XENICAL® (orlistat) logo

Drug Safety & Medical Communications

For Drug Safety and Medical Communications, please contact INTEGRATED THERAPEUTIC SOLUTIONS INC at the number: 1-888-236-5445.

Product Complaints

Please contact info@h2-pharma.com for any product complaint.

Ordering Questions

Please contact orders@h2-pharma.com for any ordering question.

FULL PRESCRIBING INFORMATION

Indication

XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).

Important Safety Information

XENICAL is contraindicated in patients:

Warnings and Precautions:

It is not known if XENICAL is present in human milk. Caution should be exercised when XENICAL is administered to a nursing woman.

The most commonly observed adverse events (incidence of ≥5% and twice that of placebo) were oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. In general, the first occurrence of these events was within 3 months of starting therapy.

Overall, approximately 50% of all episodes of GI adverse events associated with XENICAL treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Patients and caregivers may also report side effects to the Safety Call Center at 1-888-236-5445.

CHEPLAPHARM is a family-owned pharmaceutical company, headquartered in Germany. We offer our branded products on a global level. By focusing on an internationally oriented Buy and Build Strategy, we generate annually increasing growth rates. The close collaboration with our business partners and our international subsidiaries allows CHEPLAPHARM to successfully realize its corporate strategy.
H2-Pharma, LLC is a privately owned and operated pharmaceutical company focused on the sales, marketing and development of branded and generic pharmaceuticals. H2‐Pharma has the experience and distribution infrastructure to market and distribute products across the spectrum, and do so with a level of personal service that is unmatched in the industry.