Efgartigimod alfa

What is Efgartigimod alfa?

• Efgartigimod alfa (Vyvgart) is a neonatal Fc receptor blocker used for the treatment of generalized myasthenia gravis (gMG).

What are the uses of this medicine?

• Efgartigimod alfa (Vyvgart) is used for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

How does this medicine work?

• Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
• The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Concomitant use of Vyvgart 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.
• When concomitant long-term use of such medications is essential for patient care, consider discontinuing Vyvgart and using alternative therapies.

Is this medicine FDA approved?

• It was approved for medical use in the United States in December 2021.

How should this medicine be used?

• Because Vyvgart causes transient reduction in IgG levels, immunization with live-attenuated or live vaccines is not recommended during treatment with Vyvgart.

Recommended dosage:

• The recommended dosage of Vyvgart is 10 mg/kg administered as an intravenous infusion over one hour once weekly for 4 weeks.
• 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 safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established.
• If a scheduled infusion is missed, Vyvgart may be administered up to 3 days after the scheduled time point.

Administration:

• Dilute Vyvgart prior to administration.
• Administer via intravenous infusion only.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 400 mg in 20 mL (20 mg/mL) single-dose vial.

This medicine is available in fallowing brand namesː

• Vyvgart

What side effects can this medication cause?

The most common side effects of this medicine include:

• Respiratory tract infection
• Headache
• Urinary tract infection
• Paraesthesia
• Myalgia

What special precautions should I follow?

• Vyvgart may increase the risk of infection. During treatment with Vyvgart, monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding Vyvgart until the infection has resolved.
• Immunization with vaccines during Vyvgart 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 Vyvgart causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with Vyvgart.
• Hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in Vyvgart-treated patients. If a hypersensitivity reaction occurs during administration, discontinue Vyvgart infusion and institute appropriate supportive measures if needed.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on the use of Vyvgart during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• efgartigimod alfa

Inactive ingredients:

• arginine hydrochloride
• polysorbate 80
• sodium chloride
• sodium phosphate, dibasic, anhydrous
• sodium phosphate, monobasic, monohydrate
• water

Who manufactures and distributes this medicine?

Manufactured by:

• argenx BV
• Industriepark 7
• Zwijnaarde, Belgium

Distributed by:

• argenx US, Inc.
• 33 Arch Street
• Boston, MA

What should I know about storage and disposal of this medication?

• Store Vyvgart 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.

• Dailymed label info on Efgartigimod alfa
• FDA Efgartigimod alfa

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