sodium ferric gluconate
Ferrlecit, the brand name for sodium ferric gluconate complex, is an iron supplement that's given as an injection through the vein. It's FDA approved to treat iron-deficiency anemia in adults and children with chronic kidney disease (CKD) who are receiving hemodialysis and epoetin alfa (Epogen, Procrit, Retacrit). Ferrlecit (sodium ferric gluconate) is given with each dialysis session. It's administered by a healthcare professional typically as an intravenous (IV) infusion over an hour, but it can also be given as a faster injection for adults. Side effects can include low blood pressure, stomach upset, and headaches.
What is Ferrlecit (sodium ferric gluconate)?
What is Ferrlecit (sodium ferric gluconate) used for?
- Iron-deficiency anemia (low red blood cell count due to low iron levels) in people age 6 years and older with chronic kidney disease receiving hemodialysis and epoetin alfa (Epogen, Procrit, Retacrit)
How Ferrlecit (sodium ferric gluconate) works
Ferrlecit (sodium ferric gluconate) is an iron supplement that helps replenish your body with this important mineral. Iron helps your bone marrow make red blood cells. It also helps make hemoglobin, a protein in red blood cells that's essential for delivering oxygen to different parts of your body.
Drug facts
Side effects of Ferrlecit (sodium ferric gluconate)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Adults:
- Nausea, vomiting, or diarrhea (35%)
- Injection site reaction (33%)
- Lower blood pressure (29%)
- Cramps (25%)
- Higher blood pressure (13%)
- Dizziness (13%)
- Abnormal changes in red blood cells (11%)
- Shortness of breath (11%)
- General pain (10%)
- Chest pain (10%)
- Leg cramps (10%)
Children:
- Lower blood pressure (35%)
- Headache (24%)
- Higher blood pressure (23%)
- Fast heart rate (17%)
- Vomiting (11%)
Less Common Side Effects
Adults:
- Weakness
- Headache
- Fatigue
- Back or arm pain
- Itchiness
- Fever
- Infections
Children:
- Nausea
- Diarrhea
- Stomach pain
- Sore throat
- Fever
- Infections
Ferrlecit (sodium ferric gluconate) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: wheezing, excessive sweating, back pain, chest pain, nausea, chills, flushing, rash, itching
- Low blood pressure: fainting, dizziness, weakness, blurry vision, clammy skin, shallow breathing
- High iron levels: fatigue, weakness, darkening of skin color, stomach or joint pain
The following Ferrlecit (sodium ferric gluconate) side effects have also been reported
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
Abdominal or stomach pain
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
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
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
shakiness
shivering
shortness of breath
slow or irregular heartbeat
slurred speech
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
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
increased menstrual flow or vaginal bleeding
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:
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
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
stomach discomfort or upset
swollen, red, or tender area of infection
voice changes
watery eyes
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.
Pros and cons of Ferrlecit (sodium ferric gluconate)
Pros
- IV infusion can be given at the same time as dialysis, so it's convenient for people with a busy schedule
- Safe for children as young as 6 years old with chronic kidney disease (CKD)
Cons
- Requires blood pressure monitoring to make sure this medication is safe for you
- Not a recommended option during pregnancy
- Has a risk of severe allergic reactions
Pharmacist tips for Ferrlecit (sodium ferric gluconate)
- Make sure to get your routine blood tests done on time while you're receiving Ferrlecit (sodium ferric gluconate). These blood tests check your iron levels and red blood cells. They help your prescriber check that the medication is working and is safe for you.
- Be sure to plan for some extra time after your appointment. Your care team will need to check your blood pressure during the infusion and for up to 30 minutes after you've received Ferrlecit (sodium ferric gluconate). This is because the medication can cause dangerously low blood pressure. Tell your care team right away if you faint or feel dizzy or nauseous after you've received Ferrlecit (sodium ferric gluconate).
- Your care team will watch for allergic reactions during your infusion and after you've received Ferrlecit (sodium ferric gluconate). This medication can sometimes cause allergic reactions that can be life-threatening. Tell your care team right away if you experience wheezing, shortness of breath, dizziness, chest pain, a lot of sweating, chills, flushing, or itching. They'll know how to help relieve these symptoms.
- Don't take any other iron supplements while you're getting treated with Ferrlecit (sodium ferric gluconate). This can raise your risk for having too much iron in the body, which can cause fatigue, weakness, darkening skin color, or joint pain.
- In general, it's recommended that you follow an iron-rich diet to help restore your iron levels. Examples of high-iron foods include red meats (like beef or pork), dark leafy greens (like broccoli or spinach), beans, and iron-enriched pasta and rice. Talk to your care team about how much iron you need to include in your diet every day.
Common questions about Ferrlecit (sodium ferric gluconate)
It's possible. Some people have had joint pain after their Ferrlecit (sodium ferric gluconate) infusion. But joint pain generally doesn't appear to be a common side effect of the medication. People have had other types of pain, like leg cramps and leg pain, more commonly (at least 10% of adults taking Ferrlecit (sodium ferric gluconate) in clinical trials). Tell your prescriber or primary care provider if you have joint pain after you get Ferrlecit (sodium ferric gluconate) infused.
No, Ferrlecit (sodium ferric gluconate) IV infusions don't typically make you urinate more. In general, more urination or frequent urination isn't a usual side effect with IV iron infusions. Talk to your care team or CKD specialist if you notice that you're going to the bathroom more than usual. They can help figure out what might be causing it.
No, black stool isn't a typical side effect of IV iron infusions like Ferrlecit (sodium ferric gluconate). But iron supplements that are taken by mouth, like ferrous sulfate, can cause you to have black stools as a side effect.
Ferrlecit (sodium ferric gluconate) is FDA approved for use with dialysis sessions. But the manufacturer doesn't specify whether there's a minimum time frame required between doses. One study suggested that Ferrlecit (sodium ferric gluconate) can be given once per day safely. Keep in mind, though, that the study was about adults with heart failure who were in the hospital and not about people with chronic kidney disease who need hemodialysis. Also, the dose was slightly different and given daily for 4 days. Discuss with your care team about how often you need Ferrlecit (sodium ferric gluconate).
Ferrlecit (sodium ferric gluconate) and Venofer (iron sucrose) are different IV iron supplements that treat iron-deficiency anemia. Both medications are approved for people receiving hemodialysis, but Venofer is also approved for people receiving peritoneal dialysis and people who don't need dialysis. In addition, children 6 years and older can take Ferrlecit whereas children as young as 2 can take Venofer. Also, Ferrlecit generally takes a little longer to infuse than Venofer. And although severe allergic reactions aren't common, studies suggest that the risk for these reactions might be higher with Ferrlecit than with Venofer. Talk with your care team to learn more about comparisons between the two medications.
Both Ferrlecit (sodium ferric gluconate) and Feraheme (ferumoxytol) are IV iron products that help raise iron levels in the body. Ferrlecit is approved for people ages 6 years and older with chronic kidney disease (CKD) whereas Feraheme is approved for only adults with and without CKD. In addition, a treatment course of Feraheme is only about 2 doses because each dose contains a good amount of iron. But you'll probably need more doses of Ferrlecit to complete treatment because each dose of Ferrlecit has a smaller amount of iron than that of Feraheme. In addition, studies suggest that Feraheme has a higher risk of severe allergic reactions than Ferrlecit. Discuss with your care team about comparing between the two medications.
Currently, Ferrlecit (sodium ferric gluconate) is only FDA approved for people with iron-deficiency anemia (IDA) who are receiving dialysis and epoetin alfa (Epogen, Procrit, Retacrit). But a small study suggested that Ferrlecit (sodium ferric gluconate) might work well and be safe for treating IDA in people who don't have kidney problems (which also means that they don't need dialysis). More research is needed to learn more about the medication's role in treating IDA for people who don't need dialysis.
It's not completely clear how safe Ferrlecit (sodium ferric gluconate) is during pregnancy because it hasn't been well-studied. But in general, it's recommended to avoid Ferrlecit (sodium ferric gluconate) while pregnant unless the benefits are clearly greater than the risks. This is because Ferrlecit (sodium ferric gluconate) contains benzyl alcohol as a preservative, which can cause gasping syndrome (a life-threatening condition that leads to difficulty breathing) in babies who were born early or have a low birth weight. Ask your healthcare professional about safer treatment options if you're pregnant and you require treatment with iron infusions.
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Risks and warnings for Ferrlecit (sodium ferric gluconate)
Ferrlecit (sodium ferric gluconate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious allergic reactions
- Risk factors: History of allergy to another iron product
Ferrlecit (sodium ferric gluconate) can cause allergic reactions that can sometimes be serious and life-threatening, for example, anaphylaxis. Some symptoms of an allergic reaction are changes in blood pressure, fast heart rate, dizziness, rash, hives, difficulty breathing, throat tightness, and nausea. Your care team will keep an eye on you for allergic reactions for at least 30 minutes after the IV infusion. Seek medical help right away if you have any symptoms of an allergic reaction.
Low blood pressure
Ferrlecit (sodium ferric gluconate) can lower your blood pressure. If a drop in blood pressure happens, it's typically after the IV infusion and then the blood pressure usually goes back up within 1 to 2 hours. Your care team might check your blood pressure or watch for symptoms of low blood pressure, like lightheadedness, dizziness, and weakness, after your infusion.
Too much iron in the body
Your care team will make sure that you get the right amount of IV iron supplementation that you need to treat your IDA. Too much iron in the body (iron overload) can be harmful. It can lead to liver, heart, and joint problems, as well as other organ damage.
To lower your risk for having too much iron in the body, don't take any other iron supplements during your treatment with Ferrlecit (sodium ferric gluconate). Tell your care team right away if you have fatigue, weakness, darkening skin color, or joint pain. These might be signs of high iron levels in your blood. Keep these signs in mind if your prescriber recommends that you take another iron supplement after you complete your treatment with Ferrlecit (sodium ferric gluconate).
Not approved for newborns or infants because of risk of serious breathing problem (gasping syndrome)
- Risk factors: Newborns | Infants with low birth weight | Currently pregnant | Breastfeeding
Ferrlecit (sodium ferric gluconate) isn't approved for use in newborns or infants. This is because certain Ferrlecit (sodium ferric gluconate) products contain a preservative called benzyl alcohol. Newborns and infants with low birth weight who are given products containing this preservative can develop a rare, but serious and sometimes life-threatening, medical condition called gasping syndrome.
If you're pregnant or breastfeeding, talk with your care team before you receive Ferrlecit (sodium ferric gluconate). This is because it's possible that your baby could potentially be exposed to benzyl alcohol in the womb or through your breast milk. Ferrlecit (sodium ferric gluconate) isn't the preferred choice for iron infusions during pregnancy. To be safe, your prescriber will probably choose a different iron supplement product for you.
Ferrlecit (sodium ferric gluconate) dosage
Typical dosage for Ferrlecit (sodium ferric gluconate)
Ferrlecit (sodium ferric gluconate) is usually given by a healthcare professional in a healthcare setting (such as a dialysis center or infusion center). Your prescriber will determine the appropriate dose for you or your child each time the medication is given.
- Adults (age 18 and over): The typical dose is 125 mg injected into a vein (IV) once every dialysis session. The dose is either given as an IV infusion over 1 hour or as a quicker injection over 10 minutes.
- Children (age 6 and over): The dose will depend on the child’s weight. In general, the typical dose is 1.5 mg/kg (maximum 125 mg) injected into a vein once every dialysis session. The dose is given as an IV infusion over 1 hour.
Interactions between Ferrlecit (sodium ferric gluconate) and other drugs
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
- 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
- Mycophenolic Acid
- Zinc
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