Nulecit (Intravenous)

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 make red blood cells. When the body does not get enough iron, it cannot produce enough normal red blood cells. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

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

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 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 low blood pressure (hypotension). 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 (e.g., gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any specific problems that would limit the use of sodium ferric gluconate complex injection in children. However, safety and effectiveness have not been confirmed in children younger than 6 years old.

Geriatric

Studies conducted so far have not indicated any specific problems in the elderly that would limit the use of sodium ferric gluconate complex injection. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and a dose adjustment for patients receiving sodium ferric gluconate complex injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may adjust the dose or take other precautions. It's especially important that your healthcare professional knows if you are taking any of the medicines listed below when you receive this medicine. The following interactions have been chosen based on their potential significance and may not be all-inclusive.

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

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

Using this medicine with any of the following may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Delafloxacin
• Minocycline
• Zinc

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been chosen based on their potential significance and may not be all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects but might be necessary in some cases. If used together, your doctor may adjust the dose or frequency of this medicine or provide special instructions regarding food, alcohol, or tobacco use.

• Phytic Acid Containing Food

Other Medical Problems

Other medical conditions may influence the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Heart disease or
• Hypotension (low blood pressure)—Use with caution as it may worsen these conditions.

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

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your health care professional may also 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, 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.

In the U.S.

• Ferrlecit
• Nulecit

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Mineral-Trace Mineral

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.