Generic name: efgartigimod alfa-fcab (Intravenous route)
Drug class: Immune globulins
Medically reviewed by R. Shah MD. Updated on March 19, 2022.
Available Dosage Forms:
What is Vyvgart
Vyvgart is a za allotype Fc fragment (fragment, crystallized) generated from human immunoglobulin G1 (IgG1). The efgartigimod alfa-fcab Fc fragment is a homodimer made up of two identical peptide chains with 227 amino acids each, connected by two interchain disulfide bridges that have an affinity for FcRn. Efgartigimod alfa-fcab has a molecular weight of about 54 kDa.
Vyvgart (efgartigimod alfa-fcab) injection is a single-dose vial of sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for infusion after dilution.
At a dosage of 20 mg/mL, each 20 mL single-dose vial contains 400 mg of efgartigimod alfa-fcab. L-arginine hydrochloride (31.6 mg), polysorbate 80 (0.2 mg), sodium chloride (5.8 mg), sodium phosphate dibasic anhydrous (2.4 mg), sodium phosphate monobasic monohydrate (1.1 mg), and water for injection, USP, at a pH of 6.7 are also present in each mL of solution.
Mechanism of Action
Efgartigimod alfa-fcab is a human IgG1 antibody fragment which binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
Uses for Vyvgart
Efgartigimod alfa-fcab injections are utilized to address a muscle and nerve issue known as myasthenia gravis for those who are anti-acetylcholine (AChR) antigen positive.
This medication should be administered only by or under the supervision of your physician.
Before making use of Vyvgart
- In making a decision to take any medicine, the dangers of using the medication should be considered in relation to the benefits it can bring. This is a decision that you as well as your physician make. In this case to be considered, the following factors should be assessed:¶
- Inform your doctor whether you’ve had an unusual reaction or an allergic reaction to this medicine, or other medications. Inform your health care doctor if you are suffering from other kinds of allergies, like dyes, foods preservatives, animals, or dyes. For products that are not prescription-only, you must look over the label or ingredient list carefully.
- Studies have not been conducted to determine the connection between age and the effects of efgartigimod’s alfafcab-fcab injection on the children’s population. Safety and effectiveness haven’t been confirmed.
- The studies that have been conducted up to now haven’t revealed the existence of geriatric-specific issues that hinder the effectiveness of efgartigimod’s alfa-fcab injections in the older.
- There aren’t enough studies of women that can determine the risks to babies when using this medication while breastfeeding. Be sure to weigh the benefits of this medication against the risk of using this medication during nursing.
Interactions with medications
- Certain medicines shouldn’t be taken together In other instances, two medicines could be combined even though there is a chance of interaction. In these instances, the doctor may decide to alter the dosage or take other precautions if required. Inform your healthcare provider whether you’re having any additional prescriptions or non-prescription (over-the-counter [OTCor over-the-counter [OTC]) medication.
Interactions with alcohol/food/tobacco/alcohol
- Certain medications shouldn’t be taken during or in conjunction with having food items or eating particular kinds of food as interactions could happen. The use of tobacco or alcohol together with certain medications can create interactions. Talk to your doctor about the interactions of your medication in conjunction with alcohol, food, or tobacco.
Other medical issues
- The presence of any other medical issues could impact the usage of this medicine. It is important to inform your doctor if there are any other medical issues including:
- The presence of an infection and its history of it can decrease the body’s ability to combat infection.
Proper use of Vyvgart
A nurse or another trained medical professional will provide you with the medicine at a medical facility. It is administered via an injection in your veins. The medicine should be administered slowly, and the needle should remain there for at least one hour. The medication is typically given once per week for 4 weeks.¶
Consult your physician or pharmacist to get instructions.
Warnings and precautions
It is crucial to have your doctor monitor your progress on a regular basis to ensure that the medication is functioning effectively. It is possible to have blood tests to look for any adverse negative effects.
Contact your doctor immediately If you begin to experience a cough that won’t disappear night sweats, weight loss or chills, fever, flu-like symptoms (eg running or nasal congestion, headache blurred vision, feeling sick all the time) pain, or difficulty urinating, or ulcers, sores, or white spots around the mouth and on your lips. These are signs that you are suffering from an infection.
This medication can cause serious allergic reactions, like angioedema which could be life-threatening and requires urgent medical treatment. Inform your doctor immediately when you notice a large or hive-like swelling of your eyes, face or lips, tongue the throat, hands feet, sex organs, itching on the skin and rash, or difficulty breathing after taking this medication.
If you are receiving treatment with efgartigimod alfa-fcab do not receive any immunizations (vaccines) without the approval of your physician. Live-virus vaccines are not used with efgartigimod fcab.
Don’t take any other medication without discussing them with your physician. This includes prescription and prescription (over-the-counter OTC) medications as well as herbal or vitamin supplements.
Dosage and administration
Since Vyvgart produces a temporary decrease in IgG levels, vaccination using live or attenuated vaccines isn’t recommended when treating with VYVGART. Assess the need for administering immunizations that are appropriate for your age according to the immunization guidelines prior to the beginning of a new treatment regimen using Vyvgart.
Recommended Dose and Dose Schedules
Mix Vyvgart with water prior to administering. Use intravenous infusions only.
The recommended dose of Vyvgart will be 10 mg per kilogram, administered by intravenous injection over an hour every week for four weeks. For patients who weigh 120kg plus, the prescribed dosage for Vyvgart amounts to 1200 mg (3 vials) per infusion.
The next treatment cycle should be administered in accordance with the results of a clinical assessment. The risk of starting the subsequent cycles earlier than 50 days following the commencement of the previous cycle has not been proven.
If an infusion scheduled for the day is not completed, Vyvgart may be administered for up to 3 days following the time period scheduled. Then, you can resume the initial regimen of dosing until the treatment process is complete.
Preparation and Administration Instructions
Before the administration, Vyvgart single-dose vials require the diluting of 0.9 percent Sodium Chloride Injection USP for the total volume that can be administered of 125mL
Verify to ensure that your Vyvgart Solution is transparent, slightly opaque, and color from yellow to almost colorless. Drug products for parenteral use are to be visually examined for discoloration and particles before administration if the solution and container allow. Avoid using when opaque particles, discoloration, or any additional foreign matter are observed.
Utilize an aseptic technique while preparing the Vyvgart to dilute the solution for intravenous injection. Each vial is designed for one dose only.
Recycle any leftover portion.
- Calculate the dosage (mg) and the total drug quantity (mL) in Vyvgart solution that is required, as well as the number of vials required according to the recommended dosage depending on the weight of the patient’s body. Each vial has 400mg of Vyvgart, at 20 mg per milliliter.
- Simply remove the dose in Vyvgart out of the vial(s) using a sterile needle and syringe. Then, discard any remaining part in the vials.
- Reduce the amount of Vyvgart by adding 0.9 percent sodium chloride injection, USP to make a total volume of 125mL that can be used to administer intravenous infusion.
- Gently flip the bag containing the dilute Vyvgart and shake it gently to ensure thorough mixing of both the substance and diluting.
- The diluted solution can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene-vinyl acetate (EVA), or ethylene/polypropylene copolymer bags (polyolefins bags), and with PE, PVC, EVA, or polyurethane/polypropylene infusion lines.
Storage Conditions of the Diluted Solution
- Vyvgart is not preservative-free. Dose immediately after diluting and finish the infusion within four hours after dilution.
- If immediate use isn’t possible, the dilute solution can be kept refrigerated between 2degC and 8degC (36degF up to 46degF) until 8 hours. Don’t freeze. Keep away from sunlight. Let the drug infusion attain room temperature prior to the infusion. Finish the infusion within four hours after removing it from the fridge. Avoid heating the infusion or any other way than through ambient air.
- Vyvgart is to be administered via an intravenous injection by a medical professional.
- Check the Vyvgart dilute solution for particles or discoloration prior to the administration. Don’t use the solution if it has discolored or if foreign or opaque particles are visible.
- Infuse the concentrated 125mL solution intravenously for one hour with an 0.2 millimeter inline filter.
- Following the administration of Vyvgart Then clean the entire line with 0.9 percent Sodium Chloride Injection USP.
- Monitor patients throughout the administration period and for one hour afterward for symptoms and signs that indicate hypersensitivity. If hypersensitivity reactions occur after administration, stop the use of Vyvgart and take appropriate protective measures
- Other medicines should not be injected through infusion ports in the side or combined with Vyvgart.
Vyvgart side effects
In addition to its beneficial effects, some medicines may result in unwanted negative effects. While not all adverse effects can be present, if they do occur, they could require medical attention.
Consult your physician or nurse right away when any of these adverse effects happen:
- Bladder pain
- Bloody or cloudy urine
- uncomfortable pain, burning, or difficult or painful
- difficulties in moving
- chest pain
- the constant urge to urinate
- joint pain
- Side or lower back discomfort
- Muscle cramps, aches, stiffness, or pain
- sore throat
- swollen joints
The exact cause is not known.
- Inability to breathe or swallow
- fast heartbeat
- Large, hive-like swellings on cheeks, eyelids, and lips. It can also be seen on tongues, lips hands, legs, throat feet, or sex organs
- itching on the skin, rash or itchy, redness
- swelling of the throat, face, or the tongue
- Trouble breathing
Certain side effects can be experienced which usually don’t require medical treatment. These side effects can disappear when your body adjusts the medication. Additionally, your doctor could be able to inform you of ways to avoid or minimize the effects of these adverse effects. Talk to your physician in the event that any of these symptoms persist or become troubling or if you have concerns about these:
- Itching, burning, crawling, and numbness. Prickling “pins and needles”, or tingling sensations
Other adverse side effects that are not listed can also occur in certain patients. If you experience any other side effects, you should consult with your doctor.
Consult your physician for advice from a medical professional regarding adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.
How supplied and stored
Vyvgart (efgartigimod alfa-fcab) injection is a preservative-free, sterile, colorless to slightly yellow, clear to a slightly opalescent solution supplied as 400 mg/20 mL (20 mg/mL) in one single-dose vial per carton
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.
Refer to Dosage and Administration (2.3) for information on the stability and storage of the diluted solutions of Vyvgart.
Always check with your healthcare practitioner to make sure the information on this page pertains to your specific situation.