romosozumab

Action and Spectrum

Drug Interaction

Adverse Reaction

>10%: 

Arthralgia  

1-10%: 

Headache  

Hypersensitivity  

Injection site reactions  

Muscle spasms  

Asthenia  

Peripheral edema  

Neck pain  

Insomnia  

Paresthesia 

<1%: 

Hypocalcemia 

Frequency undefined: 

Atypical femoral fracture 

Osteonecrosis of the jaw 

Black Box Warning

Contraindication / Caution

Romosozumab is contraindicated in patients hypersensitive to the formulation’s active ingredient and other excipients. 

Pregnancy / Lactation

Pregnancy consideration:  

Not indicated for pregnant women. 

Breastfeeding warnings:  

Not indicated for lactating women. 

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester. 
• Category B: No evidence shows the risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women.    
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a product in humans; Pregnant women must take care of the potential risks. 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms. However, despite potential dangers may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over the benefits. The drug is not for pregnant women. 
• Category N: No data is available for the drug under this category. 

Pharmacology

Adminstartion

Patient Information Leaflet

Patient information leaflet 

Generic Name:  romosozumab 

Pronounced: ro-mo-so-zu-mab 

Why do we use romosozumab? 

Romosozumab belongs to the category of monoclonal antibodies. It treats osteoporosis in postmenopausal women.