NURTEC ODT 4 Dosage And Administration

rimegepant

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4.1 Dosing Considerations

  • Hepatic impairment:
    The use of NURTEC ODT in patients with severe hepatic impairment should be avoided (see 10.3 Pharmacokinetics). 
  • Renal impairment:
    Use of NURTEC ODT in patients with end-stage renal disease (CLcr < 15 mL/min) and those undergoing dialysis should be avoided (see 10.3 Pharmacokinetics).

4.2 Recommended Dose and Dosage Adjustment

The recommended dose is 75 mg rimegepant, as needed, once daily.

The maximum dose per day is 75 mg rimegepant. The safety of taking more than 15 doses in a 30-day period has not been established.

Geriatric population:

There is limited experience with rimegepant in patients aged 65 years or older. Clinical trials with rimegepant did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (n=131 treated with rimegepant). In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects. (see 7.1.4 Geriatrics, 10.3 Pharmacokinetics).

Hepatic impairment:

No dosage adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations of rimegepant were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment. Avoid use of NURTEC ODT in patients with severe hepatic impairment (see 7.1.5 Hepatic Impairment, 10.3 Pharmacokinetics).

Renal impairment:

No dosage adjustment is required in patients with mild, moderate, or severe renal impairment.  NURTEC ODT has not been studied, and therefore should be avoided, in patients with end-stage renal disease (CLcr < 15 mL/min) and in patients on dialysis (see 7.1.6 Renal Impairment, 10.3 Pharmacokinetics).

4.4 Administration

Instruct the patient on the following administration instructions:

  • Use dry hands when opening the blister pack.
  • Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
  • As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue.
  • The ODT will disintegrate in saliva so that it can be swallowed without additional liquid. NURTEC ODT may be taken with or without food.
  • Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.
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4 Dosage And Administration

4.1 Dosing Considerations

  • Hepatic impairment:
    The use of NURTEC ODT in patients with severe hepatic impairment should be avoided (see 10.3 Pharmacokinetics). 
  • Renal impairment:
    Use of NURTEC ODT in patients with end-stage renal disease (CLcr < 15 mL/min) and those undergoing dialysis should be avoided (see 10.3 Pharmacokinetics).

4.2 Recommended Dose and Dosage Adjustment

The recommended dose is 75 mg rimegepant, as needed, once daily.

The maximum dose per day is 75 mg rimegepant. The safety of taking more than 15 doses in a 30-day period has not been established.

Geriatric population:

There is limited experience with rimegepant in patients aged 65 years or older. Clinical trials with rimegepant did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (n=131 treated with rimegepant). In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects. (see 7.1.4 Geriatrics, 10.3 Pharmacokinetics).

Hepatic impairment:

No dosage adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations of rimegepant were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment. Avoid use of NURTEC ODT in patients with severe hepatic impairment (see 7.1.5 Hepatic Impairment, 10.3 Pharmacokinetics).

Renal impairment:

No dosage adjustment is required in patients with mild, moderate, or severe renal impairment.  NURTEC ODT has not been studied, and therefore should be avoided, in patients with end-stage renal disease (CLcr < 15 mL/min) and in patients on dialysis (see 7.1.6 Renal Impairment, 10.3 Pharmacokinetics).

4.4 Administration

Instruct the patient on the following administration instructions:

  • Use dry hands when opening the blister pack.
  • Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
  • As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue.
  • The ODT will disintegrate in saliva so that it can be swallowed without additional liquid. NURTEC ODT may be taken with or without food.
  • Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.

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