Injectafer

Iron is contained in many vitamin or mineral supplements. Taking certain products together can cause you to get too much iron. Avoid taking any vitamin or mineral supplement your doctor has not recommended.

Other drugs may interact with ferric carboxymaltose, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Ferric carboxymaltose is injected into a vein through an IV. A healthcare provider will give you this injection.

Ferric carboxymaltose is usually given in two doses, 7 days apart. Your doctor will determine whether you need a repeat course of these two doses.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when ferric carboxymaltose is injected.

You will be watched closely for at least 30 minutes after receiving ferric carboxymaltose, to make sure you do not have an allergic reaction to the medication.

Tell your doctor if you have any changes in weight. Ferric carboxymaltose doses are based on weight, and any changes may affect the dose.

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with ferric carboxymaltose.

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

Overdose symptoms may include weakness, joint problems, and problems with balance or walking.

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

Included as part of the PRECAUTIONS section.

Iron is contained in many vitamin or mineral supplements. Taking certain products together can cause you to get too much iron. Avoid taking any vitamin or mineral supplement your doctor has not recommended.

Other drugs may interact with ferric carboxymaltose, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Dizziness or passing out.
• This medicine may stain your skin brown near where it is given if it leaks from the vein. This may last for a long time. Tell your nurse if you have any leaking of fluid or other signs where the drug is going into your body.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach.
• Flushing.
• Headache.
• Irritation where this medicine is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

5.1 Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. [see Adverse Reactions (6.1 and 6.2)].  In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.

5.2 Hypertension

In clinical studies, hypertension was reported in 3.8% (67/1,775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes.   Monitor patients for signs and symptoms of hypertension following each Injectafer administration [see Dosage and Administration (2)].

5.3 Laboratory Test Alterations

In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer.

Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula:

[FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k, 

where n ≈ 103, m ≈ 8, l ≈ 11, and k ≈ 4
(l represents the mean branching degree of the ligand).

The chemical structure is presented below:

Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection.  Injectafer is available in 15 mL single-use vials.  Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0.

Vial closure is not made with natural rubber latex.

Injectafer (ferric carboxymaltose injection)

Please read this information carefully before taking this medication. This summary does not tell you everything about Injectafer. Speak with your doctor or healthcare professional if there is something you do not understand or if you would like to learn more about Injectafer. Your doctor or healthcare professional is your best source of information about this medicine.

What is Injectafer?

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Injectafer is used to treat iron deficiency anemia. Iron deficiency anemia may be caused by several medical conditions including heavy menstrual bleeding, pregnancy, childbirth, inflammatory bowel disease, other malabsorption diseases, bariatric surgery, or chronic kidney disease.

General information about using Injectafer safely and effectively

Injectable iron is administered only by or under the supervision of your health care professional.

Serious or life threatening allergic reactions have been reported with intravenous iron products. Tell your health care professional if you have ever had any unusual or allergic reaction to any IV iron.

Patients should report to their healthcare professional any signs and symptoms of an allergic reaction to Injectafer, in particular rashes, shortness of breath and wheezing.

Iron is not easily eliminated from the body, and its build up may be lead to a condition called iron overload which may be harmful.  Certain medical conditions such as liver disease may also make you more likely to develop iron overload. Ask your doctor or healthcare professional.

Who should not take Injectafer?

You should not be given Injectaferif you have anemia that is not caused by iron deficiency, or if you have iron overload.

If you are pregnant or plan to become pregnant please notify your doctor or healthcare professional. They will decide whether it is safe for you to receive Injectafer.

How should I take Injectafer?

Injectafer is administered intravenously (into your vein) by your doctor or health care professional in two doses.

What should I avoid while taking Injectafer?

You should not take iron supplements by mouth if you are receiving iron injections. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

What are the possible side effects of Injectafer?

The side effects of Injectaferare infrequent, usually mild and generally do not cause patients to stop treatment. The most common side effects are nausea, injection site reactions (including pain or bruising at the injection site), asymptomatic reductions in blood phosphorus, flushing, headache, hypertension, dizziness, and increased alanine aminotransferase. Potentially long lasting brown staining of skin near injection site may occur. 

These are not all the possible side effects of Injectafer. For more information ask your doctor or healthcare professional.   

Talk to your doctor if you think you have side effects from taking Injectafer.

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

Other drugs may interact with ferric carboxymaltose, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.