Bortezomib 3.5 mg Injection (Single-Dose Vial)

Bortezomib is a chemotherapy drug (a proteasome inhibitor) used to treat certain blood cancers. It works by blocking the 26S proteasome inside cells, preventing the breakdown of proteins that trigger cell death. Cancer cells (especially myeloma cells) cannot survive when this proteasome is inhibited, so they undergo apoptosis. Brand names include Velcade® (bortezomib for injection).

Uses:

Bortezomib injection is FDA-approved for adults with multiple myeloma and mantle cell lymphoma. It is often given in combination with other chemotherapy (e.g. dexamethasone, melphalan, cyclophosphamide, etc.). It may be used as initial therapy, or for relapsed/refractory disease after prior treatment.

Formulation and Dosage

• Form: Each vial contains 3.5 mg of bortezomib as a sterile lyophilized (freeze-dried) powder. There are no preservatives, so each vial is single-use only.
• Reconstitution: The powder must be dissolved in 0.9% sodium chloride (sterile saline) before injection. For intravenous (IV) administration, add 3.5 mL saline to the 3.5 mg vial (yielding 1.0 mg/mL). For subcutaneous (SC) (under-the-skin) use, add 1.4 mL saline (yielding 2.5 mg/mL). Gently mix to dissolve (do not shake vigorously). Use the reconstituted solution immediately (the drug has no preservative) and discard any unused portion within about 8 hours.

Dosage:

The typical starting dose is 1.3 mg/m² of body surface area, given as either a rapid IV push (3–5 seconds) or an SC injection. Treatment schedules vary, but a common regimen is twice weekly on days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest. Dose adjustments may be needed for patients with liver impairment or other factors. Your doctor will calculate the exact dose and schedule; do not change the dose on your own.

Administration:

Bortezomib is given only by healthcare professionals in a clinic or hospital. Do not attempt to self-inject unless specifically trained. It can be given into a peripheral vein or via a central line. Rotating injection sites (for SC) can help reduce local irritation. Since IV and SC concentrations differ, double-check the preparation before giving any dose. Important: Bortezomib must never be administered intrathecally (into the spine) – this is contraindicated and can be fatal.

Side Effects and Precautions

Bortezomib has several potential side effects. Some of the most common (occurring in ≥20% of patients) include:

• Gastrointestinal: Nausea, vomiting, diarrhea or constipation are very common. Your doctor may prescribe anti-nausea or anti-diarrheal medications if needed. Staying hydrated and eating small frequent meals can help manage these effects.
• Blood Cell Counts: Bortezomib suppresses bone marrow. You may develop thrombocytopenia (low platelets) or neutropenia (low white cells). This raises the risk of bleeding or infection. Regular blood tests (CBC) are required before each dose to monitor your counts. Notify your provider if you see unusual bruising, bleeding, or signs of infection (fever, sore throat).
• Neuropathy (Nerve Effects): Many patients experience peripheral neuropathy – tingling, numbness or burning in the hands and feet. This can cause pain or weakness, and may worsen if not addressed. Report any new numbness, tingling, or difficulty walking to your doctor promptly. In severe cases, the dose may need to be reduced or delayed. Ask your doctor about strategies to protect your nerves (such as avoiding extreme cold or drugs that worsen neuropathy).
• Fatigue and General: Tiredness, weakness, loss of appetite, fever, and rash are also fairly common. Rest when needed. Over-the-counter pain relievers (as recommended by your doctor) or cool showers may help with fatigue or fever.
• Hypotension and Dizziness: Bortezomib can cause low blood pressure. If you feel dizzy when standing, get up slowly and drink plenty of fluids. Patients on blood pressure medication or who become dehydrated should be cautious.
• Herpes Zoster (Shingles): Bortezomib significantly increases the risk of shingles (reactivation of herpes zoster). In clinical trials, 6–11% of bortezomib-treated patients developed shingles. Your doctor will likely prescribe antiviral medication (e.g. acyclovir) to prevent this. Discuss antiviral prophylaxis with your provider.

Serious Warnings: Though less common, bortezomib can cause serious problems. These include heart failure or heart damage, severe lung problems, and a rare brain condition called Posterior Reversible Encephalopathy Syndrome (PRES), which involves headaches, vision changes, or seizures. Always report any chest pain, sudden shortness of breath, severe headache, confusion, or other alarming symptoms immediately. Bortezomib may also cause birth defects – effective birth control is essential for both men and women during treatment.

Monitoring and Follow-Up

Your healthcare team will monitor you closely during bortezomib therapy:

• Laboratory Tests: Blood counts and liver function tests are checked before each dose. Your doctor may also monitor blood glucose if you have diabetes. If blood counts fall too low, the doctor may delay or reduce the next dose.
• Physical Exams: Numbness in the hands/feet is checked, blood pressure is measured regularly. Tell your doctor about any new, worsening, or unusual symptoms (numbness, bleeding, rash, severe nausea, mood changes, etc.).
• Medications: Review all your medicines with the doctor – some drugs can interact with bortezomib. For example, strong CYP3A4 inhibitors (like certain antifungals or antibiotics) or inducers (like rifampin) can alter bortezomib levels. Also inform your doctor about any herbal supplements or over-the-counter products.
• Vaccination/Prophylaxis: Because bortezomib weakens the immune system, expect to avoid live vaccines during treatment. Annual flu shots (inactivated vaccine) and pneumonia vaccines are often recommended before starting therapy. Antiviral prophylaxis (as mentioned) and sometimes Pneumocystis pneumonia prophylaxis may be given.

Storage and Handling

• Before Use: Store unopened vials at room temperature (68–77°F/20–25°C) in the original carton, protected from light. Avoid excessive heat or freezing.
• After Reconstitution: Once mixed with saline, bortezomib solution should be kept at room temperature and used within 8 hours. It may be stored at up to 77°F (25°C) in the vial or syringe during that time. Do not freeze the reconstituted solution and do not use after 8 hours. Discard any remaining solution after a single patient use.
• Precautions: Handle the drug carefully (wear gloves) and dispose of needles/syringes safely. Keep all chemotherapy agents out of reach of children and pets.

Patient Tips and Key Advice

• Prevent Nausea & Diarrhea: Eat small, bland meals and sip clear liquids. Take prescribed anti-nausea pills or antidiarrheal meds as directed. Staying hydrated (water, electrolyte drinks) helps reduce dizziness and gastrointestinal upset.
• Manage Neuropathy: Let your doctor know immediately if you feel burning, tingling, or loss of feeling in hands or feet. Use non-slip slippers and handrails to prevent falls. Protect your hands/feet from extreme temperatures and avoid alcohol, which can worsen nerve symptoms.
• Monitor Blood Sugar: If you have diabetes, check your blood glucose more often. Bortezomib can affect blood sugar control. Your diabetes medicines may need adjustment.
• Stay Active (Safely): Light exercise (walking, stretching) can help combat fatigue and nerve symptoms, but listen to your body. Rest when you feel very tired.
• Prevent Infections: Practice good hand hygiene and avoid crowds or sick people. Report fever, cough, or any sign of infection right away.
• Avoid Pregnancy: Use effective birth control during treatment and for the advised period afterward. Bortezomib can cause fetal harm. Men should also use condoms to avoid fathering a pregnancy on treatment.
• Ask About Prophylaxis: Remind your doctor to prescribe antiviral medication to prevent shingles. If you haven’t had chickenpox or shingles before, you may discuss vaccines with your doctor prior to therapy.
• Do Not Share Doses: Each vial is for one patient and one use. Never use leftover drug on another day or another person.
• Report Reactions: Immediately tell your provider if you have a sudden rash, trouble breathing, severe back pain, or any allergic symptoms after the injection. Emergency care is needed for these.
• Arrange Support: Because bortezomib can cause fatigue or dizziness, plan to have someone drive you home after treatment if you feel lightheaded.

Always follow your healthcare team’s instructions exactly. Keep all appointments and lab tests, and communicate any concerns. This information is a general guide; your doctor and pharmacist will give you detailed counseling tailored to your health needs.