Feromax

Each 5 mL of solution contains ferric hydroxide in complex with sucrose equivalent to elemental iron 100 mg.

Feromax is an aqueous complex of polynuclear iron (III)-hydroxide in sucrose (Feromax) for IV use. Feromax injection has a molecular weight of approximately 34,000-60,000 daltons.

Each mL contains 20 mg elemental iron as Feromax in water for injection. Feromax is available in 5 mL single dose ampule (100 mg elemental iron per 5 mL). Feromax contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5-11.1 at 20°C. It contains no preservatives. The osmolarity is not less than 1150 and not more than 1350 mOsmol/L.

Feromax is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).

Feromax is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Feromax injection is used to treat iron deficiency anemia in people with kidney disease. It is usually given with another medication to promote the growth of red blood cells (such as Aranesp, Epogen, or Procrit).

This medication is not for treating other forms of anemia not caused by iron deficiency.

Feromax injection may also be used for other purposes not listed in this medication guide.

Dosage: Calculation of

Dosage: The dosage has to be individually adapted according to the total iron deficit calculated with the following formula:

Total Iron Deficit (mg) = body weight (kg) x [target Hb - actual Hb] (g/L) x 0.24* + depot iron (mg).

Up to 35 kg Body Weight: Target Hb=130 g/L resp. depot iron=15 mg/kg body weight.

>35 kg Body Weight: Target Hb=150 g/L resp. depot iron=500 mg.

*Factor 0.24=0.0034 x 0.07 x 1000.

(Iron content of haemoglobin ~=0.34%/Blood volume ~=7% of body weight/factor 1000=Conversion from g to mg.)

Total Amount of Feromax to be Administered (in mL): Divide total iron deficit (mg) by 20 mg/mL.

If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be split. If no response of the haematological parameters is observed after 1-2 weeks, the original diagnosis should be reconsidered.

Calculation of Dosage for Iron Replacement Secondary to Blood Loss and to Support Autologous Blood Donation: The required Feromax dose to compensate the iron deficit is calculated according to the following formulas: If the Quantity of the Blood Lost is Known: The administration of 200 mg IV iron (= 10 mL Feromax) results in an increase in haemoglobin which is equivalent to 1 unit blood (= 400 mL with 150 g/L Hb content).

Iron to be replaced (mg) = number of blood unit lost x 200 or amount of Feromax needed (mL) = number of blood units lost x 10.

If the Hb Level is Reduced: Use the previous formula considering that the depot iron does not need to be restored.

Iron to be replaced (mg) = body weight (kg) x 0.24 x [target Hb - actual Hb] (g/L)

For example: Body weight 60 kg, Hb deficit = 10 g/L --> iron to be replaced ~=150 mg -->7.5 mL Feromax needed.

Normal

Dosage: Adults and

Elderly:

Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed Feromax 0.15 mL (iron 3 mg) per kg body weight once to 3 times a week depending on the haemoglobin level.

Maximum Tolerated Single Dose: Adults and

Elderly:

Infusion: If the clinical situation demands the single dose may be increased to 0.35 mL Feromax/kg body weight (=7 mg iron/kg body weight) not exceeding 25 mL Feromax (500 mg iron), diluted in 500 mL 0.9% w/v NaCl infused over at least 3.5 hrs once a week.

Administration: Feromax is exclusively administered IV by drip infusion, by slow injection or directly into the venous limb of the dialyser and is not suitable for IM use and for total dose infusion (TDI), where the full dose of iron required, representing the patient's total iron deficit is administered in 1 complete infusion.

Before administration of the 1st therapeutic dose of Feromax in a new patient, a test dose of 1-2.5 mL Feromax (20-50 mg iron), 1 mL (20 mg iron) in children >14 kg body weight and ½ the daily dose (1.5 mg/kg) in children <14 kg body weight should be given by the chosen method of administration. Facilities for cardiopulmonary resuscitation must be available. If no adverse reactions occur within a waiting period of at least 15 min after administration, the remaining portion of the initial dose can be given.

Infusion: Feromax may preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection). One mL Feromax (20 mg iron) has to be diluted exclusively in a maximum of 20 mL of 0.9% w/v NaCl solution, immediately prior to infusion (ie, 5 mL in a maximum of 100 mL of 0.9% w/v NaCl up to 25 mL in a maximum of 500 mL of 0.9% NaCl). The solution should be infused at a rate of 100 mL in at least 15 min; 200 mL in at least 30 min; 300 mL in at least 1.5 hrs; 400 mL in at least 2.5 hrs; 500 mL in at least 3.5 hrs.

If clinical circumstances demand, Feromax may be diluted in less than the specified amount of 0.9% w/v NaCl solution, producing a higher Feromax concentration. However, the rate of infusion must be adapted according to the amount of iron given per minute (eg, 10 mL Feromax = 200 mg iron should be infused in at least 30 min; 25 mL Feromax = 500 mg iron should be infused in at least 3.5 hrs). For stability reasons, dilutions of lower Feromax concentrations are not permissible.

IV Injection: Feromax may be administered by slow IV injection at a rate of 1 mL undiluted solution/min (ie, 5 min/5 mL amp) not exceeding 10 mL Feromax (200 mg iron) per injection. After an injection, extend the arm of the patient.

Injection into dialyser: Feromax may be administered directly into the venous limb of the dialyser under the same conditions as for IV injection.

See also:
What is the most important information I should know about Feromax?

You should not receive this medication if you have ever had an allergic reaction to an iron injection, or if you have iron overload (the buildup of excess iron) or hemochromatosis.

Before you receive Feromax injection, tell your doctor if you have low blood pressure, hepatitis, or if you have received many blood transfusions in the past.

Feromax injection can make it harder for your body to absorb iron medications you take by mouth. Tell your doctor if you are taking iron supplements or other iron-based oral medications.

Use Feromax as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Feromax is usually administered as an injection at your doctor's office or clinic. Ask your doctor or pharmacist any questions you may have about Feromax.
• If you miss a dose of Feromax, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Feromax.

Use: Labeled Indications

Iron-deficiency anemia: Treatment of iron-deficiency anemia in chronic kidney disease (CKD)

KDIGO guideline recommendations: For CKD patients with anemia and receiving dialysis, IV iron may be indicated if an increase in the hemoglobin concentration (without initiating or increasing the dose of an erythropoiesis stimulating agent) is desired and the transferrin saturation (TSAT) is ≤30% and ferritin is ≤500 ng/mL; for CKD patients not on dialysis, a trial of oral iron is suggested, although the route of administration is selected based on the severity of iron deficiency, venous access, response to prior oral iron therapy, patient adherence, and cost. There is insufficient evidence to recommend IV iron if ferritin level is >500 ng/mL or TSAT is >30% (KDIGO 2012).

Off Label Uses

Chemotherapy-associated anemia

Data from 2 multicenter, randomized clinical trials support the use of Feromax in the management of patients with chemotherapy-associated anemia.

Based on guidelines from the American Society of Clinical Oncology and the American Society of Hematology for Management of Cancer-Associated Anemia With Erythropoiesis-Stimulating Agents, the use of iron supplementation (either oral or IV) reduces the risk for red blood cell transfusions and should be considered (independent of iron status) in all patients receiving erythropoiesis-stimulating agents.

See also:
What other drugs will affect Feromax?

As with all parenteral iron preparations, Feromax should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, an oral iron therapy should at least be started 5 days after the last injection.

Incompatibilities: Feromax must only be mixed with 0.9% w/v NaCl solution. No other therapeutic agent should be added.

See also:
What are the possible side effects of Feromax?

Exposure to Feromax has been documented in 231 patients undergoing chronic hemodialysis in the previously mentioned clinical trials and in 1,051 patients undergoing hemodialysis in 2 post-marketing safety studies. About 1,600 hemodialysis patients treated with Feromax have been reported in the medical literature.

The safety of Feromax has been documented in 3 efficacy studies (A, B and C previously described) and 2 post-marketing studies involving a total of 1,282 patients. In the first post-marketing safety study, 665 chronic hemodialysis patients were treated with Feromax doses of 100 mg at each dialysis session for up to 10 consecutive dialysis sessions for their iron deficiency or on a weekly basis for 10 weeks for maintenance of iron stores. Serious adverse events and drug-related nonserious adverse events were collected. In the second post-marketing safety study, 386 hemodialysis patients were exposed to a single dose of Feromax (100 mg IV by slow injection over 2 min or 200 mg IV by slow injection over 5 min). The mean age of patients enrolled in the 2 post-marketing safety studies was 59 years, with a range of 20-93 years. Males made up 60% of the population. The ethnicity of the patients enrolled in the 2 studies included Blacks (44%), Caucasians (41%), Asians (3%), Hispanics (11%) and others (1%).

Adverse Events Observed in Studies A, B and C: Adverse reactions, whether or not related to Feromax administration, reported by >5% of treated patients from a total of 231 patients in the 3 studies are as follows: Hypotension (36%), cramps/leg cramps (23%), nausea, headache, vomiting and diarrhea.

Adverse events, whether or not related to Feromax administration, reported by >1% of treated patients from a total of 231 patients in the 3 studies are categorized as follows by body system either by investigator term or by COSTART terminology and ranked in order of decreasing frequency within each body system. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving iron IV.

Body as a Whole: Headache, fever, pain, asthenia, feeling unwell, malaise and accidental injury.

General and Cardiovascular Disorders: Hypotension, chest pain, hypertension, hypervolemia.

Gastrointestinal System Disorders: Nausea, vomiting, abdominal pain, elevated liver enzymes, diarrhea.

Central and Peripheral Nervous System: Dizziness.

Musculoskeletal System: Cramps/leg cramps, musculoskeletal pain.

Respiratory System: Dyspnea, pneumonia, cough.

Skin and Appendages: Pruritus, application site reaction.

Adverse Events Observed in Two Post-Marketing Safety Studies: In the 2 post-marketing safety studies, 665 patients received multiple doses of Feromax and 386 patients received a single dose of Feromax. In the multiple dose study, 72% of the patients received up to 10 doses, 27% received between 11-30 doses and 1% received 40-50 doses of Feromax; only serious adverse events and nonserious adverse events considered by the investigators to be drug-related were collected.

Adverse events reported by >1% of 1,051 treated patients are as follows: Congestive heart failure, sepsis and taste perversion.

Hypersensitivity Reactions: See Warnings and Precautions.

In studies A, B and C and 2 post-marketing safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes or pruritus.

No serious or life-threatening hypersensitivity reactions associated with Feromax administration were observed in these studies. From the post-marketing spontaneous reporting system, there were 83 reports of anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea or convulsion) associated with Feromax administration between 1992 and 2002 based on estimated use in >2 million patients.

One hundred thirty (11%) of the 1151 patients evaluated in the 4 US trials had prior other iron IV therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with Feromax, there were no occurrences of adverse events that precluded further use of Feromax.