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Multiple Myeloma

VELCADE® (bortezomib) is indicated for the treatment of patients with multiple myeloma.

Mantle Cell Lymphoma

VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.


General Dosing Guidelines

The recommended starting dose of VELCADE is 1.3 mg/m². VELCADE may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL. When administered intravenously, VELCADE is administered as a 3 to 5 second bolus intravenous injection. VELCADE is for intravenous or subcutaneous use only. VELCADE should not be administered by any other route.

Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.

Dosage in Previously Untreated Multiple Myeloma

VELCADE is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 1. In Cycles 1-4, VELCADE is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, VELCADE is administered once weekly (days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of VELCADE.

Table 1: Dosage Regimen for Patients with Previously Untreated Multiple Myeloma

Twice Weekly VELCADE (Cycles 1-4) Week 1 2 3 4 5 6
VELCADE (1.3 mg/m²) Day 1 -- -- Day 4 Day 8 Day 11 rest period Day 22 Day 25 Day 29 Day 32 rest period
Melphalan(9 mg/m²) Prednisone(60 mg/m²) Day 1 Day 2 Day 3 Day 4 -- -- rest period -- -- -- -- rest period
Once Weekly VELCADE (Cycles 5-9 when used in combination with Melphalan and Prednisone)
Week 1 2 3 4 5 6
VELCADE (1.3 mg/m²) Day 1 -- -- Day 4 Day 8 Day 11 rest period Day 22 Day 25 Day 29 Day 32 rest period
Melphalan(9 mg/m²) Prednisone(60 mg/m²) Day 1 Day 2 Day 3 Day 4 -- -- rest period -- -- -- -- rest period

Dose Modification Guidelines for VELCADE When Given in Combination with Melphalan and Prednisone

Prior to initiating any cycle of therapy with VELCADE in combination with melphalan and prednisone:

Table 2: Dose Modifications during Cycles of Combination VELCADE, Melphalan and Prednisone Therapy

Toxicity Dose modification or delay
Hematological toxicity during a cycle: If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle Consider reduction of the melphalan dose by 25% in the next cycle
If platelet count is not above 30 x 109/L or aNc is not above 0.75 x 109/L on a VELCADE dosing day (other than day 1) Withhold VELCADE dose
If several VELCADE doses in consecutive cycles are withheld due to toxicity Reduce VELCADE dose by 1 dose level (from 1.3 mg/m² to 1 mg/m², or from 1 mg/m² to 0.7 mg/m²)
Grade 3 or higher non-hematological toxicities Withhold VELCADE therapy until symptoms of toxicity have resolved to Grade 1 or baseline. Then, VELCADE may be reinitiated2 with one dose level reduction (from 1.3 mg/m² to 1 mg/m², or from 1 mg/m² to 0.7 mg/m²). For VELCADE-related neuropathic pain and/or peripheral neuropathy, hold or modify VELCADE as outlined in Table 3.

For information concerning melphalan and prednisone, see manufacturer's prescribing information.

Dose modifications guidelines for peripheral neuropathy are provided.

Dosage and Dose Modifications for Relapsed Multiple Myeloma and Mantle Cell Lymphoma

VELCADE (1.3 mg/m²/dose) is administered twice weekly for 2 weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12-21). 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 Studies]. At least 72 hours should elapse between consecutive doses of VELCADE.

VELCADE therapy should be withheld at the onset of any Grade 3 non-hematological or Grade 4 hematological toxicities excluding neuropathy as discussed below [see WARNINGS AND PRECAUTIONS]. Once the symptoms of the toxicity have resolved, VELCADE therapy may be reinitiated at a 25% reduced dose (1.3 mg/m²/dose reduced to 1 mg/m²/dose; 1 mg/m²/dose reduced to 0.7 mg/m²/dose).

For dose modifications guidelines for peripheral neuropathy see Management of Peripheral Neuropathy section.

Dose Modifications for Peripheral Neuropathy

Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy. Patients with pre-existing severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment.

Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule.

For dose or schedule modification guidelines for patients who experience VELCADE-related neuropathic pain and/or peripheral neuropathy see Table 3.

Table 3: Recommended Dose Modification for VELCADE related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy

Severity of Peripheral Neuropathy Signs and Symptoms* Modification of Dose and Regimen
Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) without pain or loss of function No action
Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**) Reduce VELCADE to 1 mg/m²
Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL ***) Withhold VELCADE therapy until toxicity resolves. When toxicity resolves reinitiate with a reduced dose of VELCADE at 0.7 mg/m² once per week.
Grade 4 (life-threatening consequences; urgent intervention indicated) Discontinue VELCADE
*Grading based on NCI Common Terminology Criteria CTCAE v4.0
**Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money etc;
***Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden

Dosage in Patients with Hepatic Impairment

Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated per the recommended VELCADE dose. Patients with moderate or severe hepatic impairment should be started on VELCADE at a reduced dose of 0.7 mg/m²per injection during the first cycle, and a subsequent dose escalation to 1.0 mg/m²or further dose reduction to 0.5 mg/m²may be considered based on patient tolerance (see Table 4) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Table 4: Recommended Starting Dose Modification for VELCADE in Patients with Hepatic Impairment

  Bilirubin Level SGOT (AST) Levels Modification of Starting Dose
Mild Less than or equal to 1.0x ULN More than ULN None
More than 1.0x-1.5x ULN Any None
Moderate More than 1.5x-3x ULN Any Reduce VELCADE to 0.7 mg/m² in the first cycle. Consider dose escalation to 1.0 mg/m² or further dose reduction to 0.5 mg/m² in subsequent cycles based on patient tolerability.
Severe More than 3x ULN Any
Abbreviations: SGOT = serum glutamic oxaloacetic transaminase;
AST = aspartate aminotransferase; ULN = upper limit of the normal range.

Administration Precautions

The drug quantity contained in one vial (3.5 mg) may exceed the usual dose required. Caution should be used in calculating the dose to prevent overdose.

When administered subcutaneously, sites for each injection (thigh or abdomen) should be rotated. New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, erythematous, or indurated.

If local injection site reactions occur following VELCADE administration subcutaneously, a less concentrated VELCADE solution (1 mg/mL instead of 2.5 mg/mL) may be administered subcutaneously. Alternatively, the intravenous route of administration should be considered.

VELCADE is an antineoplastic. Procedures for proper handling and disposal should be considered [see HOW SUPPLIED/Storage and Handling].

Reconstitution/Preparation for Intravenous and Subcutaneous Administration

Proper aseptic technique should be used. Reconstitute only with 0.9% sodium chloride. The reconstituted product should be a clear and colorless solution.

Different volumes of 0.9% sodium chloride are used to reconstitute the product for the different routes of administration. The reconstituted concentration of bortezomib for subcutaneous administration (2.5 mg/mL) is greater than the reconstituted concentration of bortezomib for intravenous administration (1 mg/mL). Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.

For each 3.5 mg single-use vial of bortezomib reconstitute with the following volume of 0.9% sodium chloride based on route of administration (Table 5):

Table 5: Reconstitution Volumes and Final Concentration for Intravenous and Subcutaneous Administration

Route of administration Bortezomib (mg/vial) Diluent (0.9% Sodium Chloride) Final Bortezomib concentration (mg/mL)
Intravenous 3.5 mg 3.5 mL 1 mg/mL
Subcutaneous 3.5 mg 1.4 mL 2.5 mg/mL

Dose must be individualized to prevent overdosage. After determining patient body surface area (BSA) in square meters, use the following equations to calculate the total volume (mL) of reconstituted VELCADE to be administered:

  • Intravenous Administration [1 mg/mL concentration]

VELCADE dose (mg/m²) x patlent BSA (m²) / 1 mg / ml = Total VELCADE volume (ml) to be administered

  • Subcutaneous Administration [2.5 mg/mL concentration]

VELCADE dose (mg/m²) x patlent BSA (m²) / 2.5 mg / ml = Total VELCADE volume (ml) to be administered

Stickers that indicate the route of administration are provided with each VELCADE vial. These stickers should be placed directly on the syringe of VELCADE once VELCADE is prepared to help alert practitioners of the correct route of administration for VELCADE.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. If any discoloration or particulate matter is observed, the reconstituted product should not be used.

Stability: Unopened vials of VELCADE are stable until the date indicated on the package when stored in the original package protected from light.

VELCADE contains no antimicrobial preservative. Reconstituted VELCADE should be administered within 8 hours of preparation. When reconstituted as directed, VELCADE may be stored at 25°C (77°F). The reconstituted material may be stored in the original vial and/or the syringe prior to administration. The product may be stored for up to 8 hours in a syringe; however, total storage time for the reconstituted material must not exceed 8 hours when exposed to normal indoor lighting.


Dosage Forms And Strengths

Each single-use vial of VELCADE contains 3.5 mg of bortezomib as a sterile lyophilized white to off-white powder.

Storage And Handling

VELCADE® (bortezomib) for Injection is supplied as individually cartoned 10 mL vials containing 3.5 mg of bortezomib as a white to off-white cake or powder.

NDC 63020-049-01

3.5 mg single use vial

Unopened vials may be stored at controlled room temperature 25°C (77°F); excursions permitted from 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Retain in original package to protect from light.

Consider handling and disposal of VELCADE according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact1.


1. “OSHA Hazardous Drugs“ (refer to antineoplastic weblinks including OSHA Technical Manual). OSHA.

Distributed and Marketed by: Millennium Pharmaceuticals, Inc. 40 Landsdowne Street Cambridge, MA 02139. Rev 15

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.


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