What is the most important information I should know about INJECTAFER?
INJECTAFER may cause serious side effects, including:
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.
See “What are the possible side effects of INJECTAFER?” for more information about side effects.
What is INJECTAFER?
INJECTAFER is a prescription iron replacement medicine used for the treatment of:
- iron deficiency anemia (IDA) in:
- adults and children 1 year of age and older who cannot tolerate iron taken by mouth (oral) or who have not responded well to oral iron
- adults who have chronic kidney disease who are not on dialysis (non-dialysis-dependent chronic kidney disease)
- iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity)
It is not known if INJECTAFER is safe and effective in children with IDA who are under 1 year of age.
It is not known if INJECTAFER is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity.
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 healthcare provider before receiving INJECTAFER?
Before receiving INJECTAFER, tell your healthcare provider about all of your medical conditions, including if you:
- 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 hereditary telangiectasia (HHT) or Osler-Weber-Rendu syndrome
- have had an allergic reaction to iron given into your vein
- have previously received INJECTAFER
- have high blood pressure (hypertension)
- 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 by intravenous (IV) infusion by your healthcare provider.
- INJECTAFER is usually given in 2 doses at least 7 days apart for iron deficiency anemia or 6 weeks apart for iron deficiency with mild to moderate heart failure to improve exercise capacity.
- 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.
- 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.
What are the possible side effects of INJECTAFER?
INJECTAFER may cause serious side effects, including:
- See “What is the most important information I should know about INJECTAFER?”
-
Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive INJECTAFER. 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 of the following signs or symptoms of allergic reactions during or after treatment with INJECTAFER:
- 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
-
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 blood phosphate levels
- dizziness
In children:
- low blood phosphate levels
- injection site reactions
- rash
- headache
- vomiting
This is the most important information to know about INJECTAFER, but not all the possible side effects. Call your doctor for medical advice about side effects.
You are encouraged to report Adverse Drug Events to American Regent, Inc.® at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
Please see the Full Prescribing Information, including BOXED WARNING, for INJECTAFER.