Efgartigimod-Hyaluronidase SC

Efgartigimod-Hyaluronidase SC is a combination medication indicated for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.

• Efgartigimod-Hyaluronidase SC is available under the following different brand names: Vyvgart Hytrulo, efgartigimod alfa/hyaluronidase-qvfc

Common side effects of Efgartigimod-Hyaluronidase SC include:

• respiratory tract infections
• headache
• urinary tract infections
• injection site reactions

Serious side effects of Efgartigimod-Hyaluronidase SC include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• signs of infection, such as fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in the color of sputum, pain while passing urine, mouth sores, or a wound that will not heal

Rare side effects of Efgartigimod-Hyaluronidase SC include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, solution for SC

• 1008 mg/11,200 units/5.6 mL (180 mg/2000 units/mL)

Myasthenia gravis

Adult dosage

• 1008 mg/11,200 units (5.6 mL) SC every week for 4 weeks
• Administer subsequent treatment cycles according to clinical evaluation
• Safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle is not established

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Efgartigimod-Hyaluronidase SC has severe interactions with the following drug:
  • upadacitinib
• Efgartigimod-Hyaluronidase SC has serious interactions with no other drugs.
• Efgartigimod-Hyaluronidase SC has moderate interactions with at least 74 other drugs.
• Efgartigimod-Hyaluronidase SC has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Efgartigimod-Hyaluronidase SC?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Efgartigimod-Hyaluronidase SC?”

Cautions

• Hypersensitivity reactions
  • Hypersensitivity reactions, including rash, angioedema, urticaria, and dyspnea, observed
  • Monitor patients during administration and for at least 30 min after administration for clinical signs and symptoms of hypersensitivity reactions
  • If a reaction occurs, institute appropriate supportive measures if needed
• Immunization
  • Immunization with vaccines during treatment has not been studied; the safety of immunization with live or live, attenuated vaccines and response to immunization with any vaccine are unknown
  • Vaccination with live, attenuated, or live vaccines is not recommended during treatment
  • Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiating a new treatment cycle
• Infections
  • May increase the risk for infection
  • Most common infections were urinary tract infections and respiratory infections
  • Delay administration in patients with an active infection until the infection is resolved
  • During treatment, monitor for clinical signs and symptoms of infections
  • If a serious infection occurs, administer appropriate treatment, and consider withholding therapy until the infection resolved
• Drug interaction overview
  • Fc receptor antagonists
    • Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor (FcRn)
    • Efgartigimod may decrease concentrations of drugs that bind to human FcRn (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the immunoglobulin G [IgG] subclass)
    • When concomitant, long-term use of such medications is essential for patient care, consider discontinuing therapy and using alternative therapies

Pregnancy and Lactation

• No data available on the use of efgartigimod alfa-fcab during pregnancy
• There is no evidence of adverse developmental outcomes following administration of up to 100 mg/kg/day in rats and rabbits
• Fetal or neonatal adverse reactions
• Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
• Efgartigimod may be transmitted from the mother to the developing fetus
• May reduce maternal IgG antibody levels, and reduction in passive protection for the newborn is anticipated
• Consider the risks and benefits before administering live or live-attenuated vaccines to infants exposed in utero
• Lactation
  • There is no information regarding the presence of efgartigimod alfa-fcab in human milk, its effects on breastfed infants, or milk production
  • Maternal IgG is known to be present in human milk