PARTNERSHIPS AND COMMERCIAL AGREEMENTS
Under agreement with VIVUS, Alvogen Korea (Alvogen Korea Co., Ltd.) is responsible for obtaining and maintaining regulatory approvals and sales and marketing activities in South Korea. In South Korea, Alvogen promotes QSYMIA jointly with Chong Kun Dang Pharmaceutical Corporation (CKD).
LIMITATIONS OF USE
The effect of QSYMIA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Warnings and Precautions
QSYMIA (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in QSYMIA.
QSYMIA can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during QSYMIA therapy. If a patient becomes pregnant while taking QSYMIA, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
South Korea