"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 "...
The following adverse reactions are discussed in greater detail in other sections of the prescribing information:
- Nephrogenic systemic fibrosis [see CONTRAINDICATIONS, BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reactions described in this section were observed in a total of 1,309 subjects (24 healthy volunteers and 1,285 patients in clinical trials). Patients ranged in age from 12 to 85 years (mean age of 50 years) and 680 subjects (52%) were men. The ethnic distribution was 84% White, 9% Black, 3% Asian, and 4% other.
Overall, 460 subjects (35%) reported at least one adverse reaction. Most adverse reactions were mild or moderate in severity. The most commonly noted adverse reactions were: injection associated discomfort (26%), headache (9.4%), vasodilatation (6.4%), taste perversion (6.2%), dizziness (3.7%), nausea (3.2%), and paresthesia (2.2%). Table 2 lists adverse reactions reported in 1% or greater of patients.
Table 2 : Adverse Reactions Experienced by ≥ 1%
|Body System or Event||OptiMARK
(N = 1309)
|Injection associated discomfort||26.4%|
|Injection Site Reaction||1.5%|
The following adverse reactions occurred in less than 1% of the patients:
Metabolic and Nutritional: increased creatinine, edema, hypercalcemia
Special Senses: parosmia, tinnitus
The following adverse reactions have been identified during post-approval use of OptiMARK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to OptiMARK.
- Nephrogenic Systemic Fibrosis (NSF)
- Hypersensitivity reactions including bronchospasm and laryngeal/pharyngeal edema
Read the OptiMARK (gadoversetamide injection) Side Effects Center for a complete guide to possible side effects
Drug interactions with other contrast agents and other drugs have not been studied.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/15/2014
Additional OptiMARK 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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