Vafseo Dosage

Pre-Treatment and On-Treatment Evaluations of Anemia, Iron Stores, and Liver Tests

Evaluation of Anemia and Iron Stores
Correct and exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) before initiation of VAFSEO. Evaluate iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of therapy.

Measure hemoglobin (Hb) at baseline and as recommended in section 2.4.

Liver Testing
Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin prior to the initiation of VAFSEO and monthly after initiation for the first 6 months and then monitor as clinically indicated [see Warnings and Precautions (5.2)].

Discontinue VAFSEO if there are persistent ALT or AST elevations greater than 3 times upper limit of normal (ULN) or if ALT or AST elevations greater than 3 times ULN are accompanied by a bilirubin increase greater than 2 times ULN [see Warnings and Precautions (5.2)].

Important Dosing Information

Individualize dosing and use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. Do not target a hemoglobin level higher than 11 g/dL.

VAFSEO can be taken with or without food.

VAFSEO should be swallowed whole. Tablets should not be cut, crushed, or chewed.

VAFSEO can be administered without regard to the timing or type of dialysis [see Clinical Pharmacology (12.3)].

If a dose of VAFSEO is missed, it should be taken as soon as possible, unless it is the same day as the next dose. In this case, the missed dose should be skipped, and the next dose taken at the usual time. Double doses should not be taken to make-up for a missed dose.

Recommended Starting Dose of VAFSEO

Adults Not Being Treated with an ESA
The recommended starting dose is 300 mg orally once daily.

Adults Being Switched from an ESA
When converting from an ESA to VAFSEO, the recommended starting dose is 300 mg orally once daily.

Taking into account the gradual rise in Hb with VAFSEO, red blood cell (RBC) transfusions or ESA treatment may be considered during the transition phase if Hb values fall below 9 g/dL or Hb response is considered not acceptable. Patients receiving RBC transfusions should continue VAFSEO treatment during the transfusion period. VAFSEO should be paused for those patients receiving temporary ESA rescue treatment and may be resumed when Hb levels are greater than or equal to 10 g/dL. Depending on the ESA used for rescue, the pause in VAFSEO treatment should be extended to:

• 2 days after the last dose of epoetin
• 7 days after the last dose of darbepoetin alfa
• 14 days after the last dose of methoxy polyethylene glycol-epoetin beta.

Following ESA rescue, VAFSEO should be resumed at the prior dose or with a dose that is 150 mg greater than the prior dose, with subsequent titration according to the dose titration guidelines given below in this section.

Monitoring Response to Therapy and Dose Adjustment

Following initiation of therapy and after each dose adjustment, monitor hemoglobin (Hb) levels, every two weeks until stable, then monitor at least monthly [see Warnings and Precautions (5.1)].

Dose Titration
Increase the dose no more frequently than once every 4 weeks. Decreases in dose can occur more frequently.

Adjust dose in increments of 150 mg to achieve or maintain Hb levels within 10 g/dL to 11 g/dL. Doses may range from 150 mg to a maximum of 600 mg. When adjusting the dose, consider the patient’s Hb variability, Hb rate of rise and rate of decline, and VAFSEO responsiveness. A single Hb excursion may not require a dosing change.

• If the Hb rises rapidly (e.g., more than 1 g/dL in any 2-week period or more than 2 g/dL in 4 weeks), interrupt or reduce the dose.
• If the Hb level exceeds 11 g/dL, interrupt the dose of VAFSEO until Hb is less than or equal to 11 g/dL then resume with a dose that is 150 mg less than the dose prior to interruption.
• Treatment with VAFSEO should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in Hb level is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting therapy.

Dosage Adjustments Due to Drug Interactions

Oral Iron and Phosphate Binders
VAFSEO should be administered at least 1 hour before dosing oral iron supplements, products containing iron, or iron-containing phosphate binders [see Drug Interactions (7.1)].

VAFSEO should be administered at least 1 hour before or 2 hours after dosing non-iron-containing phosphate binders [see Drug Interactions (7.1)].