Iron sucrose injection

No data are available regarding overdosage of Venofer in humans. Excessive dosages of Venofer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Venofer to patients with iron overload. [See CONTRAINDICATIONS]

Toxicities in single-dose studies in mice and rats, at intravenous iron sucrose doses up to 8 times the maximum recommended human dose based on body surface area, included sedation, hypoactivity, pale eyes, bleeding in the gastrointestinal tract and lungs, and mortality.

Call your doctor for instructions if you miss an appointment for your iron sucrose injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• chest pain;

• a light-headed feeling, like you might pass out; or

• increased blood pressure (severe headache, pounding in your neck or ears, anxiety, confusion).

Common side effects may include:

• headache, dizziness;

• nausea, vomiting;

• diarrhea;

• muscle or joint pain, back pain;

• pain in an arm or leg;

• itching; or

• bruising or irritation where the medicine was injected.

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.

Usual Adult Dose for Iron Deficiency Anemia:

Hemodialysis Dependent Chronic Kidney Disease (HDD-CKD):
5 mL (100 mg elemental iron) undiluted slow IV over 2 to 5 minutes. Alternatively, 5 mL (100 mg elemental iron) diluted in a maximum of 100 mL of 0.9% sodium chloride IV over at least 15 minutes. Repeat at consecutive hemodialysis sessions for a total cumulative dose of 1000 mg.

Non- Dialysis Dependent Chronic Kidney Disease (NDD-CKD):
10 mL (200 mg elemental iron), undiluted, IV over 2 to 5 minutes administered on 5 different occasions within a 14- day period to achieve a total cumulative dose of 1000 mg within the 14- day period.

Alternatively, 25 mL (500 mg elemental iron), diluted in a maximum of 250 mL sodium chloride 0.9%, IV over 210 to 240 minutes administered on day 1 and day 14 to give a cumulative dose of 1000 mg within a 14- day period. However, there is limited experience with this dosage regimen. A clinical trial (n=30) reported hypotension in 2 patients following administration of this dosage regimen.

Peritoneal Dialysis Dependent Chronic Kidney Disease (PDD-CKD):
Two infusions of 15 mL (300 mg elemental iron) each diluted in a maximum of 250 mL of 0.9% sodium chloride administered IV over 90 minutes 14 days apart, followed by one infusion of 20 mL (400 mg elemental iron) diluted in a maximum of 250 mL of 0.9% sodium chloride administered over 150 minutes 14 days after second dose for a total cumulative dose of 1000 mg infused within a 28 day period.

Applies to iron sucrose: intravenous solution

Cardiovascular

Hypotension has been reported in all patients receiving intravenous iron with the highest incidence reported in HDD-CKD patients. Hypotension following administration of iron sucrose may be related to both the rate of administration and total dose administered; therefore, caution should be taken to ensure administration of iron sucrose according to the manufacturer recommended guidelines.[Ref]

Cardiovascular side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included chest pain (6.1%), cardiac murmur (0.4%), hypertension (6.5%), hypotension (39.4%), and fluid overload (3.0%).

Cardiovascular side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included chest pain (1.4%), cardiac murmur (2.2%), hypertension (6.5%), hypotension (2.2%), and fluid overload (1.4%).

Cardiovascular side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included chest pain (2.7%), hypertension (8.0%), hypotension (2.7%), and fluid overload (1.3%).[Ref]

Musculoskeletal

Musculoskeletal side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included arthralgia (3.5%), back pain (2.2%), muscle cramp (29.4%), and pain in extremity (5.6%).

Musculoskeletal side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included arthralgia (1.4%), back pain (2.2%), muscle cramp (0.7%), myalgia (3.6%), and pain in extremity (4.3%).

Musculoskeletal side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included arthralgia (4.0%), back pain (1.3%), muscle cramp (2.7%), myalgia (1.3%), and pain in extremity (2.7%).[Ref]

Gastrointestinal

Gastrointestinal side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included abdominal pain (3.5%), constipation (1.3%), diarrhea (5.2%), dysgeusia (0.9%), nausea (14.7%), and vomiting (9.1%).

Gastrointestinal side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included abdominal pain (1.4%), constipation (4.3%), diarrhea (7.2%), dysgeusia (7.9%), nausea (8.6%), and vomiting (5%).

Gastrointestinal side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included abdominal pain (4.0%), constipation (4.0%), diarrhea (8.0%), nausea (5.3%), and vomiting (8.0%).

Dry mouth has also been reported.[Ref]

Nervous system

Nervous system side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included dizziness (6.5%), headache (12.6%), and asthenia (2.2%).

Nervous system side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included dizziness (6.5%), headache (2.9%), hypoesthesia (0.7%), and asthenia (0.7%).

Nervous system side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included dizziness (1.3%), headache (4.0%), and asthenia (2.7%).[Ref]

Respiratory

Respiratory side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included cough (3.0%), dyspnea (3.5%), upper respiratory infection (1.3%), pharyngitis (0.4%), and nasopharyngitis (0.9%).

Respiratory side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included cough (2.2%), dyspnea (3.6%), exacerbated dyspnea (2.2%), nasal congestion (1.4%), sinusitis (0.7%), upper respiratory infection (0.7%), allergic rhinitis (0.7%), and nasopharyngitis (0.7%).

Respiratory side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included nasopharyngitis (2.7%), sinusitis (4.0%), upper respiratory tract infection (2.7%), cough (1.3%), dyspnea (1.3%), nasal congestion (1.3%), and pharyngitis (6.7%).

Pneumonia and cough have also been reported.[Ref]

Local

Local side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included burning (3.6%), extravasation (2.2%), and pain (2.2%) at the injection site.[Ref]

Dermatologic

Dermatologic side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included pruritus (3.9%) and rash (0.4%).

Dermatologic side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included pruritus (2.2%) and rash (1.4%).

Dermatologic side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included pruritus (2.7%).[Ref]

Hepatic

Hepatic side effects have included elevated liver enzymes (1% to 5%).[Ref]

Immunologic

Immunologic side effects have included a possible increase in susceptibility to infections.[Ref]

Endocrine

Endocrine side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included hypoglycemia (0.4%).

Endocrine side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included gout (2.9%), hyperglycemia (2.9%), and hypoglycemia (0.7%).

Endocrine side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included hypoglycemia (4.0%).[Ref]

Other

Other side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included edema (0.4%), fatigue (1.7%), feeling abnormal (3.0%), peripheral edema (2.6%), pyrexia (3.0%), and graft complication (9.5%).

Other side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included ear pain (2.2%), edema (6.5%), fatigue (3.6%), peripheral edema (7.2%), pyrexia (0.7%), and graft complication (1.4%).

Other side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included peripheral edema (5.3%), pyrexia (1.3%), catheter site infection (4.0%), and peritoneal infection (8.0%).

Accidental injury and fever have also been reported.[Ref]

Genitourinary

Genitourinary side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included urinary tract infection (0.4%).

Genitourinary side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included urinary tract infection (0.7%) and proteinuria.

Genitourinary side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included urinary tract infection (1.3%).[Ref]

Hypersensitivity

Hypersensitivity side effects have included wheezing, dyspnea, hypotension, rashes, and pruritus. Hypersensitivity reactions to iron sucrose are reported to occur in less than 0.1% of patients. Anaphylactic reactions consisting of anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, and/or convulsion have also been reported.[Ref]

Serious hypotensive episodes have been reported in two patients following administration of iron sucrose at a dosage of 500 mg.

Between 1992 and February 2005, a total of 104 reports of anaphylactoid reactions including serious or life-threatening reactions have been collected in postmarketing spontaneous reporting worldwide based on estimated use in over 3.8 million patients.

Four U.S. trials involving the administration of iron sucrose to patients with HDD-CKD (n=1,151) included 130 (11%) patients who reportedly had a previous history of intravenous iron therapy and were reported to be intolerant, that is, precluded from further use of that iron product. Following administration of iron sucrose, it was reported that none of these patients had an adverse reaction that would preclude them from further use of iron sucrose.[Ref]

Ocular

Ocular side effects associated with the use iron sucrose in the treatment of HDD-CKD have included conjunctivitis (0.4%).

Ocular side effects associated with the use iron sucrose in the treatment of PDD-CKD have included conjunctivitis (2.7%).[Ref]

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

Hemodialysis Dependent Chronic Kidney Disease (HDD-CKD):
5 mL (100 mg elemental iron) undiluted slow IV over 2 to 5 minutes. Alternatively, 5 mL (100 mg elemental iron) diluted in a maximum of 100 mL of 0.9% sodium chloride IV over at least 15 minutes. Repeat at consecutive hemodialysis sessions for a total cumulative dose of 1000 mg.

Non- Dialysis Dependent Chronic Kidney Disease (NDD-CKD):
10 mL (200 mg elemental iron), undiluted, IV over 2 to 5 minutes administered on 5 different occasions within a 14- day period to achieve a total cumulative dose of 1000 mg within the 14- day period.

Alternatively, 25 mL (500 mg elemental iron), diluted in a maximum of 250 mL sodium chloride 0.9%, IV over 210 to 240 minutes administered on day 1 and day 14 to give a cumulative dose of 1000 mg within a 14- day period. However, there is limited experience with this dosage regimen. A clinical trial (n=30) reported hypotension in 2 patients following administration of this dosage regimen.

Peritoneal Dialysis Dependent Chronic Kidney Disease (PDD-CKD):
Two infusions of 15 mL (300 mg elemental iron) each diluted in a maximum of 250 mL of 0.9% sodium chloride administered IV over 90 minutes 14 days apart, followed by one infusion of 20 mL (400 mg elemental iron) diluted in a maximum of 250 mL of 0.9% sodium chloride administered over 150 minutes 14 days after second dose for a total cumulative dose of 1000 mg infused within a 28 day period.

No adjustment recommended

Data not available

No adjustment recommended