Tyenne Dosage

Generic name: TOCILIZUMAB 80mg in 4mL
Dosage form: injection, solution, concentrate
Drug class: Interleukin inhibitors

Medically reviewed by Drugs.com. Last updated on Dec 30, 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 TYENNE 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, GCA, PJIA and SJIA – It is recommended that TYENNE not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or ALT or AST above 1.5 times the upper limit of normal (ULN).

Recommended Dosage for Rheumatoid Arthritis

TYENNE may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an intravenous infusion or as a subcutaneous injection.

Recommended Intravenous Dosage Regimen:

The recommended dosage of TYENNE 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.
•: Doses exceeding 800 mg per infusion are not recommended in RA patients.

Recommended Subcutaneous Dosage Regimen:

Patients less than 100 kg weight	162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
Patients at or above 100 kg weight	162 mg administered subcutaneously every week

When transitioning from TYENNE intravenous therapy to subcutaneous administration administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every other week dosing is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

Recommended Dosage for Giant Cell Arteritis

Recommended Intravenous Dosage Regimen:

The recommended dosage of TYENNE for adult patients given as a 60-minute single intravenous drip infusion is 6 mg per kg every 4 weeks in combination with a tapering course of glucocorticoids.

TYENNE can be used alone following discontinuation of glucocorticoids.

•: Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.
•: Doses exceeding 600 mg per infusion are not recommended in GCA patients.

Recommended Subcutaneous Dosage Regimen:

The recommended dose of TYENNE for adult patients with GCA is 162 mg given once every week as a subcutaneous injection in combination with a tapering course of glucocorticoids.

A dose of 162 mg given once every other week as a subcutaneous injection in combination with a tapering course of glucocorticoids may be prescribed based on clinical considerations.

TYENNE can be used alone following discontinuation of glucocorticoids.

When transitioning from TYENNE intravenous therapy to subcutaneous administration, administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every other week dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.

Recommended Dosage for Polyarticular Juvenile Idiopathic Arthritis

TYENNE may be used as an intravenous infusion or as a subcutaneous injection 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 TYENNE 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

Recommended Subcutaneous Dosage Regimen:

Recommended Subcutaneous PJIA Dosage
Patients less than 30 kg weight	162 mg once every 3 weeks
Patients at or above 30 kg weight	162 mg once every 2 weeks

When transitioning from TYENNE intravenous therapy to subcutaneous administration, administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.

Recommended Dosage for Systemic Juvenile Idiopathic Arthritis

TYENNE may be used as an intravenous infusion or as a subcutaneous injection alone 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 TYENNE 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

Recommended Subcutaneous Dosage Regimen:

Recommended Subcutaneous SJIA Dosage
Patients less than 30 kg weight	162 mg once every two weeks
Patients at or above 30 kg weight	162 mg once every week

When transitioning from TYENNE intravenous therapy to subcutaneous administration, administer the first subcutaneous dose when the next scheduled intravenous dose is due.

Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.

Preparation and Administration Instructions for Intravenous Infusion

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

•: Use a sterile needle and syringe to prepare TYENNE.
•: Patients less than 30 kg: use a 50 mL infusion bag or bottle of 0.9% or 0.45% Sodium Chloride Injection, USP, and then follow steps 1 and 2 below.
•: Patients at or above 30 kg weight: use a 100 mL infusion bag or bottle, and then follow steps 1 and 2 below.
-: Step 1. Withdraw a volume of 0.9% or 0.45% Sodium Chloride Injection, USP, equal to the volume of the TYENNE injection required for the patient's dose from the infusion bag or bottle.

For Intravenous Use: Volume of TYENNE Injection per kg of Body Weight
Dosage	Indication	Volume of TYENNE injection per kg of body weight
4 mg/kg	Adult RA	0.2 mL/kg
6 mg/kg	Adult GCA	0.3 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 TYENNE for intravenous infusion from the vial(s) and add slowly into the 0.9% or 0.45% Sodium Chloride Injection, USP infusion bag or bottle. To mix the solution, gently invert the bag to avoid foaming.
•: The prepared solution for infusion should be used immediately. If not used immediately, the diluted tocilizumab solutions may be refrigerated at 36°F to 46°F (2°C to 8°C) up to 24 hours, or stored at room temperature at or below 77°F (25°C) for up to 4 hours and should be protected from light. Administration of diluted TYENNE solution must be completed within this period of time.
•: TYENNE solutions do not contain preservatives; therefore, unused product remaining in the vials should not be used.
•: Allow the fully diluted TYENNE 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.
•: TYENNE 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 TYENNE 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 TYENNE solutions are compatible with polypropylene, polyethylene and polyvinyl chloride infusion bags and bottles, and glass infusion bottles.

Preparation and Administration Instructions for Subcutaneous Injection

•: TYENNE for subcutaneous injection is not intended for intravenous drip infusion.
•: Assess suitability of patient for subcutaneous home use and instruct patients to inform a healthcare professional before administering the next dose if they experience any symptoms of allergic reaction. Patients should seek immediate medical attention if they develop symptoms of serious allergic reactions. TYENNE subcutaneous injection is intended for use under the guidance of a healthcare practitioner. After proper training in subcutaneous injection technique, a patient may self-inject TYENNE or the patient's caregiver may administer TYENNE if a healthcare practitioner determines that it is appropriate. PJIA and SJIA patients may self-inject with the TYENNE prefilled syringe or autoinjector, or the patient's caregiver may administer TYENNE if both the healthcare practitioner and the parent/legal guardian determine it is appropriate.
Patients, or patient caregivers, should be instructed to follow the directions provided in the Instructions for Use (IFU) for additional details on medication administration.
•: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use TYENNE prefilled syringes (PFS) or prefilled autoinjectors exhibiting particulate matter, cloudiness, or discoloration. TYENNE for subcutaneous administration should be clear and colorless to pale yellow. Do not use if any part of the PFS or autoinjector appears to be damaged.
•: Patients using TYENNE for subcutaneous administration should be instructed to inject the full amount in the syringe (0.9 mL) or full amount in the autoinjector (0.9 mL), which provides 162 mg of TYENNE, according to the directions provided in the IFU.
•: Injection sites should be rotated with each injection and should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Dosage Modifications due to Serious Infections or Laboratory Abnormalities

Serious Infections

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

Laboratory Abnormalities

Rheumatoid Arthritis and Giant Cell Arteritis

Liver Enzyme Abnormalities
Lab Value	Recommendation for RA	Recommendation for GCA
Greater than 1 to 3x ULN	Dose modify concomitant DMARDs if appropriate For persistent increases in this range: • For patients receiving intravenous TYENNE, reduce dose to 4 mg per kg or hold TYENNE until ALT or AST have normalized • For patients receiving subcutaneous TYENNE, reduce injection frequency to every other week or hold dosing until ALT or AST have normalized. Resume TYENNE at every other week and increase frequency to every week as clinically appropriate	Dose modify immunomodulatory agents if appropriate For persistent increases in this range: • For patients receiving Intravenous TYENNE, hold TYENNE until ALT or AST have normalized • For patients receiving subcutaneous TYENNE, reduce injection frequency to every other week or hold dosing until ALT or AST have normalized. Resume TYENNE at every other week and increase frequency to every week as clinically appropriate
Greater than 3 to 5x ULN (confirmed by repeat testing)	Hold TYENNE dosing until less than 3x ULN and follow recommendations above for greater than 1 to 3x ULN For persistent increases greater than 3x ULN, discontinue TYENNE	Hold TYENNE dosing until less than 3x ULN and follow recommendations above for greater than 1 to 3x ULN For persistent increases greater than 3x ULN, discontinue TYENNE
Greater than 5x ULN	Discontinue TYENNE	Discontinue TYENNE

Low Absolute Neutrophil Count (ANC)
Lab Value (cells per mm3)	Recommendation for RA	Recommendation for GCA
ANC greater than 1000	Maintain dose	Maintain dose
ANC 500 to 1000	Hold TYENNE dosing When ANC greater than 1000 cells per mm3: • For patients receiving intravenous TYENNE, resume TYENNE at 4 mg per kg and increase to 8 mg per kg as clinically appropriate • For patients receiving subcutaneous TYENNE, resume TYENNE at every other week and increase frequency to every week as clinically appropriate	Hold TYENNE dosing When ANC greater than 1000 cells per mm3: • For patients receiving intravenous TYENNE, resume TYENNE at 6 mg per kg • For patients receiving subcutaneous TYENNE, resume TYENNE at every other week and increase frequency to every week as clinically appropriate
ANC less than 500	Discontinue TYENNE	Discontinue TYENNE

Low Platelet Count
Lab Value (cells per mm3)	Recommendation for RA	Recommendation for GCA
50,000 to 100,000	Hold TYENNE dosing When platelet count is greater than 100,000 cells per mm3: • For patients receiving intravenous TYENNE, resume TYENNE at 4 mg per kg and increase to 8 mg per kg as clinically appropriate • For patients receiving subcutaneous TYENNE, resume TYENNE at every other week and increase frequency to every week as clinically appropriate	Hold TYENNE dosing When platelet count is greater than 100,000 cells per mm3: • For patients receiving intravenous TYENNE, resume TYENNE at 6 mg per kg • For patients receiving subcutaneous TYENNE, resume TYENNE at every other week and increase frequency to every week as clinically appropriate
Less than 50,000	Discontinue TYENNE	Discontinue TYENNE

Polyarticular and Systemic Juvenile Idiopathic Arthritis

Dose reduction of tocilizumab products has not been studied in the PJIA and SJIA populations. Dose interruptions of TYENNE 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 and GCA. If appropriate, dose modify or stop concomitant methotrexate and/or other medications and hold TYENNE dosing until the clinical situation has been evaluated. In PJIA and SJIA the decision to discontinue TYENNE for a laboratory abnormality should be based upon the medical assessment of the individual patient.