Drug Interaction:
Oral hypoglycemcis Cytarabine, Inhibitors of CYP3A4 or 2C 19 Ketaconazole, Amiadarone, antivirals, isoniazid Metronidazole, statins, Nitrofurantoin, Hypotensives
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
219. Bortezomib inj 3.5mg/vial 09-10-08
(Addl.Indication)
Treatment of multiple myeloma
U.S.FDA APPROVED DRUGS DURING 2007
45. Bortezomib 2mg/vial 28-03-07
(addl.pack size) As approved
127. Bortezomib injection 22-08-07
(addl.indcn)
For treatment of patients with mantle
cell lymphoma who have received
at least one prior therapy
VELCADE(bortezomib) for Injection
Initial Approval- 2003
RECENT MAJOR CHANGES
Dosage and Administration
Managent of peripheral Neuropathy (2.5) - 1/2012
Administration Precautions (2.7) - 1/2012
Reconstitution / Preparations (2.7) - 1/2012
Intervenous and Sub-cutaneous
Administration (2.8) - 1/2012
Warnings and Precautions
Peripheral Neuropathy (5.1) - 1/2012
Bortezominb for Injection ( subcutaneous route of administration as alternate
to intervenous route ( Additional route of administration)
Indication-
Same as already approved
Approved by FDA on 28-01014 (Ref- FDA approved List- 2014)
Monotherapy for treatment of progressive multiple myeloma
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Bortezomib 2mg/vial as approved 28-03-2007
Addl.pack size
2.Bortezomib inj.3.5mg/vial 09-10-2008
Addl.Indication
Treatment of patients with multiple myeloma
3.Bortezomin for injection 3.5mg ( sub-cutaneous route 28-01-2014
of administration as an alternate to intravenous route)
Addl.route of administration
same as already approved
4.Bortezomib injection 05-09-2007
Addl.Indication
For the treatment of patients with multiple cell lymphoma who
have received at least one prior therapy
Adverse Reaction:
Peripheral neuropathy, pain polyneuropathy rash,myalgia myopathy, arthalgia, anorexia infections insomnia, anxiety , depression tinnitus, dizzines, vertigo taste disturbances blurred vision, eye pain
Contra-Indications:
Severe hepatic impairment
Acute diffuse infiltrative pulmonary and pericardial disease
Pregnancy Lactation
Special precautions-
Renal or hepatic impairment
Amyloidiosis
Risk of haematological toxicites particularly thrombocytopenia
Monitor and platelet counts throughout treatment
Monitor patients who experience constipation
Risk of pulmonary disease perform pretreatment chest X RAY and monitor for new or worsening symptoms
Dosages/ Overdosage Etc:
Indication-
Monotherapy for treatment of progressive multiple myeloma
Dosage-
Given as 3-5 second IV bolus inj
Previously untreated multiple myeloma - treat for nine- 6 week cycles in combination with oral melphalan and oral prednisolone
Patient Information:
Bortezomib-
1. Bortezomib may cause fatigue, dizziness, syncope, and orthostatic /postural hypotension.
Advice patients not to drive or operate machinery if they experience these symptoms.
2. Advice patients to take appropiate measures if they experience vomiting/and/or diarrhea, to
avoid dehydration
3. Advice patients to seek medical advice if they experience light headedness, dizziness, or
fainting spells.
4. Advice patients to use effective contracepives measures to prevent pregnancy and to
avoid breast feeding during treatment with bortezomib
Pregnancy and lactation:
Use contraindicated Observe caution
Manufacturer Details