TM Owner Celltrion
Yuflyma 40mg/0.4ml Injection
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Indications & Clinical Uses
- Yuflyma 40 mg/0.4 mL (adalimumab-aaty) is a tumour necrosis factor (TNF) blocker and a biosimilar to Humira (adalimumab), given by subcutaneous injection, usually every other week, from a prefilled auto-injector or syringe.
- In the US it is approved for moderately to severely active rheumatoid arthritis, juvenile idiopathic arthritis (from age 2), psoriatic arthritis, ankylosing spondylitis, Crohn's disease (adults and children from age 6), ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and non-infectious uveitis; age limits differ by condition.
- Doses differ by condition, and some conditions such as Crohn's disease start with higher loading doses (160 mg, then 80 mg).
- The 40 mg/0.4 mL presentation is a small-volume, high-concentration product, so the volume differs from adalimumab products supplied as 40 mg/0.8 mL.
- Yuflyma is made by Celltrion.
Side Effects
- Boxed warning: adalimumab products increase the risk of serious infections that can lead to hospitalisation or death, including tuberculosis, bacterial sepsis and invasive fungal infections, and lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers.
- Very common reactions (more than 1 in 10 people) include infections such as upper respiratory infection (17% in rheumatoid arthritis studies) and sinusitis (11%), injection site reactions (8%), headache (12%) and rash (12%); nausea occurred in 9%.
- Report fever, persistent cough, weight loss, night sweats, unusual bruising or bleeding, new numbness or vision changes, swelling of the ankles or breathlessness, and any signs of an allergic reaction.
- Do not inject if you have an infection.
Precautions & Warnings
- Before and during treatment you will be checked for tuberculosis and hepatitis B, because latent infections can reactivate.
- The label has no contraindications, but warns about serious infections, lymphoma and other cancers (including hepatosplenic T-cell lymphoma, especially with azathioprine or 6-mercaptopurine), demyelinating disease, new or worsening heart failure, blood disorders, lupus-like reactions, liver problems, psoriasis worsening and serious allergic reactions.
- Adalimumab crosses the placenta in the third trimester; discuss pregnancy plans with your provider, and ask about live vaccines for babies exposed in the womb.
- Avoid live vaccines.
- Store in the refrigerator at 2°C to 8°C in the carton, away from light, and never freeze; it may be kept at up to 25°C for up to 31 days if needed.
Avoid Interactions
- Increased effect or toxicity: abatacept and anakinra are not recommended with Yuflyma, because they raise the risk of serious infection.
- Live vaccines should be avoided.
- Azathioprine or 6-mercaptopurine with a TNF blocker has been linked to hepatosplenic T-cell lymphoma.
- Methotrexate can reduce adalimumab clearance (by about 44% with repeated doses) but no dose change is needed.
- Reduced efficacy: the label sections reviewed did not list specific medicines that lower Yuflyma's effect.
- Tell your healthcare provider and pharmacist about all prescription and non-prescription medicines, vaccines and supplements you take or plan to take.
- Do not shake the product.
References
Frequently Asked Questions
Yuflyma (adalimumab-aaty) is a TNF-blocker biosimilar to Humira that treats rheumatoid, psoriatic and juvenile arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and non-infectious uveitis. Ages and doses depend on the condition, so your provider sets your plan.
Yuflyma (adalimumab-aaty) is injected under the skin with a prefilled auto-injector or syringe, usually 40 mg every other week for adult arthritis. Crohn's disease, colitis, psoriasis and hidradenitis have loading doses. Let it warm for 15 to 30 minutes first; do not shake it.
Common Yuflyma side effects are upper respiratory and sinus infections, injection site reactions, headache and rash. It carries a boxed warning for serious infections, including tuberculosis, and for lymphoma and other cancers. Contact your provider for fever, cough, weight loss, or unusual bruising.
Avoid live vaccines and do not combine Yuflyma (adalimumab-aaty) with abatacept or anakinra, which raise infection risk. Do not inject if you have an active infection. Ask about tuberculosis and hepatitis B screening first. Adalimumab crosses the placenta in late pregnancy, so tell your provider if you are pregnant.
Store Yuflyma (adalimumab-aaty) in the refrigerator at 2°C to 8°C in its carton, away from light, and do not freeze it. If needed, such as when travelling, it can be kept at up to 25°C for up to 31 days, then discard any unused supply.
Yuflyma (adalimumab-aaty) is a biosimilar to Humira (adalimumab), meaning it is highly similar with no clinically meaningful differences. It is a 40 mg/0.4 mL high-concentration presentation. Do not switch products without your provider, since the injection volume differs from 40 mg/0.8 mL adalimumab products.
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