This drug’s core ingredient is a high-purity monomeric compound extracted and enzymatically hydrolyzed from the Chinese medicinal herb Epimedium, belonging to small-molecule immunomodulatory anti-tumor drugs.
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Privacy Icaritin Soft Capsules is the world's first liver cancer drug approved on the basis of screening and enriching patient populations via peripheral blood composite biomarkers. It has filled the treatment gap for enriched populations of liver cancer patients with poor prognosis and serves as an important paradigm for the modernization and innovative development of traditional Chinese medicine.
Icaritin Soft Capsules are indicated for the treatment of patients with specific hepatocellular carcinoma (HCC). This medicine is primarily indicated for patients with unresectable hepatocellular carcinoma (HCC) who are ineligible for conventional treatment and have not received systemic therapy, who must simultaneously meet at least two of the following blood test criteria: AFP ≥ 400ng/mL; TNF-α < 2.5 pg/mL; IFN-γ ≥ 7.0pg/mL.
This medicinal product must be administered in qualified medical institutions with oncology treatment certification and taken under the full supervision and guidance of a professional physician. Prior to the initiation of treatment, patients must confirm the test results of three key biomarkers via authoritative detection methods: AFP (Alpha-Fetoprotein), TNF-α (Tumor Necrosis Factor-α), and IFN-γ (Interferon-γ).
The standard dosage regimen is to take 6 capsules twice daily. It is recommended to administer the capsules with warm water 30 minutes after breakfast and dinner. If a dose is missed and more than 2 hours have passed after a meal when the omission is noticed, the missed dose should not be made up; resume the regular dosing schedule for the next dose as usual.
Important note for patients: This medicinal product must be used in strict accordance with the indications and dosage specifications prescribed by the physician and stated in the package insert. The dosage regimen must not be adjusted arbitrarily by the patient without professional medical advice.
Not for use in patients allergic to any ingredient of this product, including: Icaritin (Chinese medicinal herb extract), corn oil, beeswax, gelatin, glycerin, titanium dioxide (pharmaceutical white coating pigment), yellow ferric oxide (pharmaceutical yellow colorant). Do not use if you have ever had an allergic reaction (e.g., rash, difficulty breathing) to any of these substances.
Main adverse reactions observed in clinical trials (incidence ≥1%) include:
Gastrointestinal disorders: Frequent defecation (diarrhea), nausea, abdominal distension, vomiting, stomach pain, difficult defecation (constipation), xerostomia, and gastrointestinal bleeding may occur.
Nutritional and metabolic disorders: Anorexia and hypophosphatemia (low phosphate levels in the blood).
Urinary system reactions: Abnormal proteins or red blood cells in urine (proteinuria, hematuria).
General disorders: Fatigue, pyrexia, weight loss, night sweats, and increased diaphoresis during the daytime.
Cardiovascular disorders: Premature cardiac contractions (supraventricular and ventricular extrasystoles).
Hematological disorders: Decreased red blood cell count (anemia).
Skin reactions: Pruritus, erythema or eczema.
Epistaxis.
Taste disturbance.
Abnormal laboratory test results: Liver function-related enzymes (AST, ALT,etc.), platelet count, white blood cell count, and T-wave changes on electrocardiogram (ECG), among others.
Serious adverse reactions (Grade ≥3) requiring special attention: Marked abnormal liver function (elevated AST), severe hypophosphatemia, marked thrombocytopenia, persistent hypertension, severe anemia, etc. Patients should promptly inform their physician of any physical discomfort, and the physician will decide whether to discontinue the drug or take corresponding measures based on the severity of the symptoms.
There are currently no clinical study data on the use of this medicinal product in pregnant and lactating women; therefore, both populations should avoid its use. Women of childbearing potential and their sexual partners must adopt reliable contraceptive measures during the treatment period.
This medicinal product is contraindicated in children and adolescents under 18 years of age, due to the lack of available data on the safety and efficacy of the drug in this age group.
Elderly patients have impaired metabolic function. The dosage regimen must be adjusted by a physician based on the patient’s individual clinical conditions, and patients must not determine the dosage and administration time on their own.
Hepatic Abnormalities: No severe liver disease patients (Child-Pugh score >7) in the study. Monitor liver function regularly; adjust dose or discontinue the drug if abnormalities occur.
Renal Abnormalities: No moderate-severe renal impairment patients (creatinine clearance <50 mL/min) in the trial. Monitor renal function and urine status regularly; adjust regimen if needed (mild proteinuria needs no treatment).
Gastrointestinal Disorders: Mild diarrhea/nausea in early medication needs no discontinuation; close monitoring for patients with severe pre-existing gastrointestinal diseases.
Hematological Abnormalities: Regular blood tests for patients with thrombocytopenia, coagulation disorders or anemia; adjust medication based on test results.
Cardiac Disorders: Regular ECG for angina/miocardial infarction patients; adjust regimen according to cardiac status.
Proliferative Diseases: Enhanced medical surveillance for mammary hyperplasia/endometrial thickening patients; adjust dose or discontinue the drug if necessary.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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