Nulecit

Sodium ferric gluconate is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Sodium ferric gluconate complex is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body) in adults and children who are at least 6 years old. Sodium ferric gluconate complex is for people with kidney disease who are on dialysis.

Sodium ferric gluconate complex may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss a dose of sodium ferric gluconate complex.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, sweating, vomiting; severe lower back pain; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• chest pain, trouble breathing;

• flushing (warmth, redness, or tingly feeling);

• fast or uneven heart rate; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, seizure).

Less serious side effects may include:

• pain, leg cramps;

• dizziness, general ill feeling;

• mild headache;

• nausea, vomiting, diarrhea; or

• pain, redness, swelling, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially iron supplements you take by mouth.

There may be other drugs that can interact with sodium ferric gluconate complex. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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, the number of red blood cells is lower than normal. 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.

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.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with 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.

• Dimercaprol
• Eltrombopag

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

Interactions with Food/Tobacco/Alcohol

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:

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

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

Dosages in excess of iron needs may lead to accumulation of iron in iron storage sites and hemosiderosis. Periodic monitoring of laboratory parameters of iron storage may assist in recognition of iron accumulation. NulecitTM should not be administered in patients with iron overload.

Serum iron levels greater than 300 mcg/dL may indicate iron poisoning which is characterized by abdominal pain, diarrhea, or vomiting which progresses to pallor or cyanosis, lassitude, drowsiness, hyperventilation due to acidosis, and cardiovascular collapse. Caution should be exercised in interpreting serum iron levels in the 24 hours following the administration of NulecitTM since many laboratory assays will falsely overestimate serum or transferrin bound iron by measuring iron still bound to the NulecitTM complex. Additionally, in the assessment of iron overload, caution should be exercised in interpreting serum ferritin levels in the week following NulecitTM administration since, in clinical studies, serum ferritin exhibited a non-specific rise which persisted for five days.

The NulecitTM iron complex in sucrose injection is not dialyzable.

Sodium ferric gluconate complex in sucrose injection at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg and 250 mg/kg caused deaths to mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in the respiratory rate, tremor, and convulsions.

Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events based on information from postmarketing spontaneous reports. These adverse events included hypotension, nausea, vomiting, abdominal pain, diarrhea, dizziness, dyspnea, urticaria, chest pain, paresthesta, and peripheral swelling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Applies to sodium ferric gluconate complex: intravenous solution

Along with its needed effects, sodium ferric gluconate complex (the active ingredient contained in Nulecit) 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 while taking sodium ferric gluconate complex:

• Abdominal or stomach pain
• 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 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
• depression
• diarrhea
• 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
• 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 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
• runny nose
• shakiness
• shivering
• shortness of breath
• slow or irregular heartbeat
• slurred speech
• sore throat
• 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
• weight gain
• wheezing

• 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
• increased menstrual flow or vaginal bleeding
• itching
• 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 of sodium ferric gluconate complex 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:

• Accumulation of pus
• acid or sour stomach
• anxiety
• 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

• Change in taste
• loss of taste

Applies to sodium ferric gluconate complex: intravenous solution

General

The most common adverse events were nausea, vomiting, diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (changes in morphology, color, or number of red blood cells), dyspnea, chest pain, leg cramps, pain, headache, and tachycardia.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (35%), hypertension (23%), tachycardia (17%)
Common (1% to 10%): Thrombosis
Frequency not reported: Bradycardia, vasodilatation, angina pectoris, myocardial infarction
Postmarketing reports: Hemorrhage, shock, phlebitis[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting and/or diarrhea (35%)
Common (1% to 10%): Abdominal pain
Frequency not reported: Rectal disorder, dyspepsia, eructation, flatulence, gastrointestinal disorder, melena
Postmarketing reports: Dry mouth[Ref]

Local

Very common (10% or more): Injection site reaction (33%)[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactic-type reactions[Ref]

Nervous system

Very common (10% or more): Headache (24%), dizziness (13%)
Common (1% to 10%): Headache, paresthesias, syncope
Frequency not reported: Lightheadedness, somnolence, decreased level of consciousness
Postmarketing reports: Hypertonia, loss of consciousness, convulsion, dysgeusia, hypoesthesia[Ref]

Musculoskeletal

Very common (10% or more): Cramps (25%), leg cramps (10%)
Frequency not reported: Myalgia, arthralgia, back pain, arm pain[Ref]

Respiratory

Very common (10% or more): Dyspnea (11%)
Common (1% to 10%): Coughing, upper respiratory infections, pharyngitis, rhinitis
Frequency not reported: Pneumonia, pulmonary edema[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Frequency not reported: Rash, increased sweating
Postmarketing reports: Skin discoloration[Ref]

Hematologic

Very common (10% or more): Abnormal erythrocytes (changes in morphology, color, or number of red blood cells) (11%)
Frequency not reported: Anemia, leukocytosis, lymphadenopathy[Ref]

Other

Very common (10% or more): Chest pain (10%), pain (10%)
Common (1% to 10%): Asthenia, fatigue, fever, malaise, infection, generalized edema
Frequency not reported: Infection, abscess, chills, rigors, flu-like syndrome, weakness, deafness, leg edema, peripheral edema, edema[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia
Frequency not reported: Anorexia, hypoglycemia, hypervolemia, hypokalemia[Ref]

Immunologic

Common (1% to 10%): Infection
Frequency not reported: Sepsis[Ref]

Genitourinary

Frequency not reported: Urinary tract infection, menorrhagia[Ref]

Psychiatric

Frequency not reported: Agitation
Postmarketing reports: Nervousness[Ref]

Oncologic

Frequency not reported: Carcinoma[Ref]

Ocular

Frequency not reported: Conjunctivitis, rolling of the eyes, watery eyes, puffy eye lids, arcus senilis, diplopia[Ref]

Some side effects of Nulecit may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.