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Roxadustat largely breaks through the usage constraints of traditional injectable anti-anemia drugs, boosts patients' medication adherence, and has been approved for marketing in the EU, Japan, South Korea and many other countries and regions.
AuthenticGuaranteeFast DeliveryPrivacy Roxadustat Capsules is a China's innovative Class 1 new drug and the world's first oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI). It was approved for global marketing with its first approval in China in 2018, marking a landmark achievement of the "Three Firsts" breakthrough (First-in-class R&D, first domestic production, first market launch) in China's pharmaceutical industry.
Roxadustat Capsules are indicated for the treatment of anemia associated with chronic kidney disease (CKD) in patients, including dialysis and non-dialysis patients.
Initiation of treatment with Roxadustat Capsules should be conducted under the supervision of a qualified healthcare professional.
Initial dosage is selected based on body weight: for dialysis patients, 100 mg per dose (for body weight 45–60kg) or 120mg per dose (for body weight ≥ 60kg); for non-dialysis patients, 70mg per dose (for body weight 40–60kg) or 100 mg per dose (for body weight ≥ 60kg). The drug is administered orally, three times a week (TIW).
Clinical studies have shown that food does not significantly affect the exposure of roxadustat, thus the capsules may be taken on an empty stomach or with food. For patients undergoing hemodialysis or peritoneal dialysis, roxadustat may be administered at any time before or after dialysis treatment.
If a dose is missed, do not make up the missed dose; continue to take the next dose as originally scheduled.
Roxadustat is contraindicated in the following patients:
Pregnant and lactating women.
Patients with known hypersensitivity to the active ingredient or any excipients of this product.
Ocular disorders: Eyelid edema may occur.
Gastrointestinal disorders: Including abdominal distension, mild epigastric pain, acid regurgitation, increased hiccups, nausea and vomiting.
General disorders: Fatigue, chest tightness (unrelated to cardiac causes).
Immune system reactions: Allergic reactions may occur.
Infection-related risks: Pulmonary infection, worsened cold symptoms.
Vascular-related complications: Occlusion or thrombosis may occur in arteriovenous fistulas for dialysis.
Abnormal laboratory test results: Elevations may occur in liver function parameters (ALT/AST), blood glucose and white blood cell count.
Metabolic changes: Anorexia, elevated serum potassium levels.
Nervous system reactions: Dizziness.
Sleep disturbances: Difficulty falling asleep or poor sleep quality.
Respiratory system reactions: Frequent hiccups.
Skin reactions: Pruritus.
Cardiovascular reactions: Elevated blood pressure.
Pregnancy
Clinical trials of roxadustat have not been conducted in pregnant women. Reproductive toxicity studies in animals demonstrated that roxadustat reduces the body weight of embryos and offspring. Therefore, roxadustat is contraindicated in pregnant women. Women of childbearing potential should use effective contraceptive measures during treatment and for 7 days after the last dose of roxadustat.
Lactation
It is not known whether roxadustat is excreted in human milk. A study in rats showed that roxadustat is excreted in breast milk, and this exposure may result in increased mortality, retarded growth and delayed development in rat pups. Therefore, roxadustat is contraindicated in lactating women.
The safety and efficacy of roxadustat have not been established in patients below 18 years of age.
No dose adjustment based on age is required for patients aged 65 years and older. An analysis of hemoglobin levels and roxadustat doses was performed in subjects aged ≥65 years and <65 years enrolled in Studies FGCL-4592-806 and FGCL-4592-808. The results showed no significant differences in hemoglobin levels and roxadustat doses between the two age groups.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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