"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Most of the adverse reactions reported were transient and of mild intensity. Those most commonly reported were: feeling of warmth/flushing, headache and nausea. In clinical trials with Teslascan (mangafodipir) , adverse reactions have been reported with the following frequencies given in the table below (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.
|System Organ Class||Adverse Reactions||Frequency|
|Immune system disorders||Hypersensitivity reactions (such as skin reactions, rhinitis, pharyngitis)
|Nervous system disorders||Headache
Dizziness, paraesthesia, transient perverted sensation of taste
|Eye disorders||Visual disturbance||Very rare|
Abdominal pain, diarrhoea, vomiting
|General disorders and administration site conditions||Flushing, feeling hot
Fever, injection site pain
Mangafodipir can cause transient increases of bilirubin and liver transaminases and transient decreases in plasma zinc.
The frequency of mild and moderate, non-serious adverse reactions, mainly transient warmth and flushing, is likely to increase when TESLASCAN (mangafodipir) is administered at the faster rate advised (4–6 ml/min).
Read the Teslascan (mangafodipir) Side Effects Center for a complete guide to possible side effects
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/3/2009
Additional Teslascan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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