Apremig ODT^®

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.

No Data

Apremig ODT is indicated for-
• Acute treatment of migraine with or without aura in adults.
• Preventive treatment of episodic migraine in adults.

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.

Pregnancy: There are no adequate data on the developmental risk associated with the use of rimegepant in pregnant women. 

Lactation: There are no data on the effects of rimegepant on a breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this drug and any potential adverse effects on the breastfed infant from it or from the underlying maternal condition.

Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established.

Severe hypersensitivity reactions have included dyspnea and rash, and can occur days after administration. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy.

The most common side effects are nausea, hypersensitivity including dyspnea and severe rash, abdominal pain and dyspepsia.

Rimegepant is contraindicated in patients with a history of hypersensitivity reaction to it or any other components of this product.

Concomitant administration with strong inhibitors of CYP3A4 results in a significant increase in rimegepant exposure. Concomitant administration with strong or moderate inducers of CYP3A can result in a significant reduction in rimegepant exposure, which may lead to loss of efficacy of this drug. Concomitant administration with potent inhibitors of P-gp (e.g., amiodarone, cyclosporine, lapatinib, quinidine, ranolazine) may result in increased exposure of rimegepant.

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.

No Data

No Data

Each orally disintegrating tablet contains Rimegepant Sulfate INN 85.65 mg equivalent to Rimegepant 75 mg.

Store in a cool (below 25⁰ C) and dry place protected from light. Keep away from the reach of children.

Apremig ODT: Carton of 8 tablets in blister pack.