"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Ultresa Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Ultresa (pancrelipase) is a pancreatic enzyme replacement therapy (a combination of three different enzymes) used in people with cystic fibrosis and certain other conditions to help the body absorb essential vitamins and nutrients. Ultresa is not available as a generic. The most common side effects of Ultresa include headache, throat pain and nosebleeds.
Ultresa is available in capsules containing strengths of 13,800 USP units of lipase; 27,600 USP units of protease; 27,600 USP units of amylase or in capsules containing 20,700 USP units of lipase or in capsules of 41,400 USP units of protease; 41,400 USP units of amylase. The capsules should be swallowed whole, not chewed. Dosing in children and adults is based on the patient's weight; enzyme doses are expressed as lipase units/kg of body weight per meal and should be determined by the prescribing doctor. Ultresa may cause serious side effects, including fibrosing colonopathy and irritation inside of the mouth if it is not swallowed completely. Patients should inform their doctors if they are pregnant or planning to become pregnant. It is not known if Ultresa will harm unborn babies. Women should tell their doctors if they are breastfeeding or planning to breastfeed. It is not known is Ultresa passes into breast milk. The patient and her doctor should decide whether to take Ultresa or breastfeed. Patients should not do both. Ultresa is approved for use in children 12 months or older and adults.
Our Ultresa Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ultresa FDA Prescribing Information: Side Effects
The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The short-term safety of ULTRESA was assessed in two clinical trials conducted in 40 patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). Study 1 was conducted in 31 patients, ages 8 years to 37 years; Study 2 was conducted in 9 patients, ages 7 years to 11 years.
Study 1 was a randomized, double-blind, placebo-controlled, crossover study of 31 patients, ages 8 to 37 years, with EPI due to CF. In this study, patients were randomized to receive ULTRESA at doses not to exceed 2,500 lipase units per kilogram per meal or matching placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 7 days. The mean daily dose of ULTRESA was 6,270 lipase units per kilogram body weight per day. The mean exposure to ULTRESA during this study was 5.4 days.
The most common adverse reactions ( ≥ 7%) were headache, pharyngolaryngeal pain, and epistaxis. Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 7%) treated with ULTRESA at a higher rate than with placebo in Study 1.
TABLE 1 : Adverse Reactions Occurring in at Least 2
Patients ( ≥ 7%) in Cystic Fibrosis (Study 1)
|Headache||2 (7%)||1 (3%)|
|Pharyngolaryngeal Pain||2 (7%)||1 (3%)|
Study 2 was an open-label study of 9 patients, ages 7 years to 11 years, with EPI due to CF. After a screening period of up to 15 days on individually-titrated doses of ULTRESA not to exceed 2,500 lipase units per kilogram per meal, patients entered a washout phase (no treatment) of up to 7 days before returning to a treatment phase of up to 12 days on the same individually-titrated dose of ULTRESA. Two patients discontinued during the washout phase leaving 7 patients in the treatment phase. The mean daily dose of ULTRESA was 6,361 lipase units per kilogram body weight per day during the last 4 days of the screening phase, and was 6,846 lipase units per kilogram body weight per day during the treatment phase. The mean duration of the treatment phase was 5.7 days.
Postmarketing data for ULTRESA has been available since 2003. The safety data is similar to that described below. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Pancreatic enzyme products (delayed and immediate-release) with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse events included fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus. The most commonly reported adverse events were gastrointestinal disorders, including abdominal pain, diarrhea, flatulence, constipation and nausea, and skin disorders including pruritus, urticaria and rash.
Read the entire FDA prescribing information for Ultresa (Pancrelipase) »
Additional Ultresa Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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