IMPORTANT SAFETY INFORMATION

Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.

Hyperuricemia has been reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.

Irritation of the oral mucosa may occur due to loss of protective enteric coating on the capsule contents.

The presence of porcine viruses that might infect humans cannot be definitely excluded.

Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.

The most common side effects of PANCREAZE include blurred vision, abdominal pain, flatulence, constipation, nausea, pruritus, asymptomatic elevations of liver enzymes, myalgia, muscle spasm, urticaria and rash.

Please see the PANCREAZE Medication Guide and Full Prescribing Information.

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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.

IMPORTANT SAFETY INFORMATION

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 (MAOIs); or in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines, topiramate, or any of the inactive ingredients in QSYMIA.

QSYMIA can cause fetal harm. Pregnancy testing is recommended before initiating QSYMIA treatment in patients who can become pregnant and monthly during QSYMIA therapy. Advise patients who can become pregnant of the potential risk to a fetus and to use effective contraception during QSYMIA therapy.

Acute myopia and secondary angle closure glaucoma have been reported. Immediately discontinue QSYMIA if symptoms develop. Consider QSYMIA discontinuation if visual field defects occur.

QSYMIA is associated with a reduction in height velocity (centimeters of height gained per year) in obese pediatric patients 12 to 17 years of age. Monitor height velocity in pediatric patients treated with QSYMIA.

Consider dosage reduction or discontinuation of QSYMIA if pediatric patients are not growing or gaining height as expected.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity has been reported in patients taking topiramate. QSYMIA should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with topiramate in the postmarketing setting. If a hypersensitivity reaction occurs, discontinue QSYMIA and initiate appropriate therapy.

The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, in adults include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Common side effects in pediatric patients aged 12 years and older at ≥4% and greater than placebo include depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain.

Please see the QSYMIA Medication Guide and Full Prescribing Information.

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.

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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.

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