Diafer

Package leaflet: Information for the user

Diafer, 50 mg Fe/ml, solution for injection
Ferricum derisomaltosum (iron derisomaltose)
Please read all of this leaflet carefully before use, because it contains information important for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.

Leaflet contents

1. What Diafer is and what it is used for
2. Important information before using Diafer
3. How to use Diafer
4. Possible side effects
5. How to store Diafer
6. Contents of the packaging and other information

1. What Diafer is and what it is used for

Diafer contains a combination of iron and derisomaltose (a chain of sugar molecules). The iron in Diafer is identical to that naturally present in the body.
Diafer is used in patients with low iron levels (called "iron deficiency") due to chronic kidney disease who are undergoing dialysis and in whom oral iron preparations cannot be used.
Diafer is used to replenish and maintain iron stores in the body through repeated administration.

2. Important information before taking Diafer

When not to take Diafer

• if the patient has anemia not caused by low iron levels (iron deficiency), e.g. hemolytic anemia;
• if the patient has too much iron in the body (iron overload) or impaired iron utilization;
• in case of allergy (hypersensitivity) to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in case of severe allergic reactions (hypersensitivity) to other injectable iron-containing preparations;
• in case of concomitant liver disease.

Warnings and precautions
Before starting treatment with Diafer, consult your doctor or nurse:

• if the patient has previously experienced drug allergies;
• if the patient has systemic lupus erythematosus;
• if the patient has rheumatoid arthritis;
• if the patient has asthma, eczema, or other atopic allergies;
• if the patient has a bacterial blood infection.

Children and adolescents
Diafer has not been studied in children and adolescents. Therefore, Diafer should not be administered to children and adolescents.

Interaction of Diafer with other medicines
Concomitant use of Diafer with oral iron preparations may reduce the absorption of orally administered iron. Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes medicines without a prescription and herbal medicines, because Diafer may affect the way some medicines work. Likewise, some other medicines may affect the way Diafer works.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor.
Limited data are available on the use of Diafer in pregnant women.
If pregnancy occurs during treatment, medical advice should be sought; the doctor will decide whether treatment should be continued.
If breastfeeding, consult your doctor before taking Diafer. It is unlikely that Diafer poses a risk to the breastfed infant.

Driving and operating machinery
It is unlikely that Diafer reduces the ability to drive or operate machinery.

Sodium content of Diafer
The medicine contains up to 5.4 mg of sodium (the main component of table salt) in each ml of solution. This corresponds to 0.27% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Diafer is administered

Diafer will be administered by a doctor or nurse through injection into the patient's vein or into the dialysis apparatus.
Diafer may only be administered in facilities equipped to provide appropriate and immediate medical assistance in the event of an immunologic or allergic reaction.
After each administration, the patient should remain under the supervision of a doctor or nurse for at least 30 minutes.

Overdose of Diafer

Diafer will be administered by appropriately trained medical personnel. It is unlikely that a patient will receive an excessive dose. Dosing and blood laboratory test results will be monitored by medical staff to prevent iron overload in the body.

4. Possible adverse reactions

Like all medicines, Diafer may cause adverse reactions, although not everyone will experience them.
Allergic reactions
You should contact a doctor immediately if the patient experiences any of the symptoms listed below, which may indicate a severe allergic reaction, including: swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties, as well as chest pain, which may be a symptom of a sometimes serious allergic reaction called Kounis syndrome.
Very common (may occur in more than 1 in 10 people):

• none

Common (may occur in 1 in 10 people):

• skin reactions at or near the injection site, including redness, swelling, burning, pain, bruising, skin discoloration, leakage into the tissue around the injection site, irritation

Uncommon (may occur in 1 in 100 people):

• blurred vision
• numbness
• hoarseness
• nausea, vomiting, constipation, stomach pain and abdominal discomfort
• cramps
• hypersensitivity reactions (redness, itching, rash, shortness of breath)
• feeling of warmth (or fever)
• pain and swelling near the injection site
• taste disturbances
• breathing difficulties (bronchospasm)
• digestive disturbances
• hives
• back pain

Rare (may occur in 1 in 1,000 people):

• heart rhythm disorders (arrhythmia, tachycardia)
• chest pain
• loss of consciousness
• seizures (epileptic fit)
• dizziness, restlessness, fatigue
• diarrhoea, sweating, tremor
• angioedema (a serious allergic reaction causing swelling of the face and throat)
• muscle and joint pain
• low blood pressure
• altered mental state
• malaise

Very rare (may occur in 1 in 10,000 people):

• decreased fetal heart rate
• palpitations
• effects on red blood cells (may be observed in certain blood tests)
• headache
• unusual sensations on the body surface, such as tingling
• transient deafness
• increased blood pressure
• acute and serious allergic reactions

Frequency not known (frequency cannot be estimated from the available data):

• skin discoloration
• influenza-like symptoms, which may occur from several hours to several days after injection of the medicine; typical symptoms include high body temperature and muscle and joint pain.

If any adverse reactions occur, they should be reported to a doctor. This includes any possible adverse reactions not listed in this leaflet.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diafer

Keep this medicine out of sight and reach of children.
Do not freeze.
Hospital staff will ensure that the medicine is properly stored and disposed of in the correct manner.
Do not use this medicine after the expiry date stated on the packaging or ampoule after:
EXP. The expiry date refers to the last day of the month indicated.

6. Contents of the pack and other information

What Diafer contains
The active substance in Diafer is iron (in the form of iron derisomaltose, a complex of iron and carbohydrates). One millilitre of solution contains 50 mg of iron as iron derisomaltose.
A 2 ml ampoule contains 100 mg of iron as iron derisomaltose.
The other ingredients are water for injections, sodium chloride, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

What Diafer looks like and contents of the pack
Diafer is a dark brown solution for injection supplied in a glass ampoule.
The following pack sizes are available:
Ampoule pack sizes: 1 x 2 ml, 5 x 2 ml, 10 x 2 ml, 25 x 2 ml

Marketing Authorisation Holder and Manufacturer
Pharmacosmos A/S
Roervangsvej 30
DK-4300 Holbaek, Denmark
Tel.: +45 59 48 59 59
Fax: +45 59 48 59 60
E-mail: [email protected]

This medicinal product is authorised for marketing in the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:
Denmark, Finland, Ireland, the Netherlands, Norway, Poland, Romania, Sweden, United Kingdom (Northern Ireland): Diafer

Other sources of information
The following information is intended for healthcare professionals only:

Dosage
Diafer may be administered in doses up to 200 mg, with a maximum weekly dose of 1000 mg. If iron doses higher than 200 mg are required, other intravenous iron-containing medicinal products should be used.
The iron dose should be individualised for each patient based on clinical response to treatment, including assessment of haemoglobin, ferritin, and transferrin saturation, use of erythropoiesis-stimulating agents (ESA), and ESA dose. Target levels may vary depending on the patient and local guidelines.
Maintenance iron therapy via intravenous administration may be given as small, regular doses to maintain stable iron parameters within a defined range, aiming to prevent iron deficiency or a decline in iron parameters below defined thresholds.

Children and adolescents:
Diafer is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Method of administration:
Patients should be closely monitored for subjective and objective signs of hypersensitivity reactions during and after each administration of Diafer.
Diafer must be administered only under the direct supervision of healthcare professionals trained in the recognition and management of anaphylactic reactions, and in a setting fully equipped with resuscitation equipment. Patients should be observed for potential adverse reactions for at least 30 minutes following each administration of Diafer.
Diafer may be administered as a rapid intravenous injection (bolus) or directly into the venous limb of the dialysis circuit. It may be given undiluted or diluted with up to 20 ml of sterile 0.9% sodium chloride solution.

Diafer should not be administered concurrently with oral iron preparations, as the absorption of orally administered iron may be reduced.

Shelf life after dilution with sterile 0.9% sodium chloride solution
From a microbiological standpoint, the product should be used immediately.

Special precautions for disposal and preparation of the medicinal product for use
Before use, inspect the ampoule for damage and the presence of any precipitate. Only solutions that are homogeneous and free from particulate matter should be used.
Diafer is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Diafer may only be mixed with sterile 0.9% sodium chloride solution. Other intravenous diluents must not be used. No other medicinal products should be added.
The diluted injection solution should be visually inspected before administration. Only clear solutions free from particulate matter should be used.