Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Maintenance dose: 400 mg subcutaneously every 4 weeks can be considered

Comments:

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Use: For the treatment of adults with moderately to severely active rheumatoid arthritis (RA)

Usual Adult Dose for Psoriatic Arthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Maintenance dose: 400 mg subcutaneously every 4 weeks can be considered

Comments:

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Use: For the treatment of adult patients with active psoriatic arthritis (PsA)

Usual Adult Dose for Ankylosing Spondylitis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks

Comments:

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Use: For the treatment of adults with active ankylosing spondylitis

Usual Adult Dose for Crohn's Disease - Maintenance

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4
Maintenance dose: 400 mg subcutaneously every 4 weeks

Comments:

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Use: For reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

Usual Adult Dose for Plaque Psoriasis

Initial dose:

• 400 mg subcutaneously (given as 2 subcutaneous injections or 200 mg) every other week
• For certain patients with body weight <=90 kg: 400 mg (given as 2 subcutaneous injections or 200 mg) at weeks 0, 2, and 4 followed by 200 mg every other week can be considered

Comments:

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Use: For the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks

Comments:

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Use: For the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• SERIOUS INFECTIONS: Use of this drug increases the 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. If a patient develops a serious infection or sepsis, this drug should be discontinued.
• A test for latent TB should be performed; if positive, treatment for TB should be started prior to starting therapy with this drug.
• All patients should be monitored for active TB during treatment, even if the initial latent TB test was negative.
• LYMPHOMA AND OTHER MALIGNANCIES: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers. This drug is not indicated for use in pediatric patients.

CONTRAINDICATIONS:

• History of hypersensitivity reaction to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous administration only.
• This product should be at room temperature before the injection.
• Suitable administration sites include the thigh or abdomen at least 2 inches away from the navel.
• The patient may self-inject with prefilled syringe only if the physician determines that it is appropriate, training in proper technique has been provided, and with appropriate medical follow-up as necessary.
• The needle shield inside the removable cap of the prefilled syringe contains a derivative of natural latex, and it should be handled with caution by individuals with latex sensitivity.
• For a 400 mg dose, this drug should be administered as 2 subcutaneous injections of 200 mg each on the same day at separate sites.
• This product is preservative-free, and any unused portion left in the syringe or vial should be discarded.

Storage requirements:

• Store in refrigerator at 2C to 8C; do not freeze.
• Keep in the outer carton to protect from light until time of use.
• The reconstituted vial can be stored for up to 24 hours at 2C to 8C.
• Unopened vials may be stored at room temperature 25C for 6 months.
• Prefilled syringes may be stored at room temperature 25C for up to 7 days.
• Unopened vials and prefilled syringes should not be placed back in the refrigerator.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

Monitoring: All patients must be evaluated for both active and inactive (latent) tuberculosis infection before therapy initiation using an appropriate screening test, e.g., tuberculin skin test and chest x-ray.

Patient advice:

• Read the patient information leaflet.
• Advise patients that they may experience angioedema, allergic dermatitis, dizziness (postural), dyspnea, hot flush, hypotension, injection site reactions, malaise, pyrexia, rash, serum sickness, and (vasovagal) syncope following administration of this drug.
• Patients should be advised that this drug may have a minor effect on the ability to drive and/or operate machinery.
• Patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of hematologic abnormalities or infection (e.g., persistent fever, bruising, bleeding, pallor).
• Patients should be advised to report new or worsening heart disease, neurological disease, or autoimmune disorders.

Frequently asked questions

• What are the new drugs for the treatment of rheumatoid arthritis (RA)?