trokendi xr approved for migraine treatment

Dosing & Conversion

Trokendi XR® delivers once-daily treatment that offers seamless conversion from Topamax® (topiramate)1

Once-daily Trokendi XR and twice-daily Topamax—bioequivalent at all doses1,2

converting treatment with topiramate 50 mg 25 mg 100mg or 200 mg

Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.

Dosing Considerations3

Administration with alcohol

Alcohol use should be completely avoided within 6 hours prior to and 6 hours after Trokendi XR administration.

Dose modifications in patients with renal impairment

In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose. Prior to dosing, obtain an estimated GFR measurement in patients at high risk for renal insufficiency (eg, older patients or those with diabetes mellitus, hypertension, or autoimmune disease).

Dosage modifications in patients undergoing hemodialysis

Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in patients with normal renal function. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an antiseizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account the:

  • Duration of the dialysis period
  • Clearance rate of the dialysis system being used
  • Effective renal clearance of topiramate in the patient being dialyzed

Laboratory testing prior to treatment initiation

Measurement of baseline and periodic serum bicarbonate during Trokendi XR treatment is recommended.

Dosing modifications in patients taking phenytoin and/or carbamazepine

The coadministration of Trokendi XR with phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with Trokendi XR may require adjustment of the dose of Trokendi XR.

Monitoring for therapeutic blood levels

It is not necessary to monitor topiramate plasma concentrations to optimize Trokendi XR therapy.

Administration instructions

Trokendi XR may be taken without regard to meals. Swallow capsule whole and intact. Do not sprinkle on food, chew, or crush.

Contraindications

Trokendi XR is contraindicated in patients with recent alcohol use (within 6 hours prior to and 6 hours after Trokendi XR use), and also in patients with metabolic acidosis who are taking concomitant metformin.

GFR = glomerular filtration rate.

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