Injectafer

Injectafer is an injectable iron replacement product that is given into a vein. It is used to treat iron deficiency anemia (IDA) in:

• adults and children 1 year of age and older who cannot tolerate oral iron or who have not responded well to oral iron; and
• adults who have non-dialysis-dependent chronic kidney disease.

Injectafer may also be used to treat iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure to improve their ability to exercise (improve exercise capacity).

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. Because it is given into a vein, the iron in Injectafer is delivered directly into your bloodstream.

Injectafer first received FDA approval on July 25, 2013.

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 carries a Boxed Warning for low blood phosphate levels (hypophosphatemia).

Low blood phosphate levels (hypophosphatemia)

Hypophosphatemia has happened after one or more doses of Injectafer and can be severe or serious and lead to hospitalization, softening of your bones (osteomalacia), and broken bones (fractures). Hypophosphatemia can happen even if your blood phosphate levels were normal before treatment and you do not have any risk factors for hypophosphatemia.

Your healthcare provider will check your blood phosphate levels before a repeat treatment with Injectafer if you are at risk for hypophosphatemia. If a repeat treatment is needed within 3 months of your last treatment, your healthcare provider will check your blood phosphate levels.

Tell your healthcare provider if you develop any of the following signs or symptoms of hypophosphatemia during treatment with Injectafer:

• tiredness
• muscle weakness or pain
• bone or joint pain
• broken bones

Your healthcare provider may permanently stop treatment with Injectafer if you develop severe hypophosphatemia with symptoms or if your blood phosphate levels remain low during treatment with Injectafer.

Do not receive Injectafer if you are allergic to ferric carboxymaltose or any of the ingredients in Injectafer. See the end of this Patient Information leaflet for a complete list of ingredients in Injectafer.

Before receiving 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 hereditary hemorrhagic telangiectasia (HHT) or Osler-Weber-Rendu syndrome
• 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 medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Other serious side effects

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 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.

• 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.

Common side effects

The most common side effects of Injectafer in adults include:

• nausea
• high blood pressure
• flushing
• injection site reactions
• skin redness
• low levels of phosphate in your blood
• dizziness.

The most common side effects of Injectafer in children include:

• low levels of phosphate in your blood
• injection site reactions
• rash
• headache
• vomiting.

These are not all the possible side effects of Injectafer. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Injectafer is given into your vein by intravenous (IV) infusion by your healthcare provider.
• Injectafer is usually given in 2 doses at least 7 days apart for IDA, or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.
• Injectafer can cause discoloration or staining of your skin if leaking happens at your infusion site. Tell your healthcare provider if you notice any leaking from the infusion site during your infusion.
• 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.

Active ingredient: ferric carboxymaltose.

Inactive ingredients: water for injection. Sodium hydroxide or hydrochloric acid may be added to adjust pH to 5.0-7.0.

Injectafer is distributed by American Regent, Inc., Shirley, NY 11967.

Injectafer is manufactured under license from Vifor (International) Inc, Switzerland. For more information, go to www.injectafer.com or call 1-800-734-9236.