efgartigimod alfa

Absorption: IV administration results in complete bioavailability.

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
IV	unknown	unknown	unknown

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

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 ormonoclonal antibodies.

Route/Dosage ⬆ ⬇

IV (Adults ≥120 kg): 1200 mg 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.
IV (Adults <120 kg): 10 mg/kg 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.

Availability ⬆ ⬇

Solution for injection: 20 mg/mL

Assessment ⬆ ⬇

Assess the need to administer age-appropriate vaccines before starting therapy. Live vaccines are not recommended during treatment.
Assess for infections (fever, urinary tract infection, respiratory tract infection). Delay treatment until active infection resolves.
Assess for rash, angioedema, and dyspnea. May occur 1 hr–3 wk after administration.
Monitor for signs and symptoms of hypersensitivity reactions (anaphylaxis, hypotension) during infusion and 1 hr after. Discontinue infusion if any occur and implement appropriate emergency medical interventions.
Assess for infusion-related reactions (hypertension; chills; shivering; thoracic, abdominal, and back pain) during and 1 hr after administration. Discontinue infusion and start appropriate therapy. Consider risks and benefits of readministering. May need a slower infusion rate or premedications.

Lab Test Considerations:

Monitor CBC with differential.

Implementation ⬆ ⬇

Administer by a health care professional.

IV Administration:

Y-Site Incompatibility:
- Do not administer other drugs through same IV line.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. If a scheduled infusion is missed, dose may be administered up to 3 days after scheduled time. Resume the original dosing schedule until treatment is completed. If dose is missed ≥3 days, administer subsequent doses with 1 wk between infusions to complete four infusions for a full cycle.
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.
Advise patient to notify a health care professional if hypersensitivity reactions occur. Seek immediate medical attention if needed.
Educate patient to notify a health care professional if they develop signs and symptoms of an infection or infusion-related reaction.
Rep: Sexually active male patients should use effective contraception during therapy and 90 days after last dose. Women breastfeeding during therapy should consider the risks and benefits of the infant and treatment of the mother. Pregnant patients are encouraged to enroll in the pregnancy exposure registry to monitor outcomes. Register by calling 1-855-272-6524 or https://www.Vyvgartpregnancy.com.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction in signs/symptoms and muscle weakness.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

69438- Lonza Biologics Tuas Pte.Ltd.
- 69438-0011-
  - 69438-0011-2- 12000 mL in 1 BAG (69438-0011-2)

73475- argenx US
- 73475-3041- VYVGART
  - 73475-3041-5- 1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3041-5) / 20 mL in 1 VIAL, SINGLE-DOSE

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇