China's Omalizumab(注射用奥马珠单抗):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Omalizumab

As a representative drug in the field of targeted therapy, Omalizumab for Injection has transformed the traditional treatment paradigm for allergic diseases through its precise mechanism of action and proven clinical efficacy.

Indications

Omalizumab for Injection is indicated for the treatment of chronic spontaneous urticaria in adults and adolescents (aged 12 years and above) who still have symptoms despite treatment with H1 antihistamines.

Overview

Generic Name

Omalizumab for Injection,注射用奥马珠单抗

Brand Name

恩益坦

Drug Type

Rx Drug

Approval No.

国药准字S20240043

Active Ingredient

Omalizumab

Dosage Form

150mg/vial

Specification

Injection

Description

The lyophilized product is a white loose powder, and after reconstitution, it becomes a clear, colorless to pale yellow liquid, which may show slight opalescence.

Expiry Date

24 months.

Manufacturer

CSPC Megalith Biopharmaceutical Co., Ltd

Storage

Store at 2–8℃ protected from light.Do not freeze.This product must be kept out of the reach of children.

Dosage and Administration

This product should be prescribed and administered by physicians experienced in the diagnosis and treatment of chronic spontaneous urticaria.

Dosage for Chronic Spontaneous Urticaria

Omalizumab is administered subcutaneously at a dose of 150 mg or 300 mg every 4 weeks.

The optimal duration of treatment for CSU has not been established. Reassess the need for continued treatment on a regular basis.

Administration Method

For subcutaneous injection only. Intravenous or intramuscular administration is not permitted.

Subcutaneous injection should be given in the deltoid region of the upper arm. If injection in the deltoid region is not feasible for certain reasons, the injection may also be administered in the thigh.

Experience with self-injection by patients is limited. Therefore, this product is for administration only by healthcare professionals.

Contraindications

This product is contraindicated in patients with hypersensitivity to the active ingredient of omalizumab or any of its excipients.

Adverse Reactions

Infections and Infestations: Upper respiratory tract infection, urinary tract infection.

Nervous System Disorders: Sinus headache.

Musculoskeletal and Connective Tissue Disorders: Myalgia, limb pain, musculoskeletal pain.

General Disorders and Administration Site Conditions: Pyrexia.

Administration Site Reactions: Compared with placebo-treated patients, more omalizumab-treated patients experienced administration site reactions during the study. These reactions include: Swelling, erythema, pain, bruising, pruritus, hemorrhage and urticaria.

Use in Special Populations

Pregnancy and Lactation

Women of Childbearing Potential

No special recommendations are provided for women of childbearing potential.

Pregnancy

Based on pregnancy registry studies and post-marketing spontaneous reports, a sufficient number of data from pregnant women indicate no malformations or fetal/neonatal toxicity. A prospective pregnancy registry study (EXPECT) involving 250 pregnant women with asthma exposed to omalizumab showed that the prevalence of major congenital malformations was similar between the EXPECT group and disease-matched patients (moderate to severe asthma) (8.1% vs. 8.9%). However, the interpretation of these data may be affected due to methodological limitations of the study, including small sample size and non-randomized design.

Omalizumab can cross the placental barrier. Nevertheless, animal studies have demonstrated that omalizumab exerts no direct or indirect adverse effects on reproductive system toxicity.

In non-human primates, supra-clinical doses of omalizumab are associated with age-dependent thrombocytopenia, with juvenile animals showing higher relative sensitivity.

This product may be considered for use during pregnancy if clinically necessary. For pregnant women who need to use this product, the potential benefits to the mother and the potential risks to the fetus must be comprehensively weighed.

Lactation

Immunoglobulin G (IgGs) is present in human milk; therefore, omalizumab is expected to be present in human milk. Data from non-human primates have shown that omalizumab can be secreted into milk.

In the EXPECT study, data from 154 infants exposed to omalizumab during pregnancy and through breastfeeding demonstrated no adverse effects on breastfed infants. However, the interpretation of these data may be affected due to methodological limitations of the study, including small sample size and non-randomized design.

Regarding the use of this product in lactating women, it should be noted that oral intake of immunoglobulin G undergoes proteolysis in the intestinal tract, resulting in poor bioavailability. No effects on breastfed neonates/infants are anticipated. Therefore, this product may be considered for use during lactation if clinically necessary. For lactating women who need to use this product, the potential benefits to the mother and the potential risks to the neonate must be comprehensively weighed.

Fertility

No data on the effects of this product on human fertility are available. In specially designed non-clinical fertility studies (including mating studies) in non-human primates, repeated subcutaneous administration of omalizumab at doses up to 75 mg/kg/week showed no impairment of fertility in male and female animals. In addition, no genotoxic effects were observed in various non-clinical genotoxicity studies.

Pediatric Use

For chronic spontaneous urticaria, the safety and efficacy of this product in pediatric patients under 12 years of age have not been established.

Geriatric Use

Data on the use of this product in geriatric patients (aged 65 years and above) are limited, but there is no evidence indicating that geriatric patients require a different dosage from adult patients under 65 years of age.

For more detailed drug information, please consult the official package leaflet.