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Route of administration considerations for BORUZU®

Indication and other factors can influence clinical decisions regarding routes of administration1-3

Multiple myeloma Mantle cell lymphoma
Previously untreated disease
Image, icon of an IV bag representing IV administration. OR Image, icon of a syringe representing subcutaneous administration.
Image, icon of an IV bag representing IV administration.
Relapsed or refractory disease
Image, icon of an IV bag representing IV administration. OR Image, icon of a syringe representing subcutaneous administration.
Image, icon of an IV bag representing IV administration. OR Image, icon of a syringe representing subcutaneous administration.
Pre-existing or at high risk of peripheral neuropathy Image, icon of a syringe representing subcutaneous administration. Image, icon of a syringe representing subcutaneous administration.
Hepatic impairment
Image, icon of an IV bag representing IV administration. OR Image, icon of a syringe representing subcutaneous administration.
Image, icon of an IV bag representing IV administration. OR Image, icon of a syringe representing subcutaneous administration.
  • Image, icon of a syringe representing subcutaneous administration.
  • Subcutaneous administration
  • Image, icon of an IV bag representing IV administration.
  • IV administration

Please refer to the full Prescribing Information for direction regarding administration and dose modifications.

Image, icon of a patient experiencing neuropathy.

Subcutaneous administration is associated with lower rates of peripheral neuropathy1,2

  • Rates of peripheral neuropathy (all grades) were 38% with subcutaneous administration of bortezomib compared with 53% for IV administration (P=0.044)

According to the NCCN, subcutaneous bortezomib is the preferred method of administration for patients with multiple myeloma.3

Subcutaneous administration instructions

BORUZU® does not need to be reconstituted or diluted for subcutaneous administration1

Swipe or tap to reveal subcutaneous administration instructions
Image, diagram icon of a syringe withdrawing a dose of BORUZU®.

Withdraw

  • Withdraw the appropriate BSA-based dose directly from the vial into a syringe.
  • The recommended starting dose for BORUZU® is 1.3 mg/m2.1
  • Subcutaneous administration requires no reconstitution or dilution.1
Image, diagram of a syringe labeled for the correct method of administration, "Subcutaneous".

Syringe labels

  • Place included sticker on syringe to identify the correct method of administration.1
Image, diagram of a syringe affixed with a new 4-6 mm needle.

Administer

  • Attach a fresh needle (4-6 mm) to syringe with prepared medication. Administer BORUZU® to patients using institution protocol for subcutaneous administration of chemotherapeutic agents.1,4

Please refer to the full Prescribing Information for dose modification and treatment cycle recommendations.

Recommendations for subcutaneous administration

Injection site reactions may occur with subcutaneous administration of bortezomib1

When administering BORUZU® subcutaneously:

Image, diagram showing how injection sites need to rotate between the thigh and the abdomen.

Rotate the sites for each injection
(thigh or abdomen).1

Image, icon of a syringe depicting the air sandwich injection technique.

Consider using the air sandwich (also known
as air lock) injection technique.4-6

If a local injection site reaction occurs following administration, BORUZU® may be administered at a less concentrated dose (1 mg/mL instead of 2.5 mg/mL).1

Steps for air sandwich injection technique4:

  1. Withdraw BORUZU® from the vial. DO NOT exceed the maximum volume of 2 mL per injection site.
  2. Attach a new 4-6 mm needle to syringe with prepared medication.
  3. DO NOT purge the needle of air.
  4. Pull 0.5-1.0 mL of air into the syringe (air behind drug when inverted).
  5. Invert syringe and inject contents at a 90° angle for needles 4-6 mm, or at a 45° angle for needles ≥8 mm, including the air behind the drug.
Image, diagram showing the air sandwich injection technique.

IV administration instructions1

BORUZU® must be diluted prior to IV administration

Swipe or tap to reveal IV administration instructions
Image, diagram demonstrating an IV bag being diluted with 0.9% sodium chloride injection.

Dilute

  • Dilute each vial with 2.1 mL of 0.9% sodium chloride injection only to obtain a final concentration of 1 mg/mL.
Image, diagram demonstrating the withdrawal of the appropriate BSA-based dose into a syringe that is labeled as "IV", which is the correct method of administration.

Withdraw

  • Withdraw the appropriate BSA-based dose into a syringe.
  • The recommended starting dose for BORUZU® is 1.3 mg/m2.
  • Place included sticker on syringe to identify the correct method of administration.
Image, diagram showing how BORUZU® is administered as a 3- to 5-second bolus IV injection.

Administer

  • Administer BORUZU® as a 3- to 5-second bolus IV injection.

Please refer to the full Prescribing Information for dose modification and treatment cycle recommendations.

Use caution when calculating the volume to be administered.

Once diluted, BORUZU® may be stored in the original vial and/or syringe at room temperature (20°C to 25°C [68°F to 77°F]) for up to 8 hours prior to use when exposed to normal indoor lighting.1

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

*While it is possible to administer BORUZU® intravenously for patients who have or are at risk for peripheral neuropathy, subcutaneous administration is preferred.1,3

BSA, body surface area; IV, intravenous.

References: 1. BORUZU. Prescribing information. Amneal Pharmaceuticals LLC; 2024. 2. Arnulf B, Pylypenko H, Grosicki S, et al. Updated survival analysis of a randomized phase III study of subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma. Haematologica. 2012;97(12):1925-1928. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.1.2025. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed February 4, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. 4. Kurtin S, Knop CS, Milliron T. Subcutaneous administration of bortezomib: strategies to reduce injection site reactions. J Adv Pract Oncol. 2012;3(6):406-410. 5. Boudreau A. Practical considerations for the integration of subcutaneous targeted therapies into the oncology clinic. Can Oncol Nurs J. 2019;29(4):267-270. 6. Becze E. Make subcutaneous administration more comfortable for your patients. January 4, 2022. Accessed January 6, 2024. https://www.ons.org/publications-research/voice/news-views/01-2022/make-subcutaneous-administration-more-comfortable

BORUZU® storage and ordering

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INDICATIONS

BORUZU® is a proteasome inhibitor indicated for the treatment of:

  • Adult patients with multiple myeloma
  • Adult patients with mantle cell lymphoma

DOSAGE AND ADMINISTRATION

BORUZU® is for subcutaneous (SC) or intravenous (IV) administration only. Because each route of administration has a different final concentration, caution should be used when calculating the volume to be administered.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • BORUZU® is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions.
  • BORUZU® is contraindicated for intrathecal administration.

WARNINGS AND PRECAUTIONS

  • Peripheral Neuropathy: Peripheral neuropathy including severe cases may occur. Manage with dose modification or discontinuation. Starting BORUZU® subcutaneously may be considered for patients with preexisting or at high risk of peripheral neuropathy.
  • Hypotension: Patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated may be at increased risk of hypotension. Use caution when treating these patients.
  • Cardiac Toxicity: Worsening and development of cardiac failure have occurred. Closely monitor patients with existing heart disease or risk factors for heart disease.
  • Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor patients closely for new or worsening symptoms and consider interrupting BORUZU® therapy.
  • Posterior Reversible Encephalopathy Syndrome (PRES): PRES has occurred in some patients. Consider MRI upon onset of visual or neurological symptoms; discontinue BORUZU® if suspected.
  • Gastrointestinal Toxicity: Nausea, diarrhea, constipation, vomiting, and other signs of gastrointestinal toxicity have occurred. Administration of antiemetic and antidiarrheal medications or fluid and electrolyte replacement may be required. Interrupt treatment with BORUZU® if severe symptoms occur.
  • Thrombocytopenia/Neutropenia: BORUZU® is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. Monitor complete blood counts regularly throughout treatment.
  • Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with BORUZU® therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions.
  • Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Monitor hepatic enzymes during treatment. Interrupt BORUZU® therapy to assess reversibility. There is limited rechallenge information in these patients.
  • Thrombotic Microangiopathy: Cases, sometimes fatal, of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), have been reported in the postmarketing setting in patients who received BORUZU®. Monitor for signs and symptoms. Discontinue BORUZU® if suspected.
  • Embryo-Fetal Toxicity: BORUZU® can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment with BORUZU® and for 7 months following treatment. Advise males with female partners of reproductive potential to use effective contraception during treatment with BORUZU® and for 4 months following treatment. If BORUZU® is used during pregnancy or if the patient becomes pregnant during BORUZU® treatment, the patient should be apprised of the potential risk to the fetus.

ADVERSE REACTIONS

  • The most commonly reported adverse reactions (≥ 20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.

DRUG INTERACTIONS

  • Strong CYP3A4 Inhibitors: Coadministration with a strong CYP3A4 inhibitor increases the exposure of bortezomib. Closely monitor patients with concomitant use.
  • Strong CYP3A4 Inducers: Coadministration with a strong CYP3A4 inducer decreases the exposure of bortezomib. Avoid concomitant use.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: BORUZU® can cause fetal harm when administered to a pregnant woman. There are no studies with the use of BORUZU® in pregnant women to inform drug-associated risks. Advise pregnant women of the potential risk to the fetus.
  • Lactation: 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. Advise nursing women not to breastfeed during treatment with BORUZU® and for 2 months after treatment.
  • Females and Males of Reproductive Potential: BORUZU® can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with BORUZU® and for 7 months after the last dose. Males with female partners of reproductive potential should use effective contraception during treatment with BORUZU® and for 4 months after the last dose. BORUZU® may affect male and female fertility.
  • Pediatric Use: Safety and effectiveness of BORUZU® have not been established in pediatric patients.
  • Geriatric Use: Of the 669 patients enrolled in the relapsed multiple myeloma study, 245 (37%) were 65 years of age or older. No overall differences in safety or effectiveness were observed between patients ≥ age 65 years and younger patients receiving BORUZU®, but greater sensitivity of some older individuals cannot be ruled out.
  • Renal Impairment: No starting dosage adjustment of BORUZU® is recommended for patients with renal impairment. In patients requiring dialysis, BORUZU® should be administered after the dialysis procedure.
  • Hepatic Impairment: No starting dosage adjustment of BORUZU® is recommended for patients with mild hepatic impairment (total bilirubin ≤ 1 × ULN and AST > ULN, or total bilirubin > 1 to 1.5 × ULN and any AST). The exposure of bortezomib is increased in patients with moderate (total bilirubin ≥ 1.5 to 3 × ULN and any AST) and severe (total bilirubin > 3 × ULN and any AST) hepatic impairment. Reduce the starting dose in patients with moderate or severe hepatic impairment.
  • Patients With Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving BORUZU® treatment may require close monitoring of their blood glucose levels and an adjustment of the dose of their antidiabetic medication.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Biosciences, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS

BORUZU® is a proteasome inhibitor indicated for the treatment of: