Patient leaflet - Molcava 50 mg Iron/ml Dispersion for injection/infusion
1. What Molcava is and what it is used for
Molcava is a medicine that contains iron.
Medicines that contain iron are used when you do not have enough iron in your body. This is called iron de ciency.
2. What you need to know before you receive Molcava
You must not receive Molcava
The doctor will determine whether you have iron de ciency by performing a blood test. • Oral iron is not e ective enough.
- You cannot tolerate oral iron.
Your doctor decides you need iron very quickly to build up your iron stores.
Warnings and Precautions
Talk to your doctor or nurse before receiving Molcava:
ciency.
- If you have anaemia not caused by iron de
If you have an iron overload (too much iron in your body) or disturbances in the utilisation
of iron.
If you are allergic (hypersensitive) to ferric carboxymaltose or any of the other ingredients of
this medicine (listed in section 6).
If you have experienced serious allergic (hypersensitive) reactions to other injectable iron
preparations.
- If you have a history of medicine allergy.
- If you have systemic lupus erythematosus.
- If you have rheumatoid arthritis.
- If you have severe asthma, eczema or other allergies.
- If you have an infection.
- If you have liver disorders.
- If you have or have had low levels of phosphate in the blood.
Molcava should not be given to children under 1 year of age.
Children and adolescents aged 1 to 13 years
Your doctor or nurse will administer Molcava undiluted by injection, or diluted by infusion:
uence on the ability to drive or operate machines. Driving and using machines
Molcava has no or negligible in
Molcava contains sodium
Breast-feeding
If you are breast-feeding, ask your doctor for advice before you are given Molcava. It is unlikely that this medicine represents a risk to the nursing child. This medicine can be used during breast-feeding.
Incorrect administration of Molcava may cause leakage of the product at the administration site, which may lead to irritation of the skin and potentially long lasting brown discolouration at the site of administration. The administration must be stopped immediately when this occurs.
Other medicines and Molcava
Tell your doctor if you are using, have recently used or might use any other medicines, including medicines obtained without prescription. If Molcava is given together with oral iron preparations, then these oral preparations could be less e cient.
Pregnancy
There is limited data from the use of Molcava 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.
Your doctor or nurse will administer Molcava undiluted by injection, during dialysis, or diluted by infusion:
a week directly into the vein.
a week directly into the vein. Because this medicine is diluted with sodium chloride solution This medicine contains up to 5.5 mg sodium (main component of cooking/table salt) in each ml of undiluted dispersion. This is equivalent to 0.3% of the recommended maximum daily dietary intake of sodium for an adult.
3. How Molcava is administered
Your doctor will decide how much of this medicine to give you, how often you need it and for how long. Your doctor will perform a blood test to determine the dose you need.
- If you are on dialysis, you may receive this medicine during a haemodialysis session via the dialyser.
or nurse after each administration.
Hb g/dL mmol/L
<10 <6.2
Patient body weight
10 to <14 6.2 to <8.7
≥14 ≥8.7
infusion)
- Your child will receive this medicine directly into the vein. It will appear as a brown solution. • If your child is on dialysis, Molcava should not be administered.
Molcava will be administered in a structure where immunoallergic events can receive
Step 2: Calculation and administration of the maximum individual iron dose(s) Based on the total iron need determined the appropriate dose(s) of Molcava should be administered taking into consideration the following:
Adults and adolescents aged 14 years and older
A single Molcava administration should not exceed:
per week. If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the rst dose.
A single Molcava administration should not exceed:
week. If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days apart from the rst dose.
The following information is intended for healthcare professionals only:
Monitor patients carefully for signs and symptoms of hypersensitivity reactions during and following each administration of Molcava. This treatment should only be administered when sta trained to evaluate and manage anaphylactic reactions are immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse e ects for at least 30 minutes following each Molcava administration.
Step 1: Determination of the iron need
The individual iron need for repletion using this medicine is determined based on the patient’s body weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the total iron need. 2 doses may be required to replenish the total iron need, see Step 2 for the maximum individual iron doses.
Table 1: Determination of the total iron need
Children below 1 year of age
Molcava is not recommended for use in children below 1 year of age.
Patients with haemodialysis-dependent chronic kidney disease
should not be exceeded in haemodialysis-dependent chronic kidney disease patients.
recommended for use.
Method of administration
Molcava must only be administered by the intravenous route: by injection, by infusion, or during a haemodialysis session undiluted directly into the venous limb of the dialyser. Molcava must not be administered by the subcutaneous or intramuscular route.
Caution should be exercised to avoid paravenous leakage when administering Molcava. Paravenous leakage of Molcava at the administration site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of administration. In case of paravenous leakage, the administration of Molcava must be stopped immediately.
Intravenous injection
Molcava may be administered by intravenous injection using undiluted dispersion. In adults and
15 mg iron/kg body weight, but should not exceed 750 mg of iron. The administration rates are as shown in Table 2:
Site Barcode/
Description
Sign-offs
TBC Ferric Carboxymaltose 50 mg/1 ml x2ml Vial
Myriad Pro 11 pt
11 pt
07.MAY.2026 15:52
NA
NA
Notes
V6 APR 2025
ushing), high blood pressure, nausea and injection/infusion Headache, dizziness, feeling hot (
site reactions (see also section 2).
Volume of Molcava required
Equivalent iron dose
No minimal prescribed time Administartion rate /
Minimum administration time Table 2: Administration rates for intravenous injection of Molcava
Uncommon (may a ect up to 1 in 100 people):
Numbness, tingling or prickling sensation on the skin, a change in your taste sensation, high heart rate, low blood pressure, di culty breathing, vomiting, indigestion, stomach pain, constipation, diarrhoea, itching, hives, redness of the skin, rash, muscle-, joint -and/or back pain, pain in arms or legs, muscle spasms, fever, tiredness, chest pain, swelling of the hands and/or the feetchills and a general feeling of discomfort. This lea et was last revised in 05/2026
Not all pack sizes may be marketed
Marketing Authorisation Holder
Viatris,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
KYMOS S.L.
Ronda de Can Fatjó, 7B
Parc Tecnologic Del Vallès
Cerdanyola Del Vallès
08290 Barcelona
Spain
Viatris Santé
1 rue de Turin
69007 Lyon
lled in glass vial with rubber If you receive more Molcava than you should
As this medicine will be given to you by trained medical sta it is not likely that you will be given too much of this medicine.
Overdose can cause accumulation of iron in your body. Your doctor will monitor iron parameters to avoid iron accumulation.
4. Possible side e ects
Like all medicines, this medicine can cause side e ects, although not everybody gets them.
Serious side e ects:
Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: rash (e.g. hives), itching, di culty breathing, wheezing and/or swelling of the lips, tongue, throat or body, and chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
In some patients these allergic reactions (a ecting less than 1 in 1,000 people) may become severe or life-threatening (known as anaphylactic reactions) and can be associated with heart and circulation problems and loss of consciousness.
Tell your doctor if you develop worsening of tiredness, muscle or bone pain (pain in your arms or legs, joints or back). That may be a sign of a decrease in blood phosphorus which might cause your bones to become soft (osteomalacia). This condition may sometimes lead to bone fractures. Your doctor may also check the levels of phosphate in your blood, especially if you need a number of treatments with iron over time.
Your doctor is aware of these possible side e ects and will monitor you during and after the administration of Molcava.
Other side e ects that you should tell your doctor about if they become serious: Common (may a ect up to 1 in 10 people):
atulence), rapid Rare (may a ect up to 1 in 1,000 people):
In mation of a vein, anxiety, fainting, feeling faint, wheeze, excessive wind (
not listed in this lea et. You can also report side e ects directly via the Yellow Card Scheme at:
freeze. For storage conditions after dilution or rst opening of the medicine, see section “The following information is intended for healthcare professionals only”.
Molcava will normally be stored for you by your doctor or the hospital.
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side e ects you can help provide more information on the safety of this medicine.
5. How to store Molcava
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light. Do not store above 30°C. Do not
Intravenous infusion
Molcava may be administered by intravenous infusion, in which case it must be diluted. In adults
swelling of the face, mouth, tongue or throat which may cause di culty in breathing, paleness and skin discolouration at other areas of the body than the administration site.
Not known (frequency cannot be estimated from the available data):
Loss of consciousness and swelling of the face.
Flu-like illness (may a ect 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 muscles and joints.
Some blood parameters may change temporarily, which could be detected in laboratory tests. The following change in blood parameters is common: decrease in blood phosphorus. The following changes in blood parameters are uncommon: increase in certain liver enzymes called alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and alkaline phosphatase, and increase in an enzyme called lactate dehydrogenase. Ask your doctor for more information.
Reporting of side e ects
If you get any side e ects, talk to your doctor or nurse. This includes any possible side e ects
For infusion, Molcava must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in Table 3. Note: for stability reasons, Molcava should not be diluted to concentrations less than
4101058 Monitoring measures
Re-assessment should be performed by the clinician based on the individual patient’s condition.
allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated using Table 1 above.
Incompatibilities
The absorption of oral iron is reduced when administered concomitantly with parenteral iron
after the last administration of Molcava.
Overdose
Administration of Molcava in quantities exceeding the amount needed to correct iron de cit at the time of administration may lead to accumulation of iron in storage sites eventually leading to haemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognising iron accumulation. If iron accumulation has occurred, treat according to standard medical practice, e.g. consider the use of an iron chelator.
In-use stability
Shelf-life after rst opening of the container:
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately.
Shelf-life after dilution with sterile 0.9% m/V sodium chloride solution:
From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would normally not be longer than 24 hours at 2 to 8 ºC, unless the dilution has taken place in controlled and validated aseptic conditions.
6. Contents of the pack and other information
What Molcava contains
The active substance is ferric carboxymaltose, an iron carbohydrate compound. The hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.
What Molcava looks like and contents of the pack
Molcava is an opaque dark brown colour aqueous dispersion stopper and aluminium seal.
Volume of
required
Molcava
Equivalent iron dose Maximum amount of
sterile 0.9% m/V sodium chloride solution
Minimum administration time Table 3: Dilution plan of Molcava for intravenous infusion
No minimal
prescribed time