Posology : מינונים

4.2   Posology and method of administration

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

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

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

Posology

Rheumatoid arthritis
The recommended dose of Hadlima 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 Hadlima.

Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics can be continued during treatment with Hadlima. 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 Hadlima 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.

Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis

The recommended dose of Hadlima 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 Hadlima 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 Hadlima 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 Hadlima 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 Hadlima 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 Hadlima.

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

Should treatment be interrupted, Hadlima 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 Humira 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), 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 Humira. Some patients who experience decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg Humira 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 Hadlima 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 Hadlima 40 mg every other week may benefit from an increase in dosage to 40 mg Hadlima every week or 80 mg every other week.

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

Uveitis
The recommended dose of Hadlima 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 Hadlima alone. Treatment with Hadlima 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 Hadlima.

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 Hadlima for adult intestinal Behcet's disease patients is 160 mg as subcutaneous injection. The initial dose is followed by 80mg two weeks later. Four weeks after the initial dose begin 40 mg every other week.

Hadlima should be used when the signs and symptoms caused by intestinal Behcet's disease remain clearly evident after appropriate treatment with existing drug (steroids or immunosuppressant, 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.

Special populations

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

Hadlima is not indicated for children and adolescents under 18 years of age.
Method of administration

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

A 40 mg pre-filled syringe and pre-filled pen are available for patients to administer a full 40 mg dose.