Oral methadone and buprenorphine remain gold standards for OUD. New depot buprenorphine, retarded morphine, and diacetylmorphine offer alternatives, especially for refractory patients. Depot options improve adherence, supporting tailored, long-term management.
The Immunoglobulin National Society (IgNS) will hold its 14th National Conference from Oct. 16 to 19 in Dallas. The conference is the premier annual event for clinicians, business professionals, and industry leaders in the immunoglobulin (Ig) therapy and biologics space. Attendees will learn about the latest advancements in patient care and make connections with colleagues.
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Discover a way to administer VYVGART Hytrulo that can fit into your patients' lives, including at home.1
The VYVGART Hytrulo prefilled syringe allows patients and caregivers to administer a fixed 5-mL dose in ~20-30 seconds. Refers to actual subcutaneous injection time. Monitor for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the patient should seek medical attention.1
100% of patients with gMG and caregivers successfully used the prefilled syringe and interacted with the associated labeling, packaging, and instructional materials across 2 human factors studies (15 patients and 15 caregivers of gMG patients). All participants were able to follow the Instructions for Use and prepare and administer the dose into the simulated injection pad unaided.2*
Patients and/or caregivers will receive in-person injection training until ready to inject.1†
*Human factors studies evaluated participants’ ability to follow injection instructions and successfully prepare the product in a simulated-use environment. During the unaided injection, 2 use errors and one close call occurred. The use errors were participants not putting the product back into the original packaging before putting into the refrigerator, and the close call was a participant removing the needle cap at the incorrect time. Performance of critical tasks did not result in any patterns of use errors, close calls, or difficulties that would lead to patient harm (including compromised medical care). Findings were based on performance, observed behaviors, subjective feedback, and human factors analyses, and therefore were not traditionally statistically analyzed.2
†After proper instruction on subcutaneous injection technique, a patient or caregiver may inject VYVGART Hytrulo prefilled syringe. See full Prescribing Information.1
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis.
Please see the full Prescribing Information for VYVGART Hytrulo.
Discover more about the VYVGART Hytrulo prefilled syringe
IMPORTANT SAFETY INFORMATION AND INDICATION
CONTRAINDICATIONS
VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO. Reactions have included anaphylaxis and hypotension leading to syncope.
WARNINGS AND PRECAUTIONS
Infections
VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infections (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART HYTRULO administration in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART HYTRULO until the infection has resolved.
Immunization
Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO. The safety of immunization with live vaccines and the immune response to vaccination during treatment with VYVGART HYTRULO are unknown. Because VYVGART HYTRULO causes a reduction in immunoglobulin G (IgG) levels, vaccination with live vaccines is not recommended during treatment with VYVGART HYTRULO.
Hypersensitivity Reactions
In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Monitor for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.
Infusion/Injection-Related Reactions
Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion/injection-related reaction occurs, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART HYTRULO following a severe infusion/injection-related reaction. If a mild to moderate infusion/injection-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion/injection rates, and pre-medications.
ADVERSE REACTIONS
In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.
USE IN SPECIFIC POPULATIONS
Pregnancy
As VYVGART HYTRULO is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risk and benefits should be considered prior to administering live vaccines to infants exposed to VYVGART HYTRULO in utero.
Lactation
There is no information regarding the presence of efgartigimod alfa or hyaluronidase, from administration of VYVGART HYTRULO, 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 VYVGART HYTRULO and any potential adverse effects on the breastfed infant from VYVGART HYTRULO or from the underlying maternal condition.
INDICATION
VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Please see the full Prescribing Information.
You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).
Dosage Form and Strength:
VYVGART Hytrulo is available as a single-dose subcutaneous injection containing 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe.
References: 1. VYVGART Hytrulo. Prescribing information. argenx US Inc; 2025. 2. Data on file. REF-03778. argenx US Inc. January 2025.
For US audiences only.
VYVGART Hytrulo is a registered trademark of argenx.
© 2025 argenx US-VYV_HYT-25-00037 V2 09/2025. All Rights Reserved.
Source : https://pubmed.ncbi.nlm.nih.gov/41042847/
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