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AVSOLA (INFLIXIMAB-AXXQ)
AVSOLA (generic name: INFLIXIMAB-AXXQ) is a drug developed by AMGEN INC. It is currently FDA-approved.
At a glance
| Generic name | INFLIXIMAB-AXXQ |
|---|---|
| Sponsor | AMGEN INC |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) Discontinue AVSOLA if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment
Common side effects
- Infusion-related reactions
- Infections (upper respiratory, sinusitis, pharyngitis)
- Headache
- Abdominal pain
- Fever or chills
Serious adverse events
- Serious infusion reactions (anaphylaxis, convulsions, erythematous rash, hypotension)
- Cardiopulmonary reactions (chest pain, hypotension, hypertension, dyspnea)
- Pruritus/urticaria with cardiopulmonary reactions
- Anaphylaxis
- Convulsions
Key clinical trials
- Phase II Study of Infliximab for the Treatment of Immune Checkpoint Inhibitor Colitis (Phase 2)
- A Phase II Study of PD-1 Blockade With or Without LAG-3 Inhibition in Combination With Infliximab for the Treatment of Metastatic Melanoma and Prevention of Adverse Events (Phase 2)
- Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (Phase 4)
- Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease (Phase 2)
- EPIC - A Phase 2, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) in (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AVSOLA CI brief — competitive landscape report
- AVSOLA updates RSS · CI watch RSS
- AMGEN INC portfolio CI
Frequently asked questions about AVSOLA
What is AVSOLA?
AVSOLA (INFLIXIMAB-AXXQ) is a pharmaceutical drug developed by AMGEN INC.
Who makes AVSOLA?
AVSOLA is developed and marketed by AMGEN INC (see full AMGEN INC pipeline at /company/amgen).
What is the generic name of AVSOLA?
INFLIXIMAB-AXXQ is the generic (nonproprietary) name of AVSOLA.
What development phase is AVSOLA in?
AVSOLA is FDA-approved (marketed).
What are the side effects of AVSOLA?
Common side effects of AVSOLA include Infusion-related reactions, Infections (upper respiratory, sinusitis, pharyngitis), Headache, Abdominal pain, Fever or chills. Serious adverse events: Serious infusion reactions (anaphylaxis, convulsions, erythematous rash, hypotension), Cardiopulmonary reactions (chest pain, hypotension, hypertension, dyspnea), Pruritus/urticaria with cardiopulmonary reactions, Anaphylaxis.
Related
- Manufacturer: AMGEN INC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing