Monover

Package Leaflet: Information for the User

Monover 100 mg/ml, Solution for Injection and Infusion

Iron derisomaltose
(ferricum derisomaltosum)

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Monover and what is it used for

Monover contains a combination of iron and derisomaltose (a sugar molecule chain). The way iron is bound in Monover is similar to that in ferritin, which occurs naturally in the body. This allows Monover to be administered in large doses as injections.
Monover is used for low iron content in the body (so-called iron deficiency or iron deficiency anemia):
if oral iron does not work or is not tolerated;
if the doctor decides that iron needs to be administered quickly to replenish stores in the body.

2. Important information before taking Monover

When not to take Monover:

if the patient is allergic (hypersensitive) 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 products;
if the patient has anemia that is not caused by iron deficiency;
if the patient has too much iron in the body (overload) or has difficulty utilizing iron;
if the patient has liver function disorders, such as liver cirrhosis.

Warnings and precautions

Before starting Monover, the patient should discuss it with their doctor or nurse:
if the patient has a history of drug allergy;
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 persistent bacterial infection in the blood;
if the patient has impaired liver function.
Incorrect administration of Monover may cause it to leak from the injection site, leading to skin irritation and possible long-term brown discoloration at the injection site. In such cases, administration of the medicine should be stopped immediately.

Children and adolescents

Monover is intended only for adults. It should not be administered to children and adolescents.

Monover and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Monover administered with oral iron preparations may cause a decrease in the absorption of oral iron.

Pregnancy and breastfeeding

There is limited data on the use of Monover in pregnant women. If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor. In case of pregnancy during treatment, the patient should consult her doctor, who will decide whether to continue using the medicine.
In case of breastfeeding, the patient should consult her doctor before taking Monover.
Monover is unlikely to pose a risk to the breastfed child.

Driving and using machines

The patient should ask their doctor if they can drive vehicles and operate machines while taking Monover.

Monover contains sodium

The medicine contains up to 9.4 mg of sodium (the main component of common salt) in each ml of solution containing 100 mg of iron. This corresponds to 0.47% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to administer Monover

Before administering Monover, the doctor will perform a blood test to determine the required dose of Monover.
The doctor or nurse will administer Monover by injection or intravenous infusion.

• Monover can be administered as an intravenous injection, up to 500 mg in a single dose, up to 3 times a week.
• Monover can be administered during dialysis.
• Monover can be administered as a single intravenous infusion in a dose of up to 20 mg of iron/kg body weight or as weekly infusions until the total required dose is achieved.

Monover can only be administered in conditions that allow for immediate implementation of appropriate treatment in case of an immune-allergic reaction in the patient.
After each administration of the medicine, the patient should remain under the supervision of a doctor or nurse for at least 30 minutes to detect any adverse reactions.

In case of receiving a higher dose of the medicine than recommended

Monover is administered by properly trained medical personnel. There is a low probability of receiving too high a dose of the medicine. Medical personnel monitor the dose of the medicine and the results of laboratory blood tests to avoid excessive iron in the body.

4. Possible side effects

Like all medicines, Monover can cause side effects, although not everybody gets them.

Allergic reactions

Acute allergic reactions may occur, but they are rare.
The patient should immediately inform their doctor or nurse if they 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 symptom of a sometimes severe allergic reaction called Kounis syndrome.
Common(may occur in up to 1 in 10 patients)
Nausea
Skin reactions at the injection site or near the injection site, including redness, swelling, burning, pain, bruising, discoloration, leakage into the tissue around the injection site, irritation
Rash
Uncommon(may occur in up to 1 in 100 patients)
Hypersensitivity reactions with possible shortness of breath and bronchospasm
Headache
Numbness
Taste disturbances
Blurred vision
Loss of consciousness
Dizziness
Fatigue
Increased heart rate
Low or high blood pressure
Chest pain, back pain, muscle or joint pain, muscle spasms
Abdominal pain, vomiting, digestive disorders, constipation, diarrhea
Itching, hives, skin inflammation
Redness, sweating, fever, feeling of cold, chills
Low phosphate levels in the blood
Infection
Increased liver enzyme activity
Local vein inflammation
Exfoliative dermatitis
Rare(may occur in up to 1 in 1,000 patients)
Irregular heartbeat
Hoarseness
Seizures
Tremors
Altered mental state
Malaise
Flu-like symptoms (frequency of occurrence up to 1 in 1,000 patients) may occur within a few hours to a few days after injection; typical symptoms include high body temperature and muscle and joint pain.

Frequency not known

Discoloration of the skin in areas other than the injection site.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, more information can be gathered on the safety of the medicine.

5. How to store Monover

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, ampoule, or vial after: EXP. The expiry date refers to the last day of the month stated.
On the carton and ampoule or vial of Monover, there is also a batch number printed after "Lot".
Before use, check that the vial/ampoule is not damaged or contains sediment. Only homogeneous solutions free from sediment can be used.
The solution prepared for injection should be visually inspected before use. Only clear solutions without sediment should be used.
Monover does not require special storage conditions. Hospital staff will ensure that the medicine is stored and disposed of properly.

6. Contents of the pack and other information

What Monover contains

The active substance of Monover is iron (in the form of iron derisomaltose, an iron and carbohydrate compound). The concentration of iron in this medicine is 100 mg per 1 milliliter.
The other ingredients of the medicine are: sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injections.

What Monover looks like and contents of the pack

Monover is a dark brown, non-transparent solution for injection and infusion.
Monover is available in glass ampoules or glass vials containing:

• 1 ml of solution, corresponding to 100 mg of iron in the form of iron derisomaltose
• 2 ml of solution, corresponding to 200 mg of iron in the form of iron derisomaltose
• 5 ml of solution, corresponding to 500 mg of iron in the form of iron derisomaltose
• 10 ml of solution, corresponding to 1000 mg of iron in the form of iron derisomaltose

Pack sizes are as follows:
Ampoule sizes: 5 x 1 ml, 10 x 1 ml, 5 x 2 ml, 10 x 2 ml, 2 x 5 ml, 5 x 5 ml, 2 x 10 ml, 5 x 10 ml
Vial sizes: 1 x 1 ml, 5 x 1 ml, 10 x 1 ml, 5 x 2 ml, 10 x 2 ml, 1 x 5 ml, 2 x 5 ml, 5 x 5 ml, 1 x 10 ml, 2 x 10 ml, 5 x 10 ml
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmacosmos A/S
Roervangsvej 30
DK-4300 Holbaek
Denmark
Phone: +45 59 48 59 59
Fax: +45 59 48 59 60
Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Bulgaria, Croatia, Denmark, Estonia, Finland, Netherlands, Iceland, Lithuania, Latvia, Germany, Norway, Romania, Slovenia, Sweden, United Kingdom (Northern Ireland): Monofer
Belgium, Italy: Monoferric
Ireland, Luxembourg, Poland: Monover
Portugal: Monofar

Date of last revision of the package leaflet: 03/2025

Information intended for healthcare professionals only:
Patient monitoring is required to detect objective and subjective symptoms of hypersensitivity reactions during and after administration of Monover. Monover should only be administered when immediate medical treatment is available in case of anaphylactic reactions, and the patient should be observed for at least 30 minutes after each administration of Monover.
Any intravenous administration of iron is associated with a risk of hypersensitivity reactions. To minimize this risk, the number of intravenous iron administrations should be limited to a minimum.
Dosing
The dosing of Monover is based on a stepwise approach: [step 1] assessment of iron needs and [step 2] calculation and administration of the iron dose/doses. These steps can be repeated after evaluation of iron replenishment [step 3].
Step 1: Assessment of iron needs:
Iron needs can be determined using a simplified table (I) or the Ganzoni equation (II), shown below.
Iron needs are expressed in mg of elemental iron.
I Simplified table
Table 1: Simplified table
II Ganzoni equation
Table 2: Ganzoni equation
[mg of iron]
[kg] [g/dl] [mg of iron]
III Fixed iron needs
A fixed dose of 1000 mg of iron should be administered to the patient, and then further iron needs should be evaluated according to the guidelines in section "Step 3: Evaluation of iron replenishment". For patients weighing less than 50 kg, the simplified table or Ganzoni equation should be used to calculate iron needs.
Step 2: Calculation and administration of the maximum individual iron dose:
Based on the estimated iron needs, Monover should be administered taking into account the following:
The total weekly dose should not exceed 20 mg of iron/kg body weight.
A single infusion of Monover should not exceed 20 mg of iron/kg body weight.
A single intravenous bolus administration of Monover should not exceed 500 mg of iron.
Step 3: Evaluation of iron replenishment:
A re-evaluation, including laboratory blood tests, should be performed by the doctor based on the individual patient's condition. To evaluate the effect of intravenous iron therapy, the hemoglobin (Hb) level should be re-evaluated no earlier than 4 weeks after the last administration of Monover, taking into account the appropriate time for erythropoiesis and iron incorporation. If the patient requires further iron replenishment, iron needs should be re-calculated.
Children and adolescents:

Monover is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.
Administration:
Monover should be administered intravenously by injection or infusion.
Monover should not be administered simultaneously with oral iron products, as the absorption of oral iron may be decreased.
Intravenous bolus injection:
Monover can be administered as an intravenous bolus injection in a dose of up to 500 mg, up to three times a week, at a rate of up to 250 mg of iron per minute. It can be administered undiluted or diluted in a maximum of 20 ml of sterile sodium chloride solution (0.9%).
Table 3: Administration rate for intravenous bolus injections

Intravenous infusion:
The required dose of iron can be administered in a single infusion of Monover in a dose of up to 20 mg of iron/kg body weight or in weekly infusions until the required dose is achieved.
If the required dose of iron exceeds 20 mg of iron/kg body weight, the dose should be divided into two doses administered with at least a one-week interval. It is recommended to administer 20 mg of iron/kg body weight in the first dose, if possible. Depending on the clinical evaluation, the second administration should be preceded by a supplementary laboratory test.

Monover should be administered undiluted or after dilution with sterile sodium chloride solution (0.9%). Due to stability, Monover should not be diluted to concentrations below 1 mg of iron/ml (not including the volume of the iron derisomaltose solution) and should never be diluted in a volume exceeding 500 ml.
Injection into the dialyzer:
Monover can be administered during hemodialysis directly into the venous arm of the dialyzer, using the same procedure as described for intravenous bolus injection.
Detailed information about Monover is contained in the Summary of Product Characteristics.