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Drug: Efgartigimod alfa
Brand: Vyvgart 400mg/20ml (20mg/ml)
Manufacturer /
TM Owner
Argenx
Origin: Belgium

Vyvgart 400mg/20ml (20mg/ml) Injection

Formulated with Efgartigimod alfa, Vyvgart is an enzyme replacement or biologic protein therapy. It supplies a functional form of a deficient or therapeutic protein, addressing the biochemical root of the disease. It is used in the treatment of neurological conditions. Treatment is individualised by the prescribing physician to balance efficacy and tolerability.
Strength: 400mg/20ml (20mg/ml)
Pack Size: 1s
Storage: 2°C to 8°C
Form: Injection

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Indications & Clinical Uses

  • Vyvgart 400 mg/20 mL (20 mg/mL) injection contains efgartigimod alfa-fcab, a neonatal Fc receptor (FcRn) blocker that lowers levels of circulating IgG antibodies.
  • This intravenous vial is used for adults with generalized myasthenia gravis (gMG); the EU authorisation specifies patients who have anti-acetylcholine receptor antibodies.
  • The US label gives 10 mg per kg as an intravenous infusion over one hour once weekly for 4 weeks (a fixed 1,200 mg for people weighing 120 kg or more), with later cycles based on clinical evaluation.
  • It is prepared and given by a healthcare provider.
  • This vial is the intravenous product and must not be confused with the subcutaneous Vyvgart Hytrulo, which has a different dose, route and strength.
  • The US label holder is argenx.

Side Effects

  • The most common side effects on the US label were respiratory tract infection (33%), headache (32%) and urinary tract infection (10%).
  • Serious reactions include infections, and hypersensitivity reactions such as anaphylaxis, low blood pressure leading to fainting, angioedema (swelling), shortness of breath and rash.
  • Infusion-related reactions can occur, with high blood pressure, chills, shivering, and chest, abdominal or back pain.
  • The current US label has no boxed warning.
  • Tell your care team at once about fever or other signs of infection, swelling of the face or throat, breathing difficulty, or symptoms during or after the infusion.

Precautions & Warnings

  • Treatment should be delayed in anyone with an active infection, and patients should be monitored for signs of infection during treatment.
  • Because efgartigimod reduces IgG, the label does not recommend live vaccines during treatment.
  • Hypersensitivity and infusion reactions can occur, so the infusion is given under clinical supervision.
  • There are no human pregnancy data; animal studies at up to 10 times the human dose showed no adverse effects.
  • Discuss pregnancy and breastfeeding plans with your healthcare provider before treatment.
  • In the EU, treatment must be started by a physician experienced in neuromuscular disorders.
  • Vials are stored refrigerated at 2°C to 8°C in the original carton, protected from light, and are not frozen or shaken.

Avoid Interactions

  • Increase effect or toxicity: no specific interacting medicines are named on the label for higher toxicity.
  • Reduce efficacy: other medicines that bind to the neonatal Fc receptor (FcRn) may work less well while efgartigimod is lowering IgG, so close monitoring is needed.
  • Live vaccines are not recommended during treatment because of IgG reduction, and age-appropriate vaccines should be reviewed with your healthcare provider before a new treatment cycle.
  • Tell your healthcare provider about all medicines, vaccines and supplements you use.
  • Pharmacy point: the intravenous vial is not interchangeable with Vyvgart Hytrulo subcutaneous injection.

References

Frequently Asked Questions

Vyvgart (efgartigimod alfa) intravenous infusion treats adults with generalized myasthenia gravis, a condition where antibodies disrupt muscle signalling. In the EU it is specified for patients with anti-acetylcholine receptor antibodies. It is given by a healthcare provider, and the subcutaneous Vyvgart Hytrulo is a different product.

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