MONOFER 100 MG / ML SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

Patient leaflet - MONOFER 100 MG / ML SOLUTION FOR INJECTION/INFUSION

1. what monofer is and what it is used for

Monofer contains a combination of iron and derisomaltose (a chain of sugar molecules). The type of iron in Monofer is the same as that found naturally in the body called ‘ferritin’. This means that you can have Monofer by injection in high doses.

Monofer is used for low levels of iron (sometimes called ‘iron deficiency’ and ‘iron deficiency anaemia’) if:

Oral iron does not work or you cannot tolerate it
Your doctor decides you need iron very quickly to build up your iron stores

93×18–04-xx

What Monofer contains

The active substance is iron (as ferric derisomaltose, an iron carbohydrate compound). The concentration of iron present in the product is 100 mg per millilitre. The other ingredients are sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection.

What Monofer looks like and contents of the pack

Monofer is a dark brown, non-transparent solution for injection/infusion.

Monofer is supplied in glass ampoules or glass vials containing:

1 ml solution corresponding to 100 mg iron as ferric derisomaltose
2 ml solution corresponding to 200 mg iron as ferric derisomaltose
5 ml solution corresponding to 500 mg iron as ferric derisomaltose
10 ml solution corresponding to 1,000 mg iron as ferric derisomaltose

The pack sizes are the following:

Ampoule pack sizes: 5 × 1 ml, 10 × 1 ml, 5 × 2 ml, 10 × 2 ml, 2 × 5 ml, 5 × 5 ml, 2 × 10 ml, 5 × 10 ml

Vial pack sizes: 1 × 1 ml, 5 × 1 ml, 10 × 1 ml, 5 × 2 ml, 10 × 2 ml, 1 × 5 ml, 2 × 5 ml, 5 × 5 ml, 1 × 10 ml, 2 × 10 ml, 5 × 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:

This leaflet was last revised in 08/2021

2. what you need to know before you receive monofer

You must not receive Monofer if you:

are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.
have anaemia not caused by iron deficiency
have too much iron (overload) or a problem in the way your body uses iron
have liver problems such as ‘cirrhosis’

Warnings and precautions

Talk to your doctor or nurse before receiving Monofer if you:

have a history of medicine allergy
have systemic lupus erythematosus
have rheumatoid arthritis
have severe asthma, eczema or other allergies
have an ongoing bacterial infection in your blood
have reduced liver function

Incorrect administration of Monofer may cause leakage of the product at the injection site, which may lead to irritation of the skin and potentially long lasting brown discolouration at the site of injection. The administration must be stopped immediately when this occurs.

Children and adolescents

Monofer is for adults only. Children and adolescents should not have this medicine.

Other medicines and Monofer

Tell your doctor if you are using, have recently used or might use any other medicines.

Monofer given together with oral iron preparations can reduce the absorption of oral iron.

Pregnancy and breast-feeding

Monofer has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. If you become pregnant during treatment, you must ask your doctor for advice. Your doctor will decide whether or not you should be given this medicine.

If you are breast-feeding, ask your doctor for advice before you are given Monofer. It is unlikely that Monofer represents a risk to the nursing child.

Driving and using machines

Ask your doctor if you can drive or operate machines after having Monofer.

3. How Monofer is administered

Before administration, your doctor will perform a blood test to determine the dose of Monofer you require.

Your doctor or nurse will administer Monofer by injection or infusion into your vein.

Monofer may be administered as an intravenous injection up to 500 mg up to three times a week.
Monofer may be administered during a dialysis session
Monofer may be administered as an intravenous infusion in a dose up to 20 mg iron/kg body weight or as weekly infusions until the total dose has been administered.

Monofer will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.

You will be observed for at least 30 minutes by your doctor or nurse after each administration.

If you receive more Monofer than you should

A qualified health care professional will give you Monofer. It is unlikely that you will have too much. They will monitor your dose and blood to avoid iron building up in your body.

4. possible side effects

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

Allergic reactions

Severe allergic reactions may occur, however they are in general rare.

Tell your doctor or nurse immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath, and chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Common (may affect up to 1 in 10 people):

Nausea
Skin reactions at or near injection site including redness of the skin, swelling, burning, pain, bruising, discolouration, leakage to the tissue around the site of infusion, irritation
Rash

Uncommon (may affect up to 1 in 100 people):

Hypersensitivity reactions with potential shortness of breath and bronchospasm
Headache
Numbness
Distortion of the sense of taste
Blurred vision
Loss of consciousness
Dizziness
Fatigue
Increased heart rate
Low or high blood pressure
Chest pain, back pain, pain in your muscles or joints, muscle spasms
Stomach pain, vomiting, impaired digestion, constipation, diarrhoea
Itching, hives, skin inflammation
Flushing, sweating, fever, feeling cold, shivering
Low level of phosphate in the blood
Infection
Liver enzymes increased
Local inflammation of a vein
Skin exfoliation

Rare (may affect up to 1 in 1,000 people):

Irregular heart beat
Hoarseness
Seizure
Tremor
Altered mental status
Malaise

Flu-like illness (may affect up to 1 in 1,000 people) may occur a few hours to several days after injection and is typically characterised by symptoms such as high temperature, and aches and pains in the muscles and joints.

Not known

Skin discoloration at other areas of the body than the injection site

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The following information is intended for medical or healthcare professionals only:

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Monofer. Monofer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Monofer injection.

Each IV iron administration is associated with a risk of a hypersensitivity reaction. Thus, to minimise risk the number of single IV iron administrations should be kept to a minimum.

Posology

The posology of Monofer follows a stepwise approach: [1] determination of the individual iron need and [2] calculation and administration of the iron dose(s). The steps can be repeated after [3] post-iron repletion assessments.

Step 1: Determination of the iron need:

The iron need can be determined using either the Simplified Table (i) or the Ganzoni formula below (ii).

The iron need is expressed in mg elemental iron.

i. Simplified Table:

Table 1. Simplified Table

Hb (g/dl)	Hb (mmol/l)	Patients with bodyweight <50 kg	Patients with bodyweight 50 kg to <70 kg '	Patients with bodyweight >70 kg
>10	>6.2	500 mg	1000 mg	1500 mg
<10	<6.2	500 mg	1500 mg	2000 mg

ii. Ganzoni formula:

Table 2. Ganzoni formula

(A) It is recommended to use the patient’s ideal body weight for obese patients or pre-pregnancy weight for pregnant women. For all other patients use actual body weight.

Ideal body weight may be calculated in a number of ways e.g. by calculating weight at BMI 25 i.e. ideal body weight = 25 * (height in m)2

(B) To convert Hb [mM] to Hb [g/dl] you should multiply Hb [mM] by factor 1.61145
© For a person with a body weight above 35 kg, the iron stores are 500 mg or above. Iron stores of 500 mg are at the lower limit normal for small women. Some guidelines suggest using 10–15 mg iron /kg body weight.
(D) Default Hb target is 15 g/dl in the Ganzoni formula. In special cases such as pregnancy consider using a lower haemoglobin target.

5. How to store Monofer

Keep this medicine out of the sight and reach of children.

Do not use Monofer after the expiry date which is stated on the ampoule or vial label. EXP is the abbreviation used for expiry date. The expiry date refers to the last day of that month.

Inspect vials/ampoules visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution.

The reconstituted solution for injection should be visually inspected prior to use. Use only clear solutions without sediment.

This medicinal product does not require any special storage conditions. Hospital staff will make sure that the product is stored and disposed of correctly.