Daclizumab Side Effects

Some side effects of daclizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to daclizumab: intravenous solution

There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

If you experience a serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to daclizumab, seek emergency medical attention.

Other, less serious side effects may also occur. Continue to use daclizumab and notify your doctor if you experience

• upset stomach, nausea, or vomiting;

• diarrhea or constipation;

• tremor or dizziness;

• headache; or

• swelling of the hands, feet or legs.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to daclizumab: intravenous solution

Gastrointestinal

Gastrointestinal side effects including constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, and epigastric pain (not food related) have been reported in at least 5% of patients. Flatulence, gastritis, and hemorrhoids have been reported in between 2% and 5% of patients.

Metabolic

The manufacturer has reported that 32% of 88 daclizumab treated patients had high fasting glucose values compared to 16% of 64 placebo treated patients. Most of these high values occurred either on the first day post-transplant when patients received high doses of corticosteroids or in patients with diabetes.

Metabolic side effects including edema and edema of the extremities have been reported in at least 5% of patients. Fluid overload, diabetes mellitus, and dehydration have been reported in between 2% and 5% of patients.

Nervous system

Nervous system side effects including tremor, headache, dizziness, hypertension, hypotension, and aggravated hypertension have been reported in at least 5% of patients. Leg cramps and prickly sensation have been reported in between 2% and 5% of patients.

Genitourinary

Genitourinary side effects including oliguria, dysuria, and renal tubular necrosis have been reported in at least 5% of patients. Renal damage, urinary retention, hydronephrosis, urinary tract bleeding, urinary tract disorder, and renal insufficiency have been reported in between 2% and 5% of patients.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported both on initial exposure and following reexposure to daclizumab.

It is recommended that medications used in the treatment of severe hypersensitivity reactions be available for immediate use. If a severe hypersensitivity reaction occurs, therapy with daclizumab should be permanently discontinued.

General

General side effects including posttraumatic pain, insomnia, chest pain, fever, pain, and fatigue have been reported in at least 5% of patients. Shivering and generalized weakness have been reported in between 2% and 5% of patients.

Respiratory

Respiratory side effects including dyspnea, pulmonary edema, and coughing have been reported in at least 5% of patients. Atelectasis, congestion, pharyngitis, rhinitis, hypoxia, rales, abnormal breath sounds, and pleural effusion have been reported in between 2% and 5% of patients.

Dermatologic

Dermatologic side effects including impaired wound healing without infection and acne have been reported in at least 5% of patients. Pruritus, hirsutism, rash, night sweats, and increased sweating have been reported in between 2% and 5% of patients.

Musculoskeletal

Musculoskeletal side effects including musculoskeletal pain and back pain have been reported in at least 5% of patients. Arthralgia and myalgia have been reported in between 2% and 5% of patients.

Cardiovascular

Cardiovascular side effects including tachycardia have been reported in at least 5% of patients.

Hematologic

Hematologic side effects including thrombosis have been reported in at least 5% of patients.

Other

Other side effects including lymphocele have been reported in at least 5% of patients.

Psychiatric

Psychiatric side effects including depression and anxiety have been reported in between 2% and 5% of patients.

Ocular

Ocular side effects including blurred vision have been reported in between 2% and 5% of patients.

Local

Local side effects including application site reaction have been reported in between 2% and 5% of patients.

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