Medical Editor: John P. Cunha, DO, FACOEP
Zenapax (daclizumab) is an immunosuppressant used to prevent the body from rejecting a transplanted kidney. Zenapax is usually used as part of a treatment regimen including other medications. Common side effects of Zenapax include:
- upset stomach
- headache, or
- swelling of the hands, feet or legs
The recommended dose for Zenapax in adult and pediatric patients is 1.0 mg/kg. Some vaccines may not be effective, or may be harmful, if received during treatment with Zenapax. Avoid close contact with people who have recently been vaccinated with a "live" vaccine (e.g. oral polio vaccine, nasal influenza vaccine) as there is a chance that the virus can be passed on to you. Other drugs may interact with Zenapax. Tell your doctor all medications you use. During pregnancy, Zenapax should be used only when prescribed. It is recommended that women of childbearing age should use birth control before, during, and for 4 months after completion of treatment with this medication. Consult your doctor about birth control. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, consult your doctor before breastfeeding.
Our Zenapax (daclizumab) 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.
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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zenapax (Daclizumab)
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug. Rates observed in clinical studies may not reflect those observed in clinical practice. Adverse reaction information obtained in clinical trials does, however, provide a basis for identifying adverse events that appear to be related to drug use and for approximating the rate of occurrence.
The safety of ZENAPAX (daclizumab) was determined in four clinical studies of renal allograft rejection, three of which were randomized controlled clinical trials, in 629 patients receiving renal allografts of whom 336 received ZENAPAX (daclizumab) and 293 received placebo. All patients received concomitant cyclosporine and corticosteroids. In these clinical trials, ZENAPAX (daclizumab) did not appear to alter the pattern, frequency or severity of known major toxicities associated with the use of immunosuppressive drugs.
The use of ZENAPAX (daclizumab) was associated with a higher incidence of mortality when compared to placebo in a large (n=434) randomized controlled study of patients receiving cardiac transplants (see WARNINGS and Incidence of Infectious Episodes).
Adverse events were reported by 95% of the patients in the placebo-treated group and 96% of the patients in the group treated with ZENAPAX (daclizumab) . The proportion of patients prematurely withdrawn from the combined studies because of adverse events was 8.5% in the placebo-treated group and 8.6% in the group treated with ZENAPAX (daclizumab) .
ZENAPAX (daclizumab) did not increase the number of serious adverse events observed compared with placebo. The most frequently reported adverse events were gastrointestinal disorders, which were reported with equal frequency in ZENAPAX (daclizumab) - (67%) and placebo-treated (68%) patient groups.
The incidence and types of adverse events were similar in both placebo-treated patients and patients treated with ZENAPAX (daclizumab) . The following adverse events occurred in ≥ 5% of patients treated with ZENAPAX (daclizumab) . These events included: Gastrointestinal System: constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, epigastric pain not food-related; Metabolic and Nutritional: edema extremities, edema; Central and Peripheral Nervous System: tremor, headache, dizziness; Urinary System: oliguria, dysuria, renal tubular necrosis; Body as a Whole - General: posttraumatic pain, chest pain, fever, pain, fatigue; Autonomic Nervous System: hypertension, hypotension, aggravated hypertension; Respiratory System: dyspnea, pulmonary edema, coughing; Skin and Appendages: impaired wound healing without infection, acne; Psychiatric: insomnia; Musculoskeletal System: musculoskeletal pain, back pain;Heart Rate and Rhythm: tachycardia; Vascular Extracardiac: thrombosis; Platelet, Bleeding and Clotting Disorders: bleeding; Hemic and Lymphatic: lymphocele.
Metabolic and Nutritional: fluid overload, diabetes mellitus, dehydration; Urinary System: renal damage, hydronephrosis, urinary tract bleeding, urinary tract disorder, renal insufficiency; Body as a Whole - General: shivering, generalized weakness; Central and Peripheral Nervous System: urinary retention, leg cramps, prickly sensation; Respiratory System: atelectasis, congestion, pharyngitis, rhinitis, hypoxia, rales, abnormal breath sounds, pleural effusion; Skin and Appendages: pruritus, hirsutism, rash, night sweats, increased sweating; Psychiatric: depression, anxiety; Musculoskeletal System: arthralgia, myalgia; Vision: vision blurred; Application Site: application site reaction.
Incidence of Malignancies
One and 3 years posttransplant, the incidence of malignancies was 2.7% and 7.8%, respectively, in the placebo group compared with 1.5% and 6.4%, respectively, in the ZENAPAX (daclizumab) group. Addition of ZENAPAX (daclizumab) did not increase the number of posttransplant lymphomas up to 3 years posttransplant. Lymphomas occurred at a frequency of ≤ 1.5% in both placebo-treated and ZENAPAX (daclizumab) -treated groups.
No differences in abnormal hematologic or chemical laboratory test results were seen between groups treated with placebo or ZENAPAX (daclizumab) with the exception of fasting blood glucose. Fasting blood glucose was measured in a small number of patients treated with placebo or ZENAPAX (daclizumab) . A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of patients treated with ZENAPAX (daclizumab) had high fasting blood glucose values. Most of these high values occurred either on the first day posttransplant when patients received high doses of corticosteroids or in patients with diabetes.
Incidence of Infectious Episodes
The overall incidence of infectious episodes, including viral infections, fungal infections, bacteremia and septicemia, and pneumonia, was not higher in patients treated with ZENAPAX (daclizumab) than in placebo-treated patients in trials of renal transplantation. In a large randomized study of ZENAPAX (daclizumab) used for the prevention of allograft rejection in patients receiving cardiac allografts, more patients receiving ZENAPAX (daclizumab) experienced severe or fatal infections after 12 months of therapy when compared to those receiving placebo (10% vs 7%, respectively). The risks of infection or death may be increased in patients receiving concomitant anti-lymphocyte antibody therapy (see WARNINGS).
The types of infections reported in trials of renal transplantation were similar in both the ZENAPAX (daclizumab) -treated and the placebo-treated groups. Cytomegalovirus infection was reported in 16% of the patients in the placebo group and 13% of the patients in the ZENAPAX (daclizumab) group. One exception was cellulitis and wound infections, which occurred in 4.1% of placebo-treated patients and 8.4% of patients treated with ZENAPAX (daclizumab) . At 1 year posttransplant, 7 placebo patients and 1 patient treated with ZENAPAX (daclizumab) had died of an infection. At 3 years posttransplant, 8 placebo patients and 4 patients treated with ZENAPAX (daclizumab) had died of infection.
Low titers of anti-idiotype antibodies to daclizumab were detected in the adult patients treated with ZENAPAX (daclizumab) with an overall incidence of 14%. The incidence of anti-daclizumab antibodies observed in the pediatric patients was 34%. No antibodies that affected efficacy, safety, serum daclizumab levels or any other clinically relevant parameter examined were detected. The data reflect the percentage of patients whose test results were considered positive for antibodies to daclizumab in an ELISA assay and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in the assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to daclizumab with the incidence of antibodies to other products may be misleading.
The following adverse reactions have been identified and reported during post-approval use of ZENAPAX (daclizumab). Because the reports of these reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.
Severe acute hypersensitivity reactions including anaphylaxis characterized by hypotension, bronchospasm, wheezing, laryngeal edema, pulmonary edema, cyanosis, hypoxia, respiratory arrest, cardiac arrhythmia, cardiac arrest, peripheral edema, loss of consciousness, fever, rash, urticaria, diaphoresis, pruritus, and/or injection site reactions, as well as cytokine release syndrome, have been reported during post-marketing experience with ZENAPAX (daclizumab) . The relationship between these reactions and the development of antibodies to ZENAPAX (daclizumab) is unknown.
Read the entire FDA prescribing information for Zenapax (Daclizumab)
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