bDMARDs Quick Reference Guide

Adalimumab

Adalimumab

HomeMonographsAdalimumab

Active ingredient

Adalimumab

Mechanism of action

Tumour necrosis factor (TNF) – alpha inhibitor

Molecule type

IgG monoclonal antibody (recombinant human)

PBS listed indications

DermatologyModerate to severe hidradenitis suppurativa 

Severe chronic plaque psoriasis 

GastroenterologyComplex refractory fistulising Crohn disease 

Severe Crohn disease 

Moderate to severe ulcerative colitis 

RheumatologyAnkylosing spondylitis 

Severe active juvenile idiopathic arthritis* 

Severe active rheumatoid arthritis 

Severe psoriatic arthritis 

*Paediatric dosing information is outside the scope of this guide. Please refer to paediatric specific references if required. 

Reference product (brand)

Humira

Biosimilar brands

Amgevita, Hadlima, Hyrimoz, Idacio

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Pre-filled syringe

Amgevita – 40mg/0.8mL 

Hadlima – 40mg/0.8mL 

Humira  20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL 

Hyrimoz – 40mg/0.8mL 

Idacio  40mg/0.8mL 

Pre-filled pen 

Amgevita SureClick® - 40mg/0.8mL 

Hadlima PushTouch™ auto injector, – 40mg/0.8mL  

Humira – 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL

Hyrimoz SensoReady® pen – 40mg/0.8mL

Idacio – 40mg/0.8mL 

Instructions for patient self-administration

Amgevita Instructions for patient self-administration are included with the product. 
Hadlima Instructions for patient self-administration are included with the product. 
Humira Pre-filled syringe: https://www.medsinfo.com.au/media/veihumis

40mg/0.8mL pen: https://www.medsinfo.com.au/media/veihumip  

40mg/0.4mL pen: https://www.medsinfo.com.au/media/veihu40p  

80mg/0.8mL pen: https://www.medsinfo.com.au/media/veihu80p  

Hyrimoz Instructions for patient self-administration are included with the product. 
Idacio Instructions for patient self-administration are outlined in the CMI. 

Frequency of administration

Every 2 weeks

Storage

Store at 2-8oC (refrigerate do not freeze).

Keep pre-filled syringes and pens in the outer carton until time of use to protect from light.

Amgevita, Hadlima, Humira, Idacio: may be stored at temperatures of up to 25oC for a maximum period of 14 days (must be protected from light). Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded even if it is returned to the refrigerator.

Hyrimoz: may be stored at temperatures of up to 25oC for a maximum period of 21 days (must be protected from light). Once removed from the refrigerator for room temperature storage, the syringe must be used within 21 days or discarded even if it is returned to the refrigerator.

Leave pre-filled syringes and pens at room temperature for 15-30 minutes to allow the medicine to warm up prior to injecting.

Standard dosing

Hidradenitis suppurativa: 160mg on day 1 (or 80mg on days 1 and 2), followed by 80mg on day 15 (2 weeks later). Two weeks later (day 29) continue with a dose of either 40mg once a week or 80mg every 2 weeks. 

Plaque psoriasis: Initial dose (day 0) 80mg (as one 80mg injection or two 40mg injections) followed by 40mg every 2 weeks, starting one week after the initial dose. 

Ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis: 40mg once every 2 weeks. 

Crohn disease and ulcerative colitis:

DoseFrequency
Induction160mgInitial dose (day 0) – 160mg (2 x 80mg injections) OR one 80mg injection per day for two consecutive days (day 0 and 1)
80mgSecond dose (day 14) as one 80mg injection OR two 40mg injections
Maintenance40mgStarting day 28 and continuing every 2 weeks

Treatment with csDMARDs (e.g., methotrexate) may continue during treatment with adalimumab.

Dose variations

Plaque psoriasis: Patients with inadequate response after 16 weeks may benefit from an increase in dose to 40mg each week or 80mg every 2 weeks.
This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways.

Rheumatoid arthritis: Patients not taking methotrexate may benefit from an increase in dose to 40mg each week or 80mg fortnightly.
This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways.

Patients with rheumatoid arthritis who are in remission or have low disease activity may have their dose of adalimumab down-titrated by their rheumatologist.

  • Dose reduction – standard dosing reduced to 50% of standard dose.
  • Dose interval increase from 40mg/2weeks →
    • Stepwise increase in dose interval by 50% every three months (complete stop at fourth step)
    • Stepwise increase in dose interval every three months, to 40mg/3weeks then 40mg/4weeks (then stop)
    • Increased interval from every 2 weeks → every 3 weeks

Crohn disease and ulcerative colitis: Patients who experience a decrease in response may benefit from an increase in dose to 40mg each week or 80mg every 2 weeks.
This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways.

Special notes

Therapeutic drug monitoring of adalimumab can be used to guide management in Crohn disease and ulcerative colitis. A steady state trough level of 5-12 microgram/mL is commonly used.

 

Adalimumab is not recommended for patients with serious or untreated infection, e.g. sepsis, abscess, hepatitis B, active TB (before completing TB treatment).
May reactivate inactive hepatitis B and latent TB (begin TB treatment before starting a TNF-alpha inhibitor).
Patients with suspected latent or active TB should be treated in consultation with an Infectious Diseases physician.

Treatment with another cytokine modulator (e.g. TNF-alpha inhibitor, abatacept, anakinra, rituximab, tocilizumab) is not recommended due to increased risk of infection.

 

TNF-alpha inhibitors like adalimumab are contraindicated with anakinra.

 

Adalimumab is contraindicated in moderate or severe heart failure (NYHA class III–IV) and left ventricular ejection fraction <50%; use cautiously in mild disease as TNF-alpha inhibitors may worsen heart failure.

 

Rare cases of serious blood dyscrasias (some fatal) have been reported in patients taking adalimumab. Monitor full blood count regularly.

 

A drug-induced lupus is rarely seen following administration of any TNF-alpha inhibitor. Patients presenting with a new rash or joint pain should be referred to their prescriber. This does not represent a class effect, and patients may be successfully rechallenged with a different TNF-alpha inhibitor without recurrence of a drug-induced lupus.

 

Live vaccines should not be given concurrently with adalimumab.

References

Pharmaceutical benefits Scheme (PBS) listing. Available from  https://www.pbs.gov.au/pbs/search?term=adalimumab&analyse=false&search-type=medicines [accessed 8/10/21]

Product information. Available from www.tga.gov.au [accessed 8/10/21]

Australian Medicines Handbook 2020 (online). Adelaide: Australian Medicines Handbook Pty Ltd; 2020 July. Available from: https://amhonline.amh.net.au/

NPS Medicinewise. Down-titration strategies. Available from https://www.nps.org.au/bdmards/rheumatology-conditions/titration-strategies [accessed 12/5/21]

Mitrev N et al. consensus statement on TDM of anti-TNF therapy in IBD. Aliment Pharmacol Ther. 2017;46:1037-1053