Apremig ODT: Each orally disintegrating tablet contains Rimegepant Sulfate INN 85.65 mg equivalent to Rimegepant 75 mg.
Apremig ODT is the preparation of Rimegepant which is a calcitonin gene-related peptide receptor antagonist. The relationship between pharmacodynamic activity and the mechanism (s) by which Apremig ODT exerts its clinical effects is unknown.
Apremig ODT should be taken in oral route. The ODT should be placed on the tongue using dry hands immediately after opening, alternatively, the ODT may be placed under the tongue. The ODT will disintegrate in saliva so that it can be swallowed without additional liquid. Do not store the ODT outside the pack for future use. Recommended dosing for acute treatment of migraine. The recommended dosage 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. Recommended dosing for preventive treatment of episodic migraine. The recommended dosage is 75 mg taken orally every other day.
Strong and moderate CYP3A4 inhibitors (itraconazole, clarithromycin, fluconazole) increase rimegepant exposure; strong and moderate CYP3A inducers (rifampin, carbamazepine, St. John's wort) decrease efficacy; P-gp and BCRP inhibitors increase plasma levels.
Rimegepant is contraindicated in patients with a history of hypersensitivity reaction to it or any other components of this product.
Common: Nausea, abdominal pain, dyspepsia. Rare: Hypersensitivity reactions (dyspnea, severe rash).
Overdose
There is limited clinical experience with overdose. Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. No specific antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be significantly removed by dialysis because of high serum protein binding.
Category C. Inadequate human data on developmental risks; use only if potential benefit justifies fetal risk. Lactation: Excretion in human milk unknown; discontinue nursing or discontinue drug.
Store below 25°C in a dry place. Protect from moisture. Keep out of reach of children.