Efgartigimod Alfa And Hyaluronidase (human Recombinant)
Generic Name: efgartigimod alfa and hyaluronidase (human recombinant)
Brand Names:
Vyvgart Hytrulo
11 DESCRIPTION VYVGART HYTRULO is a fixed-combination drug product containing efgartigimod alfa and hyaluronidase (human recombinant). Efgartigimod alfa, a neonatal Fc receptor blocker, is a human immunoglobulin G1 (IgG1) -derived Fc fragment (fragment, crystallized) of the za allotype, produced in Chinese hamster ovary (CHO) cells.
Overview
11 DESCRIPTION VYVGART HYTRULO is a fixed-combination drug product containing efgartigimod alfa and hyaluronidase (human recombinant). Efgartigimod alfa, a neonatal Fc receptor blocker, is a human immunoglobulin G1 (IgG1) -derived Fc fragment (fragment, crystallized) of the za allotype, produced in Chinese hamster ovary (CHO) cells.
Uses
1 INDICATIONS AND USAGE VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive ( 1 ) chronic inflammatory demyelinating polyneuropathy (CIDP) ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for instructions on dosage, preparation, and administration. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ) Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO. ( 2.1 ) Important Administration Information VYVGART HYTRULO is for subcutaneous use only. ( 2.2 ) Prefilled syringe can be administered by patients and/or caregivers. ( 2.2 ) Vial to be administered with a winged infusion set by a healthcare professional only. ( 2.2 ) gMG: recommended dose and dose schedule Administer in cycles of once weekly injections for 4 weeks.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion/Injection-Related Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥ 10%) in patients with gMG treated with efgartigimod alfa-fcab were respiratory tract infections, headache, and urinary tract infection. Injection site reactions were common (≥ 15%) in patients with gMG and CIDP who were treated with VYVGART HYTRULO ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact argenx at 1-833-argx411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 VYVGART HYTRULO and using alternative therapies. ( 7 ) 7.1 Effect of VYVGART HYTRULO on Other Drugs Concomitant use of VYVGART HYTRULO with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates 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.
Warnings
5 WARNINGS AND PRECAUTIONS Infections: Delay administration of VYVGART HYTRULO to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with VYVGART HYTRULO. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART HYTRULO until the infection has resolved. ( 5.1 ) Hypersensitivity Reactions: Anaphylaxis, hypotension leading to syncope, angioedema, dyspnea, rash, and urticaria have occurred in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab product. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention. 4 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 [see Warnings and Precautions (5.2) ].
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART HYTRULO during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART HYTRULO or efgartigimod alfa containing products during pregnancy.
Storage
Store VYVGART HYTRULO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. Do not shake. If needed, unopened vials may be stored in the original carton for up to 3 days at room temperature at 20°C to 25°C (68°F to 77°F) for a single period before administration or returned to refrigeration.
Frequently Asked Questions
What is Efgartigimod Alfa And Hyaluronidase (human Recombinant) used for?▼
1 INDICATIONS AND USAGE VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive ( 1 ) chronic inflammatory demyelinating polyneuropathy (CIDP) ( 1 )
What are the side effects of Efgartigimod Alfa And Hyaluronidase (human Recombinant)?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion/Injection-Related Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥ 10%) in patients with gMG treated with efgartigimod alfa-fcab were respiratory tract infections, headache, and urinary tract infection. Injection site reactions were common (≥ 15%) in patients with gMG and CIDP who were treated with VYVGART HYTRULO ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact argenx at 1-833-argx411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Efgartigimod Alfa And Hyaluronidase (human Recombinant) during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART HYTRULO during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART HYTRULO or efgartigimod alfa containing products during pregnancy.
What are the important warnings for Efgartigimod Alfa And Hyaluronidase (human Recombinant)?▼
5 WARNINGS AND PRECAUTIONS Infections: Delay administration of VYVGART HYTRULO to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with VYVGART HYTRULO. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART HYTRULO until the infection has resolved. ( 5.1 ) Hypersensitivity Reactions: Anaphylaxis, hypotension leading to syncope, angioedema, dyspnea, rash, and urticaria have occurred in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab product. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention. 4 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 [see Warnings and Precautions (5.2) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.