Samary 153 Sm Oxabiphor (Samarium, 153Sm oxabifor)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for intravenous administration.
Composition:
In 1 ml of the drug contains:
Active substances:

Samaria-153 240- 1500 MBq

Samaria (as a complex 62.5 μg

samarium oxabiphor)

Sodium oxabiphosphate 20 mg


Excipients:

Sodium chloride

Water for injections

Description:Colorless transparent liquid.
Pharmacotherapeutic group:Radiopharmaceutical therapeutic agent.
ATX: & nbsp
  • 153 Sm-Samarium-lexidronic acid
    • Pharmacodynamics:

    The drug "Samarium, 153 Sm Oxabiphor "has the ability to selectively accumulate in metastatic and inflammatory-destructive foci in the bone tissue.With the presence of a radionuclide of samarium-153, emitting beta particles, the drug acts on the cells of the metastatic or inflammatory focus and the surrounding nerve endings, causing both analgesic and antiproliferative effect.The presence of gamma radiation allows you to record the distribution and accumulation of the drug in the body with a gamma camera. osteoscintigraphy with samarium-153 in the lesions, the accumulation of the drug is recorded 2-3 times or more higher than in the symmetric parts of the healthy tissue.These data usually correspond to the results of diagnostics with osteotropic compounds 99m Tc, in connection with which it can be used as a selection criterion for radionuclide therapy with the drug "Samaria, 153 Sm oxabifor ".

    Pharmacokinetics:

    After intravenous administration of "Samaria, 153Sm Oxabiphore "for the first two hours it accumulates in the kidneys, bladder, there is a slight inclusion of the drug in the liver and the projection of the nasal sinuses.After two hours it begins to fix in the bones, mainly in the affected areas (metastatic foci, inflammation zones, places of former fractures) During the first day, the accumulation of the drug in the bone tissue increases with the predominant localization in the above-mentioned foci.After fixation in bone foci, the decrease in activity occurs mainly due to physical decay and, although in rare cases, it may be observed enhancement relative accumulation of the drug in the individual foci in the first three days due to redistribution. During the first two days with urine output from 28% to 42% of the administered activity. Maximum excretion falls on the first 8-12 hours. The level of excretion depends on the function of the kidneys, the extent of bone damage and the activity of fixing the drug in the outbreaks.

    Indications:

    The drug "Samarium, l53Sm Oxabiphor "is used in adults and is intended for use in oncology practice in order to permanently reduce the intensity of the pain syndrome caused by the presence of metastatic bone damage, as well as to inhibit the growth of metastatic tissue in the bone foci.In addition, the drug can be used in rheumatological practice to permanently reduce arthralgia for chronic diseases of the musculoskeletal system, accompanied by a strong pain syndrome (rheumatoid arthritis, deforming arthrosis, etc.).

    Contraindications:
    1. Hypersensitivity to the drug or its components.
    2. Severe renal and / or hepatic insufficiency.
    3. Low platelet count (below 100.0 x 109 / l).
    4. Low level of leukocytes (below 2,0х109 / l).
    5. Progressive decrease in the number of blood cells.
    6. Preliminary massive myelosuppressive chemotherapy.
    7. The threat of compression fracture of the spine.

    Pregnancy and lactation:During pregnancy and during lactation, the use of the drug is contraindicated.
    Dosing and Administration:
    The drug is administered intravenously.In order to reduce the radiation load on personnel and safety during the procedure, it is advisable to use the preliminary dilution technique in 50-100 ml of physiological saline. To do this, it is recommended to establish a system for intravenous infusions and begin the drip introduction of saline. Then, temporarily blocking the tube of the system with the clamp, it is necessary to enter into the vial with physiological solution all the required amount of the solution "Samarium, 153Sm oxabibor", then continue the intravenous drip infusion.
    In oncologic practice it is recommended to use activity at the rate of 1.5 mCi / kg of body weight of the patient. In some cases, it can be increased to 2.0 mCi / kg or reduced to 1.0 mCi / kg body weight.
    In rheumatological practice, it is recommended to use activity at the rate of 0.5 mCi / kg of body weight. In the presence of indications, the drug administration can be repeated after 3 months.

    BODIES

    The absorbed dose, mGy / MBq

    Bladder

    0,702

    Liver

    0,0067

    Kidneys

    0,351

    Small intestine

    0,00783

    Lower part of large intestine

    0,00999

    The upper part of the large intestine

    0,0051

    Eggs

    0,00756

    Ovaries

    0,00918
    Whole body effective equivalent dose (mSv / MBq)) 0.01161
    Side effects:
    Immediately during the introduction and in the first hours after it, no reactions or side effects have been recorded. During the first three days, small toxic reactions are possible in the form of nausea, passing alone or cured by taking 1 -2 tablets of cerucal (metoclopramide).
    During the first two weeks, pain can be increased due to the radiation reaction of tissues in the lesions. An exacerbation can be stopped by taking analgesics and (or) anti-inflammatory drugs. Clinical effect usually manifests after two weeks. It has a persistent character (over 3 months, and in some patients - more than 6 months after a single injection).
    Overdose:Data on drug overdose are absent.
    Interaction:
    Radionuclide therapy "Samarium, 153Sm oxabiphore" can be combined with chemotherapy and hormone therapy, monitoring the general condition of the patient and peripheral blood parameters (see "Contraindications").


    Special instructions:
    The drug can be used in specialized medical institutions,
    having additional treatment plants or in regional oncological dispensaries under condition of urine collection within the first two days after administration with subsequent exposure for the decay of the radionuclide.Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99), "Radiation Safety Standards" (NRB-99), Methodological Guidelines "Hygienic Requirements for Radiation Safety in Radionuclide Diagnostics by Radiopharmaceuticals" (MU - 2.6.1.1892-04).
    Form release / dosage:Solution for intravenous administration.
    Packaging:Solution are packed in batches of 500, 1000, 2000 MBq for the set date and time of delivery to vials for medicines with a capacity of 15 ml, hermetically sealed with rubber medical plugs I-I and crimped with aluminum caps. A sticker of writing or label paper is applied to the bottle. Each bottle is accompanied by a passport and instruction on the use of the drug. The bottle, passport and instructions for use are placed in a transport package for radioactive substances.
    Storage conditions:In accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99) and the "Norms of Radiation Safety" (NRB-99).
    Shelf life:
    4 days from the date and time of manufacture.
    Do not use after the expiry date of the drug.
    Terms of leave from pharmacies:For hospitals
    Registration number:P N000008 / 01
    Date of registration:18.01.2010 / 28.09.2015
    The owner of the registration certificate:NIFHI them. LYKARPOVA NIFHI them. LYKARPOVA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.02.2016
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