem cell transplantation. In combination w/ melphalan & prednisone for adult patients w/ previously untreated multiple myeloma who are not eligible for high dose chemotherapy w/ haematopoietic stem cell transplantation. In combination w/ dexamethasone, or w/ dexamethasone & thalidomide, for induction treatment of adult patients w/ previously untreated multiple myeloma who are eligible for high dose chemotherapy w/ haematopoietic stem cell transplantation. In combination w/ rituximab, cyclophosphamide, doxorubicin & prednisone adult patients w/ previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Dosage/Direction for Use
Starting dose: 1.3 mg/m2 administered either as a 3-5 sec bolus IV inj at a conc of 1 mg/mL or via SC inj at a conc of 2.5 mg/mL. Moderate or severe hepatic impairment Use a lower starting dose.
Contraindications
Hypersensitivity to bortezomib, boron, mannitol or nitrogen. Acute diffuse infiltrative pulmonary & pericardial disease.
Special Precautions
Not to be administered intrathecally. GI & haematological toxicity. Monitor platelet counts prior to each dose. Antiviral prophylaxis is recommended in case of HZV reactivation. Closely monitor for clinical & laboratory signs of active HBV infection during & following rituximab combination treatment. Monitor for neurological symptoms or signs suggestive of progressive multifocal leukoencephalopathy. Patients w/ new or worsening peripheral neuropathy; any risk factors for seizures; history of syncope receiving medicinal products known to be associated w/ hypotension or who are dehydrated due to recurrent diarrhoea or vomiting; risk factors for or existing heart disease. Discontinue in patients developing posterior reversible encephalopathy syndrome. QT-interval prolongation; pulmonary disorders; tumour lysis syndrome; potentially immunocomplex-mediated reactions. Concomitant use w/ potent CYP3A4 inhibitors, oral hypoglycemics. Renal & hepatic impairment. Pregnancy & lactation.
Adverse Reactions
Nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster & myalgia.
Drug Interactions
Increased exposure w/ potent CYP3A4 inhibitors. CYP2C19 inhibitors. Reduced efficacy w/ CYP3A4 inducers.
ATC Classification
L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Velcade powd for inj 3.5 mg
Packing/Price
(single-use) 1's
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