Rozanolixizumab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Neonatal Fc Receptor Blocker
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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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 ].
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 ]. 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.
| 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 |
| 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 |
Drug interactions
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- Rozanolixizumab
Label text (2 paragraphs)
Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing RYSTIGGO and using alternate therapies. ( 7.1 )
7.1 Effect of RYSTIGGO on Other Drugs Concomitant use of RYSTIGGO with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing RYSTIGGO and using alternative therapies.
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for rozanolixizumab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RYSTIGGO during pregnancy. Patients or their healthcare providers may contact UCBCares at 1-844-599-CARE (2273) or email ucbcares@ucb.com, so that information about the exposure of RYSTIGGO during pregnancy and/or breastfeeding can be collected. As a healthcare professional, please ask about becoming a member of the MGBase registry (https://www.mgbase.org). 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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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