Bortezomib

بورتزومیب

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsProteasome inhibitor

Market / country: 🇺🇸 USA

Velcade (US)

🧮 Dose calculator

Multiple myeloma · Regimen source: FDA Velcade · 2.1FDA Velcade · 2.2FDA Velcade · 2.6

  • • Relapsed: twice weekly on days 1, 4, 8, 11 then 10-day rest. Untreated: with melphalan and prednisone per Table 1. At least 72 h between doses. IV and SC concentrations differ — calculate the volume carefully. Moderate/severe hepatic impairment: 0.7 mg/m². FDA Velcade · 2.6FDA Velcade · 2.2FDA Velcade · 2.1FDA Velcade · 2.8
  • • Only under an oncologist; protocol, cycle interval and adjustment rest with the treating team. FDA Velcade · 2

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🛡️ Safety & information

Contraindications

  • ⛔ Hypersensitivity to bortezomib, boron or mannitol; intrathecal administration (fatal). FDA Velcade · 4

Warnings

  • • Peripheral neuropathy; hypotension; cardiac and pulmonary toxicity; PRES; GI toxicity; thrombocytopenia and neutropenia; tumour lysis; hepatotoxicity; TMA; embryo-fetal toxicity. FDA Velcade · 5

Formulations

  • 3.5 mg vial (IV 1 mg/mL or SC 2.5 mg/mL after reconstitution) — powder for injection 🇺🇸 USA FDA Velcade · 3

👥 Special populations

  • 🤰 PregnancyDangerous / avoid

    Label: can cause fetal harm. Dangerous in pregnancy. FDA Velcade · 8.1

    “Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animals, VELCADE can cause fetal harm when administered to a pregnant woman.”
  • 🤱 BreastfeedingUse with caution

    Label: use with caution while breastfeeding; see the label text. FDA Velcade · 8.2

    “Risk Summary There are no data on the presence of bortezomib or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production.”
  • 👶 ChildrenUse with caution

    The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Velcade · 8.4

    “Safety and effectiveness have not been established in pediatric patients.”
  • 👴 Older adultsUse with caution

    Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Velcade · 8.5

    “Of the 669 patients enrolled in the relapsed multiple myeloma study, 245 (37%) were 65 years of age or older: 125 (38%) on the VELCADE arm and 120 (36%) on the dexamethasone arm.”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Velcade · 8.3

    “Contraception Females Advise females of reproductive potential to use effective contraception during treatment with VELCADE and for seven months after the last dose.”

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