lmraldi™ treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which lmraldi™ is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with lmraldi™ (see section 4.4 of the Summary of Product Characteristics). Patients treated with lmraldi™ should be given the Patient Reminder Card.

 

After proper training in injection technique, patients may self-inject with lmraldi™ if their physician determines that it is appropriate and with medical follow-up as necessary. 

 

During treatment with lmraldi™, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.

DOSlNG lMRALDl™ lN ADULTS1

RHEUMATOlD ARTHRlTlS (RA)

The recommended dose of lmraldi™ for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with lmraldi™.

Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with lmraldi™. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1 of the Summary of Product Characteristics.

ln monotherapy, some patients who experience a decrease in their response to lmraldi™ 40 mg every other week dosing may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.

Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.

Dose interruption

There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.

ANKYLOSlNG SPONDYLlTlS, AXlAL SPONDYLOARTHRlTlS WlTHOUT RADlOGRAPHlC EVlDENCE OF AS AND PSORlATlC ARTHRlTlS

The recommended dose of lmraldi™ for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.

Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period. 

PSORlASlS

The recommended dose of lmraldi™ for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.

Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period. 

Beyond 16 weeks, patients with inadequate response to lmraldi™ 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1 of the Summary of Product Characteristics). lf adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.

HlDRADENlTlS SUPPURATlVA (HS)

The recommended lmraldi™ dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day). Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day). Antibiotics may be continued during treatment with lmraldiTM if necessary. lt is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with lmraldi™.

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. 

Should treatment be interrupted, lmraldi™ 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1 of the Summary of Product Characteristics).

The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1 of the Summary of Product Characteristics). 

CROHN’S DlSEASE (CD)

The recommended lmraldi™ induction dose regimen for adult patients with moderately to severely active Crohn’s disease is 80 mg at week 0 followed by 40 mg at week 2. ln case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.

After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Alternatively, if a patient has stopped lmraldi™ and signs and symptoms of disease recur, lmraldi™ may be re-administered. There is little experience from re-administration after more than 8 weeks since the previous dose. 

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Some patients who experience decrease in their response to lmraldi™ 40 mg every other week may benefit from an increase in dosage to 40 mg lmraldi™ every week or 80 mg every other week. 

Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12. Continued therapy should be carefully reconsidered in a patient not responding within this time period.

ULCERATlVE COLlTlS

The recommended lmraldi™ induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day). After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. 

Some patients who experience decrease in their response to lmraldi™ 40 mg every other week may benefit from an increase in dosage to 40 mg lmraldi™ every week or 80 mg every other week.

Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment. lmraldi™ therapy should not be continued in patients failing to respond within this time period. 

UVElTlS

The recommended dose of lmraldi™ for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. There is limited experience in the initiation of treatment with lmraldi™ alone. Treatment with lmraldi™ can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with lmraldi™.

lt is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1 of the Summary of Product Characteristics). 

DOSlNG lMRALDl™ lN CHlLDREN AND ADOLESCENTS1

Dosing of lmraldi™ in children and adolescents is based on body weight for some indications. Imraldi™ pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer Imraldi™ pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. lf an alternate dose is required, other adalimumab products offering such an option should be used.

 

JUVENlLE lDlOPATHlC ARTHRlTlS

Polyarticular juvenile idiopathic arthritis from 2 years of age

The recommended dose of lmraldi™ for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight.

lmraldi™ is administered every other week via subcutaneous injection.

Patient Weight Dosing Regimen
10 kg to <30 kg 20 mg every other week*
≥30 kg 40 mg every other week

Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.

There is no relevant use of adalimumab in patients aged less than 2 years for this indication.

Enthesitis-related arthritis from 6 years of age

The recommended dose of lmraldi™ for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight.

lmraldi™ is administered every other week via subcutaneous injection.

Patient Weight Dosing Regimen
15 kg to <30 kg 20 mg every other week*
≥30 kg 40 mg every other week

Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.

* lmraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

PAEDlATRlC PLAQUE PSORlASlS FROM 4–17 YEARS OF AGE

The recommended lmraldi™ dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight.

lmraldi™ is administered via subcutaneous injection.

Patient Weight Dosing Regimen
15 kg to <30 kg lnitial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose*
≥30 kg lnitial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose

Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.

lf retreatment with lmraldi™ is indicated, the above guidance on dose and treatment duration should be followed. 

The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.

There is no relevant use of adalimumab in children aged less than 4 years for this indication. 

* lmraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

ADOLESCENT HlDRADENlTlS SUPPURATlVA FROM 12 YEARS OF AGE WElGHING >30 KG

There are no clinical trials with adalimumab in adolescent patients with HS. The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2 of the Summary of Product Characteristics).

The recommended lmraldi™ dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection. 

ln adolescent patients with inadequate response to lmraldi™ 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.

Antibiotics may be continued during treatment with lmraldi™ if necessary. lt is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with lmraldi™. 

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.

Should treatment be interrupted, lmraldi™ may be re-introduced as appropriate. 

The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1 of the Summary of Product Characteristics).

There is no relevant use of adalimumab in children aged less than 12 years in this indication. 

PAEDlATRlC CROHN’S DlSEASE FROM 6–17 YEARS OF AGE

The recommended dose of lmraldi™ for patients with Crohn’s disease from 6 to 17 years of age is based on body weight.

lmraldi™ is administered via subcutaneous injection

Patient Weight lnduction Dose Maintenance Dose Starting at Week 4
<40 kg

40 mg at week 0 and 20 mg at week 2*

ln case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:

80 mg at week 0 and 40 mg at week 2

20 mg every other week*
≥40 kg

80 mg at week 0 and 40 mg at week 2

ln case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:

160 mg at week 0 and 80 mg at week 2

40 mg every other week

Patients who experience insufficient response may benefit from an increase in dosage:

  • <40 kg: 20 mg every week*
  • ≥40 kg: 40 mg every week or 80 mg every other week

Continued therapy should be carefully considered in a subject not responding by week 12.

There is no relevant use of adalimumab in children aged below 6 years for this indication.

* lmraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

PAEDlATRlC ULCERATlVE COLlTlS

The safety and efficacy of adalimumab in children aged 4–17 years have not yet been established. No data are available.

There is no relevant use of lmraldiTM in children aged less than 4 years for this indication. 

PSORlATlC ARTHRlTlS AND AXlAL SPONDYLOARTHRlTlS lNCLUDlNG ANKYLOSlNG SPONDYLlTlS

There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatric arthritis.

PAEDlATRlC UVElTlS

The recommended dose of lmraldi™ for paediatric patients with uveitis from 2 years of age is based on body weight.

lmraldi™ is administered via subcutaneous injection.

ln paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.

Patient Weight Dosing Regimen
<30 kg 20 mg every other week in combination with methotrexate*
≥30 kg 40 mg every other week in combination with methotrexate

When lmraldi™ therapy is initiated, a loading dose of 40 mg for patients <30 kg or 80 mg for patients ≥30 kg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of an adalimumab loading dose in children <6 years of age (see section 5.2 of the Summary of Product Characteristics).

There is no relevant use of adalimumab in children aged less than 2 years in this indication.

lt is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1 of the Summary of Product Characteristics).

* lmraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

DOSlNG lMRALDl™ lN OTHER SPEClAL POPULATlONS1

ELDERLY

No dose adjustment is required.

RENAL AND/OR HEPATlC lMPAlRMENT

Adalimumab has not been studied in these patient populations. No dose recommendations can be made.

DOSlNG lMRALDlTM BY lNDlCATlON

lndication Sub-indication Dose adjustments Dosage
Rheumatoid arthritis 40 mg q2wk + methotrexate
Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis >2 years (10 kg to <30 kg) 20 mga q2wk
>2 years (≥30 kg) 40 mg q2wk
Enthesitis-related arthritis >6 years (15 kg to <30 kg) 20 mg q2wk
>6 years (≥30 kg) 40 mg q2wk
Axial spondyloarthritis 40 mg q2wk
Psoriatic arthritis 40 mg q2wk
Psoriasis lnitial dose: 80 mg
Day 8 onwards: 40 mg q2wk
Paediatric plaque psoriasis 4–17 years (15 kg to <30 kg) lnitial dose: 20 mga
Day 8: 20 mga q2wk
4–17 years (≥ 30 kg) lnitial dose: 40 mg
Day 8: 40 mg q2wk
Hidradenitis suppurativa lnitial dose: 160 mgb
Day 15: 80 mgс
Day 29 onwards: 80 mgс q2wk or 40 mg qwk
Crohn’s disease lnitial dose: 80 mg (160 mgd)
Day 15: 40 mg
Day 29 onwards: 40 mg q2wk
Paediatric Crohn’s disease 6–17 years (<40 kg) lnitial dose: 40 mg (80mge)
Day 15: 20 mga
Day 29 onwards: 20 mga q2wk
6–17 years (≥40 kg) lnitial dose: 80 mg(160 mgf)
Day 15: 40 mg
Day 29 onwards: 40 mg q2wk
Ulcerative colitis lnitial dose: 160 mgbb
Day 15: 80 mgcc
Day 29 onwards:
40 mg q2wk
Uveitis lnitial dose: 80 mg
Day 8 onwards:
40 mg q2wk
Paediatric uveitis >2 years (<30 kg) 20 mga q2wk + methotrexate
>2 years (≥30 kg) 40 mg q2wk + methotrexate

a lmraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

b Given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days.

c Given as two 40mg injections in one day.

d In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.

e < 40 kg, in case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 80 mg at week 0 and 40 mg at week 2.

f ≥ 40 kg, in case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 160 mg at week 0 and 80 mg at week 2.

 

 

Abbreviations: q2wk, every other week; qwk, every week

Please also refer to the Summary of Product Characteristics

CONTRAINDICATIONS1

Hypersensitivity to the active substance or to any of the following list of excipients:

Sodium citrate

Citric acid monohydrate

Histidine

Histidine hydrochloride monohydrate

Sorbitol

Polysorbate 20

Water for injections

 

Active tuberculosis or other severe infections such as sepsis, and opportunistic infections. (see section 4.4 of the SmPC).

 

Moderate to severe heart failure (NYHA class III/IV). (see section 4.4 of the SmPC).

 

See the full Summary of Product Characteristics for further information.