Usual Adult Dose for Rheumatoid Arthritis

IV Dosing Regimen:

• Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
• Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
• Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter

Subcutaneous Dosing Regimen:

• Optional IV loading dose:
• Weight less than 60 kg: 500 mg IV once
• Weight 60 to 100 kg: 750 mg IV once
• Weight more than 100 kg: 1000 mg IV once
• Subcutaneous injection: 125 mg subcutaneously once a week

Comments:

• This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDS), such as tumor necrosis factor (TNF) antagonists.
• The IV infusion should be administered over 30 minutes.
• Before the first subcutaneous dose, an optional loading dose may be administered as a single IV infusion; if an IV loading dose is used, the first subcutaneous injection should be administered within 1 day of the infusion.
• For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.

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

Usual Adult Dose for Psoriatic Arthritis

IV Dosing Regimen:

• Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
• Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
• Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter

Subcutaneous Dosing Regimen: 125 mg subcutaneously once a week

Comments:

• This drug may be used with or without nonbiologic DMARDs.
• The IV infusion should be administered over 30 minutes.
• For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.

Use: For the treatment of patients with active psoriatic arthritis

Usual Adult Dose for Graft Versus Host Disease - Prophylaxis

10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose

Comments:

• Before administering this drug, recommended antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation should be administered and continued for 6 months after hematopoietic stem cell transplantation (HSCT); additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
• The IV infusion should be administered over 60 minutes.

Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft versus host disease (aGVHD) in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

IV Dosing Regimen:
6 years or older:

• Weight less than 75 kg: 10 mg/kg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
• Weight 75 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
• Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter

Maximum dose: 1000 mg/dose

Subcutaneous Dosing Regimen:
2 years or older:

• Weight 10 to less than 25 kg: 50 mg subcutaneously once a week
• Weight 25 to less than 50 kg: 87.5 mg subcutaneously once a week
• Weight at least 50 kg: 125 mg subcutaneously once a week

Comments:

• This drug may be used as monotherapy or concomitantly with methotrexate.
• The IV infusion should be administered over 30 minutes.
• Subcutaneous administration: Patients may self-inject or the patient's caregiver may administer this drug if both the health care provider and parent/legal guardian decides it is appropriate; the ability of pediatric patients to self-inject with the autoinjector has not been tested.

Use: For the treatment of patients with moderately to severely active polyarticular juvenile idiopathic arthritis

Usual Pediatric Dose for Graft Versus Host Disease - Prophylaxis

2 to less than 6 years: 15 mg/kg IV on the day before transplantation (Day -1), then 12 mg/kg IV on Days 5, 14, and 28 after transplantation
6 years or older: 10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose

Comments:

• Before administering this drug, recommended antiviral prophylaxis for EBV reactivation should be administered and continued for 6 months after HSCT; additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
• The IV infusion should be administered over 60 minutes.

Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of aGVHD in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
IV Infusion:

• Use an infusion set and a sterile, nonpyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 microns).
• For rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis, administer the entire diluted solution over 30 minutes.
• For prophylaxis of aGVHD, administer the entire diluted solution over 60 minutes.
• Infusion of the diluted solution must be completed within 24 hours of reconstitution of the vials.
• Do not infuse concomitantly in the same IV line with other agents.

Subcutaneous Administration:

• The prefilled syringes and ClickJect autoinjectors are for subcutaneous use only under the guidance of a health care provider; do not use for IV infusion.
• Rotate injection sites and avoid injections into areas where the skin is tender, bruised, red, or hard.

Storage requirements:

• Refrigerate at 2C to 8C (36F to 46F); protect from light by storing in original package until time of use.
• IV infusion: May store diluted solution at room temperature or refrigerate at 2C to 8C (36F to 46F) up to 24 hours before use; discard diluted solution if not administered within 24 hours.
• Subcutaneous injection: Do not freeze.

Reconstitution/preparation techniques:

• For IV infusion: This drug must be reconstituted (using only the provided silicone-free disposable syringe) and further diluted prior to administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: Sterile Water for Injection, USP; 0.9% Sodium Chloride Injection, USP
• There have been no physical or biochemical compatibility studies to evaluate coadministration of this drug with other agents.

General:

• Limitations of Use: The concomitant use of this drug with other potent immunosuppressants (e.g., bDMARDS, JAK inhibitors) is not recommended.

Monitoring:

• Infections/Infestations: For signs of infection (when transitioning from TNF antagonist therapy to this drug); for EBV reactivation; for CMV infection/reactivation (for 6 months posttransplant)
• Respiratory: For worsening respiratory status in patients with COPD

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Notify health care professional immediately if symptoms of an allergic reaction occur on the day of administration or the day after administration.
• Patients treated with the IV formulation who are using glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ)-based monitoring systems for glucose: Consider using other methods for glucose monitoring (e.g., those based on glucose dehydrogenase nicotine adenine dinucleotide [GDH-NAD], glucose oxidase, or glucose hexokinase test methods) or you may get falsely elevated blood glucose readings on the day this drug is infused.

Frequently asked questions

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