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 side effectsEfgartigimod 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

Allergies

Pediatric

Geriatric

Breastfeeding

Interactions with medications

Interactions with alcohol/food/tobacco/alcohol

Other medical issues

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.

Missed dose

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

For consumers

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:

More commonly

  • Bladder pain
  • Bloody or cloudy urine
  • cough
  • uncomfortable pain, burning, or difficult or painful
  • difficulties in moving
  • febrile
  • chest pain
  • the constant urge to urinate
  • joint pain
  • Side or lower back discomfort
  • Muscle cramps, aches, stiffness, or pain
  • Sneezing
  • 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:

More popular

  • Itching, burning, crawling, and numbness. Prickling “pins and needles”, or tingling sensations
  • headache

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.

For professionals

General

The most frequently reported adverse reactions that have been reported have included headaches, respiratory tract infections or urinary tract infection. 

Respiratory

  • 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.

Nervous system

  • 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)

Immunologic

  • Very widespread (10 percent or more) Antibodies to drugs (20 percent)
  • common (1 10% to 10 percent) Neutralizing antibodies

Hematologic

  • 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).

Genitourinary

  • 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.

Hypersensitivity

  • Frequency not disclosed Hypersensitivity reactions such as the rash, angioedema, and dyspnea

Musculoskeletal

  • Common (1% to 10%): Myalgia

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.

 

Efgartigimod alfa-fcab

Additional information

Always check with your healthcare practitioner to make sure the information on this page pertains to your specific situation.

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