Iron sucrose (Intravenous)

Iron sucrose injection is an iron replacement product used to treat iron deficiency anemia (not enough iron in the blood) in patients with chronic kidney disease (CKD).

Iron is a mineral that the body needs to make red blood cells. When the body does not have enough iron, it cannot produce the normal amount of red blood cells needed to maintain good health. This condition is known as iron deficiency (iron shortage) or iron deficiency anemia.

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

It is very important that your doctor checks you closely while you are getting this medicine. Blood tests may be needed to look for unwanted effects. You may also need to check your blood pressure at home. If you notice any changes in your normal blood pressure, call your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

Dizziness, lightheadedness, or fainting may happen, especially if you get up suddenly from lying down or sitting. These symptoms are more likely to happen when you start using this medicine, or when the dose is increased.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been enough studies to determine how iron sucrose injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies so far have not shown any specific problems for older adults that would limit the use of iron sucrose injection. However, older patients may be more likely to have age-related kidney, liver, or heart issues, which could require careful consideration and possible dose adjustments when receiving iron sucrose injection.

Breast Feeding

There are not enough studies to determine the risk to infants when this medication is used by breastfeeding women. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. It is important for your healthcare professional to know if you are taking any of the medicines listed below when receiving this medicine. The following interactions are based on their potential significance and are not a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in certain cases. If 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 medicines may increase the risk of certain side effects, but it may be the best treatment for you. If prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Delafloxacin
• Minocycline
• Zinc

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are based on their potential significance and are not a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, but this may be unavoidable 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

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Hypotension (low blood pressure)—Use with caution. This condition may worsen.

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects happen:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chest pain or tightness in the chest
• confusion
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• nervousness
• pounding in the ears
• rapid weight gain
• slow or fast heartbeat
• sweating
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

Less common

• Fever

Incidence not known

• Chest discomfort
• difficulty swallowing
• hives or itching
• increased sweating
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of consciousness
• noisy breathing
• slow or irregular heartbeat
• swelling of the joints

Some side effects may happen 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

• Change in taste
• diarrhea
• muscle cramps
• nausea or vomiting
• pain in the arms or legs
• pain or burning sensation in the injection site

Less common

• Abdominal or stomach pain
• ankle, knee, or great toe joint pain
• body aches or pain
• chills
• difficulty with moving
• ear congestion or pain
• flushed, dry skin
• fruit-like breath odor
• increased hunger or thirst
• increased urination
• lack or loss of strength
• pain or redness at the injection site
• pale skin at the injection site
• runny nose, sneezing
• sore throat
• unexplained weight loss

Rare

• Burning, dry, or itching eyes
• discharge or excessive tearing
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

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.

• Venofer

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Mineral-Trace Mineral

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.