RYSTIGGO ROZANOLIXIZUMAB 140 mg/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Neonatal Fc Receptor Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Rozanolixizumab-noli is used to treat certain types of myasthenia gravis(MG; a disorder of the nervous system that causes muscle weakness). Rozanolixizumab is in a class of medications called Fc receptor blockers. It works by reducing the amount of IgG (an antibody that attacks neuromuscular receptors in patients with myasthenia gravis) circulating in the body.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $4,873.04 | $29,238.27 / 6 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9333 | $23.588 / J9333 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rystiggo 140 mg/mLthis 50474-0983-86 | UCB, | 1 vial | — | — | FDA listed | — |
| Rystiggo 140 mg/mL 50474-0982-84 | UCB, | 1 vial | — | — | FDA listed | — |
| Rystiggo 140 mg/mL 50474-0980-79 | UCB, | 1 vial | — | — | FDA listed | — |
| Rystiggo 140 mg/mL 50474-0981-83 | UCB, | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Jun 26, 2035 |
Is there a biosimilar for RYSTIGGO 840 MG/6 ML VIAL?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50474-0983-86 You're viewing this | 1 VIAL, GLASS in 1 CARTON (50474-983-86) / 6 mL in 1 VIAL, GLASS | 2024-07-15 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO. ( 2.1 ) For subcutaneous infusion only. ( 2.2 ) The recommended dosage is administered as a subcutaneous infusion once weekly for 6 weeks.
( 2.2 ) 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 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. ( 2.2 )
2.1Recommended 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) ] .
2.2Recommended 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 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.
2.3Preparation 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 lo…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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. Injection: 280 mg/2 mL (140 mg/mL) in a single-dose vial. ( 3 ) 420 mg/3 mL (140 mg/mL) in a single-dose vial.
( 3 ) 560 mg/4 mL (140 mg/mL) in a single-dose vial. ( 3 ) 840 mg/6 mL (140 mg/mL) in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections: Delay administration of RYSTIGGO to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with RYSTIGGO. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved.
( 5.1 ) Aseptic Meningitis: Serious events of aseptic meningitis have been reported. Monitor for symptoms; diagnostic workup and treatment should be initiated according to the standard of care. ( 5.2 ) Hypersensitivity Reactions: Angioedema and rash have occurred.
If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy. ( 5.3 )
5.1Infections 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.
5.2Aseptic 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.
5.3Hypersensitivity 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1) ] Aseptic Meningitis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, the safety of RYSTIGGO has been evaluated in 196 patients who received at least one dose of RYSTIGGO, including 88 patients exposed to at least 5 treatment cycles and 9 patients exposed to at least 10 treatment cycles.
In a placebo-controlled study (Study 1) in patients with gMG, 133 patients received RYSTIGGO [see Clinical Studies (14) ] . Of these 133 patients, approximately 56% were female, 68% were White, 12% were Asian, and 6% were of Hispanic or Latino ethnicity. The mean age at study entry was 52.5 years (range 19 to 89 years).
Patients treated with RYSTIGGO received 1 treatment cycle in Study 1. In an extension study, the minimum time for initiating subsequent treatment cycles, specified by study protocol, was 63 days from the start of the previous treatment cycle. Patients treated with RYSTIGGO on average initiated 4 cycles in one year (range 1 to 7 cycles).
The median time between start of treatment cycles was 98 days for patients treated with RYSTIGGO who initiated 4 cycles. Adverse reactions reported in at least 5% of patients treated with RYSTIGGO and more frequently than placebo are summarized in Table 2. The most common adverse reactions (reported in at least 10% of patients treated with RYSTIGGO) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
Table 2: Adverse Reactions in at least 5% of Patients Treated with RYSTIGGO and More Frequently than in Patients who Received Placebo in Study 1 (Safety Population) Adverse Reaction RYSTIGGO (N = 133) % Placebo (N = 67) % Headache 44 19 Any infection 23 19 Upper respiratory tract infection 8 6 Diarrhea 20 13 Pyrexia 17 2 Hypersensitivity reactions 11 5 Nausea 10 8 Administration site reactions 8 3 Abdominal pain 8 6 Arthralgia 7 3 Infections In Study 1 and the extension studies, out of 196 patients treated with RYSTIGGO, 94 (48%) patients reported infections.
Common infections (at least 5% frequency) were upper respiratory tract infections (17%), COVID-19 (14%), urinary tract infections (9%), and herpes simplex (6%). Serious infections were reported in 4% of patients treated with RYSTIGGO. Three fatal cases of pneumonia were identified caused by COVID-19 infection in two patients and an unknown pathogen in one patient.
Six cases of infections led to discontinuation of RYSTIGGO [see Warnings and Precautions (5.1) ]. Aseptic Meningitis In clinical trials, one patient with gMG and two patients with another neurological disease experienced a serious adverse reaction of drug-induced aseptic meningitis, which led to hospitalization and discontinuation of RYSTIGGO [see Warnings and Precautions (5.2) ]. Hypersensitivity Reactions and Administration Site Reactions In clinical trials, hypersensitivity reactions occurred within 1 day to 2 weeks of administration.
One patient discontinued RYSTIGGO due to a hypersensitivity reaction [see Warnings and Precautions (5.3) ]. Local reactions at the administration site occurred within 1 to 3 days after the most recent RYSTIGGO infusion. Headache In Study 1, seven (5.3%) cases of severe headache were reported in p…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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 )
7.1Effect 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy 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 [email protected], 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.
8.2Lactation 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.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric 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.
🤰 Pregnancy ▾
8.1Pregnancy 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 [email protected], 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
12.2Pharmacodynamics In Study 1 [see Clinical Studies (14) ] , the pharmacological effect of rozanolixizumab-noli was assessed by measuring the decrease in serum IgG levels and AChR and MuSK autoantibody levels. In patients testing positive for AChR and MuSK autoantibodies who were treated with RYSTIGGO, there was a reduction in total IgG levels relative to baseline. Decreases in AChR autoantibody and MuSK autoantibody levels followed a similar pattern.
12.3Pharmacokinetics Rozanolixizumab-noli exhibited nonlinear pharmacokinetics. Rozanolixizumab-noli exposure increased in a greater than dose-proportional manner over a dose range from 1 mg/kg to 20 mg/kg (two times the maximum recommended dose) following subcutaneous administration. Absorption Following subcutaneous administration of rozanolixizumab-noli, peak plasma levels were achieved after approximately 2 days in healthy subjects.
Distribution The apparent volume of distribution of rozanolixizumab-noli is
6.6L. Elimination Metabolism Rozanolixizumab-noli is expected to be degraded by proteolytic enzymes into small peptides and amino acids. Excretion The apparent clearance for the rozanolixizumab-noli is
0.89L/day. Specific Populations Age, Sex, and Race The pharmacokinetics of rozanolixizumab-noli were not affected by age, sex, or race based on a population pharmacokinetics analysis. Patients with Renal Impairment No dedicated pharmacokinetic study has been conducted in patients with renal impairment.
Renal impairment is not expected to affect the pharmacokinetics of rozanolixizumab-noli. Based on a population pharmacokinetic analysis, which included participants with mild to moderate renal impairment, renal function (estimated glomerular filtration rate [eGFR] 38–161 mL/min/1.73 m 2 ) had no clinically significant effect on rozanolixizumab-noli apparent clearance. No dose adjustment is required in patients with renal impairment.
Patients with Hepatic Impairment No dedicated pharmacokinetic study has been conducted in patients with hepatic impairment. Hepatic impairment is not expected to affect the pharmacokinetics of rozanolixizumab-noli. Drug Interaction Studies Clinical drug interaction studies have not been performed with rozanolixizumab-noli.
P450 Enzymes Rozanolixizumab-noli is not metabolized by cytochrome P450 enzymes. Interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely. Drug Interactions with Other Drugs or Biological Products Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn [see Drug Interactions (7.1) ] .
12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of rozanolixizumab-noli or of other rozanolixizumab products. The anti-drug antibody (ADA) incidence from Study 1 (MG0003) was 37% (49/133) at the end of the observation period after one treatment cycle of 6-week dosing.
The incidence of neutralizing antibodies was 21% (28/133). For patients who developed ADA, there was up to 60% decrease in trough concentrations compared with those in ADA negative patients. However, these observations need to be interpreted with caution because of the limitations with PK analytical assay sensitivity.
There appears to be no clinically meaningful impact of ADA (including neutralizing antibodies) on efficacy of rozanolixizumab-noli. The safety profile appears to be similar in ADA positive and ADA negative patients.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied RYSTIGGO (rozanolixizumab-noli) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish yellow solution supplied as: NDC Description Strength 50474-980-79 2 mL single-dose glass vial in a carton 280 mg/2 mL 50474-981-83 3 mL single-dose glass vial in a carton 420 mg/3 mL 50474-982-84 4 mL single-dose glass vial in a carton 560 mg/4 mL 50474-983-86 6 mL single-dose glass vial in a carton 840 mg/6 mL
16.2Storage and Handling 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 20 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 20 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 20 days or if the expiration date has passed, whichever occurs first.
📦 Storage and Handling ▾
16.2Storage and Handling 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 20 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 20 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 20 days or if the expiration date has passed, whichever occurs first.
📋 Description ▾
11 DESCRIPTION Rozanolixizumab-noli, a neonatal Fc receptor blocker, is a recombinant, humanized IgG4P monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary DG44 cell line. Rozanolixizumab-noli has an approximate molecular weight of 148 kDa. RYSTIGGO 140 mg/mL (2 mL, 3 mL, 4 mL, and 6 mL vials) RYSTIGGO (rozanolixizumab-noli) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish yellow solution for subcutaneous infusion.
Each single-dose vial contains 280 mg, 420 mg, 560 mg, or 840 mg of rozanolixizumab-noli at a concentration of 140 mg/mL with a pH of 5.6. Each mL also contains histidine (1.05 mg), L-histidine hydrochloride monohydrate (4.87 mg), polysorbate 80 (0.30 mg), proline (28.78 mg), and water for injection, USP.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Infections Instruct patients to communicate any history of infections to the healthcare provider and to contact their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions (5.1) ] . Vaccinations Advise patients to complete age-appropriate vaccines according to immunization guidelines prior to initiation of a new treatment cycle with RYSTIGGO. Administration of live or live-attenuated vaccines is not recommended during treatment with RYSTIGGO [see Warnings and Precautions (5.1) ] .
Aseptic Meningitis Inform patients that RYSTIGGO could cause aseptic meningitis. Instruct patients to contact their healthcare provider if symptoms consistent with meningitis develop [see Warnings and Precautions (5.2) ] . Hypersensitivity Reactions Inform patients about the signs and symptoms of hypersensitivity reactions.
Advise patients to contact their healthcare provider immediately for signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.3) ] . Pregnancy Registry Advise patients that there is a registry that monitors outcomes in patients with Myasthenia Gravis, including women exposed to RYSTIGGO during pregnancy and/or breastfeeding [see Use in Specific Populations (8.1) ].