Efgartigimod alfa-fcab side effects
Generic name: efgartigimod alfa-fcab (Intravenous route)
Drug class: Immune globulins
Brand name: Vyvgart
Medically reviewed by R. Shah MD. Updated on March 19, 2022.
What is Efgartigimod alfa-fcab
Efgartigimod alfa-fcab side effects are unwanted reactions that may be experienced while using this drug.
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.
Efgartigimod alfa-fcabinjection 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 Efgartigimod alfa-fcab
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 Efgartigimod alfa-fcab
- 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 Efgartigimod alfa-fcab
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.
Efgartigimod alfa-fcab 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.
The most frequently reported adverse reactions that have been reported have included headaches, respiratory tract infections or urinary tract infection.
- Very frequent (10 percent or more) Infections of the respiratory tract (33 percent)
- In clinical trials, 33% patients who received this medication had respiratory tract infections, in comparison to 29% of patients who received placebo.
- Very widespread (10 percent plus): Headache (32 percent; also migraine or procedural headache)
- The most common (1 10% to 10 10%) The term “paraesthesia” refers to the sensation (included oral hypoesthesia as well as hypoesthesia, hyperesthesia, and hypesthesia)
- Very widespread (10 percent or more) Antibodies to drugs (20 percent)
- common (1 10% to 10 percent) Neutralizing antibodies
- Very widespread (10 percent or more) Below normal counts of WBC (12 percent) and below normal lymphocytes (28 percent) in addition to normal neutrophils (13 percent)
- Insufficient levels of WBCs and lymphocytes as well as neutrophils were found in patients who received this medication (12 percent 2,8 percent and 13% respectively) when compared to placebo (5 19%, 13%, and 6% respectively).
- Very frequent (10 percent or more) Infections of the urinary tract ( UTI; 10 percent)
- In clinical studies in clinical trials, 10 percent of patients treated with this medication experienced UTI as opposed to 5percent of placebo patients.
- Frequency not disclosed Hypersensitivity reactions such as the rash, angioedema, and dyspnea
- Common (1% to 10%): Myalgia
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.