ADALIMUMAB-ADBM (Cyltezo)
ADALIMUMAB-ADBM risk profile, scheduling, and guidance for claims professionals and care workers . Also known as Cyltezo.
ADALIMUMAB-ADBM (brand names: Cyltezo) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. TNF-alpha inhibitor biosimilar with minimal direct occupational risk but potential for increased infection susceptibility.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (1 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
TNF-alpha inhibitor biosimilar with minimal direct occupational risk but potential for increased infection susceptibility.
Regulatory and Compliance Guidance
When ADALIMUMAB-ADBM appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
WorkSafe Victoria Drugs of Dependence Guidelines require monitoring for all S8 opioids. WorkCover QLD Pain Intervention Guidelines recommend multimodal pain management with opioids as a last resort.
United Kingdom NICE / MHRA / FPM
NICE NG193 (Chronic Pain) recommends against initiating opioids for chronic primary pain. The Faculty of Pain Medicine (FPM) Opioids Aware resource recommends structured opioid prescribing with regular review, dose limits, and documented tapering plans.
For personal injury claims in the UK, opioid prescribing duration and dose should be reviewed against NICE and FPM guidelines. Costs may be recoverable as a disbursement in high-value PI claims.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning . SERIOUS INFECTIONS ( 5.1 , 6.1 ): 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. Discontinue CYLTEZO if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting CYLTEZO. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. SERIOUS INFECTIONS Patients treated with adalimumab products, including CYLTEZO, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue CYLTEZO if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CYLTEZO use and during therapy. Initiate treatment for latent TB prior to CYLTEZO use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with CYLTEZO prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CYLTEZO, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions (5.2) ]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions (5.2) ] .
The CDC Clinical Practice Guideline for Prescribing Opioids (2022) recommends non-opioid therapies as first-line treatment for pain. When opioids are prescribed, the lowest effective dose should be used for the shortest duration needed.
For workers compensation claims, many states require prior authorization for opioids beyond initial acute prescribing. State drug formularies (e.g. California MTUS, Texas, New York) may restrict or require step therapy before opioid approval.
New Zealand ACC / BPAC NZ / Medsafe
BPAC NZ recommends reassessing opioid therapy at regular intervals and limiting duration. The NZ Opioid Prescribing B-QuiCK Guide provides structured prescribing and tapering protocols.
ACC (Accident Compensation Corporation) covers treatment-related medications for accepted claims. Opioid prescribing beyond guidelines may require ACC clinical review and approval.
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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.