Adalimumab-aaty (Yuflyma autoinjector)
Pronunciation: pronunciation varies by local usage.
- Generic name
- adalimumab-aaty
- Brand names
- Yuflyma
- Drug class
- TNF-blocker; biosimilar to adalimumab (Humira)
- Form
- Autoinjector
- Route
- Subcutaneous injection
- Legal status
- Prescription-only biologic medicine
Availability and supply rules vary by country
Trade names by country: India
Australia: · Full directory
What adalimumab-aaty is and how it works
Yuflyma (adalimumab-aaty) is a TNF-blocker biosimilar to Humira (adalimumab). It is delivered in a high-concentration autoinjector for subcutaneous use and is approved for multiple inflammatory conditions. (1)
The approved uses, dosing, and minimum ages vary by indication and are determined by a specialist. Yuflyma is a maintenance treatment, not a rescue medication, and requires TB testing, monitoring for infections, and prescriber oversight before any self-injection.
Mechanism of action: how adalimumab-aaty works
Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody that binds specifically to tumor necrosis factor (TNF)-alpha and blocks its interaction with p55 and p75 cell surface TNF receptors, thereby neutralizing the biological activity of TNF. (1)
What adalimumab-aaty is used for
Rheumatoid arthritis
Yuflyma is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis. (1)
Polyarticular juvenile idiopathic arthritis (pJIA)
Indicated for children aged 2 years and older with moderately to severely active pJIA. (1)
Psoriatic arthritis
Indicated for adults with active psoriatic arthritis. (1)
Ankylosing spondylitis
Indicated for adults with active ankylosing spondylitis. (1)
Crohn’s disease
Indicated for adults and children aged 6 years and older with moderately to severely active Crohn’s disease. (1)
Ulcerative colitis
Indicated for adults with moderately to severely active ulcerative colitis. (1)
Plaque psoriasis
Indicated for adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. (1)
Hidradenitis suppurativa
Indicated for patients aged 12 years and older with moderate to severe hidradenitis suppurativa. (1)
Non-infectious uveitis
Indicated for patients aged 2 years and older with non-infectious intermediate, posterior, and panuveitis. (1)
Before taking adalimumab-aaty
Do not take / not appropriate for
- There are no absolute contraindications; however, live vaccines must be avoided and serious infections, sepsis, or hypersensitivity must be managed as directed by the prescriber. (all indications) (1)
Tell your clinician about
- History or suspicion of tuberculosis (TB), including latent TB, or any known exposure.
- Current or recent infection, fever, persistent cough, weight loss, night sweats, or other systemic symptoms.
- History of hepatitis B virus infection, liver problems, blood disorders, neurologic disorders (e.g., multiple sclerosis, optic neuritis), heart failure, or lupus.
- Pregnancy, breastfeeding, or plans for either; use of any other biologic medicines, especially abatacept or anakinra.
- Planned or recent vaccinations, particularly live vaccines.
How to take adalimumab-aaty
- Yuflyma is injected subcutaneously, typically as a 40 mg dose every other week for rheumatoid arthritis and several other indications; exact dosing, interval, and duration are determined by the prescriber based on indication, weight (in children), and response.
- Self-injection may be possible after adequate training and if the physician determines it appropriate, with medical follow-up as required.
- Do not change the dose, frequency, or device without prescriber direction.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If a dose is missed, inject as soon as remembered, then return to the normal schedule unless the prescriber advises otherwise. This is a general clinical principle; the exact handling of missed doses should follow the prescriber’s plan.
Overdose
In case of an incorrect dose, multiple injections, or suspected overdose, contact the prescribing clinic or poison control center promptly. Monitor for signs of infection or hypersensitivity. (1)
Side effects
Very common adverse reactions (>10%) include infections (upper respiratory, sinusitis), injection-site reactions, headache, and rash.
Injection-site reactions
What to notice: Redness, swelling, pain, itching, or bruising at the injection site (20% of patients vs 14% placebo).
What to do: Rotate sites; tell the treatment team if reactions are severe, persist, or are accompanied by systemic symptoms. (1)
Upper respiratory infections, sinusitis
What to notice: Nasal congestion, sinus pressure, cough, sore throat.
What to do: Mention to the prescriber if symptoms are prolonged or severe. (1)
Headache, rash
What to notice: New or worsening headache; skin rash.
What to do: Report persistent or severe symptoms to the prescriber. (1)
Signs of serious infection
What to notice: Fever that does not go away, severe fatigue, body aches, cough, skin sores, or other symptoms of a serious infection.
What to do: Contact the prescriber promptly; do not self-administer while waiting for advice. (1)
Cytopenias/pancytopenia
What to notice: Persistent fever, easy bruising, unusual bleeding, or pallor.
What to do: Seek immediate medical evaluation. (1)
Demyelinating disease
What to notice: Numbness, tingling, vision changes (optic neuritis), weakness, or balance problems.
What to do: Contact the prescriber urgently. (1)
Heart failure or lupus-like syndrome
What to notice: New or worsening breathlessness, leg swelling, or extreme fatigue (heart failure); rash on cheeks or arms, joint pain, or fever (lupus-like).
What to do: Seek prompt medical attention. (1)
Serious warnings
Serious infections and sepsis — emergency
Symptoms: Fever, chills, severe fatigue, body aches, cough, skin lesions, or any sign of a worsening infection. Specific infections include tuberculosis (reactivation of latent TB), bacterial sepsis, and invasive fungal infections.
Action: The prescriber will discontinue Yuflyma if a serious infection or sepsis develops. Patients must seek emergency care immediately for any suspected severe infection. (1)
Malignancy, including lymphoma — critical
Symptoms: Unexplained weight loss, swollen glands, persistent fever, drenching night sweats, or new lumps. Hepatosplenic T-cell lymphoma (HSTCL) is a rare aggressive lymphoma reported predominantly in adolescent/young-adult males with inflammatory bowel disease, often on concurrent azathioprine or 6-mercaptopurine.
Action: Report any concerning symptoms promptly; the prescriber will evaluate and may adjust treatment. (1)
Hepatitis B reactivation — critical
Symptoms: Fatigue, jaundice, abdominal pain, dark urine, or laboratory signs of liver injury.
Action: Carriers of hepatitis B virus are monitored during treatment; if reactivation occurs, the prescriber will discontinue the medicine and initiate appropriate treatment. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Abatacept or anakinra | Combination with these biologics increases the risk of serious infections. | Avoid co-administration; inform the prescriber of all treatments. (1) |
| Methotrexate | Methotrexate reduces adalimumab clearance, but standard dosing does not require a dose adjustment. | No dose adjustment is needed based on concurrent methotrexate alone. (1) |
| Live vaccines | Immunosuppression may increase the risk of vaccine-induced infection. | Avoid live vaccines during treatment; ensure vaccinations are up-to-date before starting Yuflyma if possible. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Children and adolescents
Minimum ages vary by indication: pJIA and uveitis from age 2; Crohn’s disease from age 6; hidradenitis suppurativa from age 12. Dosing, safety, and self-injection suitability are determined by the specialist using indication-specific parameters. (1)
Pregnancy and breastfeeding
Adalimumab crosses the placenta in the third trimester and may affect infant immune responses; live vaccines are typically delayed in infants exposed during pregnancy. First-trimester exposure in registry data showed a major-birth-defect rate of 10%, but interpretation should involve the specialist. Breastfeeding decisions are made with the care team. (1)
Patients at risk of tuberculosis or hepatitis B
All patients must be tested for latent TB before starting and monitored during treatment. Hepatitis B carriers require monitoring for reactivation. (1)
Monitoring
Before starting
- Evaluate for latent tuberculosis (TB) with a TB test and medical history; initiate TB treatment if indicated before starting Yuflyma.
- Assess for risk of hepatitis B infection, carry out serologic testing if indicated, and monitor carriers on treatment.
- Review complete medical history including neurologic disorders, heart failure, blood disorders, and prior malignancies.
- Confirm vaccination status; administer necessary non-live vaccines before initiation; avoid live vaccines.
During treatment
- Monitor for signs and symptoms of infection, malignancy, demyelinating disease, cytopenias, heart failure, and lupus-like reactions at every visit.
- For hepatitis B carriers, monitor liver enzymes and HBV DNA regularly.
- Reassess appropriateness of continued treatment, injection technique, and the ability to recognize adverse events if self-injecting.
- Do not abruptly change background medications such as methotrexate without specialist guidance.
Storage
Store refrigerated at 2–8°C in the original carton to protect from light. Do not freeze or shake. Before injection, the autoinjector can be allowed to sit at room temperature for 15–30 minutes. Do not use if it has been exposed to extreme heat or cold beyond labeled conditions. Dispose of used autoinjectors in a sharps container.
Professional information
Clinician-facing context based on US prescribing information only. Other regions may differ. Always consult the approved local label for exact indications, dosing, and safety.
United States
Indication: Any Yuflyma use
Dose summary: Dosing is indication-specific and determined by the prescriber. Commonly 40 mg subcutaneously every other week for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Other indications or pediatric dosing may differ (e.g., loading doses, weight-based dosing). Refer to the full US label.
Renal context: No specific renal dosing adjustments are mentioned in the US label; use with specialist judgment. (1)
Hepatic guidance
No specific hepatic dosing adjustments are provided; use with caution and specialist monitoring in patients with known liver disease or hepatitis B carriers.
Overdose note
In the event of a suspected overdose, monitor for adverse effects and provide supportive care; no specific antidote is available. (1)
Frequently asked questions
Is Yuflyma the same as Humira?
Yuflyma is an FDA-licensed biosimilar to Humira. It contains the same active ingredient class (adalimumab) with no clinically meaningful differences, and is delivered in a high-concentration autoinjector. (1)
Can I inject Yuflyma myself?
Yes, if your physician determines it is appropriate and you receive training. Typically, you will inject 40 mg under the skin every other week for many indications, but your dose and schedule may differ. (1)
Why do I need a tuberculosis test before starting Yuflyma?
TNF blockers can reactivate latent tuberculosis, which is a serious infection. Therefore, testing and evaluation are required before the first dose, and monitoring continues during treatment. (1)
What symptoms should prompt me to seek urgent medical attention?
Fever or infection signs that persist, unusual bruising or bleeding, numbness or vision changes, new or worsening breathlessness or leg swelling, and any severe injection reaction should be evaluated immediately. (1)
What is the mechanism of action of adalimumab-aaty?
Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody that binds specifically to tumor necrosis factor (TNF)-alpha and blocks its interaction with p55 and p75 cell surface TNF receptors, thereby neutralizing the biological activity of TNF. (1)
What is the generic name of Adalimumab-aaty (Yuflyma autoinjector)?
The generic name is adalimumab-aaty. It is sold under brand names including Yuflyma. (1)
What class of drug is adalimumab-aaty?
Adalimumab-aaty (Yuflyma autoinjector) is classed as: TNF-blocker; biosimilar to adalimumab (Humira). (1)
References
- YUFLYMA (adalimumab-aaty) injection, Celltrion USA, label revised 2025-11U.S. National Library of Medicine DailyMed · United States · dated 2025-11 · accessed 2026-08-08 · source 1
- Yuflyma — FDA approval record (Drugs@FDA BLA761219)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 2
- adalimumab-aaty — RxNorm normalized drug concept (RXCUI 2639649)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 3
Brand names by country
Single-ingredient adalimumab-aaty names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
India
- Exemptia40 mg/0.8 mL · Zydus Lifesciences Limited
- Mabura40 mg · Hetero Healthcare Limited