Injectafer® (ferric carboxymaltose injection) is available by prescription only. Ask your healthcare provider if Injectafer is right for you.
What is Injectafer?
Injectafer is a prescription iron replacement medicine used for the treatment of:
- iron deficiency anemia (IDA) in:
- adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron
- adults who have chronic kidney disease who are not on dialysis (non-dialysis dependent chronic kidney disease)
- iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity)
It is not known if Injectafer is safe and effective in children with IDA who are under 1 year of age.
It is not known if Injectafer is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity.
IMPORTANT SAFETY INFORMATION
Who should not receive Injectafer?
You should not receive Injectafer if you are allergic to ferric carboxymaltose or any of the other ingredients in Injectafer. The active ingredient in Injectafer is ferric carboxymaltose, the inactive ingredients are: water for injection, sodium hydroxide or hydrochloric acid.
What should I tell my healthcare provider before receiving Injectafer?
Before you receive Injectafer, tell your healthcare provider about all of your medical conditions, including if you:
- have had an allergic reaction to iron given into your vein
- have a history of trouble absorbing certain vitamins or phosphate in your body
- have inflammatory bowel disease
- have hyperparathyroidism
- have low vitamin D levels
- have high blood pressure
- have previously received Injectafer
- are pregnant or plan to become pregnant. Injectafer may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Injectafer
- are breastfeeding or plan to breastfeed. Injectafer passes into your breast milk. It is not known if Injectafer will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Injectafer
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Injectafer?
Injectafer is given into your vein (intravenously) by your healthcare provider.
Injectafer is usually given in 2 doses at least 7 days apart for iron deficiency anemia or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.
If your healthcare provider decides it is right for you, Injectafer may be given intravenously by your healthcare provider as a single-dose treatment.
Injectafer treatment may be repeated if your healthcare provider decides it is needed.
What are the possible side effects of Injectafer?
Injectafer may cause serious side effects, including:
The most common side effects of Injectafer include:
- In adults:
- nausea
- high blood pressure
- flushing
- injection site reactions
- skin redness
- low levels of phosphate in your blood
- dizziness
- In children:
- low levels of phosphate in your blood
- injection site reactions
- rash
- headache
- vomiting
These are not all of the possible side effects of Injectafer.
Call your healthcare provider for medical advice about side effects.
To report side effects, contact American Regent at 1-800-734-9236 or Email: pv@americanregent.com Fax: 1-610-650-0170.
You may also report side effects to the FDA at 1-800-332-1088 or www.fda.gov/medwatch.
The risk information provided here is not comprehensive. To learn more about Injectafer, talk with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.americanregent.com or call 1-800-645-1706.
Please see Full Prescribing Information for Injectafer.