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CARFILZOMIB-PROMOMED

about the product

The drug CARFILZOMIB-PROMOMED is a lyophilizate for the preparation of an infusion solution, which externally is a lyophilized powder or a porous mass from white to yellowish in color, without visible inclusions.

2023-08-01_0001_ЛВ_КАРФИЛЗОМИБ-ПРОМОМЕД лио.pdf

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Specifications

Name

CARFILZOMIB-PROMOMED

Dosage form

LYOPHILIZATE FOR PREPARATION OF INFUSION SOLUTION

Nosological classification

Antitumor drugs

INN

CARFILZOMIB

Dosages

60 mg

ATC code

L01XG02

Active substance

carfilzomib

Pharmacotherapeutic group

Cancer drugs

use

Always use the drug in full accordance with the recommendations of the attending physician.
If in doubt, consult your doctor.
Therapy with CARFILZOMIB-PROMOMED can only be performed by a doctor who has experience in the use of antitumor drugs.
Recommended dose
Adults
The dose of the drug is calculated based on the surface area of your body. Your height and weight will be measured to determine the surface area of your body. Your doctor will use this value to correctly determine the dose for you.
People with a BPT of more than 2.2 m2 should receive the drug at a dose calculated for BPT of 2.2 m2. If the body weight changes by <20%, no dose change is required.
Depending on the dose, the infusion (a method of slow administration of the drug in the form of a solution into the bloodstream) can last 10 or 30 minutes.
Special patient groups
Elderly patients
Overall, the incidence of certain adverse events (including heart failure) was higher at the age of 75 years and older compared with people under 75 years of age.
Patients with impaired liver function
If you have moderate or severe liver dysfunction, be sure to inform your doctor about it. If necessary, you will be assigned an additional examination and/ or blood test.
Patients with impaired renal function
If you have mild, moderate, or severe kidney failure, be sure to tell your doctor about it. If necessary, you will be assigned an additional examination.
Route and/or method of administration
The drug CARFILZOMIB-PROMOMED will be administered to you intravenously by infusion.
Duration of therapy
The duration of therapy will be determined by your doctor. If you have any additional questions about the use of the drug, contact your doctor.

Help

Package leaflet

The drug CARFILZOMIB-PROMOMED is indicated for use only in adults over the age of 18:

in combination with daratumumab (used for blood cancer) and dexamethasone (a drug used to treat serious allergic reactions, blood diseases, cerebral edema and other diseases), lenalidomide (used for blood cancer) and dexamethasone, or dexamethasone alone is indicated for the treatment of multiple myeloma (a malignant blood disease) in people who received at least one line of previous antitumor therapy; monotherapy (single drug treatment) of recurrent (the appearance of new foci of previously cured tumors in the body) and refractory (lack of minimal response to treatment or progression after treatment) multiple myeloma in people who have received at least 2 previous lines of therapy, including bortezomib (used for blood cancer) and an immunomodulatory agent (affects affects the immune system or participates in its functioning).

Symptoms
With the erroneous administration of carfilzomib at a dose of 200 mg, acute chills (cold in the body), decreased blood pressure, decreased urine output, edema, general lethargy, increased bleeding from damaged skin and mucous membranes, a tendency to bruise (thrombocytopenia) and a decrease in the level of lymphocytes in laboratory blood analysis (lymphopenia) have been reported.
Treatment
The specific antidote (drug used to treat poisoning with a substance) for carfilzomib in case of overdose is unknown. In case of overdose, you will be under medical supervision, especially for the development of adverse drug reactions to the drug.

Like all medications, CARFILZOMIB-PROMOMED can
It can cause undesirable reactions, but they do not occur in everyone.
For more information about all possible adverse reactions and the frequency of their occurrence, see the instructions in the corresponding table.

Do not use CARFILZOMIB-PROMOMED:

if you are allergic to carfilzomib or any other components of the drug (listed in section 6 of the leaflet);
if you are breastfeeding.

Caution should be exercised when using CARFILZOMIB-PROMOMED together with medications:

Oral contraceptives (birth control pills taken orally by ingestion) – You need to follow effective measures to prevent pregnancy. Your doctor will recommend alternative effective methods of contraception;
digoxin is used as part of complex therapy for the treatment of chronic heart failure;

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 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

Store and transport in the refrigerator (2-8 °C). Store in the original packaging (pack). Do not freeze. The prepared solutions should be used immediately. The storage time of the prepared solutions should not exceed 24 hours at a temperature of 2 to 8 ° C.

Do not use the drug in children aged 0 to 18 years, as efficacy and safety have not been established.