Bortoma

Bortoma

bortezomib

Manufacturer:

Eugia Aurobindo

Distributor:

Tersia Pharma

Marketer:

Tersia Pharma
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
Monotherapy or in combination w/ pegylated lipos doxorubicin or dexamethasone for adults w/ progressive multiple myeloma who have received at least 1 prior therapy & already undergone or are unsuitable for haematopoietic stem cell transplantation. In combination w/ melphalan & prednisone for adults w/ previously untreated multiple myeloma who are not eligible for high-dose chemotherapy w/ haematopoietic stem cell transplantation; dexamethasone, or dexamethasone & thalidomide for induction treatment of adults w/ previously untreated multiple myeloma who are eligible for high-dose chemotherapy w/ haematopoietic stem cell transplantation; rituximab, cyclophosphamide, doxorubicin & prednisone for adults w/ previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Dosage/Direction for Use
IV/SC Administer as 3-5 sec as IV bolus through peripheral or central IV catheter, or SC through the thighs (right or left) or abdomen (right or left). Progressive multiple myeloma in patients who have received at least 1 prior therapy: Monotherapy 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8, & 11 in 21-day treatment cycle for 2 cycles following confirmation of complete response. Patient who does not achieve complete remission Total of 8 cycles. At least 72 hr should elapse between consecutive doses. Combination therapy 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8, & 11 in 21-day treatment cycle. At least 72 hr should elapse between consecutive doses. Combination w/ pegylated lipos doxorubicin 30 mg/m2 pegylated lipos doxorubicin on day 4 of treatment cycle as 1 hr IV infusion administered after bortezomib inj. Administer up to 8 cycles as long as patients have not progressed & tolerate treatment. May continue treatment for at least 2 cycles after 1st evidence of complete response, even if this requires treatment for >8 cycles, in patients achieving complete response. Continue for as long as treatment is tolerated & continue to respond in patients whose levels of paraprotein continue to decrease after 8 cycles. Combination w/ dexamethasone Dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, & 12 of treatment cycle. Patient achieving response or stable disease after 4 cycles of combination therapy Continue to receive same combination for max of 4 additional cycles. Previously untreated multiple myeloma patients who are not eligible for haematopoietic stem cell transplantation: Combination w/ melphalan & prednisone 1.3 mg/m2 twice wkly on days 1, 4, 8, 11, 22, 25, 29 & 32 in cycles 1-4, & once wkly on days 1, 8, 22 & 29 in cycles 5-9. At least 72 hr should elapse between consecutive doses. 6-wk period = treatment cycle. 9 mg/m2 melphalan & 60 mg/m2 prednisone orally on days 1, 2, 3 & 4 of 1st wk of each treatment cycle. Administer 9 cycles. Previously untreated multiple myeloma patients eligible for haematopoietic stem cell transplantation (induction therapy): Combination w/ dexamethasone 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8, & 11 in 21-day treatment cycle. At least 72 hr should elapse between consecutive doses. Dexamethasone 40 mg orally on days 1, 2, 3, 4, 8, 9, 10 & 11 of treatment cycle for 4 cycles. Combination w/ dexamethasone & thalidomide 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8, & 11 in 28-day treatment cycle. At least 72 hr should elapse between consecutive doses. Dexamethasone 40 mg on days 1, 2, 3, 4, 8, 9, 10 & 11 of treatment cycle. Thalidomide 50 mg orally daily on days 1-14, increase dose to 100 mg on days 15-28 if tolerated, & may be further increased to 200 mg daily from cycle 2 thereafter. Administer 4 cycles of this combination therapy. Patient w/ at least partial response Give 2 additional cycles. Previously untreated mantle cell lymphoma: Combination w/ rituximab, cyclophosphamide, doxorubicin & prednisone 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8 & 11 followed by 10-day rest period on days 12-21 for 6 cycles. Patient w/ response 1st documented at cycle 6 May give 2 additional cycles. Rituximab 375 mg/m2, cyclophosphamide 750 mg/m2 & doxorubicin 50 mg/m2 as IV infusions on day 1 of each 3-wk treatment cycle. Prednisone 100 mg/m2 orally on days 1, 2, 3, 4 & 5 of each treatment cycle. Moderate or severe hepatic impairment 0.7 mg/m2 during 1st treatment cycle, & subsequent dose escalation to 1 mg/m2 or further dose reduction to 0.5 mg/m2 based on patient tolerability.
Contraindications
Hypersensitivity. Acute diffuse infiltrative pulmonary & pericardial disease.
Special Precautions
Not to be administered intrathecally. Discontinue treatment if progressive multifocal leukoencephalopathy (PML) is diagnosed; serious immunocomplex-mediated reactions occur; in patients developing posterior reversible encephalopathy syndrome. GI toxicity including nausea, diarrhoea, vomiting & constipation. Withhold therapy when platelet count is <25,000/microliter or ≤30,000/microliter in combination w/ melphalan & prednisone. Haematological toxicities (thrombocytopenia, neutropenia & anaemia); GI & intracerebral haemorrhage. HZV & HBV reactivation. John Cunningham virus infection resulting in PML. Severe motor neuropathy w/ or w/o sensory peripheral neuropathy. Orthostatic/postural hypotension; dizziness, light-headedness or fainting spells. Acute development or exacerbation of CHF, &/or new onset of decreased left ventricular ejection fraction. Acute diffuse infiltrative pulmonary disease of unknown aetiology eg, pneumonitis, interstitial pneumonia, lung infiltration, & acute resp distress syndrome. Tumour lysis syndrome. Patients w/ any risk factors for seizures, or existing heart disease; history of syncope receiving medicinal products known to be associated w/ hypotension; who are dehydrated due to recurrent diarrhoea or vomiting. Closely monitor patients w/ constipation; history of hepatitis B & carriers of hepatitis B for clinical & lab signs of active HBV infection; PML at regular intervals for any new or neurological symptoms or signs that may be suggestive of PML; for symptoms of neuropathy eg, burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness; high tumour burden prior to treatment. Monitor platelet counts prior to each dose & throughout treatment. Frequently monitor patients CBC w/ differential throughout treatment. Perform HBV screening in patients at risk of infection w/ HBV before treatment initiation; neurological evaluation in patients experiencing new or worsening peripheral neuropathy; prompt diagnostic evaluation in the event of new or worsening pulmonary symptoms (eg, cough, dyspnoea). Concomitant use w/ medicinal products known to be associated w/ neuropathy (eg, thalidomide); potent CYP3A4 inhibitors, CYP3A4- or CYP2C19 substrates; oral hypoglycemics. Moderate influence on the ability to drive & use machines. Renal impairment. Moderate or severe hepatic impairment. Male & female patients of childbearing potential must use effective contraceptive measures during & for 3 mth following treatment. Pregnancy. Discontinue breastfeeding during treatment. Childn <18 yr.
Adverse Reactions
Thrombocytopenia, neutropenia, anaemia, febrile neutropenia; decreased appetite; neuropathies, peripheral sensory neuropathy, dysaesthesia, neuralgia; nausea & vomiting symptoms, diarrhoea, constipation; musculoskeletal pain; pyrexia, fatigue, asthenia; hair disorder. Herpes zoster (including disseminated & ophth), pneumonia, Herpes simplex, fungal & bacterial infection, sepsis (including septic shock); leukopenia, lymphopenia; dehydration, hypokalaemia, hyponatraemia, abnormal blood glucose, hypocalcaemia, enzyme abnormality, DM, fluid retention; mood & sleep disorders & disturbances, anxiety disorder; motor neuropathy, loss of consciousness (including syncope), dizziness, dysgeusia, lethargy, headache, neuropathies, encephalopathy, peripheral sensorimotor & autonomic neuropathy; eye swelling, abnormal vision, conjunctivitis; vertigo, dysacusis (including tinnitus); hypotension, orthostatic hypotension, HTN; dyspnoea, epistaxis, upper/lower resp tract infection, cough, hiccups; GI haemorrhage (including mucosal) & inflammation, dyspepsia, stomatitis, abdominal distension, pain (including GI & splenic pain) & discomfort, oropharyngeal pain, oral disorder & ulceration, flatulence, gastritis, dysphagia; hepatic enzyme abnormality, hepatotoxicity (including liver disorder); rash, pruritus, erythema, dry skin, dermatitis; muscle spasms, pain in extremity, muscular weakness; renal impairment, UTI; oedema (including peripheral), chills, pain, malaise, inj site reaction; decreased/increased wt, hyperbilirubinaemia, abnormal protein analyses; hypersensitivity; cardiac fibrillation (including atrial) & failure (including left & right ventricular), arrhythmia, MI, ventricular dysfunction.
Drug Interactions
Increased mean AUC w/ potent CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Reduced mean AUC w/ strong CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarb & St. John's wort). Concomitant use w/ oral hypoglycemics.
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
Bortoma powd for inj 3.5 mg
Packing/Price
((lyo)) 1's
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