RYBREVANT FASPRO™ Receives FDA Approval for First-Line EGFR-Mutated NSCLC
December 26, 2025
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Brand Name :
Xolair Prefilled Syringe, Xolair
Synonyms :
omalizumab
Class :
Anti-asthmatic, monoclonal antibody
Brand Name :
Xolair Prefilled Syringe, Xolair
Synonyms :
omalizumab
Class :
Anti-asthmatic, monoclonal antibody
Dosage Forms & Strengths
Injection
Single-dose prefilled syringe
75mg/0.5ml
150mg/ml
Reconstitution of lyophilized powder
150mg/vial
125mg/ml
150 - 375
mg
Subcutaneous (SC)
every 2-4 weeks
150 - 375
mg
Subcutaneous (SC)
every 2-4 weeks
Dosage Forms & Strengths
Injection
Single-dose prefilled syringe
75mg/0.5ml
150mg/ml
Reconstitution of lyophilized powder
150mg/vial
125mg/ml
<6 years: Safety and efficacy not established
6 to <12 years: 75-375mg subcutaneous every 2-4 weeks
≥12 years: 150-375mg subcutaneous every 2-4 weeks
<12 years: Safety and efficacy not established
≥12 years: 150-300mg subcutaneous every four weeks
may increase the toxic effects of each other
it may decrease the therapeutic effect of Fc Receptor-Binding Agents
Frequency defined:
>10%
Reaction at the site of injection
Headache
1-10%
Nasal polyps
Upper abdominal pain
Dizziness
Headache
Arthralgia
Injection site reaction
Chronic urticaria
Nausea
Sinusitis
Nasopharyngitis
Upper respiratory tract infection
Pain
Dizziness
Earache
Dermatitis
Fracture
Arthralgia
Leg pain
Fatigue
Pruritis
Arm pain
Pregnancy consideration: A
Lactation: Excretion of the drug in breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Patient information leaflet
Generic Name: Omalizumab
Pronounced: [ OH-ma-LIZ-oo-mab]
Why do we use Omalizumab?
It is used to treat and reduce allergic reactions in the body like chronic hives, nasal polyps, and asthma
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