LYNOZYFIC 5 mg/2.5mL
linvoseltamab-gcpt · INJECTION, SOLUTION, CONCENTRATE · Regeneron Pharmaceuticals, Inc.
LYNOZYFIC is a injection, solution, concentrate containing linvoseltamab-gcpt at 5 mg/2.5mL, taken intravenous. Manufactured by Regeneron Pharmaceuticals, Inc..
Key Facts
- Brand Name
- LYNOZYFIC
- Generic Name
- linvoseltamab-gcpt
- NDC Code (Product)
61755-054- Manufacturer
- Regeneron Pharmaceuticals, Inc.
- Strength
- 5 mg/2.5mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761400
- Drug Class
- Bispecific B Cell Maturation Antigen-directed CD3 T Cell Engager [EPC]
- Marketing Start
- 07/02/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). LYNOZYFIC is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Premedicate to reduce the risk of CRS and infusion-related reactions (IRR). ( 2.1 , 2.3 ) Administer only as an intravenous infusion. ( 2.1 , 2.6 ) Recommended Dosage ( 2.2 ): Dosing Schedule Day Dose of LYNOZYFIC Step-Up Dosing Schedule Day 1 Step-up dose 1 5 mg Day 8 Step-up dose 2 25 mg Day 15 First treatment dose 200 mg Weekly Dosing Schedule One week after Day 15 treatment dose and once weekly from Week 4 to Week 13 for 10 treatment doses Second and subsequent treatment doses 200 mg Biweekly (Every 2 Weeks) Dosing Schedule Week 14 and every 2 weeks thereafter Subsequent treatment doses 200 mg Patients who have achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg Every 4 Weeks Dosing Schedule At Week 24 or after and every 4 weeks thereafter Subsequent treatment doses 200 mg Patients should be hospitalized for 24 hours after administration of the first step-up dose and for 24 hours after administration of the second step-up dose. ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) 2.1 Important Administration Instructions Administer LYNOZYFIC intravenously …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Effects of LYNOZYFIC on Other Drugs Certain CYP substrates Monitor for toxicity unless otherwise recommended in the Prescribing Information of certain CYP substrates where minimal changes in the concentration may lead to serious adverse reactions when used concomitantly with LYNOZYFIC. Linvoseltamab-gcpt causes the release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress cytochrome P450 (CYP) enzyme activity . Concomitant use with LYNOZYFIC increases CYP substrate exposure which may increase the risk of adverse reactions related to these substrates. Increased CYP substrate exposure is more likely to occur from initiation of the LYNOZYFIC step-up dosing schedule up to 14 days after the first 200 mg dose, and during and after CRS [see Warnings and Precautions (5.1) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.4) ] Neutropenia [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥20%) are musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥30%) are decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-844-467-2998 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial…
Frequently Asked Questions
What is LYNOZYFIC used for?
LYNOZYFIC contains linvoseltamab-gcpt. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is LYNOZYFIC a controlled substance?
LYNOZYFIC is not classified as a controlled substance by the DEA.
What is the generic name for LYNOZYFIC?
The generic name for LYNOZYFIC is linvoseltamab-gcpt. There are no other listed brand versions of linvoseltamab-gcpt.
What is the NDC code for LYNOZYFIC 5 mg/2.5mL?
The NDC (National Drug Code) for LYNOZYFIC 5 mg/2.5mL is 61755-054, listed by Regeneron Pharmaceuticals, Inc..
Other LYNOZYFIC Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)