Ferrlecit

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, sweating, vomiting; severe lower back pain; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• chest pain, trouble breathing;

• flushing (warmth, redness, or tingly feeling);

• fast or uneven heart rate; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, seizure).

Less serious side effects may include:

• pain, leg cramps;

• dizziness, general ill feeling;

• mild headache;

• nausea, vomiting, diarrhea; or

• pain, redness, swelling, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Distribution

Extent

Ferric iron in plasma combines with transferrin and is carried to the bone marrow and incorporated into hemoglobin.9 27 29 30 31

Elimination

Half-life

Following IV administration, terminal elimination half-life of drug-bound iron was approximately 1 hour in healthy iron-deficient adults.1

Following IV administration of 1.5 or 3 mg/kg, terminal elimination half-life was 2 or 2.5 hours, respectively, in iron-deficient pediatric patients.a

Special Populations

In vitro, <1% of the iron species in a single dose was removed during hemodialysis periods of up to 270 minutes using membranes with pore sizes corresponding to 12,000–14,000 daltons.99

Sodium ferric gluconate complex injection is used to treat iron deficiency anemia (not enough iron in the blood). It is used in patients with kidney disease who are receiving dialysis and a medicine called epoetin to prevent anemia. Sodium ferric gluconate complex is an iron replacement product.

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, the number of red blood cells is lower than normal. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

This medicine is to be given only by or under the direct supervision of a doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Abdominal or stomach pain
• anxiety
• arm, back, or jaw pain
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• bloody, black, or tarry stools
• blue lips and fingernails
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• cold sweats
• confusion
• convulsions
• cool, pale skin
• cough or hoarseness
• coughing that sometimes produces a pink frothy sputum
• decreased level of consciousness
• decreased urine
• depression
• diarrhea
• difficult or labored breathing
• difficult, burning, or painful urination
• difficult, fast, or noisy breathing, sometimes with wheezing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• eye pain
• fainting
• fast or slow heartbeat
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth or heat
• fever or chills
• flushing or redness of the skin, especially on the face and neck
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• increased hunger
• increased sweating
• increased thirst
• irregular heartbeat
• joint pain
• leg cramps
• lightheadedness
• loss of appetite
• lower back or side pain
• mood changes
• muscle aches and pains
• muscle cramps
• nausea or vomiting
• nervousness
• nightmares
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• pounding in the ears
• rapid weight gain
• rapid, shallow breathing
• runny nose
• shakiness
• shivering
• shortness of breath
• slow or irregular heartbeat
• slurred speech
• sore throat
• sweating
• swelling in the legs and ankles
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• trouble sleeping
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs
• weight gain
• wheezing

• Bleeding gums
• bluish color
• changes in skin color
• cold, clammy skin
• coughing up blood
• excessive muscle tone
• face is warm or hot to touch
• fast, weak pulse
• hives
• increased menstrual flow or vaginal bleeding
• itching
• muscle stiffness
• muscle tension or tightness
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or black, tarry stools
• red or dark brown urine
• skin rash
• sweating
• tenderness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Accumulation of pus
• acid or sour stomach
• anxiety
• belching
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• cramps
• deafness
• difficulty with moving
• discharge or excessive tearing
• double vision
• ear congestion
• excess air or gas in the stomach or intestines
• feeling unusually cold
• full feeling
• heartburn
• hyperventilation
• increased sweating
• indigestion
• irritability
• longer or heavier menstrual periods
• loss of appetite
• loss of voice
• passing of gas
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• restlessness
• rolling of the eyes
• seeing double
• shivering
• sleepiness or unusual drowsiness
• sneezing
• stomach discomfort or upset
• swollen, red, or tender area of infection
• voice changes
• watery eyes
• weight loss

• Change in taste
• loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• It is used to treat anemia.

• If you have an allergy to ferric gluconate or any other part of Ferrlecit (ferric gluconate).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Anemia from a cause other than low iron stores or too much iron in your body.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Ferrlecit with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Ferrlecit affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Ferrlecit, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Known hypersensitivity to sodium ferric gluconate or any of its components.