Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia

Exclusion Criteria

• •Parenteral iron use within 4 weeks prior to screening.
• •History of \> 10 blood transfusions in the past 2 years.
• •Anticipated need for blood transfusion during the study.
• •Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).
• •Current or acute or chronic infection other than viral upper respiratory tract infection
• •Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years).
• •Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).
• •Pregnant or lactating women.
• •Severe peripheral vascular disease with significant skin changes.
• •Seizure disorder currently being treated with medication.
• •Baseline ferritin ≥ 50 ng/mL.
• •Baseline TSAT ≥ 20%.
• •History of hemochromatosis or hemosiderosis or other iron storage disorders.
• •Known positive hepatitis with evidence of active disease.
• •Hemoglobin greater than the upper limit of normal.
• •Calcium or phosphorous outside the normal range.
• •Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).
• •Known positive HIV-1/HIV-2 antibodies (anti-HIV)
• •Received an investigational drug within 30 days before randomization.
• •Chronic alcohol or drug abuse within the past 6 months.
• •Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk.
• •Subject unable to comply with the study requirements.