the effects on the ability to drive and use machines have been performed. However depending on dose and schedule as well as the sensitivity of the individual patient, Roferon-A may have an effect on the speed of reaction which could impair certain operations, e.g., driving, operation of machinery etc.
4.8 Undesirable effects
Combination therapy with ribavirin: Also see ribavirin labeling if interferon alfa-2a is to be administered in combination with ribavirin in patients with chronic hepatitis C.
The following data on adverse reactions are based on information derived from the treatment of cancer patients with a wide variety of malignancies and often refractory to previous therapy and suffering from advanced disease, patients with chronic hepatitis B, and patients with chronic hepatitis C.
Approximately two thirds of cancer patients experienced anorexia and one half nausea. Cardiovascular and pulmonary disorders were seen in about one fifth of cancer patients and consisted of transient hypotension, hypertension, oedema, cyanosis, arrhythmias, palpitations and chest pain. Most cancer patients received doses that were significantly higher than the dose now recommended and may explain the higher frequency and severity of adverse reactions in this patient group compared with patients with hepatitis B where adverse reactions are usually transient, and patients return to pre-treatment status within 1 to 2 weeks after the end of therapy. Cardiovascular disorders were very rarely seen in patients with hepatitis B. In hepatitis B patients, changes in transaminases usually signal an improvement in the clinical state of the patient.
The majority of the patients experienced flu-like symptoms such as fatigue, pyrexia, rigors, decreased appetite, myalgia, headache, arthralgia and diaphoresis. These acute side-effects can usually be reduced or eliminated by concurrent administration of paracetamol and tend to diminish with continued therapy or dose modification although continuing therapy can lead to lethargy, asthenia and fatigue.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Body System
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)
Infections and infestations
- Pneumonia
- Herpes simplex1
Blood and lymphatic system disorders2
- Leukopenia
- Thrombocytopenia
- Anemia
- Agranulocytosis
- Hemolytic anemia
-Idiopathic thrombocytopenic purpura
Immune system disorders
- Autoimmune disorder
- Acute hypersensivity reactions3
- Sarcoidosis
- Graft rejections†
Endocrine disorders
- Hypothyroidism
- Hyperthyroidism
- Thyroid dysfunction
Metabolism and nutrition disorders
- Anorexia
- Nausea
- Inconsequential hypocalcemia
- Dehydration
- Electrolyte imbalance
- Diabete mellitus
- Hyperglycemia
- Hypertriglyceridemia
-Hyperlipidemia
Psychiatric disorders
- Depression
- Anxiety
- Mental status changes
- Confusional state
