Loading…
VYVGART is a brand name for Efgartigimod Alfa, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VYVGART® (efgartigimod alfa for injection) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 1.1 Pediatrics Pediatrics (˂ 18 years of age): The safety and efficacy of VYVGART in children and adolescents below the age…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Dilute Vyvgart prior to administration. Administer via intravenous infusion only. 3 Reconstitution. The recommended dosage of Vyvgart is 10 mg/kg administered as an intravenous infusion over one hour once weekly for 4 weeks (one treatment cycle).
In patients weighing 120 kg or more, the recommended dose of Vyvgart is 1200 mg (3 vials) per infusion. Administer subsequent treatment cycles based on clinical evaluation. The frequency of Vyvgart treatment cycles may vary by patient.
The safety of initiating subsequent cycles sooner than 4 weeks from the last infusion of the previous treatment cycle has not been established.
Pediatrics (˂ 18 years of age):
The safety and efficacy of Vyvgart in children and adolescents below the age of 18 years has not been established. Vyvgart is not indicated for use in pediatric patients.
Geriatrics (≥ 65 years of age):
Eleven (11/84 – 13%) patients aged 65 and over were treated with Vyvgart in the placebo-controlled study. The number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger adult patients.
Renal Impairment:
No dose adjustment of Vyvgart is needed for patients with mild renal impairment. 73 m2). 9% Sodium Chloride Injection, USP, to make a total volume to be administered of 125 mL. Check that the Vyvgart solution is clear to slightly opalescent and colorless to slightly yellow.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if opaque particles, discoloration, or other foreign particles are present.
Use aseptic technique when preparing the Vyvgart diluted solution for intravenous infusion. Each vial is for single- use only. Discard any unused portion in accordance with local requirements. Preparation • Calculate the dose (mg), total drug volume (mL) of Vyvgart solution required, and the number of vials needed based on the recommended dose according to the patient's body weight.
Each vial contains a total of 400 mg of Vyvgart at a concentration of 20 mg per mL. 2 Recommended Dose and Dosage Adjustment. • Gently withdraw the calculated dose of Vyvgart from the vial(s) with a sterile syringe and needle. Discard any unused portion of the vials in accordance with local requirements.
1 Adverse Reaction Overview In the placebo-controlled Phase 3 Study ARGX-113-1704 (Study 1704), the most common adverse reactions (≥ 10%) seen in patients who received at least one dose of Vyvgart included headache (reported by 29% of Vyvgart-treated patients and 28% of placebo-treated patients), upper respiratory tract infection (reported by 11% of Vyvgart-treated patients and 5% of placebo-treated patients), and urinary tract infection (reported by 10% of Vyvgart-treated patients and 5% of placebo-treated patients) (Table 2).
Adverse reactions of severity Grade ≥3 (according to the Common Terminology Criteria for Adverse Events) were reported by 11% (9/84) of Vyvgart-treated patients and 10% (8/83) of placebo-treated patients. The proportion of patients treated with Vyvgart who discontinued treatment due to adverse reactions was 4% (3/84).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In the placebo-controlled Phase 3 study (Study 1704) in patients with gMG, 84 patients received Vyvgart 10 mg/kg.
See 14 CLINICAL TRIALS. The frequency of Vyvgart treatment cycles at the recommended dose regimen varied by patient. See 4 DOSAGE AND ADMINISTRATION. The safety of initiating subsequent cycles sooner than 4 weeks from the last infusion of the previous treatment cycle has not been established.
A total of 21/84 (25%) patients on Vyvgart received a single treatment cycle, 56/84 (67%) patients received 2 treatment cycles, and 7/84 (8%) patients received 3 treatment cycles. The mean and median times to the second treatment cycle were 94 days and 72 days from the initial infusion of the first treatment cycle, respectively.
• Other medications should not be injected into infusion side ports or mixed with Vyvgart. 5 Missed Dose If a scheduled infusion is missed, Vyvgart may be administered up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.
5 OVERDOSAGE There are no known specific signs and symptoms of overdose with Vyvgart. In the event of an overdose the adverse events are not expected to be different from those observed at the recommended dose. Patients should be monitored for adverse reactions and appropriate symptomatic and supportive treatment initiated.
There is no specific antidote for overdose with Vyvgart. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition and Packaging Description Vyvgart (efgartigimod alfa for injection) is a preservative free, sterile, colorless to slightly yellow, clear to slightly opalescent solution supplied as 400 mg/20 mL (20 mg/mL) in one single-use vial.
7 WARNINGS AND PRECAUTIONS Immune Infections As Vyvgart causes a reduction in IgG levels, the risk of infections may increase. The most common infections observed in clinical trials were upper respiratory tract infections and urinary tract infections.
While the majority of infections were mild to moderate in severity, serious infections were reported. 2 Clinical Trial Adverse Reactions. Monitor for clinical signs and symptoms of infections during treatment with Vyvgart. Delay Vyvgart administration in patients with an active infection until the infection is resolved.
If a serious infection occurs, administer appropriate treatment and consider withholding Vyvgart until the infection has resolved. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous 20 mg/mL efgartigimod alfa solution L-arginine hydrochloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate polysorbate 80, water for injection VYVGART® (efgartigimod alfa for injection) Page 7 of 20 Immunization Administer all vaccines according to immunization guidelines at least 4 weeks before initiation of treatment with Vyvgart.
Vyvgart is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Efgartigimod Alfa in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
9% Sodium Chloride Injection, USP to make a total volume of 125 mL for intravenous infusion. • Gently invert the infusion bag containing the diluted Vyvgart without shaking to ensure thorough mixing of the product and the diluent. • The diluted solution can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), or ethylene/polypropylene copolymer bags (polyolefins bags), and with PE, PVC, EVA, or polyurethane/polypropylene infusion lines.
Storage Conditions of the Diluted Solution • Vyvgart does not contain preservatives. Administer immediately after dilution and complete the infusion within 4 hours of dilution. • If immediate use is not possible, the diluted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 8 hours.
Do not freeze. Protect from light. Allow the diluted drug to reach room temperature before administration. Complete the infusion within 4 hours of removal from the refrigerator. Do not heat the diluted drug in any manner other than via ambient air.
See 11 STORAGE, STABILITY AND DISPOSAL. 4 Administration • Vyvgart should be administered via intravenous infusion by a healthcare professional. • Visually inspect Vyvgart diluted solution for particles or discoloration prior to administration.
Do not use if discolored, or if opaque or foreign particles are seen. 2 micron in-line filter. 9% Sodium Chloride Injection, USP. • Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of infusion reactions.
Should a reaction occur, discontinue the infusion and institute VYVGART® (efgartigimod alfa for injection) Page 6 of 20 appropriate supportive measures, if needed. Once resolved, and based on the severity of the reaction, administration may be cautiously resumed, if needed at a slower rate based on clinical evaluation.
See 7 WARNINGS AND PRECAUTIONS. • Other medications should not be injected into infusion side ports or mixed with Vyvgart. 5 Missed Dose If a scheduled infusion is missed, Vyvgart may be administered up to 3 days after the scheduled time point.
Thereafter, resume the original dosing schedule until the treatment cycle is completed.
Adverse reactions reported in at least 5% of patients treated with Vyvgart and more frequently than placebo (≥ 3 patients) are summarized Table 2.
VYVGART® (efgartigimod alfa for injection) Page 9 of 20 Table 2:
Adverse Reactions Reported in ≥ 5% of Patients with Myasthenia Gravis Treated With Vyvgart and More Frequently Than in Placebo-Treated Patients (≥ 3 patients) in Study ARGX-113-1704 Adverse reaction Vyvgart (N=84) n (%) Placebo (N=83) n (%) Infections and infestations Bronchitis 5 (6) 2 (2) Upper respiratory tract infection 9 (11) 4 (5) Urinary tract infection 8 (10) 4 (5) Injury, poisoning and procedural complications Procedural headache 4 (5) 1 (1) Musculoskeletal and connective tissue disorders Myalgia 5 (6) 1 (1) Infections The most frequently reported adverse reactions were infections.
Overall, treatment emergent infections were reported in 46% (n=39) of patients treated with Vyvgart and 37% (n=31) of patients treated with placebo. The most reported infections were upper respiratory tract infections and urinary tract infections.
A higher frequency of patients who received Vyvgart compared to placebo were observed to have below normal levels for white blood cell counts (12% versus 5%, respectively), lymphocyte counts (28% versus 19%, respectively), and neutrophil counts (13% versus 6%, respectively).
The majority of infections and hematology abnormalities were mild to moderate in severity. Serious infections have been reported in patients treated with Vyvgart. 2% of patients treated with placebo. Procedural headache was reported when a headache was judged to be temporally related to the intravenous infusion of Vyvgart.
All were mild or moderate except one event which was reported as severe (Grade 3). 3 Less Common Clinical Trial Adverse Reactions (occurring in ˂5% of Patients with Myasthenia Gravis treated with Vyvgart and more frequently than in placebo-treated patients (≥ 2 patients) in Study ARGX-113-1704) Eye Disorders: visual impairment General Disorders and Administration Site Conditions: pain Immune System Disorders: seasonal allergy Infections and Infestations: ear infection, sinusitis Injury, Poisoning and Procedural Complications: skin abrasion Nervous System Disorders: migraine, hypoesthesia VYVGART® (efgartigimod alfa for injection) Page 10 of 20
The safety of immunization with live vaccines and the immune response to vaccination during treatment with Vyvgart are unknown. Because Vyvgart causes a reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with Vyvgart.
For all other vaccines, vaccination should take place at least 2 weeks after the last infusion of a treatment cycle and 4 weeks before initiating the next cycle.
Reproductive Health:
Female and Male Potential • Fertility There is no clinical experience with Vyvgart use and its potential effect on fertility. Sensitivity/Resistance Hypersensitivity and Infusion related reactions Hypersensitivity reactions such as rash, pruritis or anaphylactic reactions may occur.
In clinical trials, infusion-related reactions were mild or moderate and did not lead to treatment discontinuation. Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of infusion reactions.
Should a reaction occur, discontinue the infusion and institute appropriate supportive measures, if needed. 4 Administration). Patients should be informed of the signs and symptoms of hypersensitivity reactions and advised to contact their healthcare provider immediately should they occur.
1 Pregnant Women There are no available clinical data on the use of Vyvgart during pregnancy. Reproductive and developmental toxicity studies were conducted in rats and rabbits. See 16 NON CLINICAL TOXICOLOGY. Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester.
Therefore, Vyvgart may be transmitted from the mother to the developing fetus. As Vyvgart is expected to reduce maternal IgG antibody levels, and is also expected to inhibit the transfer of maternal antibodies to the fetus, reduction in passive protection to the newborn is anticipated.
Risk and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to Vyvgart in utero. 2 Breast-feeding There is no information regarding the presence of Vyvgart 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. A risk to the breastfed newborn/infant cannot be excluded. VYVGART® (efgartigimod alfa for injection) Page 8 of 20 The developmental and health benefits of breastfeeding and the mother's clinical need for Vyvgart should be considered, as well as any potential adverse effects on the breastfed infant from Vyvgart or from the underlying maternal condition.
3 Pediatrics Pediatrics (˂18 years): The safety and efficacy of Vyvgart in children and adolescents below the age of 18 years has not been established. Vyvgart is not indicated for use in pediatric patients. 4 Geriatrics Geriatrics (≥ 65 years of age): Eleven (11/84 – 13%) patients aged 65 and over were treated with Vyvgart in the placebo-controlled study.
The number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger adult patients.