about the product
Solid gelatin capsules, opaque, cylindrical in shape with hemispherical ends. The contents of the capsules are powder or granules of yellow color. The presence of lumps and columns is allowed, which easily disintegrate when lightly pressed with a glass rod, and may look like a compacted mass in the form of a cylinder.
Specifications
Name
POMALIDOMIDE-PROMOMED
Dosage form
CAPSULES
Nosological classification
Immunosuppressants
INN
POMALIDOMIDE
Dosages
1 mg; 2 mg; 3 mg; 4 mg
ATC code
L04AX06
Active substance
pomalidomide
Pharmacotherapeutic group
Cancer drugs
use
Always take the drug in full accordance with the recommendations of your doctor.
If in doubt, consult your doctor.
You will be treated by a doctor who has experience in the treatment of multiple myeloma.
Recommended dose
The recommended starting dose of pomalidomide is 4 mg orally once a day from day 1 to 21 of repeated 28-day cycles.
The recommended dose of dexamethasone is 40 mg orally once a day on days 1, 8, 15 and 22 of each 28-day cycle.
Depending on the results of your tests and your reaction to the drug, your doctor may prescribe a lower dose, suspend or cancel therapy.
Tell your doctor if you have liver dysfunction – your doctor may prescribe you a lower dose. Tell your doctor if you are on hemodialysis. In this case, your doctor will advise you when and how to take POMALIDOMIDE-PROMOMED.
Route and/or method of administration
Inside.
Take the drug at the same time every day.
The drug POMALIDOMIDE-PROMOMED should be swallowed whole, washed down with water.
The drug can be taken regardless of the meal.
Capsules should not be opened, cracked, or chewed.
Precautions
If the powder from the capsule gets on the skin, it must be rinsed immediately with soap and water. If the powder from the capsule gets on the mucous membranes, they should be thoroughly rinsed with water.
You will be treated by a doctor who has experience in the treatment of multiple myeloma.
Recommended dose
The recommended starting dose of pomalidomide is 4 mg orally once a day from day 1 to 21 of repeated 28-day cycles.
The recommended dose of dexamethasone is 40 mg orally once a day on days 1, 8, 15 and 22 of each 28-day cycle.
Depending on the results of your tests and your reaction to the drug, your doctor may prescribe a lower dose, suspend or cancel therapy.
Tell your doctor if you have liver dysfunction – your doctor may prescribe you a lower dose. Tell your doctor if you are on hemodialysis. In this case, your doctor will advise you when and how to take POMALIDOMIDE-PROMOMED.
Route and/or method of administration
Inside.
Take the drug at the same time every day.
The drug POMALIDOMIDE-PROMOMED should be swallowed whole, washed down with water.
The drug can be taken regardless of the meal.
Capsules should not be opened, cracked, or chewed.
Precautions
If the powder from the capsule gets on the skin, it must be rinsed immediately with soap and water. If the powder from the capsule gets on the mucous membranes, they should be thoroughly rinsed with water.
Help
Package leaflet
The active ingredient of the drug POMALIDOMIDE-PROMOMED is pomalidomide, which belongs to the group of drugs "immunosuppressants; other immunosuppressants".
It affects the immune system by suppressing the growth and reproduction of myeloma tumor cells (a blood cancer).
POMALIDOMIDE-PROMOMED is used to treat adult patients over the age of 18 with a blood cancer called multiple myeloma.
POMALIDOMIDE-PROMOMED is used in combination with dexamethasone (a glucocorticosteroid drug) in patients previously treated with lenalidomide (a drug that reduces immune activity (an immunosuppressant)) and bortezomib (an antitumor drug). If there is no improvement or you feel worse, you should consult a doctor.
If you accidentally take more of the drug than you should, contact your doctor immediately or contact the emergency department of the nearest hospital. If possible, take the package with you to show the doctor which drug you have taken.
Like all medications, POMALIDOMIDE-PROMOMED can cause undesirable reactions, but they do not occur in everyone.
Seek medical attention immediately and tell your doctor if you notice the following symptoms:
Very often – may occur in more than 1 person out of 10
• Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection – decreased white blood cell count (leukopenia)
Bleeding or bruising for no reason, including nosebleeds and bleeding from the intestines or stomach – decreased platelet count (thrombocytopenia)
• Rapid breathing, rapid pulse, fever and chills, very little or no urine, nausea and vomiting, confusion, loss of consciousness (neutropenic sepsis)
• Fever, shortness of breath, cough, sputum production (pneumonia)
Often – may occur in no more than 1 person out of 10
• Pain and swelling of the limb, redness or paleness of the skin, burning sensation, thickening along the vessel (deep vein thrombosis); chest pain, shortness of breath, cough, bluish skin, fainting – possible symptoms of a blocked pulmonary artery thrombus (pulmonary embolism)
• Shortness of breath, swelling of the arms and legs, fatigue, dry cough, cardiac arrhythmias (heart failure)
• A feeling of compression, compression or pain in the chest, which can spread to the left arm, lower jaw, under the left shoulder blade; lack of air, dizziness – signs of an acute heart attack (myocardial infarction)
Infrequent – may occur in no more than 1 person out of 100
• Changes in the appearance of the skin or neoplasms on the skin (squamous cell carcinoma and basal cell carcinoma)
(For more information about all possible adverse reactions, see the leaflet)
Do not take POMALIDOMIDE-PROMOMED if:
- You are allergic to pomalidomide or any other components of the drug (listed in section 6 of the leaflet);
- You are pregnant;
- You are unable to comply with the necessary contraceptive measures (for men);
- You are not able to comply with all the conditions of the Pregnancy Prevention Program (for women).
Tell your doctor what you are taking, have recently taken, or can start
- take any other medications, in particular:
- fluvoxamine, used to treat depression;
- ketoconazole, used to treat fungal infections;
- enoxacin and ciprofloxacin used as antimicrobial agents; Warfarin, used to thin blood.
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
Organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., 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 cardboard pack after "Good before". The expiration date is the last day of the given month. Store at temperatures below 25 °C. Store in the original packaging (pack).
Do not give the drug to children aged 0 to 18 years due to the fact that the potential benefits do not exceed the risks.
The drug can cause undesirable reactions such as fatigue, lethargy, confusion and dizziness. If such symptoms occur, refrain from driving vehicles and working with mechanisms. Consult with your doctor if you still want to follow these steps.
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