Overview of VELCADE Injection to Treat Blood Cancers

VELCADE (bortezomib) is an intravenous or subcutaneous anti-cancer injection used for treating multiple myeloma and mantle cell lymphoma. It contains a proteasome inhibitor drug that disrupts cancer cell protein regulation and growth.

Below details key information healthcare professionals should know about VELCADE including its approval indications, administration and dosing guidelines, pharmacology mechanism, side effects and toxicity management, contraindications, drug interactions, effects in pregnancy/lactation, and storage requirements.

FDA Approved Indications for VELCADE Injection

The FDA has approved intravenous or subcutaneous VELCADE injection for:

Multiple Myeloma

  • Single agent or combination therapy for progressive disease after 1+ prior treatments when stem cell transplant is complete or not feasible
  • With melphalan and prednisone for previously untreated cases unsuitable for autologous hematopoietic cell transplantation (auto-HSCT)
  • Combination therapy before auto-HSCT for those eligible

Mantle Cell Lymphoma

  • Previously untreated mantle cell lymphoma cases ineligible for HSCT, in combination chemo with rituximab, cyclophosphamide, doxorubicin, and prednisone

VELCADE Injection Administration Information

  • Available as lyophilized sterile bortezomib powder in single-use 3.5mg vials
  • Requires aseptic reconstitution with 0.9% sodium chloride solution before IV bolus or SC injection
  • IV bolus over 3-5 seconds or SC slowly into thighs/abdomen at 45-90 degree angle; rotate sites
  • Use proper chemotherapy handling precautions during preparation and administration

Doses should be carefully double-checked before administration route.

  • VELCADE is for intravenous or subcutaneous use ONLY – Intrathecal administration has been fatal

Recommended VELCADE Starting Dosage and Schedule

  • Multiple myeloma: 1.3 milligrams/meters squared (mg/m^2) twice weekly for 2 weeks (Days 1, 4, 8, 11) followed by a 10 day rest
  • Mantle cell lymphoma: 1.3 mg/m^2 twice weekly on Days 1, 4, 8, 11 to 21 day cycles

This 21 day cycle (3 weeks) may repeat for around 8 total cycles with single agent or combination protocols based on regimen specifics.

  • Dose reductions or scheduling changes may apply depending on toxicity

What is the VELCADE Mechanism of Action Against Lymphoid Cancers?

The active ingredient bortezomib is a proteasome inhibitor disrupting cancer cell protein homeostasis through several mechanisms:

  • Interferes with NFκB cell signaling
  • Disrupts cell cycle control and apoptosis
  • Alters DNA repair and gene expression
  • Triggers immunomodulation changes in the tumor microenvironment

This multifaceted disruption of myeloma and MCL cancer cell regulation translates to anti-tumor activity for many patients. Combining with other chemotherapies leverages synergistic actions.

What Are Common VELCADE Side Effects and Toxicity Management?

Most common adverse effects in over 10% of patients include:

  • Gastrointestinal disturbances – nausea, diarrhea, constipation, vomiting
  • Fatigue, weakness, dizziness
  • Peripheral sensory or motor neuropathy
  • Hematology – thrombocytopenia, neutropenia, anemia
  • Pyrexia and infections like pneumonia

Serious risks requiring prompt intervention:

  • Deep vein thrombosis or pulmonary embolism
  • Posterior reversible encephalopathy syndrome
  • Significant peripheral neuropathy
  • Severe GI reactions like bleeding or perforation
  • Liver toxicity and elevated enzymes
  • Sepsis, hypotension or respiratory distress
  • Acute tumor lysis syndrome – metabolic derangements

Risks increase with repeated exposures. Careful toxicity monitoring and dose modifications for tolerability optimize therapeutic windows. Supportive care medications help manage adverse effects.

What VELCADE Contraindications and Warnings Exist?

Contraindications where risks outweigh benefits:

  • Hypersensitivity to bortezomib or boron
  • Advanced hepatic impairment
  • Severe renal dysfunction requiring dialysis
  • Pregnant or breastfeeding women

Cautions: Pretreatment severe diabetes, lung disease, cardiac dysfunction or prior allergic reactions. Concurrent antiviral prophylaxis recommended against herpes zoster reactivation.

Does VELCADE Interact With Other Anti-Cancer Medications?

  • No CYPP450 drug interactions
  • Overlapping toxicities when combining with other chemotherapies require monitoring
  • Corticosteroid premedication decreases infusion reactions
  • Caution needed when administering live vaccines – risk of systemic illness

Inform providers about all current medications a patient is taking to maximize safe coordination using multidrug chemotherapeutic VELCADE regimens against plasma cell dyscrasias and mantle cell lymphomas.

Is VELCADE Safe During Pregnancy or Breastfeeding?

No adequate controlled trials establish safety in pregnant women – assume teratogenic and embryo-fetal risks based on mechanism disrupting cell growth regulation.

Advise avoiding pregnancy or breastfeeding while getting VELCADE and for at least 3 months after last dose. Use effective contraception preventatively.

How Should Unopened and Reconstituted VELCADE Be Stored?

Unopened: Refrigerate intact vials between 36°F to 46°F in original packaging – do NOT freeze or store near freezer compartment

Reconstituted: Stable 8 hours at room temperature up to 77°F stored in vial or syringe

Avoid excess heat/moisture/sunlight. Follow mandated pharmaceutical hazardous compound handling and waste disposal protocols.

Conclusion

In summary, VELCADE injection provides proteasome-inhibiting anti-neoplastic therapy for relapsed/refractory multiple myeloma and previously untreated mantle cell lymphoma cases.

Combining with other chemotherapy, corticosteroids, or immunotherapy agents leverage synergistic mechanisms against plasma cell and lymph node cancers. Careful patient screening, dosing adjustment for tolerability, adverse effect monitoring, and prompt supportive care aid the risk/benefit optimization.

Provide patients guidance on proper VELCADE administration scheduling, potential side effects warranting urgent notification, drug interactions, and precautions around pregnancy/breastfeeding.

Report any adverse patient outcomes potentially associated with VELCADE treatments to official oversight bodies for ongoing pharmacovigilance efforts ensuring maximal safe use.