Feriv 20 mg/ml solution for injection or concentrate for infusion solution

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FERIV 20 mg/ml Injectable Solution or Concentrate for Solution for Infusion

(Iron)

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Package leaflet contents:

1. What FERIV is and what it is used for
2. Before you are given FERIV
3. Possible side effects
4. Storage of FERIV
5. Further information

1. What FERIV is and what it is used for

FERIV belongs to a group of medicines called iron preparations.

FERIV is indicated for intravenous treatment of iron deficiency in the following situations:

• Proven intolerance to oral iron preparations.
• When there is a clinical need for rapid replenishment of iron stores.
• In active inflammatory bowel disease, when oral iron preparations are ineffective or poorly tolerated.
• Demonstrated lack of patient compliance with oral iron therapy.

The diagnosis of iron deficiency should be established based on appropriate laboratory tests (e.g.: serum ferritin, plasma iron, transferrin saturation, and hypochromic red blood cells).

2. BEFORE FERIV IS ADMINISTERED TO YOU

Inform your doctor if you are allergic or have had any allergic reaction to the active substance of this medicine, to any of its components, or to any other medication, as well as if you are experiencing any muscle pain or muscle weakness.

Do not use FERIV

• If you are allergic (hypersensitive) to the product or to any of the other components of this medicine (listed in section 6).
• If you have experienced severe allergic reactions (hypersensitivity) to other injectable iron preparations.
• If you have anemia not caused by iron deficiency.
• If you have a history of iron overload problems or disorders in iron utilization.
• If you have had or currently suffer from any liver disease.
• If you have an acute or chronic infection, because intravenous iron administration may reactivate a bacterial or viral infection.

Warnings and precautions

Consult your doctor or nurse before starting to receive FERIV:

- If you have a history of allergies to medications.

- If you have systemic lupus erythematosus.

- If you have rheumatoid arthritis.

- If you have severe asthma, eczema, or other allergies.

• If you have any infection.
• If you have liver problems.

Injectable iron preparations may cause severe allergic reactions, which may require immediate administration of adrenaline together with other resuscitation measures.

In the case of mild allergic reactions, administration of antihistamines may be sufficient.

Patients with low iron-binding capacity and/or folic acid deficiency are more likely to experience an allergic reaction.

Allergic reactions, including joint pain, have frequently been reported when the recommended dose is exceeded.

Episodes of low blood pressure may occur if the injection is administered too rapidly.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

As with other parenteral iron preparations, FERIV must not be administered concomitantly with oral iron preparations, as this reduces oral iron absorption. Therefore, oral iron therapy should only be initiated at least five days after the last FERIV injection.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

FERIV has not been evaluated in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If you become pregnant during treatment, seek medical advice; your doctor will then decide whether or not FERIV should be administered.

Breastfeeding

If you are breastfeeding, ask your doctor for advice before being administered FERIV.

Driving and operating machinery

There are no data on how the administration of FERIV affects the ability to drive or operate machinery. Therefore, avoid performing tasks that may require special attention until you have determined how you tolerate the medication.

Important information about some of the components of FERIV

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule and is therefore considered essentially "sodium-free".

3. How to USE FERIV

Your doctor will determine the duration of treatment with FERIV. Do not stop treatment prematurely.

How FERIV is administered

Your doctor or nurse will administer FERIV intravenously; FERIV will be administered in a facility where immunological allergic reactions can be properly and rapidly treated.

After each administration, you will remain under observation for at least 30 minutes under the supervision of a doctor or nurse.

If you think that the effect of FERIV is too strong or too weak, tell your doctor or pharmacist.

Adults and Elderly:

The total cumulative dose of FERIV, equivalent to the total iron deficit (mg), is determined by the hemoglobin concentration and the patient's body weight. For each patient, the dose and dosing regimen of FERIV should be calculated based on the total iron deficit (see section 6 Additional Information).

Children:

The use of FERIV in children has not been adequately studied, and therefore its use is not recommended.

The total dose of FERIV should be administered as a single dose of up to 100 mg of iron (one FERIV ampoule), a maximum of three times per week. However, when clinical circumstances require a rapid replenishment of iron stores, the dosing regimen may be increased to a maximum of 200 mg of iron three times per week. For further information, see section 6 of this leaflet.

If you use more FERIV than you should

If you are given more FERIV than you should, consult your doctor immediately so that appropriate treatment can be administered.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, FERIV may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported as possible following administration of FERIV:

Nervous system disorders

Common (affects between 1 and 10 out of 100 people): Temporary changes in taste (particularly metallic taste).

Uncommon (affects between 1 and 10 out of 1,000 people): headache; dizziness.

Rare (affects between 1 and 10 out of 10,000 people): tingling.

Isolated cases: reduced alertness, dizziness sensation, confusion.

Cardiac disorders

Uncommon: low blood pressure and collapse; increased heart rate, palpitations.

Respiratory, thoracic and mediastinal disorders

Uncommon: wheezing, breathing difficulty.

Gastrointestinal disorders

Uncommon: nausea; vomiting; stomach pain; diarrhoea.

Skin and subcutaneous tissue disorders

Uncommon: itching; skin rash, skin redness, flushing.

Musculoskeletal and connective tissue disorders

Uncommon: muscle cramps, muscle pain.

Isolated cases: joint swelling.

General disorders and administration site conditions

Uncommon: fever, tremors, rashes; chest pain and tightness. Burning, swelling, and similar reactions (sometimes affecting veins) around the injection site.

Rare: allergic reactions (rarely including joint pain, and very rarely, severe allergic reactions accompanied by low blood pressure, facial swelling, and breathing difficulty); swelling of hands and feet; fatigue, weakness; general malaise.

Isolated cases: swelling of the face and tongue.

Other adverse effects with unknown frequency: reactions at the injection site: inflammation of the veins causing blood clot formation; symptoms may include red, swollen or painful skin, or hardening of the skin at the injection site.

Immediately inform your doctor if you experience chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Pseudo-flu illness may occur several hours or several days after the injection and is usually characterized by symptoms such as high temperature and muscle and joint pain.

You should consult a doctor if you experience worsening fatigue or muscle or bone pain (pain in the arms or legs, joints, or back). This may be a sign of low phosphate levels in the blood, which could cause softening of your bones (osteomalacia). This condition may sometimes lead to bone fractures. Your doctor may also monitor your blood phosphate levels, especially if you require multiple iron treatments over time.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the national reporting system, the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of FERIV

Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original container to protect from light.

Do not freeze.

Do not use FERIV after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

After first opening of the container, the product must be used immediately.

The medicinal product, once diluted in 0.9% sodium chloride solution, must be used immediately. If not used immediately, the solution must not be kept for longer than 3 hours at room temperature, unless the dilution has been carried out under validated and controlled aseptic conditions.

FERIV is presented as a translucent, dark brown aqueous solution. Before use, ampoules should be inspected visually for any sediment or damage. Only those ampoules free from sediment and containing a homogeneous solution should be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of FERIV

• The active substance is iron. Each 5 ml ampoule contains 100 mg of iron as iron sucrose [sucrose-iron(III) hydroxide complex].

• The other components are: water for injections and sodium hydroxide.

Appearance of the product and pack contents

FERIV is presented as an injectable solution or as a concentrate for solution for infusion. Each pack contains 5 ampoules of 5 ml.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

Cólquide St., No. 6, Building 2, 1st floor, office F

Prisma Building

28230 - Las Rozas, MADRID

Spain

Manufacturer

RAFARM S.A.

12 Korinthou St., N. Psychiko

15451 Athens – Greece

or

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

This summary of product characteristics was approved in November 2021.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Closely monitor patients for signs and symptoms of hypersensitivity reactions during and after each administration of FERIV.

FERIV must only be administered when trained personnel capable of recognizing and treating anaphylactic reactions are immediately available, and in a setting where full resuscitation facilities are accessible. Patients must be observed for at least 30 minutes after each FERIV injection for the occurrence of adverse reactions.

DOSAGE AND ADMINISTRATION

Adults and Elderly:

The total cumulative dose of FERIV, equivalent to the total iron deficit (mg), is determined by hemoglobin concentration and patient body weight. For each patient, the dose and dosing regimen of FERIV should be calculated based on their individual total iron deficit.

Total iron deficit [mg] = body weight [kg] × (target Hb – actual Hb) [g/L] × 0.24* + iron stores [mg]

Up to 35 kg body weight: target Hb = 130 g/L; iron stores = 15 mg/kg body weight.

Over 35 kg body weight: target Hb = 150 g/L; iron stores = 500 mg.

• Factor 0.24 = 0.0034 × 0.07 × 1000 (Iron content of hemoglobin = 0.34 % / Blood volume = 7 % of body weight / Factor 1000 = conversion from grams to milligrams)

The determination of the total required amount of FERIV can be made using the calculation above or according to the following table (based on a target Hb of 130 g/L for body weight ≤ 35 kg and 150 g/L for body weight > 35 kg):

To convert Hb (mM) to Hb (g/l), multiply the former by 16.1145.

Dosing:

The total dose of FERIV should be administered as a single dose of 100 mg iron (one vial of FERIV), up to a maximum of three times per week. However, when clinical circumstances require rapid replenishment of iron stores, the dosing regimen may be increased to 200 mg iron, up to a maximum of three times per week.

Administration:

FERIV must be administered exclusively by intravenous route, either by slow intravenous injection or by intravenous infusion. However, the preferred route of administration is intravenous infusion, as this reduces the risk of hypotensive episodes and venous extravasation.

FERIV is a strongly alkaline solution and therefore must never be administered by subcutaneous or intramuscular routes. Venous extravasation must also be avoided, as extravasation of FERIV at the injection site may cause pain, inflammation, tissue necrosis, sterile abscess, and brownish discoloration of the skin.

Intravenous infusion: FERIV must be diluted only in 0.9% sodium chloride solution (normal saline). One 5 ml vial (100 mg iron) of FERIV should be diluted in a maximum of 100 ml of 0.9% saline solution. For stability reasons, dilutions with lower concentrations of FERIV are not permitted.

The dilution must be prepared immediately before infusion, and the solution should be administered as follows:

• 100 mg iron (5 ml of FERIV) over a minimum of 15 minutes
• 200 mg iron (10 ml of FERIV) over a minimum of 30 minutes

Intravenous injection: Administration of FERIV by slow intravenous injection may be performed at a rate of 1 ml of undiluted solution per minute (i.e., 5 minutes per vial), without exceeding 2 vials of FERIV (200 mg iron) per injection.

After an intravenous injection, the patient's arm should be extended and elevated, and pressure should be applied to the injection site for at least 5 minutes to reduce the risk of extravasation.

Injection into a dialyzer: FERIV may be administered during the second half of a hemodialysis session, directly into the venous line of the dialyzer, following the procedures indicated for intravenous administration.

FERIV should only be mixed with 0.9% sodium chloride solution. Other intravenous diluent solutions and therapeutic agents should not be used due to the risk of precipitation and/or interaction. The compatibility of the product with containers other than glass, polyethylene, or polyvinyl chloride is unknown.