Usual Adult Dose for Psoriatic Arthritis

Subcutaneous: 50 mg once a month
IV: 2 mg/kg over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter

Comments:

• This drug may be given with or without methotrexate or other nonbiologic disease modifying antirheumatic drugs (DMARDs).
• Corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during therapy.
• Patients should be tested for hepatitis B viral infection before starting treatment.
• Evaluate patients for active tuberculosis and tested for latent infection before starting treatment.
• The safety and efficacy of switching between subcutaneous and IV formulations have not been established.

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

Usual Adult Dose for Ulcerative Colitis

Initial dose: 200 mg subcutaneously at week 0, followed by 100 mg at week 2
Maintenance dose: 100 mg subcutaneously every 4 weeks

Comments:

• Patients should be tested for hepatitis B viral infection before starting treatment.
• Evaluate patients for active tuberculosis and tested for latent infection before starting treatment.
• The safety and efficacy of switching between subcutaneous and IV formulations have not been established.

Use: For the treatment of patients with moderate to severe ulcerative colitis (UC) who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for:

• inducing and maintaining clinical response
• improving endoscopic appearance of the mucosa during induction
• inducing clinical remission
• achieving and sustaining clinical remission in induction responders

Usual Adult Dose for Rheumatoid Arthritis

Subcutaneous: 50 mg once a month
IV: 2 mg/kg over 30 minutes at Weeks 0 and 4, then every 8 weeks thereafter

Comments:

• This drug may be given with or without methotrexate or other nonbiologic disease modifying antirheumatic drugs (DMARDs).
• Corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during therapy.
• Patients should be tested for hepatitis B viral infection before starting treatment.
• Evaluate patients for active tuberculosis and tested for latent infection before starting treatment.
• The safety and efficacy of switching between subcutaneous and IV formulations have not been established.

Use: For the treatment of patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose for Ankylosing Spondylitis

Subcutaneous: 50 mg once a month
IV: 2 mg/kg over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter

Comments:

• This drug may be given with or without methotrexate or other nonbiologic disease modifying antirheumatic drugs (DMARDs).
• Corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during therapy.
• Patients should be tested for hepatitis B viral infection before starting treatment.
• Evaluate patients for active tuberculosis and tested for latent infection before starting treatment.
• The safety and efficacy of switching between subcutaneous and IV formulations have not been established.

Use: For the treatment of patients with active ankylosing spondylitis (AS)

Usual Pediatric Dose for Psoriatic Arthritis

IV: 80 mg/m2 over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter

Comments:

• Dosage regimen is based on body surface area (BSA).

Use: For the treatment of active psoriatic arthritis in patients 2 years of age and older

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

IV: 80 mg/m2 over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter

Comments:

• Dosage regimen is based on body surface area (BSA).

Use: For the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older

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. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
• Discontinue therapy if a patient develops a serious infection.

REPORTED INFECTIONS:

• Active tuberculosis (TB), including reactivation of latent TB. -Test patients for latent TB before therapy initiation and during therapy. Initiate treatment for latent TB prior to therapy.
• Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis.
• Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.
• Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
• Consider the risks and benefits of treatment with this drug prior to initiating therapy in patients with chronic or recurrent infection.
• Monitor patients closely for the development of signs of infection during and after treatment, including the possible development of TB in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
• LYMPHOMA AND OTHER MALIGNANCIES: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers.

CONTRAINDICATIONS: None

Safety and effectiveness of the IV route for active polyarticular juvenile idiopathic arthritis and PsA have been established in pediatric patients 2 years and older.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
SUBCUTANEOUS:

• Allow the prefilled syringe or auto-injector to reach room temperature for 30 minutes before subcutaneous injection. Do not warm in any other way.
• The solution should not be used if discolored, cloudy, or if foreign particles are present.
• Discard any remaining product.
• If multiple injections are required, rotate administration sites.
• Avoid injection into areas where the skin is tender, bruised, red, or hard.
• The patient may self-inject with prefilled syringe or autoinjector 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 shields inside the removable cap of the product are manufactured from dry natural rubber containing latex and it should be handled with caution by individuals with latex sensitivity.

IV:

• Calculate the dosage and the number of vials needed based on the recommended dosage of 2 mg/kg and the patient's weight.
• Check that the solution in each vial is colorless to light yellow.
• Do not use if opaque particles, discoloration, or other foreign particles are present.
• Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter.
• Do not infuse concomitantly in the same intravenous line with other drugs.
• Infuse the solution over 30 minutes.

Storage requirements:

• Store in a refrigerator at 2C to 8C; do not freeze.
• Keep in the original carton protected from light until time of use.
• Do not shake
• The diluted solution for infusion can be stored at room temperature 25C for up to 4 hours.
• The vials, prefilled syringe or autoinjector may be stored at room temperature 25C for up to 30 days.
• The unopened vials, prefilled syringe or autoinjector should not be placed back in the refrigerator.
• Discard the vials, prefilled syringe or autoinjector if not used within 30 days when left at room temperature.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

Monitoring:

• Patients should be tested for hepatitis B viral infection before starting treatment.
• Evaluate patients for active tuberculosis and tested for latent infection before starting treatment.

Patient advice:

• Read the patient information leaflet.
• Patients should be advised to report any signs of new or worsening medical conditions such as congestive heart failure, demyelinating disorders, autoimmune diseases, liver disease, cytopenias, or psoriasis.
• Patients should be advised to report any symptoms of infection, including tuberculosis, invasive fungal infections, and hepatitis B reactivation.
• Patients should be counseled about the risk of lymphoma and other malignancies.
• This drug may lower the ability of their immune system to fight infections.
• Inform pregnant patients that their infants should not receive live vaccines for 6 months following the last infusion of this drug during pregnancy.
• Patients should be advised that the needle cover on the prefilled syringe as well as the prefilled syringe in the prefilled autoinjector contains dry natural rubber, a derivative of latex.

Frequently asked questions

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