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VELCADE®▼3.5 mg POWDER FOR SOLUTION FOR INJECTION PRESCRIBING
INFORMATION
ACTIVE INGREDIENT: Bortezomib

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S):
Monotherapy of progressive multiple myeloma in patients who have
had at least 1 prior therapy and already undergone or are not suitable for bone
marrow transplantation. With melphalan & prednisolone for treating previously
untreated multiple myeloma patients who are not eligible for high-dose chemotherapy
with bone marrow transplant.
DOSAGE & ADMINISTRATION:
Adults and Elderly: Starting dose 1.3mg/m2 body
surface area Monotherapy: twice weekly via intravenous injection for two weeks
followed by a 10-day rest period.
When administered as a single agent, treatment should be withheld in the presence
of any Grade 3 non-haematological or Grade 4 haematological toxicity, excluding
neuropathy. Treatment may be restarted at an approximate 25% dose reduction
(1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2) following
resolution of toxicity.
The dose should be reduced to 1 mg/m2 in the presence of Grade 1 with pain or
Grade 2 (interfering with function but not with activities of daily living) neuropathy.
In the presence of Grade 2 with pain or Grade 3 (interfering with activities of daily
living) neuropathy, treatment should be withheld until symptoms of toxicity have
resolved. Reinitiate treatment at a dose of 0.7 mg/ m2 and reduce dosing schedule to
weekly.
If Grade 4 neuropathy and /or severe autonomic neuropathy occur, discontinue
treatment permanently.
Combination therapy: administered via intravenous injection in combination with
oral melphalan (9mg/m2) and prednisolone (60mg/m2) for nine 6-week treatment
cycles. Refer to SmPC for dose management. Reconstituted solution given as 3-5
second IV bolus.
When administered in combination with melphalan and prednisone, treatment should
be withheld if either the platelet counts ≤30 × 109/l or ANC ≤0.75 x 109/l on a
VELCADE dosing day (other than Day 1). Consideration should be given to reducing
subsequent doses by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
0.7 mg/m2) if several doses (≥ 3 doses during twice weekly administration or ≥ 2
doses during weekly administration) are withheld in any one cycle of treatment.
Treatment should be withheld until any ≥Grade 3 non-haematological toxicities have
returned to Grade 1 or baseline. Retreatment should be initiated with one dose level
reduction. During combination therapy the dose should be held and/or modified in the
presence of VELCADE-related neuropathic pain and/or peripheral neuropathy in the
same way as monotherapy.
Children:
Not applicable. Hepatic Impairment: mild - no dose adjustment; moderate or
severe - start on reduced dose of 0.7 mg/m2 per injection for first cycle, and then
possible increase to 1.0 mg/m2 or reduction to 0.5 mg/m2 based on tolerability. Renal
Impairment:
See precautions.
CONTRAINDICATIONS:
Hypersensitivity to bortezomib, boron or any of the
excipients.
Acute diffuse infiltrative pulmonary and pericardial disease.
SPECIAL WARNINGS & PRECAUTIONS: Monitor complete blood counts including
platelets. Gastrointestinal toxicity is very common, monitor closely. Peripheral
neuropathy is common and requires careful monitoring. Patients should undergo
neurological evaluation and possible dose modification. Special care of patients with
risk factors for seizures. Caution is advised when history of syncope on receiving
medicinal products known to be associated with hypotension; or who are dehydrated
due to recurrent diarrhoea or vomiting. Discontinue treatment if Reversible Posterior
Leukoencephalopathy Syndrome occurs. Development or exacerbation of congestive
heart failure, QT prolongation.
Monitor closely patients with cardiac risk factors and those with renal impairment.
Rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology eg
pneumonitis, interstitial pneumonia, lung infiltration and acute respiratory distress
syndrome (ARDS). A baseline pretreatment chest radiograph is recommended. In
event of new or worsening pulmonary symptoms perform prompt diagnostic
evaluation and treat appropriately. Consider benefit/risk ratio before continuing
VELCADE therapy. Immunocomplex-mediated reactions eg serum sickness,
polyarthritis with rash, proliferative glomerulonephritis: discontinue if severe.
Bortezomib exposure is increased in moderate/severe hepatic impairment; treat at
reduced doses and closely monitor for toxicities. Patients with high pre-treatment
tumour burden are at risk of tumour lysis syndrome; monitor closely. Monitor patients
closely when given concomitant CYP3A4-inhibitors. Exercise caution when combined
with CYP3A4- or CYP2C19 substrates.

SIDE EFFECTS: Very common: herpes zoster (consider antiviral prophylaxis),
thrombocytopenia, neutropenia, anaemia, appetite decreased, peripheral
neuropathy, peripheral sensory neuropathy, paraesthesia, headache, dyspnoea,
vomiting, diarrhoea, nausea, constipation, rash, myalgia, fatigue, pyrexia.
Common: pneumonia, bronchitis, sinusitis, nasopharyngitis, herpes simplex,
leukopenia, lymphopenia, dehydration, hypokalaemia, hyperglycaemia, confusion,
depression, insomnia, anxiety, polyneuropathy, peripheral neuropathy aggravated,
dizziness (excluding vertigo), dysgeusia, dysaesthesia, hypoaesthesia, tremor, vision
blurred, eye pain, vertigo, hypotension, orthostatic and postural hypotension,
phlebitis, haematoma, hypertension, dyspnoea exertional, epistaxis, cough,
rhinorrhoea, abdominal pain, stomatitis, dyspepsia, loose stools, abdominal pain
upper, flatulence, abdominal distension, hiccups, mouth ulceration,
pharyngolaryngeal pain, dry mouth, periorbital oedema, urticaria, rash pruritic,
pruritus, erythema, sweating increased, dry skin, eczema, muscle weakness,
musculoskeletal pain, pain in limb, muscle cramps, arthralgia, bone pain, back pain,
peripheral swelling, renal impairment, dysuria, asthenia, weakness, lethargy, rigors,
malaise, influenza like illness, oedema peripheral, chest pain, pain, oedema, weight
decreased, blood lactate dehydrogenase increased.
Other side effects include: herpes meningoencephalitis, septic shock, pleural
infection and effusion; tumour lysis syndrome; lymphadenopathy, pancytopenia,
haemolytic anaemia, febrile neutropenia, thrombocytopenic purpura; hypersensitivity,
immunocomplex mediated hypersensitivity, potentially immunocomplex-mediated
reactions (serum-sickness-type reaction, polyarthritis with rash, proliferative
glomerulonephritis); electrolyte imbalance; agitation, delirium, hallucinations,
restlessness, mental status changes; encephalopathy, reversible posterior
leukoencephalopathy syndrome, paraplegia, intra-cranial haemorrhage and
sub-arachnoid haemorrhage convulsions, peripheral motor neuropathy, paresis,
autonomic neuropathy; eye haemorrhage, optic neuropathy, different degrees of
visual impairment (up to blindness); deafness; tachycardia, supraventricular
tachycardia, arrhythmia, ventricular hypokinesia, atrial fibrillation, cardiac arrest/
failure, acute pulmonary oedema, angina unstable, atrioventricular block complete,
cardiopulmonary arrest, pericarditis, cardiogenic shock, myocardial infarction, sinus
arrest; ventricular arrhythmia/ tachycardia, cerebral haemorrhage; vasculitis,
pulmonary hypertension, acute respiratory distress syndrome (ARDS), acute diffuse
infiltrative pulmonary disease, pulmonary alveolar haemorrhage, pulmonary
embolism, peripheral embolism, respiratory alkalosis or arrest, wheezing, throat
tightness; ileus paralytic, acute pancreatitis, colitis, haematemesis, diarrhoea/
gastrointestinal/ rectal haemorrhage, enteritis, hepatitis, hepatic haemorrhage,
hyperbiliruinaemia, liver failure, Stevens-Johnson Syndrome, toxic epidermal
necrolysis, rash erythematous, photosensitivity reaction, eyelid/ face oedema, acute
febrile neutrophilic dermatosis (Sweet’s syndrome), vasculitic rash (including
leukocytoclastic vasculitis); muscle spasms/stiffness, joint stiffness/swelling; renal
failure, oliguria, mucosal inflammation & haemorrhage, neuralgia; blood alkaline
phosphatase increased, blood bicarbonate decreased.
Refer to SmPC for other side effects.
PREGNANCY:
Not fully established. Use effective contraceptive measures during
treatment and for 3 months following.

LACTATION:
Not recommended.
INTERACTIONS: Patients should be closely monitored when given bortezomib in
combination with potent CYP3A4-inhibitors (e.g. ketoconazole, ritonavir).
Concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin,
carbamazepine, phenytoin, phenobarbital and St. John’s Wort), is not recommended,
In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450
(CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4. No clinically relevant interaction
between melphalan-prednisolone and VELCADE. In clinical trials,
hypo/hyperglycaemia were reported in diabetic patients receiving oral
hypoglycaemics.

LEGAL CATEGORY:
POM
PRESENTATIONS, PACK SIZES, PRODUCT LICENCE NUMBERS & BASIC NHS
COSTS:
1 vial per pack. EU/1/04/274/001. £762.38.
MARKETING AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium.
FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Ltd, 50-100
Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG UK.
Janssen-Cilag Ltd 2011
Prescribing information last revised: 02 April 2012
PIVER02042012
Adverse events should be reported. Reporting forms and information
. Adverse events should
also be reported to Janssen-Cilag Ltd on 01494 567447.


Source: http://velcadecampaign.uat.creativelynxdevelopment.co.uk/assets/pdf/Velcade%20PI%20Clean%20UK-2-04-12.pdf

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