about the product
Tablets are white or almost white in color, round, biconvex. Marbling is allowed.
Specifications
Name
Kladribin
Dosage form
Pills
Nosological classification
Immunosuppressants
INN
Kladribin
Dosages
10 mg
ATC code
L04AA40
Active substance
Kladribin
Pharmacotherapeutic group
Cancer drugs
use
Always take the drug in full accordance with the recommendations of your doctor.
If in doubt, consult your doctor.
Recommended dose
The recommended total dose of the drug Cladribine is 3.5 mg / kg of human body weight for 2 years: 1.75 mg / kg per 1 course of treatment per year. The annual course of therapy consists of 2 weeks of treatment: one week at the beginning of the 1st month and one week at the beginning of the 2nd month of the corresponding treatment year.
Each week of treatment consists of 4 or 5 days, during which the drug is taken once a day at a dose of 10 mg or 20 mg (one or two tablets), depending on the patient's body weight.
The calculation of the dose and amount of the drug depending on human body weight is presented in Tables 1 and 2 below.
After completing 2 annual courses of treatment, further administration of the drug during the 3rd and 4th years is not required.
The resumption of treatment after 4 years has not been studied.
If necessary, the 2nd annual course of treatment can be postponed for up to 6 months until an acceptable number of lymphocytes is restored (for medical reasons). If the recovery period of the lymphocyte count takes more than 6 months, the use of the drug Cladribine should be discontinued.
Dose calculation
The calculation of the dose for 2 years of therapy is carried out by the attending physician based on a person's body weight in accordance with Table 1. For some body weight ranges, the number of tablets may vary from one week of treatment to another.
Oral administration of cladribine in people weighing less than 40 kg has not been studied.
Table 1. The dose of the drug Cladribine per week of treatment, depending on body weight
a patient for each year of therapy.
| Patient's body weight, kg | Dose in mg (number of tablets) per week of treatment | |
| 1st week of treatment | 2nd week of treatment | |
| ≥ 40, but <50 | 40 mg (4 tablets) | 40 mg (4 tablets) |
| ≥ 50, but <60 | 50 mg (5 tablets) | 50 mg (5 tablets) |
| ≥ 60, but <70 | 60 mg (6 tablets) | 60 mg (6 tablets) |
| ≥ 70, but <80 | 70 mg (7 tablets) | 70 mg (7 tablets) |
| ≥ 80, but <90 | 80 mg (8 tablets) | 70 mg (7 tablets) |
| ≥ 90, but <100 | 90 mg (9 tablets) | 80 mg (8 tablets) |
| ≥ 100, but <110 | 100 mg (10 tablets) | 90 mg (9 tablets) |
| ≥ 110 | 100 mg (10 tablets) | 100 mg (10 tablets) |
The drug should be taken at the same time of day during each week of therapy. If the daily dose is 2 tablets, the tablets are taken together as one dose.
Table 2. Distribution of the total number of tablets of the drug Cladribine at a dose of 10 mg by
days during a week-long course of therapy
|
Total number of tablets per day a week |
Day 1 | Day 2 | Day 3 | Day 4 | Day 5 |
| 4 | 1 | 1 | 1 | 1 | 0 |
| 5 | 1 | 1 | 1 | 1 | 1 |
| 6 | 2 | 1 | 1 | 1 | 1 |
| 7 | 2 | 2 | 1 | 1 | 1 |
| 8 | 2 | 2 | 2 | 1 | 1 |
| 9 | 2 | 2 | 2 | 2 | 1 |
| 10 | 2 | 2 | 2 | 2 | 2 |
Elderly patients
Clinical studies on the use of cladribine tablets did not include patients over 65 years of age, so it is not known whether they have a difference in response to therapy compared with younger patients.
Patients with impaired renal function
Clinical studies on the use of cladribine in patients with renal insufficiency have not been conducted.
In patients with mild renal insufficiency (creatinine clearance from 60 to 89 ml / min), no dose adjustment is required.The drug Cladribine is contraindicated in patients with moderate to severe renal insufficiency, as the safety and efficacy of the drug in this group of patients have not been established.
Patients with impaired liver function
Clinical studies on the use of cladribine in patients with hepatic insufficiency have not been conducted.
Despite the fact that the role of the liver in the process of cladribine elimination is insignificant, taking the drug Cladribine in patients with moderate to severe hepatic insufficiency (Child-Pugh index> 6) is contraindicated, as there are no data available.
Serum levels of aminotransferase, alkaline phosphatase, and total bilirubin should be obtained before starting therapy during the first and second years of treatment.
Route and (or) method of administration
Tablets are taken orally, regardless of food intake, without chewing or drinking water. Since the tablets are not coated, they must be swallowed immediately after being released from the package, not left on the surface and not held in the hands for longer than necessary. If the tablet has been left on the surface or if it breaks during release from the package, the surface must be thoroughly washed.
Hands should be dry when handling the drug. Wash your hands thoroughly after taking the drug.
Instructions for using the drug Kladribin
1. Wash and dry your hands, prepare a glass of drinking water.
2. Take the package of the drug in your hand. Open the flap of the cardboard pack.
3. In the case of a child-proof pack, simultaneously press and hold down the buttons located on the sides of the cardboard pack with the index finger and thumb of the left hand. Pull the plastic container, but do not remove it.
4. Take out the instructions for use. Make sure that you have read all the information provided in the instructions. Keep the instructions in a safe place.
5. Take a contoured cell package and squeeze 1 or 2 tablets into the palm of your hand with your thumb, or open the jar and take out 1 or 2 tablets according to the prescribed treatment regimen.
6. Put the tablet in your mouth and wash it down with water. The tablet must be swallowed immediately, without chewing or resorbing. It is necessary to avoid prolonged contact of the tablet with the skin of the hands and touching the nose, eyes and other parts of the body with the hands.
7. Wash your hands thoroughly with soap and water.
8. Keep the product in its original packaging to protect it from moisture.
9. Store the Cladribine tablets in a contour cell package or jar until the next intake. Do not remove the tablets in advance. Do not store the tablets in another container.
Help
Package leaflet
The drug Cladribine is a medicine used to treat multiple sclerosis with exacerbations in adults.
Multiple sclerosis is a disease in which the protective membrane of nerve cell processes is destroyed during inflammation.
Treatment with Cladribine reduces cases of exacerbation of multiple sclerosis and slows down the progression of disability, mainly affects lymphocytes, cells of the immune system involved in the regulation of inflammation, causing their death.
If there is no improvement or you feel worse, you should consult a doctor.
The drug Cladribine is used to treat adults over 18 years of age with highly active
recurrent multiple sclerosis, confirmed by clinical or
radiological research.
Treatment with Cladribine is selected and monitored by a doctor, so the likelihood that you will receive more or less of it than you need is minimal.
However, if you have any doubts, consult your doctor.
Your doctor will monitor your condition to make sure that you are receiving the correct dose of the drug.
In case of suspected overdose with the drug Cladribine, ask for consult your doctor. If possible, show the doctor the package of the drug.
You will be prescribed appropriate supportive treatment according to your symptoms. Your doctor will decide whether you need to stop treatment or not.
The missed dose of the drug (1 or 2 tablets) should be taken as soon as you remember it, on the same day in accordance with the treatment schedule.
A missed dose should not be taken together with a subsequent scheduled dose the next day. If you miss a dose, you should take the missed dose the next day, thus extending the course of taking the drug for a day. If two consecutive doses are missed, the same rule applies, and the number of days of the weekly course of treatment is increased by 2 days.
Do not take a double dose to compensate for a missed dose.
Like all medications, the drug Cladribine can cause undesirable reactions, but they do not occur in everyone.
Some adverse reactions can be serious and life-threatening. lives. Tell your doctor immediately if you experience any of these the following adverse reactions when taking the drug Cladribine:
Very common (may occur in more than 1 person out of 10):
− pathological decrease in the level of lymphocytes (the main cells of the immune system) in a laboratory blood test (lymphopenia).
Common (may occur in no more than 1 person out of 10):
− if you have a painful rash on one side of your body, feel unwell, have a headache, fatigue, or have a body temperature above 38 °C. (shingles), see also section 2, subsection "Special instructions and precautions".
Infrequently (may occur in no more than 1 person out of 100):
− if you have severe weakness, fever, decreased appetite, nausea, bitter taste in your mouth, belching of bile, vomiting and diarrhea (liver damage).
Very rare (may occur in no more than 1 person out of 10,000):
− if you have severe weakness, fatigue, chronic fatigue, insomnia, decreased appetite, night sweats, increased body temperature no higher than 37.5 ° C, cough, hemoptysis, chest pain, shortness of breath (tuberculosis).
Other possible adverse reactions that may occur when taking the drug Cladribine
Common (may occur in no more than 1 person out of 10):
− rashes in the form of bubbles on the oral mucosa, redness and swelling of the oral mucosa, pain when chewing, fever (herpes of the oral mucosa);
− decrease in the number of neutrophils in laboratory blood analysis;
− skin rash;
− hair loss (Alopecia).
Do not take the drug Kladribin:
• If you are allergic to cladribine or any other components of the drug (listed in section 6 of the leaflet).
• If you have an exacerbation of a chronic infection (tuberculosis or liver inflammation (hepatitis)).
• If you are infected with the human immunodeficiency virus (HIV).
• If you have a weakened immune system due to diseases or because you take other medications that weaken your immune system or reduce the production of blood cells in the bone marrow. Such medicines include:
− cyclosporine, cyclophosphamide and azathioprine (used to suppress the immune system, for example, after organ transplantation);
− Methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis);
− long-acting corticosteroids (used to reduce inflammation, for example, in asthma).
See also "Other drugs and the drug Cladribine".
• If you have moderate to severe renal insufficiency (creatinine clearance <60 ml/min).
• If you have moderate to severe liver failure.
• If you have cancer.
• If you are taking interferon beta.
• If you plan to be vaccinated with live vaccines, including attenuated (attenuated) vaccines.
• If you are pregnant or breastfeeding (see also "Pregnancy and Breastfeeding").
• Do not give the drug to children under the age of 18.
If you think that any of the above applies to you, tell your doctor about it.
Tell your doctor that you are taking, have recently taken, or may start taking any other medications.
Do not take the drug Cladribine together with drugs that weaken your immune system or reduce the production of blood cells by the bone marrow, such as:
• Cyclosporine, cyclophosphamide and azathioprine (used to suppress the immune system, for example, after organ transplantation);
• Methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis);
• Long-term corticosteroids (used to reduce inflammation, for example, in asthma). A short course of corticosteroids can be used on the recommendation of a doctor.
Do not take the drug Cladribine together with other medications for multiple sclerosis, unless it has been recommended by your doctor. Such medicines include:
alemtuzumab, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta, natalizumab or teriflunomide.
Do not take Kladribine at the same time as any other medication. At least 3 hours should elapse between taking the drug Cladribine and other oral medications. The drug Cladribine contains hydroxypropylbetadex, which can interact with other drugs in the stomach.
Talk to your doctor if you are taking:
• Drugs that can affect blood cells (for example, carbamazepine, used to treat epilepsy).
Your doctor may need to monitor you more closely.
• Some types of vaccines (live and live attenuated vaccines).
If you have been vaccinated in the last 4-6 weeks, therapy with Cladribine should be postponed. You should not receive such vaccines during treatment with Cladribine.
• Dilazep, nifedipine, nimodipine, reserpine, cilostazol, or sulindac (used to treat heart disease, high blood pressure, vascular disease, or inflammation).
• Eltrombopag (used to treat bleeding-related conditions).
• Rifampicin (used to treat certain types of infections).
• St. John's wort (used to treat depression).
• Corticosteroids (used to suppress inflammation).
Talk to your doctor if you are taking hormonal birth control pills.
medication.
The holder of the registration certificate
Russian Federation
PROMOMED RUS LLC
Address: 13 Mira Avenue, building 1, office 13, Moscow, 129090
Phone: +7 (495) 640-25-28
Email: reception@promomed.pro
Manufacturer, packer (primary packaging)
Russian Federation
JSC "Biochemist"
Address: 15A Vasenko str., Saransk, Republic of Mordovia, 430030
Packer (secondary (consumer) packaging)/releasing control characteristics
Russian Federation
JSC "Biochemist"
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia, or ARTSELLENS LLC, Russian Federation
Address: Moscow, ext. ter., Pechatniki municipal district, Volgogradsky Prospekt, 42, room 5, room 1H
For any information about the drug, as well as in cases of claims You should contact the local representative of the registration holder. identification cards:
The Russian Federation and the Republic of Armenia
PROMOMED RUS LLC
Address: 13 Mira Avenue, building 1, office 13, Moscow, 129090, Russian Federation
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro, armenia@drugsafety.ru
Keep the drug out of the reach of the child so that the child cannot see it. Do not use the drug after the expiration date (shelf life) indicated on the carton after "Good before". The expiration date is the last day of the given month. Do not store at temperatures above 25 °C. Store in the original packaging (pack). Do not dispose of the drug in the sewer. Ask the pharmacy employee how to dispose (destroy) the drug that is no longer needed. These measures will help protect the environment.
The drug Cladribine has no effect on the ability to drive vehicles and work with mechanisms.
If you are pregnant or breastfeeding, think you are pregnant, or are planning to become pregnant, consult your doctor before using the drug.
Contraception for men and women
You should use effective methods of contraception to avoid pregnancy during treatment with Cladribine and for 6 months after taking the last dose.
Talk to your doctor if you are taking hormonal contraceptives. You should additionally use barrier methods of contraception while taking the drug Cladribine and for at least 4 weeks after taking the last dose of the drug.
If you become pregnant 6 months after taking the last dose, there is no risk to the fetus, but this will mean that you will not be able to receive treatment with Cladribine during pregnancy.
If you are a man, you should use effective contraceptive methods to prevent your partner from becoming pregnant while you are being treated with Cladribine and for 6 months after taking the last dose.
Your doctor will give you recommendations on appropriate methods of contraception.
Pregnancy
Do not take the drug Cladribine if you are pregnant or planning to become pregnant.
This is important because the drug Cladribine can cause serious harm to your child. Pregnancy can be planned 6 months after the last intake of the drug Cladribine.
Breastfeeding
Do not take the drug Cladribine if you are breastfeeding. If your doctor believes that you need the drug Cladribine, he will advise you to stop breastfeeding.
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