With IV iron treatments like Injectafer, 100% of the iron is delivered into the bloodstream.

Injectafer^® (ferric carboxymaltose injection) is available by prescription only. Ask your healthcare provider if Injectafer is right for you.

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 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 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 in 2 doses at least 7 days apart. For certain patients with heart failure, 2 doses may need to be given 6 weeks apart. 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:

• Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive Injectafer and may include the following signs or symptoms: low blood pressure, feeling dizzy or lightheaded, loss of consciousness, trouble breathing, swelling, fast heartbeat, cold or clammy skin, feet or hands turn blue, itching, rash, hives, and/or wheezing. Your healthcare provider will watch you during and for at least 30 minutes after you receive Injectafer. Tell your healthcare provider right away if you develop any signs or symptoms of allergic reactions during or after treatment with Injectafer
• Symptoms of low blood phosphate levels. Injectafer may cause low levels of phosphate in your blood that may be serious and can lead to softening of your bones and broken bones (fractures), especially in people who have received multiple Injectafer treatments. Your healthcare provider may check your blood phosphate levels before a repeat treatment with Injectafer if you are at risk for low blood phosphate levels. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider should check your blood phosphate levels. Tell your healthcare provider if you develop any of the following signs or symptoms of low blood phosphate levels during treatment with Injectafer: feeling very tired, muscle weakness or pain, bone or joint pain, broken bones
• High blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with Injectafer. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive Injectafer

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, and dizziness.
• In children: low levels of phosphate in your blood, injection site reactions, rash, headache, and vomiting

These are not all of the possible side effects of Injectafer.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Injectafer

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Injectafer that is written for health professionals.

To report side effects, contact American Regent at 1-800-734-9236 or E-mail: pv@americanregent.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 www.injectafer.com/pdf/pi.pdf or call 1-800-645-1706.

Please see Full Prescribing Information for Injectafer.