rozanolixizumab

Contraindicated in:

Active infection.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

GI: diarrhea, nausea, abdominal pain

Local: injection site reactions

MS: arthralgia

Neuro: headache, ASEPTIC MENINGITIS

Misc: fever, hypersensitivity reactions (including angioedema), infection

Interactions ⬆ ⬇

Drug-drug:

May ↓ effectiveness of live vaccines or live-attenuated vaccines; concurrent use of either of these vaccines not recommended during therapy.
May ↓ effectiveness of immunoglobulin products ormonoclonal antibodies.

Availability ⬆ ⬇

Solution for SUBQ injection: 140 mg/mL

Route/Dosage ⬆ ⬇

SC (Adults ≥100 kg): 840 mg once weekly for 6 wk. Subsequent treatment cycles may be administered based on clinical evaluation and no sooner than 63 days from the start of the previous treatment cycle.
SC (Adults 50–<100 kg): 560 mg once weekly for 6 wk. Subsequent treatment cycles may be administered based on clinical evaluation and no sooner than 63 days from the start of the previous treatment cycle.
SC (Adults <50 kg): 420 mg once weekly for 6 wk. Subsequent treatment cycles may be administered based on clinical evaluation and no sooner than 63 days from the start of the previous treatment cycle.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

A human IgG1 antibody fragment that binds to the neonatal Fc receptor, resulting in the reduction of circulating IgG.

Therapeutic effects:

Reduction in signs/symptoms and muscle weakness.

Classifications ⬆ ⬇

Therapeutic Classification: antimyasthenics

Pharmacologic Classification: temporary class, monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following SUBQ administration unknown.

Distribution: Well distributed to tissues.

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

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	2 days	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. If dose is missed within 4 days of scheduled dose, administer as soon as possible; then continue dosing per schedule.
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.
Instruct patient that immunization with live or live-attenuated vaccines is not recommended during treatment.
Advise patient to notify health care professional if any signs or symptoms of an infection occur.
Inform patient of signs and symptoms of aseptic meningitis and to contact a health care professional is any occur.
Advise patient about signs and symptoms of hypersensitivity reactions and to contact health care professional immediately if any occur or seek immediate medical attention.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇

Contraind./Precautions ⬆ ⬇