Tyenne Dosage

General Considerations for Administration

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 Dosage for Giant Cell Arteritis

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 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.

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.

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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 [see Dosage and Administration (2.2, 2.4, 2.5,)].

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
6mg/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

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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 [see Use in Specific Populations (8.4)].
  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