Posology : מינונים

4.2 Posology and method of administration

Yuflyma treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Yuflyma is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Yuflyma (see section 4.4).
Patients treated with Yuflyma should be given the 'Patient safety information card'.

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

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

Yuflyma is available as 40 mg or 80 mg presentation. Thus, it is not possible to administer Yuflyma to patients that require less than a full 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used.

Posology

Rheumatoid arthritis
The recommended dose of Yuflyma 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 Yuflyma.

Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Yuflyma. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.

In monotherapy, some patients who experience a decrease in their response to Yuflyma 40 mg every other week 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.
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis

The recommended dose of Yuflyma 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.

Psoriasis

The recommended dose of Yuflyma 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 Yuflyma 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). If 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.

Hidradenitis suppurativa

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

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

Should treatment be interrupted, Yuflyma 40 mg every week or 80 mg every other week may be re- introduced (see section 5.1).

The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1).
Crohn’s disease

The recommended Yuflyma induction dose regimen for adult patients with moderately to severely active Crohn’s disease is 160 mg at Week 0 (given as four 40 mg or two 80 mg injections in one day or as two 40 mg or one 80 mg injections per day for two consecutive days), followed by 80 mg at Week 2 (given as two 40 mg or one 80 mg injections in one day), followed by a maintenance dose of 40 mg every other week via subcutaneous injection beginning at Week 4.

Aminosalicylates, corticosteriods and/or immunomodulatory agents (e.g. 6- mercaptopurine and azathioprine) may be continued during treatment with Yuflyma.

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

Ulcerative colitis

The recommended Yuflyma induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as four 40 mg or two 80 mg injections in one day or as two 40 mg or one 80 mg injections per day for two consecutive days) and 80 mg at Week 2 (given as two 40 mg or one 80 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 Yuflyma 40 mg every other week may benefit from an increase in dosage to 40 mg Yuflyma every week or 80 mg every other week.

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

Uveitis

The recommended dose of Yuflyma 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 adalimumab alone. Treatment with Yuflyma 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 Yuflyma.

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

Intestinal Behcet's disease

The initial dose of Yuflyma for adult intestinal Behcet's disease patients is 160 mg as subcutaneous injection. The initial dose is followed by 80 mg two weeks later.
From four weeks after the initial dose, 40 mg is administered every other week.

Yuflyma should be used when the signs and symptoms caused by intestinal Behcet's disease remain clearly even if patients have appropriate treatment with existing drug (steroids or immunomodulator, etc.).

Continued therapy with the same regimen should be carefully reconsidered in a patient not responding such as clinical symptoms and/or endoscopic findings within 12 weeks of treatment.

Elderly

No dose adjustment is required.
Renal and/or hepatic impairment

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

Paediatric population:

Yuflyma is available as 40 mg or 80 mg presentations. Thus, it is not possible to administer Yuflyma to paediatric patients that require less than a full 40 mg dose.
If an alternate dose is required, other adalimumab products offering such an option should be used.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis from 2 years of age
The recommended dose of Yuflyma for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1). Yuflyma is administered every other week via subcutaneous injection.

Table 1. Yuflyma Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis

Patient Weight                    Dosing Regimen
≥ 30 kg                       40 mg every other week

Note: Yuflyma is available as 40 mg or 80 mg presentations. Thus, it is not possible to administer Yuflyma to patients that require less than a full 40 mg dose.

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
The recommended dose of Yuflyma for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). Yuflyma is administered every other week via subcutaneous injection.

Table 2. Yuflyma Dose for Patients with Enthesitis-Related Arthritis 
Patient Weight                     Dosing Regimen
≥ 30 kg                        40 mg every other week

Note: Yuflyma is available as 40 mg or 80 mg presentations. Thus, it is not possible to administer Yuflyma to patients that require less than a full 40 mg dose.

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

Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis 
There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.

Paediatric plaque psoriasis

The recommended Yuflyma dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3). Yuflyma is administered via subcutaneous injection.


Table 3. Yuflyma Dose for Paediatric Patients with Plaque Psoriasis
Patient Weight                        Dosing Regimen
≥ 30 kg                       Initial dose of 40 mg,
followed by 40 mg given every other week starting one week after the initial dose

Note: Yuflyma is available as 40 mg or 80 mg presentations. Thus, it is not possible to administer Yuflyma to patients that require less than a full 40 mg dose.

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

If retreatment with adalimumab 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.

Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 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).

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

In adolescent patients with inadequate response to Yuflyma 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 Yuflyma if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Yuflyma.

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

Should treatment be interrupted, Yuflyma 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).

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

Paediatric Crohn's disease

The recommended dose of Yuflyma for patients with Crohn’s disease from 6 to 17 years of age is based on body weight (Table 4). Yuflyma is administered via subcutaneous injection.



Table 4. Adalimumab Dose for Paediatric Patients with Crohn’s disease Patient                             Induction                            Maintenance Weight                                Dose                                   Dose Starting at
Week 4
≥ 40 kg      • 80 mg at week 0 and 40 mg at week 2                       40 mg every other week
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
* Note: Yuflyma is available as 40 mg or 80 mg presentations. Thus, it is not possible to administer Yuflyma to patients that require less than a full 40 mg dose.

Patients who experience insufficient response may benefit from an increase in dosage: •    ≥ 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 less than 6 years for this indication.

Paediatric ulcerative colitis

The recommended dose of Yuflyma for patients from 6 to 17 years of age with ulcerative colitis is based on body weight (Table 5). Yuflyma is administered via subcutaneous injection.

Table 5. Yuflyma Dose for Paediatric Patients with Ulcerative Colitis Maintenance
Patient                Induction Dose
Dose Starting at
Weight
Week 4*
< 40 kg        • 80 mg at Week 0 (given as • 40 mg every other week two 40 mg injections in one day) and
• 40 mg at Week 2 (given as one 40 mg injection)
≥ 40 kg        • 160 mg at Week 0 (given     • 80 mg every other week as four 40 mg injections in one day or 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)
*Paediatric patients who turn 18 years of age while on Yuflyma should continue their prescribed maintenance dose.


Continued therapy beyond 8 weeks should be carefully considered in patients not showing signs of response within this time period.

There is no relevant use of adalimumab in children aged less than 6 years in this indication.

Paediatric Uveitis

The recommended dose of Yuflyma for paediatric patients with uveitis from 2 years of age is based on body weight (Table 6). Yuflyma is administered via subcutaneous injection.

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

Table 6. Yuflyma Dose for Paediatric Patients with Uveitis

Patient                         Dosing Regimen
Weight
≥ 30 kg                    40 mg every other week in combination with methotrexate
Note: Yuflyma is available as 40 mg or 80 mg presentations. Thus, it is not possible to administer Yuflyma to patients that require less than a full 40 mg dose.

When Yuflyma therapy is initiated, a loading dose of 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 adalimumab loading dose in children < 6 years of age (see section 5.2).

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

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

Method of administration

Yuflyma is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet.