Lunsumio 30 mg/30mL
Mosunetuzumab · CONCENTRATE · Genentech, Inc.
Lunsumio is a concentrate containing mosunetuzumab at 30 mg/30mL, taken intravenous. Manufactured by Genentech, Inc..
Key Facts
- Brand Name
- Lunsumio
- Generic Name
- Mosunetuzumab
- NDC Code (Product)
50242-142- Manufacturer
- Genentech, Inc.
- Strength
- 30 mg/30mL
- Dosage Form
- CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761263
- Marketing Start
- 12/22/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION LUNSUMIO and LUNSUMIO VELO have different dosage and administration instructions. Administer LUNSUMIO only as an intravenous infusion. ( 2.1 ) Premedicate to reduce risk of CRS and infusion-related reactions. ( 2.3 , 5.1 ) Recommended dosage for LUNSUMIO for intravenous infusion ( 2.2 ): Day of Treatment Cycle length = 21 days Intravenous Dose of LUNSUMIO Rate of Infusion Cycle 1 Day 1 1 mg Administer over a minimum of 4 hours. Day 8 2 mg Day 15 60 mg Cycle 2 Day 1 60 mg Administer over 2 hours if infusions from Cycle 1 were well-tolerated. Cycles 3+ Day 1 30 mg See Full Prescribing Information for instructions on preparation and administration. ( 2.5 ) 2.1 Important Dosing Information LUNSUMIO and LUNSUMIO VELO have different dosage and administration instructions [see Dosage and Administration (2.2) and Warnings and Precautions (5.7) ]. LUNSUMIO is for intravenous use only. Check the product label to ensure that the correct formulation (LUNSUMIO or LUNSUMIO VELO) is being prescribed and administered. Do not substitute LUNSUMIO for or with LUNSUMIO VELO. Administer LUNSUMIO to well-hydrated patients. Premedicate before each dose in Cycle 1 and Cycle 2 […
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Effect of LUNSUMIO on CYP450 Substrates LUNSUMIO causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP450 substrates. Increased exposure of CYP450 substrates is more likely to occur after the first dose of LUNSUMIO on Cycle 1 Day 1 and up to 14 days after the 60 mg dose on Cycle 2 Day 1 and during and after CRS [see Warnings and Precautions (5.1) ] . Monitor for toxicity or concentrations of drugs that are CYP450 substrates where minimal concentration changes may lead to serious adverse reactions. Consult the concomitant CYP450 substrate drug prescribing information for recommended dosage modification.
Adverse Reactions
6 ADVERSE REACTIONS The following 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 (5.3) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.4) ] Cytopenias [see Warnings and Precautions (5.5) ] Tumor Flare [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥ 20%) in patients with follicular lymphoma are CRS, fatigue, rash, headache, pyrexia, musculoskeletal pain, cough, pruritus, and peripheral neuropathy. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased hemoglobin, and decreased platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 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 clinic…
Frequently Asked Questions
What is Lunsumio used for?
Lunsumio contains Mosunetuzumab. It is a concentrate taken intravenous. Consult your doctor for specific uses.
Is Lunsumio a controlled substance?
Lunsumio is not classified as a controlled substance by the DEA.
What is the generic name for Lunsumio?
The generic name for Lunsumio is Mosunetuzumab. There are 2 other brand versions of Mosunetuzumab.
What is the NDC code for Lunsumio 30 mg/30mL?
The NDC (National Drug Code) for Lunsumio 30 mg/30mL is 50242-142, listed by Genentech, Inc..