Vyvgart Dosage, forms & strengths
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Vyvgart (efgartigimod alfa-fcab) is a neonatal Fc receptor (FcRn) blocker that is manufactured by Argenx. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. Vyvgart reduces the number of circulating antibodies that attack healthy tissues in gMG and cause complications such as muscle weakness and death. It is typically used when you have failed other immunosuppressive therapies such as Prograf (cyclosporine).
How does Vyvgart work?
Myasthenia gravis (MG) is a rare neuromuscular disease that causes symptoms such as muscle weakness of the arms and legs, drooping eyelids, double vision, fatigue, and difficulty speaking or swallowing. MG symptoms usually worsen with activity and improve with rest. Vyvgart is a human immunoglobulin G antibody fragment that binds and inhibits the neonatal Fc receptor (FcRn) to reduce IgG levels, including the abnormal AChR antibodies that are present in myasthenia gravis. It is the reduction in these circulating antibodies that helps relieve symptoms of myasthenia gravis.
Vyvgart dosage forms and strengths
- 400mg in 20ml (20mg/ml) single-dose vial for IV infusion
- The recommended dosage of Vyvgart is 10mg/kg of body weight given as a one-hour IV infusion once a week for 4 weeks. If you weigh more than 120kg, the recommended dose is 1200mg per infusion.
- You may receive additional treatment cycles based on clinical evaluation. You should not initiate a new cycle unless it has been 50 days since the start of the previous cycle.
Vyvgart dosage restrictions
- No dosage adjustment is necessary if you have mild kidney impairment.
- There is not enough data to make a recommendation if you have moderate to severe kidney impairment.
How to take Vyvgart
Vyvgart is typically given as an hour-long IV infusion by a trained healthcare professional in a doctor’s office or infusion center. You will receive Vyvgart infusions once a week for 4 weeks. If you do not have an adequate response, you may receive additional treatment cycles. You should not start a new cycle unless it has been 50 days since the start of the previous cycle. Your dose of Vyvgart for each infusion is 10mg/kg of body weight or 1,200mg if you weigh 120kg (265lbs) or more. If you miss an infusion, you can have it administered up to 3 days after its scheduled time. You should then resume the original dosing schedule until your treatment cycle is complete.
Vyvgart dosage FAQs
What are the most common side effects of Vyvgart?
The most common adverse reactions of Vyvgart in clinical trials compared to placebo include:
- Respiratory tract infections
- Urinary tract infection
- Hyperglycemia (high blood sugar)
- High cholesterol
- Low magnesium and/or calcium
- Muscle pain (myalgia)
- Shortness of breath
Sometimes, Vyvgart can cause more serious side effects, including:
- Severe hypersensitivity reactions (eyelid swelling, rash, and shortness of breath)
- Serious infection
Contact your doctor for medical advice about any adverse effects you experience while taking Vyvgart. You can report your side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What drug interactions occur with Vyvgart?
When Vyvgart is taken with other medications, it may change the way they work or increase the frequency and severity of side effects. Discuss with your doctor whether any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may interact with this medication.
Are there any contraindications or precautions with Vyvgart?
While there are no contraindications currently associated with Vyvgart, caution should be used in the following:
- You should not receive Vygart if you have an active infection. Notify your doctor if you notice any signs and symptoms of infection such as fever, chills, cough, or painful urination while taking this medication.
- Hypersensitivity reactions have occurred with this Vyvgart. If you experience a serious allergic reaction, your doctor will discontinue the infusion and administer appropriate treatment.
- Have received or are planning to receive a vaccine (immunization). You may need to receive immunizations before the initiation of a new treatment cycle with this medication. Because Vyvgart causes a reduction in immunoglobulin G levels, vaccination with live or live-attenuated vaccines is not recommended during treatment.
- Are pregnant, plan to become pregnant, are breastfeeding.
- Please read the full Prescribing Information for Vyvgart and discuss any questions you have with your doctor.
Can you take Vyvgart while you are pregnant or breastfeeding?
There is no data on the effects of Vyvgart use during pregnancy. There were no adverse outcomes in animal studies. There is also no data regarding the presence of Vyvgart in breast milk during lactation, the possible effects on the breastfed infant, or the effects on milk production. IgG made naturally by the mother is known to be present in human milk. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
How can I keep track of my myasthenia gravis symptoms?
You should keep track of your MG symptoms by filling out the myasthenia gravis activities of daily living (MG-ADL) survey once a week. You should share this information with your neurologist because it can help them determine if you need another treatment cycle.
How often should you take Vyvgart?
Vyvgart is given as an hour-long intravenous infusion once a week for 4 weeks. You should see improvements in symptoms after your first treatment cycle.
What is the maximum recommended dosage for Vyvgart?
The maximum recommended dose of Vyvgart is 10mg/kg of body weight. If you weigh 120kg (265lbs) or more, the maximum dose is 1200mg.
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