Sylvia ODT Dispersible Tablet

Acute Treatment of Migraine: Sylvia ODT ODT is indicated for the acute treatment of migraine with or without aura in adults.
 
Preventive Treatment of Episodic Migraine: Sylvia ODT ODT is indicated for the preventive treatment of episodic migraine in adults.

Rimegepant is a calcitonin gene-related peptide receptor antagonist. The relationship between pharmacodynamic activity and the mechanism(s) by which rimegepant exerts its clinical effects is unknown. No clinically relevant differences in resting blood pressure were observed when rimegepant was concomitantly administered with sumatriptan (12 mg subcutaneous, given as two 6 mg doses separated by one hour) compared with sumatriptan alone to healthy volunteers.

Acute Treatment of Migraine: The recommended dose of Rimegepant ODT is 75 mg taken orally, as needed. The maximum dose in a 24-hour period is 75 mg. The safety of using more than 18 doses in a 30-day period has not been established.
 
Preventive Treatment of Episodic Migraine: The recommended dosage of Rimegepant ODT is 75 mg taken orally every other day.
 
Administration Information: 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.
• Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.

Concomitant Administration with Strong or Moderate CYP3A4 Inhibitors: Avoid concomitant administration of Rimegepant ODT with strong inhibitors of CYP3A4. Avoid another dose of Rimegepant ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4.

Concomitant Administration with Strong or Moderate CYP3A Inducers: Avoid concomitant administration of Rimegepant ODT with strong or moderate inducers of CYP3A, which may lead to loss of efficacy of Rimegepant ODT.
 
Concomitant Administration with Potent Inhibitors of P-gp Avoid another dose of Rimegepant ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp

CYP3A4 Inhibitors: Concomitant administration of Sylvia ODT ODT with strong inhibitors of CYP3A4 results in a significant increase in Sylvia ODT exposure. Avoid concomitant administration of Sylvia ODT ODT with strong inhibitors of CYP3A4. Concomitant administration of Sylvia ODT ODT with moderate inhibitors of CYP3A4 may result in increased exposure of Sylvia ODT. Avoid another dose of Sylvia ODT ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4.
 
CYP3A Inducers: Concomitant administration of Sylvia ODT ODT with strong or moderate inducers of CYP3A can result in a significant reduction in Sylvia ODT exposure, which may lead to loss of efficacy of Sylvia ODT ODT. Avoid concomitant administration of Sylvia ODT ODT with strong or moderate inducers of CYP3A.
 
P-gp Inhibitors: Concomitant administration of Sylvia ODT ODT with potent inhibitors of P-gp (e.g., amiodarone, cyclosporine, lapatinib, quinidine, ranolazine) may result in increased exposure of Sylvia ODT. Avoid another dose of Sylvia ODT ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp

Rimegepant ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, Rimegepant ODT, or any of its components. Delayed serious hypersensitivity has occurred.

Acute treatment of migraine: the adverse reaction reported in ≥1% of patients treated with Sylvia ODT ODT is nausea.

Preventive treatment of episodic migraine: adverse reactions reported in ≥2% for Sylvia ODT and ≥ 1% higher than placebo are nausea and abdominal pain/dyspepsia.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
 
Geriatric Use: In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects. Clinical studies of NURTEC ODT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
 
Hepatic Impairment: No dosage adjustment of Sylvia ODT ODT is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations of Sylvia ODT were significantly higher in subjects with severe (Child-Pugh C) hepatic impairment. Avoid use of NURTEC ODT in patients with severe hepatic impairment
 
Renal Impairment: No dosage adjustment of Sylvia ODT ODT is required in patients with mild, moderate, or severe renal impairment. Sylvia ODT ODT has not been studied in patients with end-stage renal disease and in patients on dialysis. Avoid use of NURTEC ODT in patients with end-stage renal disease (ClCr<15 mL/min)

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.