Diafer

Package Leaflet: Information for the User

Diafer, 50 mg Fe /ml, Solution for Injection

Iron

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Diafer and what is it used for

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

2. Important information before taking Diafer

When not to take Diafer

• if you have anemia that is not caused by low iron levels (e.g. hemolytic anemia);
• if you have too much iron in your body (overload) or have difficulty using iron;
• if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6);
• if you have had a severe allergic reaction (hypersensitivity) to other injectable iron preparations;
• if you have liver disease.

Warnings and precautions

Before taking Diafer, discuss it with your doctor or nurse:

• if you have had an allergy to medicines in the past;
• if you have systemic lupus erythematosus;
• if you have rheumatoid arthritis;
• if you have asthma, eczema, or other atopic allergies;
• if you have a bacterial infection of the blood.

One ml of undiluted Diafer solution contains up to 4.6 mg (0.2 mmol) of sodium. This should be taken into account in patients controlling their sodium intake.

Children and adolescents

Diafer has not been tested in children and adolescents. Therefore, children and adolescents should not be given Diafer.

Diafer and other medicines

Diafer may reduce the absorption of oral iron preparations when taken together. Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This includes non-prescription and herbal medicines, as Diafer may affect the way some medicines work. Also, some other medicines may affect the way Diafer works.

Pregnancy, breastfeeding, and fertility

Diafer has not been tested for use in pregnant women. It is essential to inform your doctor if you are pregnant or planning to become pregnant.
If you become pregnant during treatment, consult your doctor, who will decide whether to continue taking Diafer.
If you are breastfeeding, consult your doctor before taking Diafer.

Driving and using machines

The likelihood of Diafer affecting your ability to drive or use machines is low.

3. How to take Diafer

Diafer will be administered by your doctor or nurse as an injection into a vein or into the dialysis apparatus. Diafer can only be administered in a setting where adequate and immediate medical care is available in case of an allergic reaction.
After each administration of Diafer, the patient should be monitored by a doctor or nurse for at least 30 minutes.

Overdose of Diafer

Diafer will be administered by qualified personnel. It is unlikely that you will receive too high a dose. The dosage and blood levels will be monitored, so you will not accumulate too much iron.

4. Possible side effects

Like all medicines, Diafer can cause side effects, although not everybody gets them.
Allergic reactions
Tell your doctor immediately if you experience any of the following symptoms, which may indicate a severe allergic reaction, including: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing, as well as chest pain, which may be a sign of a sometimes severe allergic reaction called Kounis syndrome.
Very common( occurring in more than 1 in 10 people):

• none

Common( occurring in less than 1 in 10 but more than 1 in 100 people):

• none

Uncommon( occurring in 1 to 10 people in 1000):

• blurred vision
• numbness
• hoarseness
• nausea, vomiting, constipation, stomach pain, and surrounding areas
• cramps
• hypersensitivity reactions (redness, itching, rash, shortness of breath)
• feeling of heat (or fever)
• pain and swelling near the injection site

Rare( occurring in 1 to 10 people in 10,000):

• heart rhythm disturbances
• chest pain
• loss of consciousness
• seizures (epileptic fit)
• dizziness, restlessness, fatigue
• diarrhea, sweating, shivering
• angioedema (a serious allergic reaction that causes swelling of the face and throat)
• muscle and joint pain
• low blood pressure, altered mental status

Very rare( occurring in less than 1 in 10,000 people):

• decreased fetal heart rate
• palpitations
• effects on red blood cells (may be visible in some blood tests)
• headache
• strange feeling on the skin surface
• transient deafness
• high blood pressure
• acute and severe allergic reactions

Frequency not known:

• flu-like symptoms may occur within a few hours to a few days after injection; typical symptoms include: high body temperature and muscle and joint pain.

If you experience any side effects, tell your doctor. This includes any possible side effects not listed in this package leaflet.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diafer

Diafer should be stored out of sight and reach of children.
Do not freeze. Hospital staff will ensure that the medicine is stored and disposed of properly.
Do not use the medicine after the expiry date, which is stated on the ampoule and carton. EXP/ Expiry date is an abbreviation for expiry date. The expiry date is the last day of the given month.

6. Contents of the pack and other information

What Diafer contains

The active substance of Diafer is iron derisomaltose. One milliliter of the solution contains 50 mg of iron in the form of iron derisomaltose. A 2 ml ampoule contains 100 mg of iron in the form of 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 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 authorization holder and manufacturer

Pharmacosmos A/S
Roervangsvej 30
DK-4300 Holbaek
Denmark

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:
Diafer
Belgium:
Diafer
Czech Republic:
Diafer
Denmark:
Diafer
Finland:
Diafer
Ireland:
Diafer
Netherlands:
Diafer
Norway:
Diafer
Poland:
Diafer
Romania:
Diafer
Sweden:
Diafer
United Kingdom: Diafer
Date of last revision of the package leaflet:12/2021
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Other sources of information

The following information is intended only for healthcare professionals or healthcare workers:
Dosing
Diafer can be administered in a dose of up to 200 mg, with a maximum weekly dose of 1000 mg. If higher doses are required, other iron medicinal products for intravenous use should be used.
The dose of iron should be determined individually for each patient based on the clinical response to treatment, including assessment of hemoglobin saturation, ferritin, and transferrin, treatment with erythropoiesis-stimulating agent (ESA), and ESA dose. Target levels may vary depending on the patient and local guidelines.
Maintenance therapy with intravenous iron may be administered in small doses at regular intervals to maintain stability of iron parameters within a certain range, in order to prevent iron deficiency or a decrease in iron parameters below certain levels.
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 should only be administered under the direct supervision of medical personnel trained in the evaluation and treatment of anaphylactic reactions, in a setting equipped with resuscitation equipment. The patient should be monitored for adverse reactions for at least 30 minutes after each administration of Diafer.
Adults and the elderly:
Diafer can be administered as a rapid intravenous injection (bolus) or as an injection directly into the venous arm of the dialyzer. It can be administered undiluted or diluted with up to 20 ml of sterile sodium chloride solution at a concentration of 0.9%.
Diafer should not be administered simultaneously with oral iron preparations, as the absorption of oral iron may be reduced.
Shelf life after dilution with sterile sodium chloride solution at a concentration of 0.9%
A shelf life of 48 hours at 30°C has been demonstrated for dilutions with up to 20 ml of sterile sodium chloride solution at a concentration of 0.9%.
For microbiological reasons, the product should be used immediately, unless the method of opening, reconstitution, and dilution precludes the risk of microbiological contamination. If not used immediately, the user is responsible for the storage conditions.
Special precautions for disposal and preparation of the medicinal product for administration
Before use, check that the ampoule is not damaged or contains sediment. Only homogeneous solutions free from sediment should be used.
Diafer is intended for single use only. Any unused product or waste material should be disposed of in accordance with local regulations.
Diafer can only be mixed with sterile sodium chloride solution at a concentration of 0.9%. Do not use other intravenous diluents. Do not add other medicinal products.
The diluted injection solution should be inspected before use. Only clear solutions without sediment should be used.