50 mg / ml solution for injection / infusion
levofolinic acid
What Sodium Levofolinate Medac is and what it is used for
Levofolinic acid contained in Sodium Levofolinate medac may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
Use of sodium levofolinate medac in combination with methotrexate
Sodium levofolinate medac belongs to a group of medicines called antidotes . These are substances used in cancer treatment with cytotoxic drugs (chemotherapy) to counteract the toxicity (toxicity) of the cytotoxins.
Sodium levofolinate medac is used to treating cancer in adults and children. It reduces the toxicity of certain substances called folic acid antagonists, such as methotrexate, by counteracting them. Folic acid antagonists reduce the effect of the body’s substance folic acid. An overdose of folic acid antagonists can also be treated with Sodium Levofolinate medac.
Use of Sodium Levofolinate medac in combination with 5 ‑ fluorouracil
It has been shown that sodium levofolinate medac increases the effect of certain cytotoxic drugs. Therefore, it is also used in cancer treatment to increase the cell-damaging effect of a cancer drug called 5-fluorouracil.
What you need to know before you use Sodium Levofolinate medac
Do not use Sodium Levofolinate medac
- if you are allergic to levofolinic acid or any of the other ingredients of this medicine (listed in section 6);
- if you have anemia due to vitamin B 12 ‑ deficiency;
- in combination with 5-fluorouracil if there are medical reasons why you should not use 5-fluorouracil, especially if you are pregnant or breast-feeding;
- in combination with 5 ‑ fluorouracil if you have severe diarrhea.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Sodium Levofolinate medac.
Generally
Sodium levofolinate medac should only be used in combination with 5-fluorouracil or methotrexate under the direct supervision of a physician experienced in the treatment of cancer.
Levofolinic acid must not be given directly into the spinal fluid (intrathecal), as severe side effects, including death, have been observed with this type of treatment.
If you get certain cytotoxic drugs (cell-damaging substances), such as hydroxycarbamide, cytarabine, mercaptopurine, and thioguanine, you may develop macrocytosis (enlarged red blood cells ). Such macrocytosis must not be treated with levofolinic acid.
If you have epilepsy and are being treated with certain medicines (phenobarbital, phenytoin, or primidone), there may be an increased risk of seizures. This is because the concentration of the epilepsy medication in your blood plasma decreases. Your doctor will probably take blood samples from you while you are being treated with levofolinic acid and even after you have stopped treatment. Then measure the concentration of the epilepsy drug in the blood plasma and adjust the dose if necessary.
Special precautions when using Sodium levofolinate medac in combination with methotrexate
Your doctor will check that you are not receiving levofolinic acid at the same time as a folic acid antagonist (eg methotrexate), as the effect of antagonist treatment could then be impaired.
Your doctor will also avoid excessive doses of levofolinic acid, as they may impair the antitumor effect of methotrexate.
However, a person who accidentally overdoses with a folic acid antagonist such as methotrexate should seek immediate medical attention.
If you already have impaired kidney function, too little fluid in your body (is dehydrated), or if you use certain medicines for inflammation or pain (so-called NSAIDs ) such as ibuprofen, diclofenac or salicylates such as acetylsalicylic acid, such as Magnecyl), the excretion of methotrexate may be delayed by the accumulation of fluid in the abdominal cavity or the space between the chest and the lung.
In such circumstances, it may be justified to give higher doses of Sodium Levofolinate medac or with a longer treatment time.
If the excretion of methotrexate is delayed, kidney function may in turn be affected, which will increase methotrexate levels in the blood.
Even in such cases, you may receive a higher dose of Sodium Levofolinate medac or be treated with levofolinic acid for a longer period.
Special precautions for use of sodium levofolinate medac in combination with 5-fluorouracil
When levofolinic acid is used with 5 ‑ fluorouracil in a combination therapy, the risk of toxic (“toxic”) effects of 5 ‑ fluorouracil may increase. The most common symptoms that may require a dose reduction are:
- decreased white blood cell count ,
- inflammation of the mucous membranes (eg in the mouth and / or stomach),
- diarrhea.
If you get watery stools twice a day and/or inflammation of the lining of the stomach (mild to moderate sores), you should contact your doctor immediately.
You must not start combination therapy with 5 ‑ fluorouracil and levofolinic acid, nor continue with combination therapy, if you get any side effects from the gastrointestinal tract, no matter how severe they are.
Especially if you get diarrhea, your doctor will monitor you very closely, as your condition can quickly deteriorate and you can have serious side effects. Once the gastrointestinal symptoms have completely stopped, your doctor will tell you to start or continue a combination treatment with levofolinic acid and 5 ‑ fluorouracil.
Elderly or weak patients, or patients who have previously received radiotherapy, should be especially careful, as levofolinic acid may increase the risk of toxic effects of 5 ‑ fluorouracil.
Other medicines and Sodium levofolinate medac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of the following medicines can be affected if they are taken with Sodium Levofolinate medac: phenobarbital, primidone, phenytoin, succinimide (medicines used to treat epilepsy ). Your doctor may check the level of these medicines in your blood and change the dose to prevent an increase in seizures (cramps).
Concomitant treatment with methotrexate may impair the effect of sodium levofolinate medac.
Concomitant use of sodium levofolinate medac and 5 ‑ fluorouracil increases the cytotoxic effect and side effects of 5 ‑ fluorouracil.
When Sodium Levofolinate medac is co-administered with folic acid antagonists (eg co-trimoxazole, pyrimethamine) the effect of the folic acid antagonist may be either reduced or completely neutralized.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
It is unlikely that your doctor will ask you to take/use a folic acid antagonist or 5 ‑ fluorouracil when you are pregnant or breastfeeding. However, if you have taken/used a folic acid antagonist during pregnancy or breastfeeding, this medicine (Sodium Levofolinate medac) can be used to reduce its side effects.
Pregnancy
There is no evidence that sodium levofolinate medac if given alone, would have harmful effects if given during pregnancy.
If you are pregnant, you should only be given methotrexate if the benefits of your treatment outweigh the risks to your baby.
If you are receiving methotrexate even though you are pregnant, you can use disodium levofolinate indefinitely to reduce or eliminate the effects of methotrexate.
If you are pregnant, you must not be treated with a combination of Sodium Levofolinate medac and 5 ‑ fluorouracil.
Breast-feeding
You must stop breastfeeding before starting treatment with methotrexate or 5-fluorouracil.
Sodium levofolinate medac can be used alone during breastfeeding, when deemed necessary.
Driving and using machines
It is unlikely that Sodium Levofolinate medac itself would affect your ability to drive or use machines. Your general condition is more important than the possible effects of Sodium Levofolinate medac.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sodium levofolinate medac contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How to use Sodium Levofolinate
Sodium levofolinate medac should only be completed and given by trained healthcare professionals.
Sodium levofolinate medac should always be given in a blood vessel, either diluted as an injection or as an infusion (drip) after dilution.
Sodium levofolinate medac must not be given in the spinal fluid (intrathecally).
Dose of sodium levofolinate medac to prevent toxic symptoms during methotrexate treatment
If you receive a methotrexate dose of more than 500 mg / m² body surface area in connection with cancer treatment, you must also receive levofolinic acid afterwards. At a dose of 100‑500 mg / m² methotrexate, your doctor may consider giving you levofolinic acid.
Your doctor will make sure that you get the dose that is appropriate for your illness.
Dose of Sodium Levofolinate medac to increase the cytotoxic effects of 5-fluorouracil
There are different treatment regimens for the combination therapy of Sodium Levofolinate medac and 5-fluorouracil (once a week, twice a month, or once a month).
Your doctor will make sure that you receive the correct dose for your illness at appropriate intervals.
If you receive more Sodium Levofolinate medac than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Very large amounts of sodium levofolinate medac may cancel out the effect of folic acid antagonists such as methotrexate. In the event of a possible overdose of the combination of 5 ‑ fluorouracil and Sodium Levofolinate medac, the instructions for overdosing on 5 ‑ fluorouracil should be followed.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Sodium Levofolinate medac and contact a doctor immediately or go to the nearest emergency room if you experience any of the following symptoms:
Very rare (may affect up to 1 in 10,000 people):
- severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may lead to difficulty swallowing or breathing) and you may feel faint .
This is a serious side effect . You may need emergency care.
Other side effects that may occur:
Uncommon (may affect up to 1 in 100 people):
- fever
Rare (may affect up to 1 in 1,000 people):
- sleep problems (insomnia), anxiety and depression after high doses
- problems with the digestive system (after high doses )
- increased incidence of seizures in patients with epilepsy
Sodium levofolinate in combination with 5 ‑ fluorouracil
If you are receiving levofolinic acid in combination with a cancer medicine that contains fluoropyrimidines, you are more likely to experience any of the following side effects from this other medicine.
Very common (may affect more than 1 user in 10):
- decreased number of blood cells (including life-threatening conditions)
- inflammation (painful swelling and redness ) in the lining of the gastrointestinal tract and mouth ( life-threatening condition has occurred)
Common (may affect up to 1 in 10 people)
- redness and swelling of the palms or soles of the feet which may cause the skin to flake (hand ‑ foot syndrome)
Has been reported (occurs in an unknown number of users):
- higher than normal levels of ammonia (a breakdown product that the body produces) in the blood
The safety profile may be affected depending on the treatment regimen used for 5 ‑ fluorouracil, as the cytotoxic effects of 5 ‑ fluorouracil are potentiated.
When the drugs are given once a month
Very common (may affect more than 1 user in 10):
- vomiting, nausea
No enhancement of other toxic effects caused by 5-fluorouracil (eg neurotoxicity which is harmful to the nervous system) has been observed.
When the drugs are given once a week
Very common (may affect more than 1 user in 10):
- severe diarrhea and dehydration that can be due to diarrhea and can lead to hospitalization and sometimes death
How to store Sodium Levofolinate medac
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 after “EXP” and the carton after “EXP”. that. ”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C).
Keep the vial in the outer carton. Sensitive to light.
Contents of the pack and other information
Content declaration
The active substance is levofolinic acid.
1 ml solution contains 54.65 mg disodium levofolinate, equivalent to 50 mg levofolinic acid.
One vial of 1 ml contains 54.65 mg of disodium levofolinate, equivalent to 50 mg of levofolinic acid.
A 4 ml vial contains 218.6 mg disodium levofolinate, equivalent to 200 mg levofolinic acid.
A 9 ml vial contains 491.85 mg disodium levofolinate, equivalent to 450 mg levofolinic acid.
The other ingredients are sodium hydroxide, hydrochloric acid, water for injections
What the medicine looks like and contents of the pack
Sodium levofolinate medac is a clear, colorless to slightly yellowish solution for injection/infusion. It is marketed in colorless I-type vials with bromobutyl rubber stoppers and aluminum flip-off caps.
Pack sizes:
Vials with 1 ml, 4 ml, or 9 ml solution for injection or infusion in packs of 1 or 5 vials. Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
medac
Society for Clinical Specialties mbH
Theater. 6
22880 Wedel
Germany
This medicinal product is authorized under the European Economic Area under the names:
| Belgium: | Levofolic 50 mg / ml solution injectable / for perfusionLevofolic 50 mg / ml solution for injection / infusionLevofolic 50 mg / ml Solution for injection / infusion |
| Estonia: | Levofolinic acid medac 50 mg / ml süste- / infusioonilahus |
| Finland: | Levofolic 50 mg / ml injection / infusion test, liuosLevofolic 50 mg / ml solution for injection or infusion |
| France: | Levofolinate sodium medac 50 mg / ml, injectable solution / for perfusion |
| Italy: | Sodio Levofolinato medac 50 mg / ml infusible or infusion solution |
| Latvia: | Levofolic 50 mg / ml injection / infusion solution |
| Lithuania: | Levofolino rūgštis medac 50 mg / ml injekcinis ar infuzinis tirpalas |
| Poland: | Levofolic 50 mg / ml solution for infusion / infusion |
| Portugal: | Levofolic 50 mg / ml injectable solution or for perfusion |
| Slovakia: | Levofolic 50 mg / ml injectable / infused solution |
| Slovenia: | Levofolic 50 mg / ml raztopina for injection / infusion |
| UK: | Levofolinic acid 50 mg / ml solution for injection / infusion |
| Sweden: | Sodium levofolinate medac |
| Germany: | Levofolic 50 mg / ml Solution for injection / infusion |