about the product
Solid gelatin capsules. The contents of the capsules are white to light yellow powder. The presence of conglomerates (lumps) is allowed, which easily disintegrate when lightly pressed with a glass stick.
Specifications
Name
Lenalidomide-Promomed
Dosage form
CAPSULES
Nosological classification
Immunosuppressants
INN
LENALIDOMIDE
Dosages
2.5 mg; 5 mg; 7.5 mg; 10 mg; 15 mg; 20 mg; 25 mg
ATC code
L04AX04
Active substance
lenalidomide
Pharmacotherapeutic group
Cancer drugs
use
Always take Lenalidomide-Promomed in full accordance with the recommendations of your doctor. If in doubt, consult your doctor.
Recommended dose
This drug should be prescribed only by a doctor who has experience in the treatment and management of patients with multiple myeloma, myelodysplastic syndromes, lymphoma from mantle cells, follicular lymphoma or lymphoma from marginal zone cells.
When Lenalidomide-Promomed is used to treat multiple myeloma in patients who do not require bone marrow transplantation or have previously undergone other treatment, it is taken together with other medications (see section 1 of the leaflet).
When Lenalidomide-Prommed is used to treat multiple myeloma in patients who have undergone bone marrow transplantation, or to treat patients with myelodysplastic syndromes, or lymphoma from mantle cells, it is taken separately.
When Lenalidomide-Promomed is used to treat follicular lymphoma or lymphoma from marginal zone cells, it is taken together with another drug called rituximab. Always take Lenalidomide-Promomed exactly as your doctor said. Consult your doctor if you are not sure how to take the drug.
If you are taking Lenalidomide-Promomed in combination with other medications, you should refer to the leaflet of these medications for additional information on their use.
Before starting treatment, the doctor will inform you about:
• how much Lenalidomide-Promomed should you take;
• how many other medications should you take in combination with Lenalidomide-Promomed, if any;
• on which days of your treatment cycle to take each medication.
Route and/or method of administration
• Capsules should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. It is recommended to press only one end of the capsule when removing it from the blister in order to reduce the risk of deformation and damage. If the powder from the damaged Lenalidomide-Prommed capsule gets on the skin, immediately and thoroughly wash the skin with soap and water; if on the mucous membranes, rinse them thoroughly with water.
• Capsules can be taken regardless of the meal time.
• You should take Lenalidomide Promomed at approximately the same time on the scheduled days.
• Medical professionals and your family members should wear disposable gloves when working with a contoured cell package or capsule. Then the gloves should be carefully removed to prevent exposure to the skin, placed in an airtight plastic plastic bag and disposed of. Then wash your hands thoroughly with soap and water. If you are pregnant or suspect that you may be pregnant, then do not interact with the contoured cell package or capsule.
Help
Package leaflet
The drug Lenalidomide-Promomed acts on the body's immune system and directly on cancer cells. It operates in several different ways:
- stops the development of cancer cells;
- stops the growth of blood vessels in a cancerous tumor;
- stimulates the immune system, which acts on cancer cells
The drug Lenalidomide-Promomed is used in adults over the age of 18 for the treatment of:
- multiple myeloma;
- myelodysplastic syndromes;
- lymphomas from cells of the mantle zone;
- follicular lymphoma or lymphoma from cells of the marginal zone.
If you have taken Lenalidomide-Promomed more than prescribed, inform your doctor immediately.
In case of overdose, symptomatic supportive therapy is recommended.
Like all medications, Lenalidomide-Promomed can cause undesirable reactions, but they do not occur in everyone.
Serious adverse reactions
Stop taking Lenalidomide-Promomed and consult your doctor immediately if you notice any of the serious adverse reactions listed below – you may need urgent medical attention.:
Infrequent – may occur in no more than 1 person out of 100:
• urticaria, rash, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction;
• widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs of the body (drug reaction with eosinophilia and systemic symptoms, which is also known as DRESS syndrome or drug hypersensitivity).
Rare – may occur in no more than 1 person out of 1000:
• a severe allergic reaction that may start as a rash in one area but spread throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
If you notice any of the following serious adverse reactions, inform your doctor immediately.:
Very often, they can occur in more than 1 person out of 10:
• fever, chills, sore throat, cough, mouth ulcers, or any other symptoms of infection (including sepsis);
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion, or fatigue that
they can be caused by high levels of calcium in the blood.
Often – may occur in no more than 1 person out of 10:
• bleeding or bruising in the absence of injury.
(For more information about all possible adverse reactions, see the leaflet)
Do not take Lenalidomide-Promomed:
- if you are allergic to lenalidomide or to any other components of the drug listed in section 6 of the leaflet;
- if you are pregnant or breastfeeding;
- if you are able to get pregnant (preserved reproductive potential), except in cases where it is possible to comply with all the necessary conditions of the Program of controlled medical use of Lenalidomide-Promomed;
- if you do not have the ability or ability to follow the necessary contraceptive measures
Tell your doctor that you are taking, have recently taken, or may start taking any other medications.
Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with Lenalidomide-Promomed, and possibly adjust the doses of the medications you are taking.
The drug Lenalidomide-Promomed may enhance the effect and side effects of certain drugs.
These include the drugs used:
- to stimulate the formation of red blood cells (erythropoietic drugs), drugs that increase the risk of thrombosis, the doctor will prescribe with caution in patients with multiple myeloma taking lenalidomide in combination with dexamethasone;
- to prevent pregnancy, such as oral contraceptives, as their effectiveness may be reduced;
- for heart diseases – for example, digoxin;
- for blood thinners – for example, warfarin; for the treatment of high cholesterol, for example, statins.
Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro
Keep the drug out of the reach of the child so that the child cannot see it. Do not take the drug after the expiration date (shelf life) indicated on the carton after "Good before". Store at a temperature not exceeding 25 ° C. Store in the original packaging (pack). The expiration date is the last day of the given month.
Do not give Lenalidomide-Promomed to children aged 0 to 18 years, as the safety and efficacy of this drug in children under the age of 18 have not been established.
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