Our Products & Pipeline
Products in the Americas
VIVUS is dedicated to meeting the needs and improving quality of life of patients with serious medical conditions and life-limiting diseases.
View our approved products in the following countries.
United StatesPANCREAZE is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Warnings and Precautions
PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor.
Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.
LINKS AND RESOURCES
QSYMIA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
- Adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
- Pediatric patients aged 12 years and older with an initial BMI in the 95th percentile or greater standardized for age and sex
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. It is recommended that patients who can become pregnant obtain a negative pregnancy test result before starting QSYMIA treatment, perform monthly pregnancy testing, and use effective contraception while taking QSYMIA. 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 common adverse reactions reported in the pediatric clinical trial included depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain. The most common adverse reactions in adults are paraesthesia, dizziness, an altered or impaired sense of taste, insomnia, constipation, and dry mouth.
REMS PROGRAM
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for QSYMIA. For more information visit: QSYMIAREMS.COM.
LINKS AND RESOURCES
CanadaPANCREASE® MT (pancrelipase) capsules are indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy.
Warnings and Precautions
Pancreatic enzyme products, including PANCREASE® MT (pancrelipase) have been associated with fibrosing colonopathy (strictures of the ileo-caecum and large intestine) if given at high doses chronically to patients with cystic fibrosis. It is not clear whether this complication is caused by high dosages of pancreatic enzymes, or whether the underlying disease is responsible. Unusual abdominal symptoms should be reviewed to exclude the possibility of colonic damage, especially if the patient is taking in excess of 6,000 lipase units/kg/meal.
PANCREASE® MT cannot be substituted (unit for unit) with other pancreatic enzyme products because they are biological products and, therefore, differ in their manufacturing processes, formulations, exact composition, enzymatic activities, stability and bioactivity in the small intestine, so the response of the patient to the estimated dose must be monitored and adjusted as necessary. Special attention to the response of the patient is required during any change in treatment from one pancreatic enzyme product to another.
LINKS AND RESOURCES
Helpful Links and Resources
LOCATIONS
ABOUT VIVUS