Rystiggo
(rozanolixizumab-noli)Dosage & Administration
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Rystiggo Prescribing Information
RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
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)].
Recommended Dosage
The recommended dosage of RYSTIGGO is based on body weight, as shown below in Table 1.
| Body Weight of Patient | Dose | Volume to be Infused |
|---|---|---|
| Less than 50 kg | 420 mg | 3 mL |
| 50 kg to less than 100 kg | 560 mg | 4 mL |
| 100 kg and above | 840 mg | 6 mL |
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.
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 20 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.
RYSTIGGO is a clear to slightly opalescent, colorless to pale brownish yellow solution available as:
- 280 mg/2 mL (140 mg/mL) in a single-dose vial.
- 420 mg/3 mL (140 mg/mL) in a single-dose vial.
- 560 mg/4 mL (140 mg/mL) in a single-dose vial.
- 840 mg/6 mL (140 mg/mL) in a single-dose vial.
Pregnancy
Risk Summary
There are limited data on RYSTIGGO use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Following administration of rozanolixizumab-noli to pregnant monkeys at doses greater than those used clinically, increases in embryonic death, reduced body weight, and impaired immune function were observed in the absence of maternal toxicity (see Data).
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
Subcutaneous administration of rozanolixizumab-noli (0, 50, or 150 mg/kg) to pregnant monkeys every 3 days throughout pregnancy (gestation day 20 to parturition) resulted in an increase in embryonic death and reduced body weight and impaired immune function in offspring at both doses. A no-effect dose for adverse developmental effects was not identified; the doses tested in monkeys are 10 and 30 times the maximum recommended human dose of approximately 10 mg/kg, on a mg/kg/week basis.
Lactation
Risk Summary
There are no data on the presence of rozanolixizumab-noli in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for RYSTIGGO and any potential adverse effects on the breastfed child from RYSTIGGO or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of RYSTIGGO did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.
None.
Infections
RYSTIGGO may increase the risk of infection [see Adverse Reactions (6.1)]. Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved.
Immunization
Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO.
Aseptic Meningitis
Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO [see Adverse Reactions (6.1)]. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.
Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO [see Adverse Reactions (6.1)]. Management of hypersensitivity reactions depend on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions [see Dosage and Administration (2.3)]. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.