1. Indications and Usage
\nPrimary Hypercholesterolemia: Adjunct to diet and statin therapy (or other lipid-lowering therapies) for adult patients with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) who have not achieved their LDL-C goals with moderate or high doses of statins.
\n2. Dosage and Administration
\nRoute of Administration: For Subcutaneous (SC) Injection ONLY.
\nRecommended Dosage: 150 mg administered once every 4 weeks or once every 8 weeks.
\nCritical Administration Instructions:
\nReconstitution: Reconstitute each 150 mg vial with 1 mL Sterile Water for Injection. Gently swirl for approximately 6-8 minutes until dissolved. The solution should be clear to pale yellow.
\nInspection: Visually inspect the solution; discard if particulates or discoloration are observed.
\nInjection Sites: Administer in the abdomen, thigh, or upper arm. Rotate injection sites as needed.
\n3. Mechanism of Action
\nPCSK9 Inhibition: Recaticimab is a monoclonal antibody that specifically binds to Proprotein Convertase Subtilisin\/Kexin type 9 (PCSK9).
\nLDL-R Protection: By inhibiting PCSK9, it prevents PCSK9 from binding to low-density lipoprotein receptors (LDL-R) on hepatocyte surfaces, thereby protecting LDL-R from lysosomal degradation.
\nCholesterol Clearance: This allows for increased recycling of LDL-R to the cell surface, enhancing the clearance of low-density lipoprotein cholesterol (LDL-C) from the bloodstream.
\n4. Safety and Warnings
\nHypersensitivity: Serious allergic reactions (e.g., rash, urticaria, angioedema) have been reported. The drug must be discontinued immediately if severe hypersensitivity occurs.
\nAnti-Drug Antibodies: As with all biologics, the development of anti-drug antibodies may occur, though clinical impact remains low.
\n5. Adverse Reactions and Clinical Research
\nMost Common Adverse Reactions: Injection site reactions (pain, erythema, swelling), upper respiratory tract infection, rhinitis, and arthralgia.
\nClinical Research Highlights: Phase 3 trials (e.g., RECITE study) demonstrated that Recaticimab significantly reduced LDL-C levels compared to placebo, with durable efficacy supporting 4-week or 8-week dosing intervals.
\n6. Drug Interactions
\nLipid-Lowering Agents: No significant pharmacokinetic interactions with statins or ezetimibe are expected, though they are commonly co-administered.
\nVaccines: Live or attenuated vaccines should be avoided.
\n7. Pharmaceutical Information
\nChemical Composition: Active Ingredient: Recaticimab. Excipients: Sucrose, Polysorbate 80, Histidine, and Histidine Hydrochloride.
\nAppearance: White to off-white lyophilized cake or powder.
\nPackaging: Single-use vial (150 mg).
\nStorage: Store in the original carton at 2\u00b0C to 8\u00b0C. Do not freeze.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u827e\u5fc3\u5b89 \u00ae\uff08Aixinan\u00ae\uff09
\nGeneric Name: Recaticimab
\nStrength: 150 mg per vial, 1 vial per box
\nManufacturer: Suzhou Sundia Biopharmaceutical Co., Ltd.
\nMarketing Authorization Holder: Jiangsu Hengrui Medicine Co., Ltd. (Guangdong Hengrui Pharmaceutical Co., Ltd.)
\nApproval Date in China: January 10, 2025
\nRegistration Number:\u56fd\u836f\u51c6\u5b57 S20250002
\nStorage: Store unopened vials at 2\u00b0C\u20138\u00b0C, protected from light; do not freeze. After reconstitution, the solution can be stored for maximum 24 hours at 2\u00b0C\u20138\u00b0C or 4 hours at room temperature (including administration time). Refer to the full package insert for detailed storage specifications.<\/p>\n
Price&Cost:Contact Us now for the best price of Recaticimab\uff08Aixinan\uff09<\/p>\n","protected":false},"featured_media":4526,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[94],"product_cat":[25,73],"product_tag":[],"class_list":["post-4525","product","type-product","status-publish","has-post-thumbnail","product_brand-heng-rui","product_cat-injection","product_cat-chinese-innovative-drug","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n