Interferon gamma-1b interacts in the following cases:
Patients with serious hepatic insufficiency and patients with severe renal insufficiency should be treated with caution since the possibility of interferon gamma-1b accumulation exists in those patients.
Simultaneous administration of interferon gamma-1b with other heterologous serum protein preparations or immunological preparations (e.g. vaccines) should be avoided because of the risk for unexpected amplified immune response.
Based on the information available it cannot be excluded that the presence of higher levels of interferon gamma-1b may impair male and female fertility. Studies in animals have shown an impact on male fertility at dose levels which are considered not relevant for human use. In younger patients the long-term effect on fertility is also not known.
Caution should be exercised when treating patients with known seizure disorders and/or compromised central nervous system function.
Caution should be exercised when administering interferon gamma-1b to patients with myelosuppression.
Elevations of AST and/or ALT (up to 25-fold) have been observed during interferon gamma-1b therapy. The incidence appeared to be higher in patients less than 1 year of age compared to older children with 6 out of 10 developing elevated enzyme levels. In one case this occurred as early as 7 days after starting therapy. Treatment with interferon gamma-1b was interrupted in all 6 of these patients and restarted at a reduced dosage in 4. Liver transaminase values returned to baseline in all patients and did not recur with rechallenge except in one patient. Caution should be especially observed in patients with hepatic insufficiency.
Reversible neutropenia and thrombocytopenia that can be severe and may be dose related have been observed during interferon gamma-1b therapy.
Patients with pre-existing cardiac disease may experience an acute, self-limiting exacerbation of their cardiac condition at doses of 250 mcg/m²/day or higher, as observed in early clinical trials, although no direct cardiotoxic effect has been demonstrated.
There are no adequate data from the use of interferon gamma-1b in pregnant women. Higher levels of endogenous interferon gamma were found in women with recurrent first trimester miscarriage compared to women with normal pregnancy. There is no evidence of any clinical relevance for interferon gamma-1b.
Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Interferon gamma-1b should not be used during pregnancy unless vitally indicated.
It is not known whether interferon gamma-1b is excreted in human milk. Because of the lack of data on neonatal effects, breastfeeding is not recommended.
Based on the information available it cannot be excluded that the presence of higher levels of interferon gamma-1b may impair male and female fertility. Studies in animals have shown an impact on male fertility at dose levels which are considered not relevant for human use. In younger patients the long-term effect on fertility is also not known.
No studies on the effect on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as fatigue, convulsion, confusional state, disorientation or hallucination during treatment. Therefore, caution should be recommended when driving a car or operating machinery.
If patients experience any of these events, they should avoid potentially hazardous tasks such as driving or operating machinery.
The clinical and laboratory toxicity associated with multiple-dose interferon gamma-1b therapy is dose- and schedule-dependent.
The most common adverse events are flu-like symptoms characterised by fever, headache, chills, myalgia or fatigue.
Adverse reactions have been ranked under headings of frequency using the following convention: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Not Known: Neutropenia#, thrombocytopenia#
Not known: Hyponatraemia*, hypoglycaemia*, hypertriglyceridaemia*
Common: Depression
Not known: Confusional state*, disorientation*, hallucination*
Not known: Convulsion*, Parkinsonian gait*, Parkinsonian rest tremor*, gait disturbance*
Not known: Cardiac failure*, myocardial infarction*, tachyarrhythmia*, atrioventricular block*
Not known: Transient ischemic attack*, deep vein thrombosis*, pulmonary embolism*, hypotension*, syncope*
Not known: Interstitial lung disease*, bronchospasm*, tachypnoea*
Very common: Nausea, vomiting, diarrhea
Common: Abdominal pain
Not known: Pancreatitis (including fatal outcome), gastrointestinal haemorrhage
Very common: Hepatic enzymes increased+
Not known: Hepatic failure*
Very common: Rash
Not known: (exacerbation of) Dermatomyositis*
Common: Myalgia, athralgia, back pain
Not known: Systemic lupus erythematosus*
Not known: (reversible) Renal failure*, proteinuria#
Very common: Fever, headache, chills fatigue, injection site pain
Not known: Chest discomfort*
Not known: Autoantibody positive*
# Cannot be estimated from the available data
+ Frequency higher in placebo group than in verum group
* Undesirable effects seen in clinical trials of conditions other than the registered indications CGD and osteopetrosis. In these trials interferon gamma-1b was usually administered at higher doses than recommended for the registered indications. Since these events have not been seen in clinical trials involving CGD or osteopetrosis but are reported in trials of patients with very diverse indications and health statuses, it is not possible to provide meaningful frequencies.
The flu-like symptoms may decrease in severity as treatment continues. Some of these symptoms can be minimised by bedtime administration. Acetaminophen (paracetamol) may also be used to ameliorate these effects. Vomiting, nausea, arthralgia and injection site tenderness have been reported in some patients.
Transient cutaneous rashes, e.g. dermatitis, maculopapular rash, pustular and vesicular eruptions, and erythema at injection site have occurred in some patients following injection but have rarely necessitated treatment interruption.
The inclusion of autoantibody production and systemic lupus erythematosus is the result of case reports in the literature. The adverse reaction “confusion” is also in the literature as a case report.
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