1. Indications and Usage
\nParoxysmal Nocturnal Hemoglobinuria (PNH):
\nTreatment of adult patients with PNH.
\nIgA Nephropathy (IgAN):
\nTreatment to reduce proteinuria and slow the decline in estimated glomerular filtration rate (eGFR) in adults at risk of rapid disease progression.
\nC3 Glomerulopathy (C3G):
\nTreatment of adults with C3G, including C3 glomerulonephritis and dense deposit disease.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Oral Use ONLY.
\nRecommended Dosage:
\nStandard Dose: 200 mg taken orally twice daily.
\nAdministration:
\nSwallow capsules whole; do not open, crush, or chew.
\nCan be taken with or without food.
\nMissed Dose: If a dose is missed, take it as soon as remembered unless it is close to the next scheduled dose. Do not double the dose to make up for a missed one.
\nSpecial Populations:
\nRenal Impairment: Not recommended for patients with severe renal impairment (eGFR <30 mL\/min\/1.73 m\u00b2).
\nHepatic Impairment: Not recommended for patients with severe hepatic impairment (Child-Pugh C).
\n3. Mechanism of Action
\nComplement Factor B Inhibition:
\nIptacopan is a small molecule that binds directly and reversibly to Complement Factor B.
\nPathway Modulation:
\nBy inhibiting Factor B, iptacopan prevents the formation of the alternative pathway C3 convertase, thereby reducing downstream effector generation and terminal complement amplification.
\nDual Control in PNH:
\nIt controls both intravascular hemolysis (mediated by Membrane Attack Complex) and extravascular hemolysis (mediated by C3b opsonization) by acting proximally in the complement cascade.
\n4. Safety and Warnings
\nSerious Infections (Boxed Warning):
\nIptacopan increases the risk of serious or fatal infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.
\nVaccination Requirements:
\nPatients must be vaccinated against encapsulated bacteria according to current clinical guidelines prior to initiating treatment.
\nContraindications:
\nActive serious infection caused by encapsulated bacteria.
\nHistory of hypersensitivity to iptacopan or any excipients.
\nMonitoring:
\nMonitor for signs and symptoms of hemolysis if treatment is discontinued. Close monitoring is required for at least 2 weeks after stopping therapy in PNH patients.
\n5. Adverse Reactions
\nMost Common (PNH):
\nHeadache, nasopharyngitis, diarrhea, abdominal pain, nausea, bacterial infections, viral infections, rash, and decreased platelet count.
\nMost Common (IgA Nephropathy):
\nUpper respiratory tract infections, dyslipidemia, and abdominal pain.
\nMost Common (C3G):
\nNasopharyngitis and viral infections.
\nLaboratory Abnormalities:
\nDecreased platelet count, increased cholesterol\/lipids, and elevated liver enzymes have been observed.
\n6. Drug Interactions
\nCYP2C8 Substrates\/Inducers\/Inhibitors:
\nIptacopan is metabolized primarily by CYP2C8.
\nStrong CYP2C8 Inducers (e.g., Rifampin): May significantly decrease iptacopan exposure, leading to reduced efficacy. Avoid concomitant use or monitor closely.
\nStrong CYP2C8 Inhibitors (e.g., Gemfibrozil): May increase iptacopan exposure, increasing the risk of adverse reactions. Avoid concomitant use or consider dose reduction.
\nOral Contraceptives:
\nInteraction has not been fully established; additional non-hormonal contraception is recommended for women of childbearing potential.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Iptacopan hydrochloride.
\nAvailable Strength: 200 mg capsules.
\nAppearance:
\nLight yellow opaque hard gelatin capsule, printed with “LNP200” on the body and “NVR” on the cap.
\nStorage:
\nStore at 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F); excursions permitted between 15\u00b0C and 30\u00b0C (59\u00b0F and 86\u00b0F).
\nKeep in the original package to protect from moisture.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u98de\u8d6b\u8fbe \u00ae(Fabhalta\u00ae )
\nGeneric Name: Iptacopan Hydrochloride
\nStrength: 200 mg per capsule
\nManufacturer: Novartis Pharma Stein AG (Switzerland)
\nMarketing Authorization Holder: Novartis Pharma Schweiz AG; Domestic filing entity: Beijing Novartis Pharma Co., Ltd.
\nApproval Date in China: April 24, 2024
\nRegistration Number: \u56fd\u836f\u51c6\u5b57HJ20240016
\nStorage: Store at 25\u00b0C (77\u00b0F); excursions permitted to 15\u201330\u00b0C (59\u201386\u00b0F). Keep the bottle tightly closed to protect from moisture. Refer to the package insert for detailed storage and handling instructions.<\/p>\n
Price&Cost:Contact Us now for the best price of Iptacopan Hydrochloride \uff08Fabhalta\uff09<\/p>\n","protected":false},"featured_media":4052,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[80],"product_cat":[26],"product_tag":[],"class_list":["post-4051","product","type-product","status-publish","has-post-thumbnail","product_brand-novartis","product_cat-capsules","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n