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.
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)
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.
Source: DailyMed
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.
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)
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
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.
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.
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.
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.
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).
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) 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.
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.
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.
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)
Adults who can't take oral iron supplements
Adults who didn't see improvement in their iron levels after oral iron supplements
Adults with chronic kidney disease (CKD)
Iron deficiency (including iron-deficiency anemia) in people who either have already tried or can't take oral iron supplements
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