VELCADE 3.5mg FOR INJECTION

BSP Pharmaceuticals S.p.A. (BSP) (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Mar 15, 2005
Approval ID: 61496471979514ee
Company: BSP Pharmaceuticals S.p.A. (BSP) (ITALY)
Type: Therapeutic

Approval Details

Approval Id: 61496471979514ee
Drug Name: VELCADE 3.5mg FOR INJECTION
Product Name: VELCADE 3.5mg FOR INJECTION
Approval Number: SIN13064P
Approval Date: 2005-03-15
Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Licence Holder: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, POWDER, FOR SOLUTION
Dosage: Dosage and Administration VELCADE® may be administered: <ul> <li>Intravenously (at a concentration of 1 mg/ml) as a 3 to 5 second bolus injection or</li> <li>Subcutaneously (at a concentration of 2.5 mg/ml)</li> </ul> Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered. At least 72 hours should elapse between consecutive doses of VELCADE®. VELCADE® IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. Intrathecal administration has resulted in death. Monotherapy Relapsed Multiple Myeloma and Relapsed Mantle Cell Lymphoma Recommended Dosage The recommended dose of VELCADE® is 1.3 mg/m2/dose 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, for relapsed multiple myeloma, 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 section for a description of dose administration during the trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). At least 72 hours should elapse between consecutive doses of VELCADE®. Dose Modification and Re-initiation of Therapy 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 1.0 mg/m2/dose; 1.0 mg/m2/dose reduced to 0.7 mg/m2/dose). Neuropathic Pain and/or Peripheral Sensory Neuropathy Table 1 contains the recommended dose modification for the management of patients who experience VELCADE®-related neuropathic pain and/or peripheral neuropathy. Severe autonomic neuropathy resulting in treatment interruption or discontinuation has been reported. Patients with pre-existing severe neuropathy should be treated with VELCADE® only after careful risk-benefit assessment. <img src="/TGIF/Velcade-Table1_060225.png" alt="Velcade Dosage Table 1" /> Combination Therapy Previously Untreated Multiple Myeloma Recommended Dosage in Combination with Melphalan and Prednisone VELCADE® (bortezomib) for Injection is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 2. 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®. <img src="/TGIF/Velcade-Table2_060225.png" alt="Velcade Dosage Table 2" /> Dose Management Guidelines for Combination Therapy with Melphalan and Prednisone Dose modification and reinitiation of therapy when VELCADE® is administered in combination with melphalan and prednisone Prior to initiating a new cycle of therapy: <ul> <li>Platelet count should be ≥70 x 109/L and the absolute neutrophil count (ANC) should be ≥ 1.0 x 109/L</li> <li>Non-hematological toxicities should have resolved to Grade 1 or baseline</li> </ul> <img src="/TGIF/Velcade-Table3_060225.png" alt="Velcade Dosage Table 3" /> For additional information concerning melphalan and prednisone, see manufacturer's prescribing information. Previously Untreated Mantle Cell Lymphoma Patients Not Eligible for Haematopoietic Stem Cell Transplantation Recommended Dosage in Combination with Rituximab, Cyclophosphamide, Doxorubicin and Prednisone For VELCADE® dosage, see Monotherapy. Six VELCADE® cycles are administered. For patients with a response first documented at Cycle 6, two additional VELCADE® cycles are recommended. The following medicinal products are administered on Day 1 of each VELCADE® 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2, and doxorubicin at 50 mg/m2. Prednisone is administered orally at 100 mg/m2 on Days 1, 2, 3, 4 and 5 of each treatment cycle. Dose Adjustments during Treatment for Patients with Previously Untreated Mantle Cell Lymphoma Prior to the first day of each cycle (other than Cycle 1): <ul> <li>Platelet count should be ≥ 100 x 109/L and absolute neutrophil count (ANC) should be ≥ 1.5 x 109/L</li> <li>Hemoglobin should be ≥ 8 g/dL (≥ 4.96 mmol/L)</li> <li>Non-hematologic toxicity should have recovered to Grade 1 or baseline</li> </ul> VELCADE® treatment must be withheld at the onset of any Grade 3 non-hematological or Grade 3 hematological toxicities, excluding neuropathy (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For dose adjustments, see Table 4 below. <img src="/TGIF/Velcade-Table4_060225.png" alt="Velcade Dosage Table 4" /> For dosing instructions for rituximab, cyclophosphamide, doxorubicin, or prednisone, see manufacturer's prescribing information. Special Patient Populations Impaired Renal Function The pharmacokinetics of VELCADE® are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE® are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE® concentrations, the drug should be administered after the dialysis procedure (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Impaired Hepatic Function 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/m2 per injection during the first cycle, and a subsequent dose escalation to 1.0mg/m2 or further dose reduction to 0.5mg/m2 may be considered based on patient tolerance (see Table 5 and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <img src="/TGIF/Velcade-Table5_060225.png" alt="Velcade Dosage Table 5" /> Method of Administration VELCADE® is administered intravenously or subcutaneously. When administered intravenously, VELCADE® is administered as a 3–5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with 0.9% sodium chloride solution for injection. For subcutaneous administration, the reconstituted solution is injected into the thighs (right or left) or abdomen (right or left). Injection sites should be rotated for successive injections. If local injection site reactions occur following VELCADE® injection subcutaneously, a less concentrated VELCADE® solution (1 mg/mL instead of 2.5 mg/mL) may be administered subcutaneously, or changed to IV injection.
Route Of Administration: INTRAVENOUS
Indication Info: Indications VELCADE® (bortezomib) for Injection is indicated as part of combination therapy for the treatment of patients with previously untreated multiple myeloma. VELCADE® (bortezomib) for Injection is indicated as monotherapy for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. VELCADE® (bortezomib) for Injection is indicated as monotherapy for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. VELCADE® (bortezomib) for Injection in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Contraindications: Contraindications VELCADE® is contraindicated in patients with acute diffuse infiltrative pulmonary and pericardial disease and hypersensitivity to bortezomib, boron, or mannitol.
Atc Code: L01XX32
Atc Item Name: xl 01 xx 32
Pharma Manufacturer Name: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/johnson-and-johnson-international-singapore-pte-ltd

Active Ingredients

BORTEZOMIB

3.5mg

BORTEZOMIB

3.5 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 15, 2005

Approval ID

61496471979514ee

Type

Therapeutic

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