Vyvgart is a prescription medicine used to improve muscle weakness in adults with generalized myasthenia gravis that is anti-AChR antibody positive. Vyvgart (efgartigimod alfa) works by lowering the amount of AChR antibodies that wrongly attack and damage a protein called acetylcholine receptor (AChR), located in muscles. The AChR helps signal muscles to contract, so when it is damaged, this causes the muscles to be weaker as they can not contract as well as normal.  Because Vyvgart reduces the AChR antibodies there is less damage to the AChR and muscle strength improves.

Infections: Vyvgart can increase your risk of infection. Call your doctor at once if you have fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Hypersensitivity reactions: Hypersensitivity reactions have occurred in some patients during clinical trials with symptoms that include rashes, swelling under the skin and trouble breathing, These hypersensitivity reactions were mild or moderate, and occurred within one hour to three weeks of medicine administration. Patients should be monitored during administration, and for 1 hour after administration for any signs or symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, the Vyvgart infusion should be stopped and appropriate supportive measures should be used if needed.

Your healthcare provider will give you a Vyvgart Infusion Guide with information on the infusion process: before, during and after. Follow all directions and read all medication guides or instruction sheets.

Vyvgart is given as a solution into a vein by a healthcare provider. The infusion usually takes approximately 1 hour, and you will be monitored during the infusion and for one hour afterwards for any allergic reactions. 

The usual dose is one infusion every week for 4 weeks. You then have a break between treatment cycles before you may have a second treatment cycle of 4 infusions. The time between infusion cycles will depend on your improvement of myasthenia gravis symptoms and any side effects you have after treatment.

Doses are based on weight so your dose may change if you gain or lose weight.

Remember to make sure you are current on all vaccines before you start Vyvgart treatment.

Usual Adult Dose for Myasthenia Gravis:

• 10 mg/kg IV once weekly for 4 weeks.
• Weight greater than 120 kg: 1200 mg IV once weekly for 4 weeks.

Comments:

• Subsequent treatment cycles should be based on clinical evaluation.
• The safety of initiating a cycle sooner than 50 days from the start of the prior cycle has not been established.
• Evaluate the need for age-appropriate immunizations prior to therapy initiation.

Use:

• For the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody positive.

To make sure Vyvgart is safe for you, tell your doctor if you:

• currently have an infection or had any infections recently.
• have received or are scheduled to receive a vaccine (immunization). Talk with your healthcare professional if you need to receive age-appropriate immunizations before starting a new treatment cycle with this medicine. The use of vaccines during Vyvgart treatment has not been studied, and the safety of live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with this medicine. 
• are pregnant or plan to become pregnant. Click on the link below for more information on Vyvgart and pregnancy.
• are breastfeeding or plan to breastfeed. Click on the link below for more information on Vyvgart and breastfeeding.

Call your doctor for instructions if you miss an appointment for your infusion.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You should avoid receiving a "live" vaccine while you are being treated with this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious Vyvgart side effects.

Call your doctor at once if you have:

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Common Vyvgart side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• headache; or
• pain and burning when you urinate, painful urination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vyvgart may have interactions with other prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use, and when you start, stop or change a dose of any medicine. To check for interactions with Vyvgart click the link below.