Pronunciation:

SOE-dee-um FER-rik Gloo-koe-nate KOM-plex

Brand Names:

• Ferrlecit
• Nulecit

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Parenteral Mineral-Trace Mineral

Uses of This Medicine:

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, it cannot produce the number of normal red blood cells. 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sodium ferric gluconate complex injection in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sodium ferric gluconate complex injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving sodium ferric gluconate complex injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Baloxavir Marboxil
• Bictegravir
• Dimercaprol
• Eltrombopag
• Erdafitinib
• Magnesium Sulfate
• Raltegravir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Delafloxacin
• Minocycline
• Zinc

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Phytic Acid Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Iron overload—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or dialysis clinic. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis and Kounis syndrome, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, chest pain or discomfort, pain or discomfort in arms, jaw, back or neck, nausea, sweating, or vomiting after you receive the medicine.

This medicine may cause hypotension (low blood pressure). Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.

This medicine contains benzyl alcohol which may cause serious reactions (eg, gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

Side Effects of This Medicine:

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:

More common

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, discomfort, heaviness, or tightness

cold sweats

confusion

cool, pale skin

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

decreased level of consciousness

decreased urine

depression

diarrhea

difficult, burning, or painful urination

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, cramps, and pains

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

seizures

shakiness

shivering

slow or irregular heartbeat

slurred speech

sore throat

stomach pain

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

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness or heaviness of the legs

weight gain

Incidence not known

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, itching, skin rash

increased menstrual flow or vaginal bleeding

muscle stiffness, 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

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:

More common

Accumulation of pus

acid or sour stomach

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

Incidence not known

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.