Ultresa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ultresa?

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.

What Are Side Effects of Ultresa?

Ultresa may cause serious side effects including:

hives,
difficulty breathing,
swelling of your face, lips, tongue, or throat,
joint pain or swelling,
severe or unusual stomach pain,
vomiting,
bloating,
diarrhea, and
constipation

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Ultresa include:

headache
sore throat
nosebleeds
stuffy nose
neck pain
strep infection
ear pain
swollen lymph nodes
abdominal pain
diarrhea
gas
constipation
nausea
itching, and
rash

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Ultresa

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.

What Drugs, Substances, or Supplements Interact with Ultresa?

Ultresa may interact with other drugs. Tell your doctor all medications and supplements you use.

Ultresa During Pregnancy or Breastfeeding

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.

Additional Information

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.

Ultresa Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

joint pain or swelling; or
symptoms of a rare but serious bowel disorder--severe or unusual stomach pain, vomiting, bloating, diarrhea, constipation.

Tell your doctor if your child is not growing at a normal rate while using pancrelipase.

Common side effects may include:

stomach pain, gas, vomiting;
diarrhea, frequent or abnormal bowel movements;
rectal itching;
headache, dizziness;
runny or stuffy nose, cough, sore throat; or
changes in your blood sugar.

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.

Ultresa Professional 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)

Adverse Reaction	ULTRESA n=30 n (%)	PLACEBO n=31 n (%)
Headache	2 (7%)	1 (3%)
Pharyngolaryngeal Pain	2 (7%)	1 (3%)
Epistaxis	2 (7%)	0

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.

Adverse reactions that occurred during treatment with ULTRESA were nasal congestion (14%), neck pain (14%), beta-hemolytic streptococcal infection (11%), ear pain (11%), and lymphadenopathy (11%).

Postmarketing Experience

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)

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