Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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 deficiency.
Molcava is used to treat iron deficiency when: – Oral iron is not effective enough. – You cannot tolerate oral iron. – Your doctor decides you need iron very quickly to build up your iron stores.
The doctor will determine whether you have iron deficiency by performing a blood test.
You must not receive Molcava – 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 anaemia not caused by iron deficiency. – If you have an iron overload (too much iron in your body) or disturbances in the utilisation of iron.
Warnings and Precautions Talk to your doctor or nurse before receiving Molcava: – 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 50 mg iron/ml dispersion for injection/infusion
ferric carboxymaltose
Molcava should not be given to children under 1 year of age.
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.
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.
Driving and using machines Molcava has no or negligible influence on the ability to drive or operate machines.
Molcava contains sodium 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.
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.
Adults and adolescents aged 14 years and older
Your doctor or nurse will administer Molcava undiluted by injection, during dialysis, or diluted by infusion: – By injection, you may receive up to 20 ml of Molcava, corresponding to 1,000 mg of iron, once a week directly into the vein. – By infusion, you may receive up to 20 ml of Molcava, corresponding to 1,000 mg of iron, once a week directly into the vein. Because this medicine is diluted with sodium chloride solution for the infusion, it may have a volume of up to 250 ml and will appear as a brown solution. – If you are on dialysis, you may receive this medicine during a haemodialysis session via the dialyser.
Children and adolescents aged 1 to 13 years
Your doctor or nurse will administer Molcava undiluted by injection, or diluted by 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 appropriate and prompt treatment. You will be observed for at least 30 minutes by your doctor or nurse after each administration.
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 efficient.
If you receive more Molcava than you should As this medicine will be given to you by trained medical staff 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: 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, difficulty 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 (affecting 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.
Your doctor is aware of these possible side effects and will monitor you during and after the administration of Molcava.
Other side effects that you should tell your doctor about if they become serious: Common (may affect up to 1 in 10 people): Headache, dizziness, feeling hot (flushing), high blood pressure, nausea and injection/infusion site reactions (see also section 2).
Rare (may affect up to 1 in 1,000 people): Inflammation of a vein, anxiety, fainting, feeling faint, wheeze, excessive wind (flatulence), rapid swelling of the face, mouth, tongue or throat which may cause difficulty 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 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 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.
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.
Uncommon (may affect 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, difficulty 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.
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 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 at: www.mhra.gov.uk/yellowcard 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.
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light. Do not store above 30°C. Do not freeze. For storage conditions after dilution or first 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.
What Molcava contains
The active substance is ferric carboxymaltose, an iron carbohydrate compound. The concentration of iron present in the product is 50 mg per millilitre. The other ingredients are 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 filled in glass vial with rubber stopper and aluminium seal.
100 mg/2 ml available in pack sizes of 1, 2 or 5 vials. 500 mg/10 ml available in pack sizes of 1, 2 or 5 vials. 1,000 mg/20 ml available in a pack size of 1 vial.
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
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.
Parc Tecnologic Del Vallès Cerdanyola Del Vallès 08290 Barcelona Spain
Viatris Santé 1 rue de Turin 69007 Lyon
This leaflet was last revised in 05/2026
The following information is intended for healthcare professionals only:
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
10 to <14 6.2 to <8.7 15 mg/kg body weight
≥14 ≥8.7 15 mg/kg body weight
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:
• 15 mg iron/kg body weight (intravenous injection) or 20 mg iron/kg body weight (intravenous infusion) • 1,000 mg of iron (20 ml Molcava)
The maximum recommended cumulative dose of Molcava is 1,000 mg of iron (20 ml Molcava) 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 first dose. Children and adolescents aged 1 to 13 years
A single Molcava administration should not exceed: • 15 mg iron/kg body weight • 750 mg of iron (15 ml Molcava) The maximum recommended cumulative dose of Molcava is 750 mg of iron (15 ml Molcava) 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 first dose.
In children aged 1 to 13 years with chronic kidney disease requiring haemodialysis is not recommended for use.
Monitor patients carefully for signs and symptoms of hypersensitivity reactions during and following each administration of Molcava. This treatment should only be administered when staff 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 effects for at least 30 minutes following each Molcava administration.
Hb Patient body weight g/dL mmol/L below 35 kg 35 kg to <70 kg 70 kg and above <10 <6.2 30 mg/kg body weight
1,500 mg 2,000 mg
1,000 mg 1,500 mg
500 mg 500 mg
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 In adults and adolescents aged 14 years and older, a single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients.
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.
Table 2: Administration rates for intravenous injection of Molcava
Volume of Molcava required Equivalent iron dose Administartion rate / Minimum administration
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 2 mg iron/ml (not including the volume of the ferric carboxymaltose dispersion).
Table 3: Dilution plan of Molcava for intravenous infusion
Volume of Molcava
required
time >4 to 10 ml >200 to 500 mg 100 ml 6 minutes >10 to 20 ml >500 to 1,000 mg 250 ml 15 minutes
Monitoring measures Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final Molcava administration to 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 preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last administration of Molcava.
Intravenous injection Molcava may be administered by intravenous injection using undiluted dispersion. In adults and adolescents aged 14 years and older, the maximum single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight, but should not exceed 750 mg of iron. The administration rates are as shown in Table 2:
time 2 to 4 ml 100 to 200 mg No minimal prescribed time >4 to 10 ml >200 to 500 mg 100 mg iron/min >10 to 20 ml >500 to 1,000 mg 15 minutes
Intravenous infusion Molcava may be administered by intravenous infusion, in which case it must be diluted. In adults and adolescents aged 14 years and older, the maximum single dose is 20 mg iron/kg body weight but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight but should not exceed 750 mg of iron.
Equivalent iron dose Maximum amount of
Minimum administration time
sterile 0.9% m/V
sodium chloride
solution
2 to 4 ml 100 to 200 mg 50 ml No minimal prescribed
Overdose Administration of Molcava in quantities exceeding the amount needed to correct iron deficit 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 first 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. Chemical and physical in-use stability of the diluted product has been demonstrated for 72 hours at 25 °C.
Molcava 50 mg iron/ml dispersion for injection/infusion comes as injection containing 50 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Molcava 50 mg iron/ml dispersion for injection/infusion is ferric carboxymaltose.
Medicines with the same active substance include: Ferinject 50 mg iron/mL dispersion for injection/infusion., Feristark 50 mg iron/ml Dispersion for Injection/Infusion. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Molcava 50 mg iron/ml dispersion for injection/infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Molcava is indicated for the treatment of iron deficiency when (see section 5.1):
• oral iron preparations are ineffective.
• oral iron preparations cannot be used.
• there is a clinical need to deliver iron rapidly.
The diagnosis of iron deficiency must be based on laboratory tests.
Carefully monitor patients for signs and symptoms of hypersensitivity reactions during and following each administration of Molcava.
Molcava 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 treatment administration (see section 4.4).
Posology
The posology of Molcava follows a stepwise approach: [1] determination of the individual iron need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion assessments. These steps are outlined below:
Step 1: Determination of the iron need
The individual iron need for repletion using Molcava 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.
Iron deficiency must be confirmed by laboratory tests as stated in 4.1.
Table 1: Determination of the total iron need.
| Hb | Patient body weight | |||
| g/dL | mmol/L | below 35 kg | 35 kg to <70 kg | 70 kg and above |
| <10 | <6.2 | 30 mg/kg body weight | 1,500 mg | 2,000 mg |
| 10 to <14 | 6.2 to <8.7 | 15 mg/kg body weight | 1,000 mg | 1,500 mg |
| ≥14 | ≥8.7 | 15 mg/kg body weight | 500 mg | 500 mg |
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:
• 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)
• 1,000 mg of iron (20 ml Molcava)
The maximum recommended cumulative dose of Molcava is 1,000 mg of iron (20 ml Molcava) 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 first dose.
Children and adolescents aged 1 to 13 years
A single Molcava administration should not exceed:
• 15 mg iron/kg body weight
• 750 mg of iron (15 ml Molcava)
The maximum recommended cumulative dose of Molcava is 750 mg of iron (15 ml Molcava) 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 first dose.
Step 3: Post-iron repletion assessments
Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final treatment administration to allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated (see Step 1).
Children below 1 year of age
The efficacy and safety of Molcava has not been investigated in children below 1 year of age. This medicinal product is therefore not recommended for use in children in this age group.
Patients with haemodialysis-dependent chronic kidney disease
In adults and adolescents aged 14 years and older, a single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients (see also section 4.4).
In children aged 1 to 13 years with chronic kidney disease requiring haemodialysis, the efficacy and safety of Molcava has not been investigated. This medicinal product is therefore not recommended for use in children aged 1 to 13 years with chronic kidney disease requiring haemodialysis.
Method of administration
Molcava must only be administered by the intravenous route:
• by injection, or
• 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.
Intravenous injection
Molcava may be administered by intravenous injection using undiluted dispersion. In adults and adolescents aged 14 years and older, the maximum single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight, but should not exceed 750 mg of iron. The administration rates are as shown in Table 2:
Table 2: Administration rates for intravenous injection of Molcava
| Volume of Molcava required | Equivalent iron dose | Administration rate / Minimum administration time |
| 2 to 4 ml | 100 to 200 mg | No minimal prescribed time |
| >4 to 10 ml | >200 to 500 mg | 100 mg iron / min |
| >10 to 20 ml | >500 to 1,000 mg | 15 minutes |
Intravenous infusion
Molcava may be administered by intravenous infusion, in which case it must be diluted. In adults and adolescents aged 14 years and older, the maximum single dose is 20 mg iron/kg body weight but should not exceed 1,000 mg of iron. In children aged 1 to 13 years, the maximum single dose is 15 mg iron/kg body weight, but should not exceed 750 mg of iron.
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 2 mg iron/ml (not including the volume of the ferric carboxymaltose dispersion). For further instructions on dilution of the medicinal product before administration, see section 6.6.
Table 3: Dilution plan of Molcava for intravenous infusion
| Volume of Molcava required | Equivalent iron dose | Maximum amount of sterile 0.9% m/V sodium chloride solution | Minimum administration time |
| 2 to 4 ml | 100 to 200 mg | 50 ml | No minimal prescribed time |
| >4 to 10 ml | >200 to 500 mg | 100 ml | 6 minutes |
| >10 to 20 ml | >500 to 1,000 mg | 250 ml | 15 minutes |
The use of Molcava is contraindicated in cases of:
• hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• known serious hypersensitivity to other parenteral iron products.
• anaemia not attributed to iron deficiency, e.g. other microcytic anaemia.
• evidence of iron overload or disturbances in the utilisation of iron.
The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last administration of Molcava.
Pregnancy
There are limited data from the use of Ferric Carboxymaltose in pregnant women (see section 5.1). Animal data suggest that iron released from ferric carboxymaltose can cross the placental barrier and that its use during pregnancy may influence skeletal development in the foetus (see section 5.3).
Molcava should not be used during the first trimester of pregnancy. Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with Molcava should be confined to the second and third trimester and should only be used if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.
Breast-feeding
Clinical studies showed that transfer of iron from Ferric Carboxymaltose to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that Molcava represents a risk to the breast-fed child. Molcava can be used during breast-feeding.
Fertility
There are no data on the effect of Ferric Carboxymaltose on human fertility. Fertility was unaffected following Ferric Carboxymaltose treatment in animal studies (see section 5.3).
Molcava has no or negligible influence on the ability to drive and use machines.
Administration of Molcava in quantities exceeding the amount needed to correct iron deficit 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 (TSAT) 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.
Ask anything about Molcava 50 mg iron/ml dispersion for injection/infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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