Universal reference book for medicines
Product name: SAMARIY, 153 SM OXABIFOR (SAMARIUM, 153 SM OXABIFOR)

Active substance: nonappropriate

Type: Radiopharmaceutical for the palliative treatment of bone metastases

Manufacturer: NIFHI them.
L.Ya. KARPOVA (Russia)
Composition, form of production and packaging
The solution for intravenous administration is
colorless, transparent.

1 ml

samarium-153 240-1500 MBq

Samarium (in the form of samarium oxabiphore) 62.5 μg

sodium oxabiphore 20 mg

[PRING] sodium chloride, water d / and.

500 MBq - Vials with a capacity of 15 ml (1) - a packaging kit for radioactive substances.

1000 MBq - Vials with a capacity of 15 ml (1) - a packaging kit for radioactive substances.

2000 MBq - Vials with a capacity of 15 ml (1) - a packaging kit for radioactive substances.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Samarium, 153 Sm Oxabiphore has the ability to selectively accumulate in metastatic and inflammatory-destructive foci in bone tissue.
Due to the presence in its composition of the radionuclide Samarium-153, which emits 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 the help of a gamma camera. According to the data of the subsequent osteoscintigraphy with Samarium-153, the accumulation of the drug is registered 2-3 times or more in the lesion lesions than in the symmetric parts of the healthy tissue. These data usually correspond to the diagnostic results with osteotropic compounds 99m Tc, and therefore it can be used as a selection criterion for radionuclide therapy with Samarium, 153 Sm oxabiphor.
PHARMACOKINETICS

After intravenous administration of Samaria, 153 Sm oxabir 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 2 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 disintegration, although in a few cases there may be an increase in the relative accumulation of the drug in individual foci during the first 3 days due to redistribution.
During the first two days with urine, from 28% to 42% of the injected activity is excreted.
Maximum withdrawal is in 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, 153 Sm Oxabiphore is used in adults.

- in oncologic practice with the aim of persistently reducing the intensity of the pain syndrome caused by the presence of metastatic damage to bones, as well as to inhibit the growth of metastatic tissue in bone foci;

- in rheumatological practice for a persistent reduction of arthralgias in chronic diseases of the musculoskeletal system, accompanied by a strong pain syndrome (rheumatoid arthritis, deforming arthrosis, etc.).

DOSING MODE

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 inject into the vial with the saline solution all the required quantity of Samarium solution, 153 Sm oxabifor, 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.

If there are indications, the administration of the drug can be repeated after 3 months.

Radiation loads on the organs and tissues of the patient when using the drug Samarium, 153 Sm oxabiphor

Organs absorbed dose, mGy / MBq

Bladder 0.702

Liver 0.0067

Kidneys 0,351

Small intestine 0.00783

The lower part of the large intestine 0.00999

The upper part of the large intestine 0.0051

Eggs 0.00756

Ovaries 0,00918

Total body (Effective equivalent dose (mSv / MBq)) 0.01161

SIDE EFFECT

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, which occurs alone or with a stopping of 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).
CONTRAINDICATIONS

- hypersensitivity to the drug or its components;

- severe renal and / or liver failure;

- low platelet count (below 100.0x10 9 / l);

- low level of leukocytes (below 2,0х10 9 / l);

- progressive decrease in the number of blood elements;

- preliminary massive myelosuppressive chemotherapy;

- threat of compression fracture of the spine.

PREGNANCY AND LACTATION

During pregnancy and during lactation, the use of the drug is contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in severe renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated in severe hepatic insufficiency.

APPLICATION FOR CHILDREN

The drug is contraindicated for children under 18 years.

SPECIAL INSTRUCTIONS

The drug can be used in specialized medical institutions that have additional treatment plants or in regional oncology dispensaries, provided that urine is collected within the first two days after administration and then maintained for the disintegration 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 during radionuclide diagnostics using radiopharmaceuticals" (MU-2.6.1.1892-04).

OVERDOSE

Data on drug overdose are absent.

DRUG INTERACTION

Radionuclide therapy Samarium, 153 Sm oxabiphore can be combined with chemotherapy and hormone therapy, monitoring the general condition of the patient and peripheral blood parameters (see Contraindications).

TERMS OF RELEASE FROM PHARMACY

It is not subject to sale through the pharmacy network.
The drug is released on request only in specialized radioisotope laboratories of medical diagnostic facilities.
TERMS AND CONDITIONS OF STORAGE

They are stored in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99) and "Norms of Radiation Safety" (NRB-99).
Shelf life - 4 days from the date and time of manufacture.
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