Ferumoxytol

FERUMOXYTOL- ferumoxytol non-stoichiometric magnetite injection
Sandoz Inc

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Warnings and Precautions (5.1)].
Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after ferumoxytol administration [see Warnings and Precautions (5.1)].
Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

Ferumoxytol is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

who have intolerance to oral iron or have had unsatisfactory response to oral iron or
who have chronic kidney disease (CKD).

2 DOSAGE AND ADMINISTRATION

The recommended dose of ferumoxytol injection is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer ferumoxytol as an intravenous infusion in 50 to 200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position.

Ferumoxytol injection does not contain antimicrobial preservatives. Discard unused portion. Ferumoxytol injection, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2 to 8 mg elemental iron per mL, should be used immediately but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours or refrigerated (2 to 8° C) for up to 48 hours

The dosage is expressed in terms of mg of elemental iron, with each mL of ferumoxytol containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second ferumoxytol infusion. The recommended ferumoxytol injection dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

For patients receiving hemodialysis, administer ferumoxytol once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each ferumoxytol infusion.

Allow at least 30 minutes between administration of ferumoxytol and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension, such as chemotherapeutic agents or monoclonal antibodies.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.

3 DOSAGE FORMS AND STRENGTHS

Ferumoxytol Injection is available in single-dose vials. Each vial contains 510 mg of elemental iron in 17 mL (30 mg per ml).

4 CONTRAINDICATIONS

Ferumoxytol is contraindicated in patients with:

Known hypersensitivity to ferumoxytol or any of its components [see Warnings and Precautions (5.1)].
History of allergic reaction to any intravenous iron product [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Serious Hypersensitivity Reactions

Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving ferumoxytol. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous ferumoxytol dose was tolerated.

Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering ferumoxytol to these patients.

Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after ferumoxytol administration for at least 30 minutes and until clinically stable following completion of each infusion [see Adverse Reactions (6.2) ].

In a clinical study in patients with IDA, regardless of etiology, hypersensitivity reactions were reported in 0.4% (4/997) of subjects receiving ferumoxytol administered as intravenous infusion over at least 15 minutes. These included one patient with severe hypersensitivity reaction and three patients with moderate hypersensitivity reactions.

In clinical studies predominantly in patients with IDA and CKD, serious hypersensitivity reactions were reported in 0.2% (4/1,806) of subjects receiving ferumoxytol (administered as a rapid intravenous injection – prior method of administration no longer approved). Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.5% (63/1,806) of these subjects.

In the post-marketing experience, fatal and serious anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of ferumoxytol may have more severe outcomes [s ee Boxed Warning , Adverse Reactions (6.2) and Use in Specific Populations (8.5)].

5.2 Hypotension

Ferumoxytol may cause clinically significant hypotension.

In a clinical study with ferumoxytol in patients with IDA, regardless of etiology, moderate hypotension was reported in 0.2% (2/997) of subjects receiving ferumoxytol administered as intravenous infusion over at least 15 minutes.

In clinical studies in patients with IDA and CKD, hypotension was reported in 1.9% (35/1,806) of subjects, including three patients with serious hypotensive reactions, who had received ferumoxytol as a rapid intravenous injection (prior method of administration no longer approved).

Hypotension has also been reported in the post-marketing experience [see Adverse Reactions (6.2)]. Monitor patients for signs and symptoms of hypotension following each ferumoxytol administration [see Dosage and Administration (2) and Warnings and Precautions (5.1)].

5.3 Iron Overload

Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy [see Dosage and Administration (2)]. Do not administer ferumoxytol to patients with iron overload.

In the 24 hours following administration of ferumoxytol, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in the ferumoxytol complex.

5.4 Magnetic Resonance (MR) Imaging Test Interference

Administration of ferumoxytol may transiently affect the diagnostic ability of MR imaging. Conduct anticipated MR imaging studies prior to the administration of ferumoxytol. Alteration of MR imaging studies may persist for up to 3 months following the last ferumoxytol dose. If MR imaging is required within 3 months after ferumoxytol administration, use T1- or proton density-weighted MR pulse sequences to minimize the ferumoxytol effects; MR imaging using T2-weighted pulse sequences should not be performed earlier than 4 weeks after the administration of ferumoxytol. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 to 2 days following ferumoxytol administration [see Clinical Pharmacology (12.3)].

Ferumoxytol will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.

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