Myborte

Myborte

bortezomib

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
Multiple myeloma. Mantle cell lymphoma in patients who have received at least 1 prior therapy.
Dosage/Direction for Use
Previously untreated multiple myeloma 1.3 mg/m2 as 3-5 sec IV bolus inj in combination w/ oral mephalan & prednisone for nine 6-wk treatment cycles. Cycles 1-4: Administer twice wkly (days 1, 4, 8, 11, 22, 25, 29 & 32). Cycles 5-9: Administer once wkly (days 1, 8, 22 & 29). At least 72 hr should elapse between consecutive doses. Relapsed multiple myeloma & mantle cell lymphoma 1.3 mg/m2/dose twice wkly for 2 wk (days 1, 4, 8 & 11) followed by 10-day rest period (days 12-21). For extended therapy of >8 cycles: As per standard schedule or for relapsed multiple myeloma, on maintenance schedule of once wkly for 4 wk (days 1, 8, 15 & 22) followed by 13-day rest period (days 23-35). At least 72 hr should elapse between consecutive doses.
Contraindications
Hypersensitivity. Acute diffuse infiltrative pulmonary & pericardial disease.
Special Precautions
Not for intrathecal administration. Discontinue use if progressive multifocal leukoencephalopathy, posterior reversible encephalopathy syndrome are diagnosed & if serious immunocomplex-mediated reactions occur. Haematological & GI toxicity; herpes zoster virus & HBV reactivation & infection; new or worsening peripheral neuropathy; seizures; patients w/ history of syncope receiving medicinal products associated w/ hypotension, or dehydrated due to recurrent diarrhoea or vomiting; risk factors for or existing heart disease; QT-interval prolongation; pneumonitis, interstitial pneumonia, lung infiltration, acute resp distress syndrome; hepatic reactions; tumour lysis syndrome. Perform HBV screening prior to initiation in patients at risk of HBV infection. Frequently monitor complete blood counts w/ differential & platelet counts. Concomitant use w/ potent CYP3A4 inhibitors, CYP3A4 or CYP2C19 substrates, oral hypoglycemics. Male & female of childbearing potential must use effective contraceptive measures during & for 3 mth following treatment. May affect ability to drive & use machines. Renal & hepatic impairment. Pregnancy. Not to be used during lactation. Childn <18 yr. Elderly ≥75 yr.
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
Reduced efficacy w/ strong CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort. Monitor blood glucose levels w/ oral antidiabetics. Potent CYP3A4 inhibitors eg, ketoconazole, ritonavir.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Myborte powd for inj 3.5 mg
Packing/Price
1's
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