Important Safety Information
Injectafer® (ferric carboxymaltose injection) is available by prescription only. Ask your doctor or healthcare provider if Injectafer is right for you.
What is Injectafer?
Injectafer is a prescription iron replacement medicine administered only by or under the supervision of your healthcare provider. Injectafer is injected into your vein to treat iron deficiency anemia in adults. Injectafer should be used only if you have not responded well to treatment with oral iron, or if you are intolerant to oral iron treatment. It is also used to treat iron deficiency anemia in adults with chronic kidney disease who are not receiving dialysis.
It is not known if Injectafer is safe and effective for use in children.
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 and/or hydrochloric acid.
What should I tell my doctor or 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 intravenously (into your vein), including Injectafer, or to other non-oral iron treatments
- If you have, or have previously experienced, iron overload, or if your body has difficulty using iron appropriately
- Have high blood pressure
- Are pregnant or plan to become pregnant. It is not known if Injectafer will harm your unborn baby. Your healthcare provider will decide if it is safe for you to take Injectafer
- Are breastfeeding or plan to breast feed. Injectafer passes into your breast milk. It is unknown whether Injectafer would pose a risk to 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.
What are the possible side effects of Injectafer?
Injectafer can cause serious side effects, including:
- Serious allergic reactions that may be life-threatening, including shock, low blood pressure, loss of consciousness, and death. Your doctor or healthcare provider will monitor you for signs and symptoms of an allergic reaction during and after each dose of Injectafer for at least 30 minutes. Other serious allergic reactions include itching, rash, hives, wheezing, or low blood pressure. You should report any signs and symptoms of an allergic reaction to Injectafer, in particular rashes, shortness of breath and wheezing to your doctor or healthcare provider.
- High blood pressure, sometimes with facial flushing, dizziness, or nausea, has been seen during treatment with Injectafer. This increase in blood pressure typically resolves within 30 minutes. Your doctor or healthcare provider will monitor you for signs and symptoms of an increase in blood pressure following each use of Injectafer.
Other serious side effects that have been reported include rash, difficulty breathing, itching, rapid heartbeat, fever, chest discomfort, chills, swelling of the face, lips, or tongue, back pain, muscle aches, and fainting.
The most common side effects of Injectafer include:
- Nausea, high blood pressure, flushing, low levels of phosphorous in your blood, dizziness, vomiting, headache, an increase in certain liver enzymes, and pain or bruising at the injection site. Potentially long-lasting brown staining of skin near the injection site may occur if Injectafer leaks out of the vein.
Excessive amounts of Injectafer may lead to a condition called iron overload, which is a buildup of iron and may be harmful.
These are not all of the possible side effects of Injectafer.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects.
General information about Injectafer
Injectafer may impact laboratory tests that measure iron in your blood for 24 hours after receiving Injectafer. Let your healthcare provider and laboratory staff know if you have received Injectafer within 24 hours of having blood tests.
To report side effects, contact American Regent at 1-800-734-9236 or E-mail: email@example.com or 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 http://www.injectafer.com/pdf/pi.pdf or call 1-800-645-1706.
Please see Full Prescribing Information for Injectafer.