Tofidence Dosage

Generic name: TOCILIZUMAB 20mg in 1mL
Dosage form: injection
Drug class: Interleukin inhibitors

Medically reviewed by Drugs.com. Last updated on Mar 27, 2024.

General Considerations for Administration

Not Recommended for Concomitant Use with Biological DMARDs

Tocilizumab products have not been studied in combination with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators because of the possibility of increased immunosuppression and increased risk of infection. Avoid using TOFIDENCE with biological DMARDs.

Baseline Laboratory Evaluation Prior to Treatment

Obtain and assess baseline complete blood count (CBC) and liver function tests prior to treatment.

RA, PJIA and SJIA – It is recommended that TOFIDENCE not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm 3, platelet count below 100,000 per mm 3, or ALT or AST above 1.5 times the upper limit of normal (ULN) [see Warnings and Precautions (5.3, 5.4)] .

Recommended Dosage for Rheumatoid Arthritis

TOFIDENCE may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an intravenous infusion.

Recommended Intravenous Dosage Regimen:

The recommended dosage of TOFIDENCE for adult patients given as a 60-minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.

Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.6), Warnings and Precautions (5.3, 5.4), and Adverse Reactions (6.1)].
Doses exceeding 800 mg per infusion are not recommended in RA patients [see Clinical Pharmacology (12.3)].

When transitioning from intravenous therapy with TOFIDENCE to subcutaneous therapy with another tocilizumab product, administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Interruption of dose is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.6) and Warnings and Precautions (5.3, 5.4).

Recommended Dosage for Polyarticular Juvenile Idiopathic Arthritis

TOFIDENCE may be used as an intravenous infusion alone or in combination with methotrexate. Do not change dose based solely on a single visit body weight measurement, as weight may fluctuate.

Recommended Intravenous Dosage Regimen:

The recommended dosage of TOFIDENCE for PJIA patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:

Recommended Intravenous PJIA Dosage Every 4 Weeks
Patients less than 30 kg weight	10 mg per kg
Patients at or above 30 kg weight	8 mg per kg

Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.6)].

Recommended Dosage for Systemic Juvenile Idiopathic Arthritis

TOFIDENCE may be used as an intravenous infusion or in combination with methotrexate. Do not change a dose based solely on a single visit body weight measurement, as weight may fluctuate.

Recommended Intravenous Dosage Regimen:

The recommended dose of TOFIDENCE for SJIA patients given once every 2 weeks as a 60-minute single intravenous drip infusion is:

Recommended Intravenous SJIA Dosage Every 2 Weeks
Patients less than 30 kg weight	12 mg per kg
Patients at or above 30 kg weight	8 mg per kg

Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.6)].

Preparation and Administration Instructions for Intravenous Infusion

TOFIDENCE for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:

Use a sterile needle and syringe to prepare TOFIDENCE.
Patients less than 30 kg: use a 50 mLinfusion bag or bottle of 0.9% Sodium Chloride Injection, USP, and then follow steps 1 and 2 below.
Patients at or above 30 kg weight: use a 100 mLinfusion bag or bottle, and then follow steps 1 and 2 below.
Step 1. Withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the TOFIDENCE injection required for the patient's dose from the infusion bag or bottle [see Dosage and Administration (2.2, 2.3, 2.4)].

For Intravenous Use: Volume of TOFIDENCE Injection per kg of Body Weight
Dosage	Indication	Volume of TOFIDENCE injection per kg of body weight
4 mg/kg	Adult RA	0.2 mL/kg
8 mg/kg	Adult RA, SJIA and PJIA (greater than or equal to 30 kg of body weight)	0.4 mL/kg
10 mg/kg	PJIA (less than 30 kg of body weight)	0.5 mL/kg
12 mg/kg	SJIA (less than 30 kg of body weight)	0.6 mL/kg

Step 2. Withdraw the amount of TOFIDENCE for intravenous infusion from the vial(s) and add slowly into the 0.9% Sodium Chloride Injection, USP infusion bag or bottle. To mix the solution, gently invert the bag to avoid foaming.
The fully diluted TOFIDENCE solutions for infusion using 0.9% Sodium Chloride Injection, USP may be stored refrigerated at 36°F to 46°F (2°C to 8°C) for up to 24 hours or room temperature at 68°F to 77°F (20°C to 25°C) for up to 12 hours and should be protected from light.
TOFIDENCE solutions do not contain preservatives; therefore, unused product remaining in the vials should not be used.
Allow the fully diluted TOFIDENCE solution to reach room temperature prior to infusion.
The infusion should be administered over 60 minutes, and must be administered with an infusion set. Do not administer as an intravenous push or bolus.
TOFIDENCE should not be infused concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of TOFIDENCE with other drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, the product should not be used.
Fully diluted TOFIDENCE solutions are compatible with infusion bags and/or infusion sets with the following materials: polypropylene, polyethylene, polyolefin, polyvinyl chloride, polyethersulfone, polyurethane, nylon and stainless steel.

Dosage Modifications due to Serious Infections or Laboratory Abnormalities

Serious Infections

Hold TOFIDENCE treatment if a patient develops a serious infection until the infection is controlled.

Laboratory Abnormalities

Rheumatoid Arthritis

Liver Enzyme Abnormalities [see Warnings and Precautions (5.3, 5.4)]
Lab Value	Recommendation for RA
Greater than 1 to 3× ULN	Dose modify concomitant DMARDs if appropriate. For persistent increases in this range: For patients receiving intravenous TOFIDENCE, reduce dose to 4 mg per kg or hold TOFIDENCE until ALT or AST have normalized.
Greater than 3 to 5× ULN (confirmed by repeat testing)	Hold TOFIDENCE dosing until less than 3× ULN and follow recommendations above for greater than 1 to 3× ULN. For persistent increases greater than 3× ULN, discontinue TOFIDENCE.
Greater than 5× ULN	Discontinue TOFIDENCE.

Low Absolute Neutrophil Count (ANC) [see Warnings and Precautions (5.4)]
Lab Value (cells per mm 3)	Recommendation for RA
ANC greater than 1000	Maintain dose.
ANC 500 to 1000	Hold TOFIDENCE dosing. When ANC is greater than 1000 cells per mm 3: For patients receiving intravenous TOFIDENCE, resume TOFIDENCE at 4 mg per kg and increase to 8 mg per kg as clinically appropriate.
ANC less than 500	Discontinue TOFIDENCE.

Low Platelet Count [see Warnings and Precautions (5.4)]
Lab Value (cells per mm 3)	Recommendation for RA
50,000 to 100,000	Hold TOFIDENCE dosing. When platelet count is greater than 100,000 cells per mm 3: For patients receiving intravenous TOFIDENCE, resume TOFIDENCE at 4 mg per kg and increase to 8 mg per kg as clinically appropriate.
Less than 50,000	Discontinue TOFIDENCE.

Polyarticular and Systemic Juvenile Idiopathic Arthritis

Dose reduction of tocilizumab products has not been studied in the PJIA and SJIA populations. Dose interruptions of TOFIDENCE are recommended for liver enzyme abnormalities, low neutrophil counts, and low platelet counts in patients with PJIA and SJIA at levels similar to what is outlined above for patients with RA. If appropriate, dose modify or stop concomitant methotrexate and/or other medications and hold TOFIDENCE dosing until the clinical situation has been evaluated. In PJIA and SJIA the decision to discontinue TOFIDENCE for a laboratory abnormality should be based upon the medical assessment of the individual patient.