YUSIMRY

ADALIMUMAB-AQVH

Manufacturer: Meitheal Pharmaceuticals Inc.

Score: 144.0

Quick Summary

YUSIMRY (adalimumab-aqvh) is a tumor necrosis factor (TNF) blocker indicated for the treatment of various conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. The drug works by binding to TNF-alpha and blocking its interaction with cell surface receptors, which helps reduce inflammation and other symptoms associated with these conditions. YUSIMRY is administered via subcutaneous injection, with dosing frequencies varying depending on the specific condition being treated. Important safety information includes warnings about serious infections, malignancies, and other potential adverse reactions. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Rheumatoid arthritis
Juvenile idiopathic arthritis
Psoriatic arthritis
Ankylosing spondylitis
Crohn's disease
Ulcerative colitis
Plaque psoriasis
Hidradenitis suppurativa
Uveitis

Important Safety Information

Warning

SERIOUS INFECTIONS and MALIGNANCY: Patients treated with adalimumab products, including YUSIMRY, are at increased risk for developing serious infections that may lead to hospitalization or death, and for developing lymphoma and other malignancies.

Contraindications

Adverse Reactions

Serious infections
Malignancies
Hypersensitivity reactions
Hepatitis B virus reactivation
Neurologic reactions
Hematological reactions
Heart failure
Autoimmunity

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with certain conditions, such as renal or hepatic impairment.

Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Adult Dose

40 mg every other week

Pediatric Dose

For patients 2 years of age and older with polyarticular JIA, 40 mg every other week for patients weighing 30 kg or more

Crohn's disease

Adult Dose

160 mg on Day 1, 80 mg on Day 15, and 40 mg every other week starting on Day 29

Pediatric Dose

For patients 6 years of age and older, 160 mg on Day 1, 80 mg on Day 15, and 40 mg every other week starting on Day 29 for patients weighing 40 kg or more

Ulcerative colitis

Adult Dose

160 mg on Day 1, 80 mg on Day 15, and 40 mg every other week starting on Day 29

Pediatric Dose

Not established

Plaque psoriasis or adult uveitis

Adult Dose

80 mg initial dose, followed by 40 mg every other week starting one week after initial dose

Pediatric Dose

Not established

Hidradenitis suppurativa

Adult Dose

160 mg on Day 1, 80 mg on Day 15, and 40 mg weekly or 80 mg every other week starting on Day 29

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant

Nursing Mothers

It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion

Pediatric Use

The safety and effectiveness of YUSIMRY have been established for reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older
The safety and effectiveness of YUSIMRY have been established for the treatment of moderately to severely active Crohn's disease in pediatric patients 6 years of age and older

Geriatric Use

A total of 519 RA patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies
The frequency of serious infection and malignancy among adalimumab-treated patients 65 years of age and older was higher than for those less than 65 years of age