RYSTIGGO Solution for injection Ref.[107277] Active ingredients: Rozanolixizumab

2.1 Recommended Vaccination

Because RYSTIGGO causes transient reduction in IgG levels, immunization with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate immunizations according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].

2.2 Recommended Dosage

The recommended dosage of RYSTIGGO is based on body weight, as shown below in Table 1.

Table 1. Recommended Dose Based on Body Weight:

Administer the recommended dosage as a subcutaneous infusion using an infusion pump at a rate of up to 20 mL/hour once weekly for 6 weeks. For detailed preparation and administration instructions, see Preparation and Administration Instructions (2.3).
Administer subsequent treatment cycles based on clinical evaluation. The safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established.

If a scheduled dose is missed, RYSTIGGO may be administered up to 4 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.

2.3 Preparation and Administration Instructions

RYSTIGGO should only be prepared and infused by a healthcare provider.

RYSTIGGO is for subcutaneous administration only using an infusion pump. Refer to the infusion pump manufacturer’s instructions for full preparation and administration information. It is recommended to use pumps where the administered volume can be pre-set as each vial contains excess volume for priming of the infusion line.

The following criteria are recommended for administration of RYSTIGGO:

• Syringe pump occlusion alarm limits should be at the maximum setting
• Administration tubing length should be 61 cm or shorter
• Infusion set with a needle of 26 gauge or larger should be used.

Read the instructions below before preparing and administering RYSTIGGO solution.

• Use aseptic technique when preparing and administering RYSTIGGO.
• Prior to use, allow vials to reach room temperature for approximately 30 minutes. Do not use heating devices. Keep the vial in the original carton to protect from light until ready to use. Do not shake.
  • Vials may be stored at room temperature up to 77°F (25°C) for a single period of up to 30 days in the original carton [see How Supplied/Storage and Handling (16.2)].
• Infuse RYSTIGGO within 4 hours of puncturing the vial. RYSTIGGO should be administered immediately after priming the infusion set.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be colorless to pale brownish-yellow, clear to slightly opalescent. Do not use the vial if the liquid looks cloudy, contains foreign particles, or has changed color.
• Use transfer needles to fill the syringe.
• Remove the needle from the syringe and attach the infusion set to the syringe.
• Follow the device manufacturer’s instructions to prepare the pump and prime the tubing.
• Choose an infusion site in the lower right or lower left part of the abdomen below the navel and clean with an alcohol wipe. Do not infuse where the skin is tender, bruised, red, or hard. Avoid infusing into tattoos, scars, or stretch marks. Rotate infusion sites for subsequent administrations.
• Insert the infusion set needle into the infusion site and secure the needle to the skin with sterile gauze and tape or a transparent dressing.
• Infuse RYSTIGGO at a constant flow rate up to 20 mL/hour.
• Monitor patients during administration and for 15 minutes after completion for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, discontinue administration of RYSTIGGO and institute appropriate supportive measures [see Warnings and Precautions (5.3)].
• When the infusion is complete, do not flush the infusion line as the volume of infusion has been adjusted taking into account the losses in the line.
• Each RYSTIGGO vial is for one-time use only. RYSTIGGO does not contain preservatives. Discard any remaining solution.

Store vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

If needed, vials may be stored at room temperature up to 77°F (25°C) for a single period of up to 30 days in the original carton to protect the vial from light. Once a vial has been stored at room temperature, it should not be returned to the refrigerator. The discard date is 30 days after removal of the vial from the refrigerator. Write the discard date in the space provided on the carton. Discard the vial if not used within 30 days or if the expiration date has passed, whichever occurs first.