Physicians Academy
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Table Of Contents
Editorial :
 Bacterial Infections in Patients with Leukemia
Article 1 :
 What after a Suicide Attempt?
Article 2 :
 Neglected Child with severe Bronchopneumonia
Picture of The Month :
 Picture of The Month November 2017
Drug Update :
 VELCADE (Bortezomib)
Abstracts from Other Journals :
 Abstracts from Other Journals-November 2017

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Nov 2017 (Volume -11Number -11)

Drug Update
VELCADE (Bortezomib)
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DRUG UPDATE

NOVEMBER 2017

VELCADE (Bortezomib)

VELCADE (bortezomib) is an antineoplastic agent for intravenous injection (IV) or subcutaneous (SC) use only. Each single dose vial contains:

1 mg of bortezomib as a sterile lyophilised powder. Inactive ingredients: 10 mg Mannitol and nitrogen qs, or

3.0 mg of bortezomib as a sterile lyophilized powder. Inactive ingredients: 30 mg mannitol and nitrogen qs, or

3.5 mg of bortezomib as a sterile lyophilised powder. Inactive ingredients: 35 mg mannitol and nitrogen qs.

Bortezomib is a modified dipeptidyl boronic acid. The product is provided as a mannitol boronic

ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine.

INDICATIONS

VELCADE, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.

VELCADE, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.

VELCADE is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

CONTRAINDICATIONS

VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron or mannitol.

PRECAUTIONS

Overall treatment with VELCADE must be done under the supervision of a physician, however administration of the drug product may be done by a healthcare professional experienced in the administration of oncology medications. There have been fatal cases of inadvertent intrathecal administration of VELCADE.

VELCADE is for intravenous or subcutaneous use only. DO NOT ADMINISTER VELCADE

INTRATHECALLY.

Overall, the safety profile of patients treated with VELCADE in monotherapy was similar to that observed in patients treated with VELCADE in combination with melphalan and prednisone.

ADVERSE EFFECTS

In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus. Information on autonomic neuropathy and its contribution to these undesirable effects is limited.

Use in Pregnancy

Category C

Women of child bearing potential should avoid becoming pregnant while being treated with VELCADE. The placental transfer of bortezomib is unknown, but any occurrence may disrupt cycling in the developing foetus, although teratogenicity was not observed in rats and rabbits at maximum tolerated doses. Bortezomib was not teratogenic in nonclinical developmental toxicity studies in rats and rabbits at the highest dose tested (approximately 0.5 mg/m2/day) when administered during organogenesis. These dosages are approximately half the clinical dose of 1.3 mg/m2 based on body surface area and calculated on a single-dose basis. Increased post-implantation loss and reduced foetal weights were seen in rabbits at the highest dose tested, which was a maternally toxic dose. Litter values were unaffected by a non-maternotoxic dose (approximately 0.3 mg/m2/day).

No placental transfer studies have been conducted with bortezomib. There are no adequate and well-controlled studies in pregnant women. If VELCADE is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be informed of the potential hazard to the foetus. Patients should be advised to use effective contraceptive measures to prevent pregnancy.

Use in Lactation

It is not known whether bortezomib or its metabolites are excreted in animal or human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-fed infants from VELCADE, women should be advised against breast-feeding while being treated with VELCADE. CCDS 1504 24 VELCADE (161207)API

Paediatric Use

The safety and effectiveness of VELCADE in children has not been established.

DOSAGE AND ADMINISTRATION

VELCADE may be administered:

Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus injection or

Subcutaneously (at a concentration of 2.5 mg/mL)

Because each route of administration has a different reconstituted concentration, caution

should be used when calculating the volume to be administered.

VELCADE IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. Intrathecal

administration has resulted in death.

Relapsed / Refractory Multiple Myeloma

Recommended Dose

The recommended dose of VELCADE is 1.3 mg/m2/dose administered twice weekly for two weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21). This 3-week period is considered a treatment cycle. At least 72 hours should elapse between consecutive doses of VELCADE. It is recommended that patients with a confirmed complete response receive 2 additional cycles of VELCADE beyond a confirmation. It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of VELCADE therapy. For extended therapy of more than 8 cycles, VELCADE may be administered on the standard schedule or on a maintenance schedule of once weekly for 4 weeks (days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 35) (see CLINICAL TRIALS for a summary of dose administration during clinical trials).

PRESENTATION AND STORAGE CONDITIONS

VELCADE is supplied in a 5 mL or 10 mL, type I, glass vial with a gray bromobutyl stopper and aluminum seal. The cap colour of the 5 mL vial is green. The cap colour for the 10 mL vial is orange for the 3.0 mg product presentation and royal blue for the 3.5 mg product presentation. The vial is contained in a transparent blister pack consisting of a tray with a lid. The 5 mL vial contains 11 mg powder (1.0 mg bortezomib) for solution for IV injection only. The 10 mL vial contains 33 mg powder for the 3.0 mg product, and 38.5 mg powder for the 3.5 mg product, for solution for IV or SC injection.

VELCADE is available in cartons containing 1 vial. Product is for single use in one patient only.

Storage

Unopened vials: Store below 25ºC. Keep the container in the outer carton in order to protect from light.

Reconstituted solution: VELCADE contains no antimicrobial preservative. The chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25°C when it is stored under normal lighting conditions in the original vial and/or syringe prior to administration. However, to reduce microbiological hazard, use as soon as possible after dilution and if storage is necessary hold at 2-8°C for up to 8 hours.

NAME AND ADDRESS OF THE SPONSOR

JANSSEN-CILAG Pty Ltd

1-5 Khartoum Rd Macquarie Park NSW 2113 Australia

POISON SCHEDULE OF THE MEDICINE

Prescription Only Medicine

DATE OF FIRST INCLUSION IN THE ARTG: 14 February 2006

DATE OF MOST RECENT AMENDMENT: 7 December 2016

Please note change(s) presented as *italicised text in Product Information.

 

For Detailed Product Information CLICK HERE to download in PDF (748 KB). Or go back to TOCs and download.

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