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Injectafer (FERRIC CARBOXYMALTOSE)
Injectafer works by providing a rapid increase in iron levels in the body.
Injectafer (FERRIC CARBOXYMALTOSE) is a small molecule medication originally developed by LUITPOLD and currently owned by Am Regent. It is used to treat iron deficiency anemia, a condition where the body does not have enough iron to produce healthy red blood cells. Injectafer works by providing a rapid increase in iron levels, which helps to alleviate symptoms of anemia such as fatigue and weakness. It is a patented medication with no generic manufacturers available. Key safety considerations include potential allergic reactions and interactions with other medications.
At a glance
| Generic name | FERRIC CARBOXYMALTOSE |
|---|---|
| Sponsor | Am Regent |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
Ferric carboxymaltose is colloidal iron (III) hydroxide in complex with carboxymaltose, carbohydrate polymer that releases iron.
Approved indications
- Iron deficiency anemia
Common side effects
- Nausea
- Hypertension
- Flushing
- Injection site reactions
- Erythema
- Hypophosphatemia
- Dizziness
- Vomiting
- Headache
- Dysgeusia
- Hepatic enzyme increased
- Rash
Key clinical trials
- Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function (PHASE3)
- Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA) (PHASE3)
- Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome (PHASE4)
- The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department (PHASE4)
- EFFICACY OF IV VERSUS ORAL IRON IN THE TREATMENT OF IRON DEFICIENCY ANEMIA DURING PREGNANCY (PHASE1)
- The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension (PHASE4)
- Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation (PHASE4)
- Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Injectafer CI brief — competitive landscape report
- Injectafer updates RSS · CI watch RSS
- Am Regent portfolio CI