Roxagen 20

✔️ Pharmacology

Roxadustat is an orally bioavailable HIF-PH inhibitor with potential anti-anemic properties. It works by inhibiting the enzyme HIF-PH, which typically degrades HIF transcription factors under normal oxygen levels. Inhibiting HIF-PH prevents the breakdown of HIF, promoting increased erythropoietin production, enhancing erythropoiesis, and improving iron metabolism. Roxadustat reduces hepcidin levels, improving iron availability and increasing hemoglobin levels. It also helps regulate iron metabolism, increasing serum transferrin, iron absorption, and iron release, especially in CKD patients.

Roxadustat has been shown to effectively boost red blood cell count while keeping plasma erythropoietin levels within a normal range, without the need for intravenous iron supplementation.

Roxadustat is also known to significantly reduce cholesterol levels, regardless of the use of statins or other cholesterol-lowering drugs.

✔️ Dosage & Administration of Roxagen 20

Roxadustat is taken orally three times a week, with a dose tailored to maintain hemoglobin (Hb) levels between 10-12 g/dL:

For patients not on erythropoiesis-stimulating agents:

• Starting dose: 50 mg three times weekly
• For patients weighing <100 kg: 70 mg three times a week
• For patients weighing ≥100 kg: 100 mg three times a week

For patients switching from erythropoiesis-stimulating agents:

• Starting dose: 70-100 mg three times weekly

✔️ Children: Roxagen 20

• Not recommended for use in children.

✔️ Liver Dysfunction: Roxagen 20

Roxadustat is not recommended for patients with severe liver impairment.

✔️ Missed Dose of Roxagen 20

Missed Dose: If there is more than 24 hours before the next dose, take the missed dose immediately. If less than 24 hours remain, skip the dose and take the next one on schedule. Do not take two doses on the same day.

✔️ Method of Administration:Roxagen 20

Roxadustat should be taken orally with or without food. Take the medication as per the advice of a registered healthcare provider.

✔️ Dose Adjustments: Roxagen 20

Increase or decrease the dose based on Hb levels using a stepwise adjustment (from 20 mg to 400 mg). Once adjusted, the dose should be maintained for at least 4 weeks. If Hb levels increase rapidly (>2.0 g/dL in 4 weeks), decrease the dose or suspend the medication immediately.

✔️ Overdose Effects of Roxagen 20

Overdosing may cause increased heart rate and elevated hemoglobin. Treatment may involve dose reduction or interruption. Roxadustat is not removed by dialysis.

✔️

Roxagen may interact with other medications, including:

• Phosphate binders and products with multivalent cations: Can decrease Roxagen's effectiveness. Take Roxagen at least 1 hour after these medications.
• Gemfibrozil and probenecid: May increase Roxagen's concentration in the blood, requiring dose adjustment.
• OATP1B1 or BCRP Substrates (e.g., statins): May increase Roxagen’s concentration, requiring dose adjustment.

✔️ Side Effects of Roxagen 20

Common side effects include hypertension, thrombosis (clots), diarrhea, peripheral edema, hyperkalemia, and nausea.

✔️ Pregnancy & Lactation

Roxadustat should not be used during pregnancy or breastfeeding.

✔️ Precautions & Warnings

Roxagen may increase the risk of thrombotic vascular events (TVEs) in patients with pre-existing risk factors. It should be used with caution in those with a history of seizures, liver disorders, or serious infections. Roxagen is not recommended for pregnant women.

✔️ Storage Conditions

Store below 30°C, in a dry place, away from light and moisture. Keep out of reach of children.