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OROXAT offers the convenience of oral administration1 with a three times per week tablet on non-consecutive days

The convenience of oral administration1

  • Oral treatment - does not have to be administered in hospital
  • No special storage conditions - avoiding the need for cold-chain storage

Taken three times per week, on non-consecutive days

Patients can start on the day that suits them

EXAMPLE SCHEDULE

OROXAT film-coated tablets are to be taken orally with or without food. Tablets are to be swallowed whole and not chewed, broken or crushed

  • The tablets should be taken at least 1 hour after administration of phosphate binders (except lanthanum) or other medicinal products containing multivalent cations such as calcium, iron, magnesium or aluminium
  • OROXAT does not require any special storage conditions

For further information on administration and dosing relating to OROXAT, please refer to the SmPC.

Reduced use of IV iron compared to ESA

  • Less IV iron was used in patients taking OROXAT compared to ESAs

Dosage instructions and reminders are available in our digital patient leaflet, which you can find in our patient benefits section (click below)

IV, intravenous; TIW, three times weekly..

OROXAT offers an individualised starting dose regimen for adult patients with symptomatic anaemia associated with CKD

ESA-naive patients

Body weightOROXAT dosage
<100 kg70 mg, 3x per week
≥100 kg100 mg, 3x per week

Patients converting from ESA treatment

  • Patients currently treated with an ESA can be converted to OROXAT. Conversion of dialysis patients otherwise stable on ESA treatment is only to be considered when there is a valid clinical reason
  • Conversion of non-dialysis patients otherwise stable on ESA treatment has not been investigated and should be based on a benefitrisk consideration for the individual patient.
  • The recommended starting dose of OROXAT is based on the average prescribed ESA dose in the 4 weeks before conversion The first OROXAT dose should replace the next scheduled dose of the current ESA.
Darbepoetin-alfa IV or SC dose (micrograms/week)Epoetin IV or SC dose (IU/week)Methoxy polyethylene glycol-epoetin beta IV or SC dose (micrograms/monthly)OROXAT dose (milligrams three times per week)
Less than 25Less than 5,000Less than 8070
25 to less than 405,000 up to 8,00080 up to and including 120100
40 up to and including 80More than 8,000 up to and including 16,000More than 120 up to and including 200150
More than 80More than 16,000More than 200200

Initial Hb monitoring requirements for OROXAT are similar to other treatments for adult patients with symptomatic anaemia associated with CKD

  • Hb levels should be monitored every 2 weeks until the desired Hb level of 10-12 g/dL is achieved and stabilised, and every 4 weeks thereafter, or as clinically indicated

CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; Hb, haemoglobin; IU, international units; IV, intravenous; SC, subcutaneous.

Starting patients on OROXAT

Which patients will you consider first?

Patients not on dialysis?

Patients new to dialysis?

How to start patients on OROXAT:

Treatment with OROXAT should be initiated by a physician experienced in the management of anaemia. All other causes of anaemia should be evaluated prior to initiating therapy with OROXAT and when deciding to increase the dose.

In addition to the presence of symptoms of anaemia, other clinical criteria should be considered in the evaluation of the individual patient's clinical course and condition.

Administration – key points

  • Adequate iron stores should be ensured prior to initiating treatment
  • The appropriate dose of OROXAT must be taken orally three times a week and not on consecutive days
  • The dose should be individualised to achieve and maintain target Hb levels of 10 to 12 g/dL
  • OROXAT treatment should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in Hb levels is not achieved. Alternative explanations for an inadequate response should be sought and addressed before re-starting OROXAT

ESA, erythropoiesis-stimulating agent; Hb, haemoglobin.

Reporting Adverse Events

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard  or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to SKF Pharma Ltd. on 0800 783 5018