Teclistamab-cqyv Injection
Teclistamab-cqyv Injection (Tecvayli) is a bispecific antibody given under the skin to treat adults with relapsed or refractory multiple myeloma, a cancer of the bone marrow's plasma cells.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Tecvayli (teclistamab-cqyv) is a specialist antibody injection for multiple myeloma that has returned or stopped responding, linking BCMA on myeloma cells to CD3 on immune T-cells so the T-cells attack the cancer; available since about 2022, it is given with daratumumab and hyaluronidase-fihj or alone, depending on prior treatment. It is a demanding treatment; fever, tiredness, muscle and bone pain and infections are most noticed. The boxed warning is for cytokine release syndrome (an immune overreaction) and neurologic toxicity including ICANS (confusion, trouble writing), both potentially fatal, so it is given only through a restricted program. Report fever, confusion or signs of infection right away.
Clinical pearls
- Expect 48-hour hospital stays after the first two step-up doses, then daily checks nearby for 48 hours after the next.
- Do not drive or use heavy machinery during step-up dosing, for 48 hours afterward, or while new neurologic symptoms last.
- Your team checks immunoglobulin (antibody) levels and may add an antiviral to prevent shingles, since serious infections are a real risk.
- Early in treatment, cytokine release can raise levels of some other medicines, so give your care team a full medicine list.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Tecvayli can cause cytokine release syndrome (CRS) and serious neurologic problems, including ICANS. These can be life-threatening or fatal.
CRS is an overreaction of the immune system. Signs include fever, chills, low blood pressure, fast heartbeat, low oxygen and headache. Neurologic problems include confusion, trouble writing, memory problems and reduced alertness. They can happen even without CRS.
The step-up dosing schedule lowers the risk of CRS. Your care team will watch you closely, and may pause or permanently stop treatment if these problems occur. Because of these risks, Tecvayli is available only through a restricted program called the TECVAYLI and TALVEY REMS.
Patient information guide A plain-language walkthrough of Teclistamab-cqyv Injection, written from its FDA label.
What Teclistamab-cqyv Injection is used for
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Teclistamab-cqyv Injection treats adults with relapsed or refractory multiple myeloma.
- Tecvayli with daratumumab and hyaluronidase-fihj: for patients who have had at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
- Tecvayli alone (monotherapy): for patients who have had at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
How Teclistamab-cqyv Injection works
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Teclistamab-cqyv is a bispecific T-cell engaging antibody. It binds CD3 on T-cells and BCMA on myeloma cells and some healthy B-lineage cells.
This links the immune cells to the cancer cells and activates them. In lab studies, the activated T-cells released inflammatory chemicals called cytokines and destroyed myeloma cells.
Teclistamab-cqyv Injection dosage
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Tecvayli is given only as an injection under the skin, by your care team.
- It begins with step-up doses, then a first full treatment dose.
- After that it is generally given weekly. Some schedules later move to every two weeks or every four weeks.
- Pretreatment medicines are given 1 to 3 hours before the early doses.
- Treatment continues until the disease progresses or side effects become unacceptable.
- If a dose is delayed, your team decides how to restart based on how long it has been.
Dosing details from the FDA-approved label
From the Teclistamab-cqyv Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- TECVAYLI in combination with daratumumab and hyaluronidase-fihj: step-up dosing schedule
- Step-up dose 1 (0.06 mg/kg) on Day 1, administered 20 hours or more after the daratumumab and hyaluronidase-fihj dose
- Step-up dose 2 (0.3 mg/kg) on Day 3, may be given between 2 to 4 days after step-up dose 1 and up to 7 days after step-up dose 1 if adverse reactions occur
- First treatment dose (1.5 mg/kg) on Day 7, may be given between 2 to 4 days after st
- Patients should be hospitalized for 48 hours after step-up dose 1 and step-up dose 2; dosage based on predetermined weight ranges (mg/kg)
- TECVAYLI in combination with daratumumab and hyaluronidase-fihj: treatment doses
- Weeks 2 to 8: 1.5 mg/kg once weekly (minimum of 5 days between doses)
- Weeks 9 to 24: 3 mg/kg every two weeks (minimum of 12 days between doses)
- Week 25 onwards: 3 mg/kg every four weeks (minimum of 25 days between doses)
- Administer until disease progression or unacceptable toxicity
- Dosage based on body weight (mg/kg)
- TECVAYLI monotherapy: step-up dosing schedule (all patients)
- Day 1: step-up dose 1 0.06 mg/kg
- Day 4: step-up dose 2 0.3 mg/kg, may be given between 2 to 4 days after step-up dose 1 and up to 7 days after step-up dose 1 to allow for resolution of adverse reactions
- Day 7: first treatment dose 1.5 mg/kg, may be given between 2 to 4 days after step-up dose 2 and up to 7 days after step-up dose 2 to allow for resolution
- Patients should be hospitalized for 48 hours after step-up dose 1 and step-up dose 2; dosage based on body weight
- TECVAYLI monotherapy: weekly dosing schedule
- Subsequent treatment doses 1.5 mg/kg once weekly, starting one week after the first treatment dose
- Maintain a minimum of 5 days between doses
- Administer until disease progression or unacceptable toxicity
- Dosage based on body weight
- TECVAYLI monotherapy: patients who have achieved and maintained a complete response or better for a minimum of 6 months
- Dosing frequency may be decreased to 1.5 mg/kg every two weeks
- Maintain a minimum of 12 days between doses
- Dosage based on body weight
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For subcutaneous injection only. ( 2.1 ) Patients should be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Instruct patients to remain within proximity of a healthcare facility and monitored daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule. ( 2.1 ) See Full Prescribing Information for the recommended dosage for TECVAYLI monotherapy and combination therapy. ( 2.2 , 2.3 ) Administer pretreatment medications as recommended. ( 2.3 ) Refer to Tables 8, 9, 10, and 11 to determine the total dose, injection volume, and number of vials based on the patient's body weight. ( 2.6 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) 2.1 Important Dosage and Administration Information TECVAYLI is for subcutaneous injection only. Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Tables 1 and 2 [see Dosage and Administration (2.3) ] . Administer TECVAYLI subcutaneously according to the step-up dosing schedule in Tables 1 and 2 to reduce the incidence and severity of cytokine release syndrome (CRS). Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Instruct patients to remain within proximity of a healthcare facility and monitor them daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1 , 5.2) ] . Refer to Tables 8, 9, 10, and 11 to determine the dosage based on predetermined weight ranges [see Dosage and Administration (2.6) ] . 2.2 Recommended TECVAYLI Dosage In Combination with Daratumumab and Hyaluronidase-fihj The recommended dosing schedule for TECVAYLI in combination with subcutaneous daratumumab and hyaluronidase-fihj is provided in Table 1. TECVAYLI should be administered until disease progression or unacceptable toxicity. Table 1: TECVAYLI Dosage Schedule in Combination with Daratumumab and Hyaluronidase-fihj Dosing schedule Week/Day TECVAYLI Dosage See Table 3 for recommendations on restarting TECVAYLI after dose delays.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Teclistamab-cqyv Injection side effects
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Common side effects include:
Common side effects
- Fever
- Cytokine release syndrome
- Injection site reactions
- Tiredness
- Muscle and bone pain
- Upper respiratory infections and pneumonia
- Headache
- Nausea and diarrhea
- Upper respiratory infections, pneumonia and COVID-19
- Low immunoglobulin levels (hypogammaglobulinemia)
When to get medical help
- Get help right away for fever, chills, trouble breathing, dizziness or a racing heartbeat. These can be signs of cytokine release syndrome.
- Get help right away for confusion, memory problems, trouble writing, severe headache, seizures, weakness or changes in alertness. These can be signs of neurologic toxicity or ICANS.
- Report signs of infection such as fever, cough or other new illness. Infections can be severe or fatal.
- Report yellowing of the skin or eyes, or other signs of liver problems.
- Report a rash, ongoing fever or a worsening injection site reaction.
Seek urgent help for signs of cytokine release syndrome, confusion or other neurologic changes, or infection. Blood tests may also show low blood counts or raised liver enzymes.
Teclistamab-cqyv Injection warnings and precautions
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- Cytokine release syndrome: can be life-threatening or fatal. It most often occurs during the step-up doses.
- Neurologic toxicity and ICANS: can be serious or fatal. Avoid driving or using heavy machinery during the step-up schedule and for 48 hours afterward.
- Liver injury: including fatal cases, so liver tests are monitored.
- Infections: can be severe or fatal. Immunoglobulin levels are monitored.
- Neutropenia: low neutrophils, so blood counts are checked.
- Injection reactions: systemic and local.
- Pregnancy: possible fetal harm.
Teclistamab-cqyv Injection interactions
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Tecvayli may raise levels of some other medicines.
- Cytokines released by Tecvayli can suppress certain CYP enzymes, which may increase exposure to medicines processed by them.
- The risk is highest from the start of step-up dosing to 7 days after the first treatment dose, and during and after CRS.
- Your team may monitor you or lower the dose of those medicines.
Interactions listed in the FDA-approved label
From the Teclistamab-cqyv Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Certain CYP substrates: TECVAYLI causes release of cytokines that may suppress activity of certain CYP enzymes, resulting in increased exposure of CYP substrates, which may increase the risk of adverse reactions of the CYP substrates; the highest risk is expected from initiation of the step-up dosing schedule up to 7 days after the first treatment dose and during and after CRS. Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate as needed.
Read the label’s full interactions text
7 DRUG INTERACTIONS TECVAYLI causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of certain cytochrome P450 (CYP) enzymes, resulting in increased exposure of CYP substrates, which may increase the risk of adverse reactions of the CYP substrates. The highest risk of drug-drug interaction is expected to occur after initiation of TECVAYLI step-up dosing schedule up to 7 days after the first treatment dose and during and after CRS [see Warnings and Precautions (5.1) ] . Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate as needed. Certain CYP Substrates : Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate, as needed ( 7 ).
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Teclistamab-cqyv Injection
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- There are no listed contraindications.
- Pregnancy: it may cause fetal harm, and pregnancy status is checked before starting. Use effective contraception during treatment and for 5 months after the last dose.
- Breastfeeding: do not breastfeed during treatment and for 5 months after the last dose.
- Children: safety and effectiveness have not been established.
- Older adults: more serious side effects were seen in people 65 and older, especially 75 and older, in the combination study.
- Severe kidney impairment or moderate to severe liver impairment: effects on drug levels are unknown.
What Teclistamab-cqyv Injection does in the body
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In studies, levels of the inflammatory cytokines IL-6 and IL-10, and of IL-2R, rose after the step-up and early weekly doses. This fits with how the drug activates T-cells.
How your body processes Teclistamab-cqyv Injection
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After an injection under the skin, about 72% of the drug is absorbed. Blood levels typically peak in about 3 to 6 days.
With weekly dosing, levels build up and reach about 90% of steady state after 12 weekly doses. After stopping, levels fall by half in about 2 weeks and by 97% in about 10 weeks. Dosing is weight-based. Age, sex, race, and mild or moderate kidney impairment did not meaningfully change drug levels.
How to store Teclistamab-cqyv Injection
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Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Teclistamab-cqyv Injection
89 supplements and herbal products have documented interactions with Teclistamab-cqyv Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 85
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Teclistamab-cqyv Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Teclistamab-cqyv Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Tecvayli for?
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Why do I have to stay in the hospital at the start?
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What side effects should I expect?
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When should I call my care team right away?
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Can I drive during treatment?
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Is it safe during pregnancy or breastfeeding?
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Is Teclistamab-cqyv Injection available over the counter?
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When was Teclistamab-cqyv Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Teclistamab-cqyv Injection on HelloPharmacist
Teclistamab-cqyv Injection forms and strengths (how it comes)
Teclistamab-cqyv Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Teclistamab-cqyv Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Tecvayli is used with daratumumab and hyaluronidase-fihj for relapsed or refractory multiple myeloma after at least one prior line of therapy.
- Tecvayli is used alone for relapsed or refractory multiple myeloma after at least four prior lines of therapy.
- Tecvayli is for subcutaneous injection only.
- Tecvayli starts with step-up doses, with hospitalization for 48 hours after each of the first two step-up doses.
- Tecvayli is preceded by pretreatment medicines (a steroid, an antihistamine and a fever reducer) 1 to 3 hours before the early doses.
Teclistamab-cqyv Injection on the U.S. market: products, makers and brands
How Teclistamab-cqyv Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Teclistamab-cqyv Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2022. Brand names on the directory include Tecvayli; the rest are generics.
How widely Teclistamab-cqyv Injection is used (Medicaid data)
A general measure of how commonly Teclistamab-cqyv Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q2 2025 – Q1 2026, summed across every form and brand of the drug.
Think of this as a proxy for how widely Teclistamab-cqyv Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Teclistamab-cqyv Injection prescribed? Of the 1,601 medications we measure, Teclistamab-cqyv Injection ranks #1,298 by Medicaid prescriptions — more than 19% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Teclistamab-cqyv Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Teclistamab-cqyv Injection NDCs with Medicaid activity.
Compare Teclistamab-cqyv Injection products
A representative set of FDA-listed product records for Teclistamab-cqyv Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 10 mg/mL | Subcutaneous | Janssen Biotech, Inc. | BLA | View NDC → |
| 90 mg/mL | Subcutaneous | Janssen Biotech, Inc. | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Teclistamab-cqyv Injection NDCs →
Teclistamab-cqyv Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Teclistamab-cqyv Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Teclistamab-cqyv Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Teclistamab-cqyv Injection FDA approval history
How Teclistamab-cqyv Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Teclistamab-cqyv Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Teclistamab-cqyv recalls since July 2021.
✅No Teclistamab-cqyv recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Teclistamab-cqyv Injection supply and shortage status
Whether Teclistamab-cqyv Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Teclistamab-cqyv Injection brand names
Teclistamab-cqyv Injection is sold under one brand name in the FDA directory — Tecvayli. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Teclistamab-cqyv Injection: manufacturers and labelers
One company lists Teclistamab-cqyv Injection products with the FDA. By number of product records, the largest are Janssen Biotech, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Teclistamab-cqyv Injection drug class (RxNorm)
Teclistamab-cqyv Injection belongs to the Other monoclonal antibodies and antibody drug conjugates class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Teclistamab-cqyv Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →