Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Vadadustat
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
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
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
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.
DRG-20075112
