Injectafer is an injectable iron replacement product that is injected into a vein and may be used to treat iron deficiency anemia (IDA) in adults and children 1 year of age and older who have an intolerance to or an unsatisfactory response to oral iron, or IDA in adults with non-dialysis dependent chronic kidney disease.
Injectafer may also be used to improve exercise capacity in adults with iron deficiency and New York Heart Association (NYHA) class II/III heart failure.

Your body normally gets iron from the foods you eat. Iron helps your body produce red blood cells that carry oxygen through your blood to tissues and organs. Injectafer is usually given after oral (taken by mouth) iron replacement medicines have been tried without success. 100% of the iron in Injectafer is delivered to the bloodstream.

Injectafer was FDA approved on July 25, 2013.

Hypersensitivity reactions have been reported after intravenous iron administration. Your healthcare provider will observe you for signs and symptoms of hypersensitivity during Injectafer administration and for at least 30 minutes afterward or until you are stable.

Injectafer may cause low levels of phosphate in your blood. Your healthcare provider will monitor your serum phosphate levels if you are at risk of low serum phosphate and require intravenous iron.
Injectafer may cause your blood pressure to increase. Your healthcare provider will monitor you for signs and symptoms of high blood pressure after each Injectafer injection.

You should not use Injectafer if you have iron overload disorder, or anemia that is not caused by iron deficiency.

It is not known if Injectafer is safe and effective in children with IDA who are under 1 year of age or in children with iron deficiency and mild to moderate heart failure to improve exercise capacity

Injectafer is injected into a vein by a healthcare provider.

• It is usually given in 2 doses, 7 days apart, or 6 weeks apart for iron deficiency with mild to moderate heart failure.
• Injectafer is administered intravenously (into a vein) either as an undiluted slow intravenous push or by infusion over at least 15 minutes.
• In some circumstances, Injectafer may be given as a single dose.
• Tell your medical caregivers if you feel any burning or pain when Injectafer is injected.
• You will be watched for at least 30 minutes to make sure you do not have an allergic reaction.

You may need frequent medical tests, even if you have no symptoms.

Treatment may be repeated with Injectafer if your healthcare provider decides it is needed.

The usual adult and pediatric dose for iron deficiency anemia depends on weight:

• 50 kg or more: 2 doses of 750 mg via slow IV push or infusion separated by at least 7 days
  
  
• Less than 50 kg: 2 doses of 15 mg/kg via slow IV push or infusion separated by at least 7 days.

Maximum dose: The total cumulative dose should not exceed 1500 mg of iron per course.

Dosage for iron deficiency with heart failure

This dose varies depending on weight and hemoglobin level. Please refer to the prescribing Information.

You should not use Injectafer if you are allergic to ferric carboxymaltose or any of the inactive ingredients present in the injection.

To make sure Injectafer is safe for you, tell your doctor if you have ever had:

• an allergic reaction to iron injected into a vein
• high blood pressure
• a history of trouble absorbing certain vitamins or phosphate in your body or have low vitamin D levels
• have inflammatory bowel disease
• have hyperparathyroidism
• have previously received Injectafer
• are pregnant or plan to become pregnant. Injectafer may harm your unborn baby and there is a risk of hypersensitivity reactions which could have serious consequences for the unborn baby. However having iron deficiency anemia during pregnancy may increase the risk of premature birth or low birth weight. The benefits of using Injectafer must outweigh any risks to the baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment.
• are breastfeeding or plan to breastfeed. Injectafer passes into your breast milk but it is not known if it will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment. If you are breastfeeding, tell your doctor if you notice diarrhea or constipation in the nursing baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Call your doctor for instructions if you miss an appointment for your Injectafer injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include pain, cough, wheezing, shortness of breath, coughing up blood, weight loss, or slowed growth in a child.

Do not take iron supplements or a vitamin/mineral supplement that your doctor has not prescribed or recommended.

Get emergency medical help if you have signs of an allergic reaction to Injectafer, such as hives; feeling like you might pass out; wheezing, difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have signs of:

• increased blood pressure - dizziness, nausea, sudden warmth or redness in your face, severe headache, pounding in your neck or ears;
• low levels of phosphorus in your blood – feeling very tired, bone pain, muscle weakness, broken bones; or
• high levels of iron stored in your body - feeling weak or tired, joint pain, finger pain, stomach pain, weight loss, irregular heartbeats, fluttering in your chest.

Common Injectafer side effects affecting more than 2% of people may include:

• nausea
• dizziness
• high blood pressure
• headache
• injection site reactions
• rash
• flushing (warmth, redness, or tingly feeling) or
• low phosphorus levels.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Other drugs may interact with ferric carboxymaltose, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.