efgartigimod alfa/hyaluronidase

REMS

Generalized myasthenia gravis in patients who are antiacetylcholine receptor antibody positive.
Chronic inflammatory demyelinating polyneuropathy.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Serious hypersensitivity.

Use Cautiously in:

Moderate or severe renal impairment;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

Local: injection site reactions

MS: myalgia

Neuro: headache, paresthesia

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), infection, infusion-related reactions

Interactions ⬆ ⬇

Drug-drug:

May ↓ effectiveness of live vaccines; concurrent use not recommended.
May ↓ effectiveness of immunoglobulin products or monoclonal antibodies.

Availability ⬆ ⬇

Solution for injection: efgartigimod alfa 180 mg and hyaluronidase 2000 units/mL

Route/Dosage ⬆ ⬇

Generalized Myasthenia Gravis

SC (Adults ): Efgartigimod alfa 1008 mg/hyaluronidase 11,200 units once weekly for 4 wk. Subsequent treatment cycles may be administered based on clinical evaluation and no sooner than 50 days from the start of the previous treatment cycle.

Chronic Inflammatory Demyelinating Polyneuropathy

SC (Adults ): Efgartigimod alfa 1008 mg/hyaluronidase 11,200 units once weekly.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Efgartigimod alfa: A human IgG1 antibody fragment that binds to the neonatal Fc receptor, resulting in the reduction of circulating IgG. Hyaluronidase: Acts locally by depolymerizing hyaluronan, which increases permeability of the subcutaneous tissue.

Therapeutic effects:

Reduction in signs/symptoms and muscle weakness in myasthenia gravis.
Delayed disease progression in chronic inflammatory demyelinating polyneuropathy.

Classifications ⬆ ⬇

Therapeutic Classification: antimyasthenics

Pharmacologic Classification: temporary class

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following subcutaneous administration unknown.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Degraded by proteolytic enzymes into small peptides and amino acids. Excretion pathway unknown.

Half-Life: 80–120 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient of risk for hypersensitivity reactions within 1 hr to 3 wk of administration and to notify health care professional if symptoms occur.
Advise patient not to receive live vaccines during therapy.
Advise patient to notify health care professional for signs of infection (respiratory tract symptoms, headache, urinary tract symptoms, paresthesia, myalgia).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Health care professionals and patients may contact the pregnancy exposure registry to enroll for monitoring of pregnancy outcomes: 1-855-272-6524; www.Vyvgartpregnancy.com.

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Indications ⬇