On December 4, 2019 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Bortezomib for Injection 3.5 mg/vial, approved by the U.S. Food and Drug Administration (USFDA) via a 505(b)(2) new drug application (NDA) pathway for intravenous use only (Press release, Dr Reddy’s, DEC 4, 2019, View Source [SID1234551927]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re pleased to bring this product to market for the customers and patients who will benefit from this cost-efficient alternative in the marketplace," explains Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. "This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio of products in the Hospital segment."

Dr. Reddy’s Bortezomib for Injection 3.5 mg/vial is for intravenous use only and is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

Important Safety Information:

What Important Information Should I Know About Bortezomib for Injection, 3.5 mg/Vial?

Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy
For intravenous use only. Do not administer Bortezomib for injection by any other route
Bortezomib for injection retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with bortezomib and who have relapsed at least six months after completing prior bortezomib treatment. Treatment may be started at the last tolerated dose
Bortezomib can cause fetal harm when administered to a pregnant woman
Who Should Not Use Bortezomib for Injection, 3.5 mg/Vial?

Patients with hypersensitivity (not including local reactions) to bortezomib or boron. Reactions have included anaphylactic reactions
Bortezomib for injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib products
If you are or plan on being pregnant. Females of reproductive potential should avoid becoming pregnant while being treated with Bortezomib for injection because of potential risk to the fetus and should use effective contraception during treatment with Bortezomib for injection and for seven months following the final dose
Males with female sexual partners of reproductive potential should not father a child and must use effective contraception during treatment with Bortezomib for injection and for four months following treatment
Females should not breastfeed during treatment with Bortezomib for injection and for two months after treatment
What should I tell my healthcare provider before taking Bortezomib for Injection, 3.5 mg/Vial?

Before taking Bortezomib for Injection, tell your doctor if you previously have had or currently do have:

Preexisting symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy
History of syncope, receiving medications known to be associated with hypotension, and are dehydrated which may increase risk of hypotension
Are at risk factors for, or have existing heart disease
Have high tumor burden, risk of tumor lysis syndrome
Are pregnant or plan to be pregnant
Are nursing
If you are receiving dialysis
Have moderate or severe hepatic impairment
Are taking medications for diabetes
Are using other prescription and non-prescription medications and/or dietary and herbal supplements
What are possible side effects of Bortezomib for Injection, 3.5 mg/Vial?

Call your doctor or get emergency help right away if you develop:

Peripheral Neuropathy
Hypotension
Cardiac Toxicity
Pulmonary Toxicity
Posterior Reversible Encephalopathy Syndrome (PRES)
Gastrointestinal Toxicity
Thrombocytopenia
Neutropenia
Tumor Lysis Syndrome
Hepatic Toxicity
Thrombotic Microangiopathy
Please refer to the Package Insert for a complete list of possible side effects associated with Bortezomib for Injection

What are the most common side effects of Bortezomib for Injection, 3.5 mg/Vial?

Nausea
Diarrhea
Thrombocytopenia
Neutropenia
Peripheral neuropathy
Fatigue
Neuralgia
Anemia
Leukopenia
Constipation
Vomiting
Lymphopenia
Rash
Pyrexia
Anorexia
Dizziness
Syncope
What should I avoid while taking Bortezomib for Injection, 3.5 mg/Vial?

Females of reproductive potential should avoid becoming pregnant while being treated with Bortezomib for injection. Females of reproductive potential must use contraception during treatment with Bortezomib for injection and for seven months following treatment
Avoid breastfeeding while receiving Bortezomib for injection and for two months after last dose
Avoid coadministration with medications that are strong CYP3A4 inducers
Avoid dehydration due to risk of hypotension, gastrointestinal toxicity, tumor lysis syndrome – Patients should drink adequate fluids
Bortezomib may cause fatigue, dizziness, syncope, orthostatic/postural hypotension, therefore Patients should not drive or operate machinery if they experience any of these symptoms
For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy’s Laboratories Medical Information Hotline at 1-888-DRL-DRUG (1-888-375-3784) or via email to [email protected] or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at View Source