Hemadus 20 Tablet

✔️ Side Effects

• Hypertension
• Vascular access thrombosis
• Diarrhea
• Peripheral edema
• Increased blood potassium levels (hyperkalemia)
• Nausea

✔️ Overdose

Possible Symptoms

An excessive dose of Hemadus may cause hemoglobin levels to rise more than intended. A temporary increase in heart rate has also been reported following administration of a high dose in a healthy adult.

Management

If an overdose is suspected, appropriate medical management may include dose reduction or temporary interruption of treatment, depending on the patient's hemoglobin level and clinical condition.

Roxadustat is not removed by dialysis.

✔️ Dosage and Administration

Roxadustat should be taken orally three times a week on non-consecutive days. The dose is individualized according to the patient's condition and hemoglobin response. The treatment goal is generally to maintain hemoglobin within the target range specified by the prescribing physician.

Patients Not Receiving Erythropoiesis-Stimulating Agents

For adults who are not currently receiving erythropoiesis-stimulating agent (ESA) therapy, the starting dose may be selected according to body weight and clinical circumstances.

The commonly recommended starting doses include:

• Less than 100 kg: 70 mg three times weekly
• 100 kg or more: 100 mg three times weekly

Some treatment protocols may use 50 mg three times weekly as an initial dose depending on the patient's clinical situation.

Patients Switching From ESA Treatment

For adults changing from erythropoiesis-stimulating agent therapy, the usual starting dose may be 70 mg or 100 mg three times weekly, depending on the previous ESA treatment and the patient's clinical condition.

The dose should subsequently be adjusted based on hemoglobin response.

Dose Adjustment

Dose adjustments should be made according to the patient's hemoglobin level and response to treatment. After a dose adjustment, the new dose should generally be maintained for at least 4 weeks before another adjustment is considered, unless a clinically important change requires earlier action.

If hemoglobin rises rapidly, particularly by more than 2 g/dL within 4 weeks following a dose increase, the dose should be reduced or treatment temporarily interrupted according to the prescribing guidelines.

Available dose steps may include:

20 mg → 40 mg → 50 mg → 70 mg → 100 mg → 150 mg → 200 mg → 250 mg → 300 mg → 400 mg

The 400 mg dose is intended only for appropriate CKD patients receiving dialysis.

Dose adjustments should always be made under medical supervision.

Missed Dose

If there are 24 hours or more remaining before the next scheduled dose, take the missed dose as soon as you remember and then continue according to your usual schedule.

If the next scheduled dose is due in less than 24 hours, skip the missed dose and take the next dose at the regular time.

Do not take two doses on the same day.

How to Take Hemadus

Hemadus tablets are taken orally and may be taken with or without food. Swallow the tablet with water and follow the dosing schedule provided by your doctor.

✔️ Drug Interaction

Hemadus may interact with certain medicines and supplements.

Phosphate Binders and Multivalent Cation Products

Phosphate binders and products containing multivalent cations may significantly reduce roxadustat absorption.

Therefore, Hemadus should generally be taken at least 1 hour after phosphate binders or other medicines/supplements containing multivalent cations.

Note: Lanthanum carbonate is an exception to this interaction.

Gemfibrozil and Probenecid

Gemfibrozil and probenecid can increase exposure to roxadustat.

• Gemfibrozil may increase roxadustat exposure by approximately 2.3-fold.
• Probenecid may also increase roxadustat exposure.

If these medicines are used together, the Hemadus dose may need adjustment based on hemoglobin monitoring.

OATP1B1 or BCRP Substrates

Roxadustat may increase the exposure of certain medicines that are substrates of OATP1B1 or BCRP transporters, including:

• Simvastatin
• Rosuvastatin
• Atorvastatin

Patients taking these medicines may require appropriate monitoring and dose adjustment according to the prescribing physician's recommendations.

✔️ Pregnancy & Lactation

Hemadus should not be initiated during pregnancy and is contraindicated during pregnancy according to the provided prescribing information.

Roxadustat is also contraindicated during breastfeeding. Women who may become pregnant should discuss appropriate treatment and contraception with their healthcare provider before starting therapy.

✔️ Precautions & Warnings

Hemadus should be used cautiously in patients who have risk factors for thrombotic vascular events (TVEs). The risk may be higher in individuals with factors such as obesity or a previous history of thrombotic events.

Use with caution in patients with a history of seizures.

Treatment should not be initiated or continued without appropriate medical assessment in patients with serious signs or symptoms of infection.

Hemadus should not be used in patients with significant liver disease, and it is not recommended for individuals with severe hepatic impairment.

Pregnancy should be excluded before treatment is initiated when clinically appropriate.

✔️ Storage:

• Store below 30°C.
• Keep in a cool and dry place.
• Protect from direct light and moisture.
• Keep out of reach and sight of children.
• Do not use the medicine after the expiry date or if the packaging is damaged.