Fresenius Kabi Introduces New Generic for the Treatment of Multiple Myeloma

Strengthening the most comprehensive injectable oncology portfolio in the industry

LAKE ZURICH, Ill.--(BUSINESS WIRE)--#FreseniusKabi--Fresenius Kabi announced today it has introduced Bortezomib for Injection, a new generic equivalent to Velcade^® in the U.S. and the newest addition to the most comprehensive injectable oncology portfolio in the industry.

Fresenius Kabi Bortezomib for Injection is available in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous (SQ) or intravenous (IV) use.

Fresenius Kabi Bortezomib for Injection is an affordable treatment option for adult patients with multiple myeloma and mantle cell lymphoma. Multiple myeloma represents nearly 2 percent of all new cancer cases in the U.S. and is expected to double in 20 years.¹ Mantle cell lymphoma represents approximately 5 percent of all non-Hodgkin’s lymphoma diagnoses annually, and there are approximately 4,000 new cases each year.^2,3

“Adding a generic equivalent Bortezomib for Injection to our expansive oncology portfolio reflects our continued plan of expanding access to affordable cancer therapies,” said John Ducker, president and CEO of Fresenius Kabi USA. “We’re pleased to be able to provide an affordable option to patients and we are especially pleased that Fresenius Kabi Bortezomib for Injection is produced at one of our U.S. facilities.”

Fresenius Kabi offers more than 30 different oncology drugs in the U.S., and nearly 90 percent are formulated, filled and finished in the U.S. Bortezomib for Injection is the newest example of the company’s commitment to investing “More in America.” This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

Bortezomib for Injection, along with other oncology medicines, is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program that offers copay assistance to eligible U.S. patients. The program can lower out-of-pocket costs to as little as $0 per month for eligible patients. To determine eligibility, patients should speak to their physician. Enrollment is a simple online process. Details can be found on the KabiCare website at kabicare.us.

Important Safety Information
INDICATIONS AND USAGE

Bortezomib for Injection is a proteasome inhibitor indicated for:

• treatment of adult patients with multiple myeloma
• treatment of adult patients with mantle cell lymphoma

IMPORTANT SAFETY INFORMATION

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

For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration. Exercise caution when calculating the volume to be administered.

Peripheral neuropathy: Manage with dose modification or discontinuation. Patients with pre-existing severe neuropathy should be treated with Bortezomib for Injection only after careful risk-benefit assessment.

Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration.

Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease.

Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms and consider interrupting Bortezomib for Injection therapy.

Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue Bortezomib for Injection if suspected.

Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia or Neutropenia: Monitor complete blood counts regularly throughout treatment.

Tumor Lysis Syndrome: Closely monitor patients with high tumor burden.

Hepatic Toxicity: Monitor hepatic enzymes during treatment. Interrupt Bortezomib for Injection therapy to assess reversibility.

Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Bortezomib for Injection if suspected.

Embryo-Fetal Toxicity: Bortezomib for Injection can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. Most commonly reported adverse reactions (incidence ≥ 20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Strong CYP3A4 inhibitors: Closely monitor patients with concomitant use.

Strong CYP3A4 inducers: Avoid concomitant use.

Patients with diabetes may require close monitoring of blood glucose and adjustment of anti-diabetic medication.

This Important Safety Information does not include all the information needed to use Bortezomib for Injection safely and effectively. Please see full prescribing information for Bortezomib for Injection at www.fresenius-kabi.com/us.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us.

References

1. Albagoush SA, Shumway C, Azevedo AM. Multiple Myeloma. [Updated 2022 Feb 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK534764/
2. Lynch DT, Koya S, Acharya U. Mantle Cell Lymphoma. [Updated 2022 Feb 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK536985/
3. Adams, Molly. “What to Know about Mantle Cell Lymphoma.” MD Anderson Cancer Center, MD Anderson Cancer Center, 28 Sept. 2020, https://www.mdanderson.org/cancerwise/what-to-know-about-mantle-cell-lymphoma-symptoms-diagnosis-and-treatment.h00-159385101.html.

Velcade^® is a registered trademark of Millennium/Takeda

Joanie Clougherty
(614) 717-5741
joan.clougherty@fresenius-kabi.com