Monover

Package leaflet: Information for the user

Monover 100 mg/ml, solution for injection and infusion
iron derisomaltose
( ferricum derisomaltosum )
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Contents of the leaflet

1. What Monover is and what it is used for
2. What you need to know before receiving Monover
3. How Monover is given
4. Possible side effects
5. How to store Monover
6. Contents of the pack and other information

1. What Monover is and what it is used for

Monover contains a combination of iron and derisomaltose (a chain of sugar molecules). The way iron is bound in Monover is similar to naturally occurring ferritin in the body. This allows Monover to be administered in high doses by injection.
Monover is used in cases of low iron levels in the body (so-called iron deficiency or iron deficiency anaemia):
when oral iron therapy is ineffective or not tolerated;
when your doctor decides that iron needs to be administered rapidly to replenish body stores.

2. Important information before using Monover

When not to use Monover:
if the patient is allergic (hypersensitive) to the active substance or to any of the
other ingredients of this medicine (listed in section 6);
in case of severe allergic reactions (hypersensitivity) to other injectable iron-containing products;
if the patient has anemia not caused by iron deficiency;
if the patient has excessive iron levels in the body (iron overload) or impaired iron utilization;
if the patient has liver function disorders, such as liver cirrhosis.

Warnings and precautions
Before starting treatment with Monover, discuss with your doctor or nurse if:
the patient has previously had allergies to medicines;
the patient has systemic lupus erythematosus;
the patient has rheumatoid arthritis;
the patient has asthma, eczema, or other atopic allergies;
the patient has a current bacterial blood infection;
the patient has impaired liver function.

Improper administration of Monover may result in leakage from the injection site, which may cause skin irritation and possible long-term brown discoloration at the injection site. In such a case, administration of the medicine must be stopped immediately.

Children and adolescents
Monover is intended only for adults. Do not administer this medicine to children or adolescents.

Monover with other medicines
Tell your doctor about all medicines the patient is currently using, has recently used, or plans to use.
Concomitant use of Monover with oral iron preparations may reduce the absorption of oral iron.

Pregnancy and breastfeeding
Limited data are available on the use of Monover in pregnant women. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor. In case of pregnancy occurring during treatment, medical advice should be sought to determine whether treatment should be continued.
If the patient is breastfeeding, consult a doctor before using Monover.
Monover is unlikely to pose a risk to the breastfed infant.

Driving and operating machinery
Ask your doctor whether it is safe to drive or operate machinery while using Monover.

Monover contains sodium
This medicine contains up to 9.4 mg of sodium (a main component of table salt) per ml of solution containing 100 mg of iron. This corresponds to 0.47% of the maximum recommended daily dietary intake of sodium for adults.

3. How Monover is administered

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

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

Monover must only be administered in settings where prompt and appropriate treatment can be initiated in case the patient experiences an immunoallergic reaction.
After each administration, the patient should remain under medical supervision by a doctor or nurse for at least 30 minutes to monitor for the occurrence of adverse reactions.

In case a higher than recommended dose of the medicine is received
Monover is administered by appropriately trained medical personnel. The likelihood of receiving an excessive dose is low. Medical staff monitor the administered dose and laboratory blood test results to prevent iron overload in the body.

4. Possible adverse reactions

Like all medicines, Monover may cause adverse reactions, although they do not occur in everyone.
Allergic reactions
Severe allergic reactions may occur, although they are usually rare.
You should immediately inform a doctor or nurse if any of the following symptoms appear in the patient, which may indicate a severe allergic reaction, including: swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties, 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 or near the injection site, including redness, swelling, burning, pain, bruising, skin discoloration, leakage into surrounding tissue, 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 cramps
Abdominal pain, vomiting, digestive disturbances, constipation, diarrhoea
Itching, urticaria, skin inflammation
Redness, sweating, fever, feeling of cold, chills
Low blood phosphate levels
Infection
Increased liver enzyme activity
Local phlebitis
Skin desquamation

Rare (may occur in up to 1 in 1,000 patients)
Irregular heartbeat
Hoarseness
Seizures
Tremor
Altered mental state
Malaise
Influenza-like symptoms (frequency up to 1 in 1,000 patients) may occur within several hours to several days after injection; typical symptoms include high body temperature and muscle and joint pain.

Frequency not known
Skin discoloration in areas of the body other than the injection site.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 Monover

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, ampoule, or vial: EXP. The expiry date refers to the last day of the stated month.
The carton, ampoule, or vial of Monover also bears a batch number following the label "Lot".
Before use, check whether the vial/ampoule is damaged or whether there is any sediment present. Only solutions that are clear and free from sediment may be used.
The solution for injection should be inspected visually before use. Use only clear solutions that do not contain any particles.
Monover does not require any special storage conditions. Hospital staff will ensure that the medicine is properly stored and disposed of appropriately.

6. Contents of the pack and other information

What Monover contains
The active substance in Monover is iron (in the form of iron derisomaltose, an iron-carbohydrate complex). The concentration of iron in this medicine is 100 mg per 1 millilitre.
The other components of the medicine are: sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Monover looks like and contents of the pack
Monover is a dark brown, opaque solution for injection and infusion.
Monover is available in glass ampoules or glass vials containing:

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

Pack sizes are as follows:
Ampoule pack 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 pack 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 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 the United Kingdom (Northern Ireland) under the following names:
Austria, Bulgaria, Croatia, Denmark, Estonia, Finland, the Netherlands, Iceland, Lithuania, Latvia, Germany, Norway, Romania, Slovenia, Sweden, United Kingdom (Northern Ireland): Monofer
Belgium, Italy: Monoferric
Ireland, Luxembourg, Poland: Monover
Portugal: Monofar

Information intended exclusively for medical professionals:

Patients should be closely monitored for objective and subjective signs of hypersensitivity reactions during and after administration of Monover. Monover may be administered only if trained personnel capable of recognizing and managing anaphylactic reactions are immediately available, and only in settings equipped with full resuscitation equipment. The patient should be observed for at least 30 minutes after each administration of Monover.
Any intravenous iron administration carries a risk of hypersensitivity reactions. To minimize this risk, the number of individual intravenous iron administrations should be reduced to a minimum.

Dosing
Dosing of Monover follows a stepwise approach: [Step 1] assessment of iron requirement and [Step 2] calculation and administration of the iron dose(s). These steps may be repeated following reassessment of iron repletion [Step 3].

Step 1: Assessment of iron requirement:
Iron requirement can be determined using either the simplified table (I) or the Ganzoni equation (II), provided below.
Iron requirement is expressed in mg of elemental iron.

I Simplified table
Table 1: Simplified table

II Ganzoni's Equation
Table 2: Ganzoni's Equation
[mg of iron] [kg] [g/dl] [mg of iron]
III Constant iron requirement
A fixed iron dose of 1000 mg should be administered to the patient, followed by assessment of further iron requirements according to the guidelines in section "Step 3: Assessment of iron repletion". In patients with body weight below 50 kg, the simplified table or Ganzoni's formula should be used to calculate iron requirements.
Step 2: Calculation and administration of the maximum individual iron dose:
Based on the estimated iron requirement described above, Monover should be administered according to the following:

• The total weekly dose must not exceed 20 mg iron/kg body weight.
• A single infusion of Monover must not exceed 20 mg iron/kg body weight.
• A single intravenous (bolus) administration of Monover must not exceed 500 mg iron.
  Step 3: Assessment of iron repletion:
  Re-evaluation, including laboratory blood tests, should be performed by the physician based on the individual patient's condition. To assess the effect of intravenous iron therapy, hemoglobin concentration should be re-evaluated no sooner than 4 weeks after the last administration of Monover, allowing adequate time for erythropoiesis and iron incorporation. If the patient requires further iron supplementation, iron requirements should be recalculated.
  Children and adolescents:
  The use of Monover is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
  Method of administration:
  Monover should be administered intravenously via injections or infusions.
  Monover should not be administered concomitantly with oral iron products, as absorption of orally administered iron may be reduced.
  Intravenous bolus injection:
  Monover can be administered as an intravenous bolus injection at a dose of up to 500 mg up to three times per week, at an administration rate of up to 250 mg iron per minute. It may be given without dilution or diluted in up to 20 mL of sterile 0.9% sodium chloride solution.
  Table 3: Rate of administration for intravenous bolus injections

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

The Monover medicinal product should be administered without dilution or after dilution with sterile 0.9% sodium chloride solution. Due to stability concerns, Monover must not be diluted to concentrations below 1 mg iron/ml (excluding the volume of ferric derisomaltose solution) and must never be diluted to a volume exceeding 500 ml.
Injection into the dialyzer:
Monover can be administered during hemodialysis directly into the venous limb of the dialyzer, using the same procedure as described for intravenous bolus injection.
Detailed information on Monover is provided in the Summary of Product Characteristics.