The following data on adverse reactions are based on the subcutaneous administration of ACTIMMUNE® at a dose of 50 mcg/m2, three times weekly, during an investigational trial in the United States and Europe in patients with CGD.1 The most common adverse events observed in patients with CGD are shown in the following table.
Common adverse events in patients with CGD
Miscellaneous adverse events that occurred infrequently and may have been related to underlying disease included back pain (2% versus 0%), abdominal pain (8% versus 3%), and depression (3% versus 0%) for ACTIMMUNE® and placebo-treated patients, respectively.
Similar safety data were observed in 34 patients with severe, malignant osteopetrosis.
Other safety considerations: Transient skin rashes have occurred in some patients following injection, but have rarely necessitated treatment interruption. Please contact your physician if you experience this adverse event.
Laboratory tests: In addition to those tests normally required for monitoring patients with CGD and osteopetrosis, the following laboratory tests are recommended for all patients on ACTIMMUNE® prior to beginning therapy and at 3 month intervals:
- Hematologic (tests of blood and blood-producing organs)
- Blood chemistries (tests measuring kidney and liver function)
* In patients less than 1 year of age, liver function tests should be performed monthly. - Urinalysis (tests measuring protein and other elements in the urine)
It is not recommended that women who are pregnant take ACTIMMUNE®.
It is not recommended that nursing mothers take ACTIMMUNE®. A decision should be made whether to discontinue nursing or to discontinue the drug, dependent upon the importance of the drug to the mother.
ACTIMMUNE® in other disease states
ACTIMMUNE® has also been evaluated in studies in which patients have generally received doses higher than 100 mcg/m2/three times weekly. All of the previously described adverse reactions that occurred in patients with CGD have also been observed in patients receiving higher doses.
Adverse reactions not observed in patients with CGD, but reported in patients receiving ACTIMMUNE® in other studies, include:
- Cardiovascular: hypotension, syncope, tachyarrhythmia, heart block, heart failure, and myocardial infarction.
- Central nervous system: confusion, disorientation, gait disturbance, Parkinsonian symptoms, seizure, hallucinations, and transient ischemic attacks
- Gastrointestinal: hepatic insufficiency, gastrointestinal bleeding, and pancreatitis, including pancreatitis with fatal outcome
- Hematologic: deep vein thrombosis and pulmonary embolism
- Immunological: increased autoantibodies, lupus-like syndrome
- Metabolic: hyponatremia, hyperglycemia, and hypertriglyceridemia
- Pulmonary: tachypnea, bronchospasm, and interstitial pneumonitis
- Renal: reversible renal insufficiency
- Other: chest discomfort, exacerbation of dermatomyositis
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of patients.
For U.S. resident use only. The product discussed herein may have different product labeling in different countries. Please see the full U.S. Prescribing Information (pdf file).
References
1. ACTIMMUNE® [package insert]. Brisbane, Calif: InterMune, Inc.; 2007.
