Capsion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CAPSION 50 - 3700 MBq capsule, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 to 3700 MBq sodium iodide (131I) at calibration date.
Iodine-131 is produced by fission of uranium-235 and by neutron bombardment of stable tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.04 days. It decays by emission of gamma radiation of 365 keV (81.2 %), 637 keV (7.3 %) and 284 keV (6.1 %) and beta radiations of maximal energy of 606 keV to stable xenon-131.
Excipient with known effect:
Each capsule contains 110 mg of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule hard.
Capsule green and orange.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Radioiodine thyroid therapy is indicated for :
- treatment of Graves disease, toxic multinodular goitre or autonomous nodules.
- treatment of papillary and follicular thyroid carcinoma including metastatic
disease.
Sodium iodide [131I] therapy is often combined with surgical intervention and with antithyroid medications.
4.2 Posology and method of administration
Posology
The activity administered is a matter for clinical judgment. The therapeutic effect is only achieved after several weeks.
- For the treatment of hyperthyroidism
Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism. The dose required depends on the diagnosis, the size of the gland, thyroid uptake and iodine clearance.
The range of activities currently prescribed, irrespective of the method used, vary in the range 200-800 MBq, but repeated treatment may be necessary. Retreatment after six months is indicated for persisting hyperthyroidism.
The following target organ doses may be used for posology calculation: autonomous nodule 300 - 400 Gy absorbed dose to target organ
toxic multinodular goitre 150 - 200 Gy absorbed dose to target organ
Graves’ disease 200 Gy absorbed dose to target organ
In Graves’ disease, multifocal or disseminated autonomy, the above mentioned target organ doses are related to the overall volume of the thyroid gland, however in the unifocal autonomy, the target organ dose is only related to the volume of the adenoma.
The activity to be administered may be calculated according to the following equation:
A (MBq) = Target dose (Gy) target volume (mL) x K Max.uptake 131I (%) x effective T1/2 (days)
Legend:
target dose = is the target absorbed dose in the whole thyroid gland
or in an adenoma
target volume = volume of the whole thyroid gland (Graves’ disease,
multifocal or disseminated autonomy)
max. uptake I-131
effective T
max. uptake of I-131 in the thyroid gland or nodules in % of the administered activity as established in a test dose
effective half-life of I-131 in the thyroid gland
K = 24.67
Other dosimetric procedures may also be used including sodium pertechnetate (Tc-99m) thyroid uptake tests to determine the appropriate target organ dose (Gy).
Fixed dose protocols may also be used.
- For thyroid ablation and treatment of metastases
The administered activities following total or subtotal thyroidectomy to ablate remaining thyroid tissue are in the range of 1850 - 3700 MBq. It depends on the remnant size and radioiodine uptake. In subsequent treatment for metastases, administered activity is in the range 3700 - 11100 MBq.
Renal impairment
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
An adjustment of the posology should be considered.
Paediatric population
The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group.
The activity to be administered in children and adolescents should be determined after performing an individual dosimetry (see sections 4.4 and 11).
Method of administration Oral use.
For patient preparation, see section 4.4.
The capsule should be taken orally by the fasting patient. It should be swallowed whole together with plenty of liquid.
To ease the passage of the capsule through the oesophagus and subsequently create the right climate for the capsule to dissolve in, it is recommended to the patient to take hot drink, rapidly after the administration.
Before giving the capsule to children, in particular to young children, it should be ensured that the capsule can be swallowed whole.
4.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see section 4.6).
- Breastfeeding (see section 4.6).
- Patients with dysphagia, oesophageal stricture, oesophageal stenosis, oesophagus diverticulum, active gastritis, gastric erosions and peptic ulcer.
- Patients with suspected reduced gastrointestinal motility (see section 4.4).
4.4 Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect.
Renal impairment
Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible. The therapeutic administration of (131I) capsules in patients with significant renal impairment, in which an activity adjustment is necessary, requires special attention.
Paediatric population
For information on the use in paediatric population, see section 4.2.
Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11).
In the treatment of children and adolescents, the radioiodine treatment of benign thyroid diseases may be performed in justified cases, especially in relapse after use of antithyroid medicinal products or when serious adverse reactions to antithyroid medicinal products do occur. However a careful consideration of the benefit/risk ratio is required due to the potential for developing cancer.
Patient preparation
Thyroid replacement should be stopped prior to radioiodine administration for thyroid carcinoma to ensure adequate uptake. A period of fourteen days is recommended for triiodothyronine and four to five weeks for thyroxine. They should be restarted two days after treatment.
Similarly carbimazole and propylthiouracil should be stopped five days prior to treatment of hyperthyroidism and possibly restarted several days later.
A low iodine diet prior to therapy will enhance uptake into functioning thyroid tissue.
Sperm banking should be considered for men who have extensive disease (see section 4.6).
Breast-feeding women must be advised to discontinue breast-feeding for 68 weeks before radioiodine administration (see section 4.6.).
In patients with suspected gastrointestinal disease, great care should be taken when administering ( I) capsules. The capsules should be swallowed whole with sufficient fluid to ensure clear passage into the stomach and upper small intestine. Concomitant use of H2 antagonists or proton pump inhibitors is advised in order to address the possible gastrointestinal reactions.
The treatment of Graves’ disease by radioactive iodine should be associated to concomitant medication by corticosteroids in patients with Graves’ ophtalmopathy.
Patients should be encouraged to increase oral fluids and urged to void as often as possible to reduce bladder radiation, especially after high activities, e.g. for radionuclide therapy. Patients with bladder voiding problems should be catheterised after high activity administration.
After treatment
To reduce radiation exposure of the salivary glands and avoid sialadenitis which may complicate high dose radioiodine administration, the patient may be advised to take sweets or drinks containing citric acid which will stimulate saliva excretion.
To reduce colon exposure, laxatives (but not stool softeners which do not stimulate the bowel) may be necessary in patient having less than one bowel movement a day.
The patient should be followed-up at appropriate intervals.
For radioprotection reasons, close contact with infants and pregnant women must be restricted. The period of close contact restriction should be adapted to the administered activity and the type of pathology.
Specific warnings
This preparation is likely to result in a relatively high radiation dose to most patients (see sections 4.8 and 11).
The administration of high dose radioiodine may result in significant environmental hazard. This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered. Suitable precautions in accordance with national regulations should be taken concerning the activity eliminated by the patients in order to avoid any contaminations.
There is little evidence of an increased incidence of cancer, leukaemia or mutations in man with respect to patients treated for benign thyroid disease with radioiodine, despite extensive use. In the treatment of children and young people however, account must be taken of the greater sensitivity of child tissue and the greater life expectancy of such patients.
The risks must also be weighed up against those of other possible treatments.
In the treatment of malignant thyroid disease, a higher incidence of bladder cancer has been reported in one study of patients receiving more than 3700 MBq ( I). Another study has reported a small excess leukaemia in patients receiving very high doses. A cumulative total activity higher than 26 000 MBq is therefore not advisable.
In patients with a known hypersensitivity for gelatine or their metabolites, sodium iodide ( I) solution should be preferred for the radioiodine therapy.
Warning related to excipient
This medicinal product contains 110 mg of sodium per capsule which has to be taken into account in patients on low sodium diet.
Precautions with respect to environmental hazard see section 6.6.
4.5 Interaction with other medicinal products and other forms of interaction
Many pharmacological agents are known to interact with radioiodide. This may happen by a variety of mechanisms which can affect the protein binding, the pharmacokinetics or influence the dynamic effects of labelled iodide. It is therefore necessary to take a full drug history and ascertain whether any medications are required to be withheld prior to the administration of sodium iodide (131I).
For example, the treatment with the following substances should be discontinued:
|
Active substances |
Period of withhold before administration of 131-iodine |
|
Antithyroid agents (e.g. carbimazole, or other imidazole derivatives such as propylthiouracil) and perchlorate |
1 week before starting treatment till several days after |
|
Salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, anticoagulants, antihistamines, antiparasitics, penicillins, sulphonamides, tolbutamide, thiopentone |
1 week |
|
Phenylbutazone |
1-2 week(s) |
|
Containing iodine expectorants and vitamins |
Approx. 2 weeks |
|
Thyroid hormone preparations |
Triiodothyronine 2 weeks Thyroxine 4-5 weeks |
|
Amiodarone *, benzodiazepines, lithium |
Approx. 4 weeks |
|
Containing iodine preparations for topical use |
1-9 month(s) |
|
Containing iodine contrast media |
Up to 1 year |
* Due to the long half-life of amiodarone, iodine uptake in the thyroid tissue can be decreased for several months.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques which do not involve ionising radiation should be considered.
Women receiving Sodium iodide (131I) should be advised NOT to become pregnant within 6-12 months of administration.
Contraception in males and females
Women are advised to use contraception for a time period of 6-12 months.
As a precaution, men should not father a child for a time period of 6 months after radioiodine treatment to allow the replacement of irradiated by non-irradiated spermatozoa.
Pregnancy
Sodium iodide (131I) is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to the fact that the absorbed dose to the uterus for this agent is likely to be in the range 11-511 mGy, and foetal thyroid gland avidly concentrates iodine during the second and third trimesters (see section 4.3).
In the case of differentiated thyroid carcinoma diagnosed in pregnancy therefore, radioiodine treatment must be postponed until after the pregnancy has ended.
Breast-feeding
Before administering a radiopharmaceutical to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breast-feeding must be discontinued for 6-8 weeks before radioiodine administration in order to ensure that lactation-associated increase in breast sodium iodide symporter activity has returned to normal. Breast-feeding must not be resumed after sodium iodide-131 therapy. Breast-feeding can be safely undertaken after future pregnancy.
Close contact with infants must be restricted. The period of close contact restriction should be adapted to the administered activity and the type of pathology.
Fertility
A potential transient impairment of gonadal function by high radioiodine therapeutic dose can be observed in male and female (see section 4.4).
4.7 Effects on ability to drive and use machines
Capsion has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
The frequencies of reported adverse reactions were derived from the medical literature. The safety profile of sodium iodide I-131 differs widely according to the doses administered, while the doses to be administered are dependent on the type of treatment (i.e. treatment of benign or malignant disease). Moreover, the safety profile depends on the cumulative doses administered and the dosing intervals which are used.
The following table presents how the frequencies are reflected in this section:
|
MedDRA Body system |
Preferred term |
Frequency |
|
SOCs |
|
Neoplasms benign, malignant and unspecified (incl. cysts and polyps) |
Gastric cancer |
Not known |
|
Bladder cancer | ||
|
Leukaemia | ||
|
Breast cancer | ||
|
Cancer induction | ||
|
Blood and lymphatic system disorders |
Bone Marrow Failure |
Not known |
|
Thrombocytopenia | ||
|
Erythrocytopenia | ||
|
Leukocytosis |
Common | |
|
Immune system disorders |
Hypersensitivity |
Not known |
|
Endocrine disorders |
Basedow’s disease |
Common |
|
Hyperthyroidism |
Not known | |
|
Hypothyroidism |
Very common | |
|
Hypoparathyroidism |
Uncommon | |
|
Thyroiditis |
Very common | |
|
Thyrotoxic crisis |
Not known | |
|
Endocrine ophthalmopathy |
Common | |
|
Nervous system disorders |
Brain oedema |
Not known |
|
Eye disorders |
Dry eye |
Very common |
|
Dacryostenosis acquired | ||
|
Lacrimal disorders | ||
|
Eye disorders |
Uncommon | |
|
Respiratory, thoracic and mediastinal disorders |
Pulmonary fibrosis, pneumonia, respiratory distress |
Not known |
|
Dyspnoea | ||
|
Tracheal stenosis | ||
|
Tracheitis | ||
|
Gastrointestinal disorders |
Salivary gland enlargment |
Very common |
|
Salivary gland pain | ||
|
Sialoadenitis | ||
|
Vomiting | ||
|
Nausea | ||
|
Tooth loss |
Not known | |
|
Gastrointestinal disorders |
Very common | |
|
Ageusia, dysgeusia | ||
|
Dry mouth |
|
Reproductive system and breast disorders |
Infertility male, infertility female, azoospermia, menstrual disorder, ovarian failure |
Not known |
|
Congenital, familial and genetic disorders |
Hereditary disorder |
Not known |
|
Congenital hypothyroidism | ||
|
General disorders and administration site conditions |
Localised oedema |
Not known |
|
Discomfort | ||
|
Pain | ||
|
Fatigue |
Very common (>1/10)
Common Qi 1/100 to <1/10)
Uncommon (>1/1,000 to <1/100)
Rare (>1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Early consequences
Some cases of adverse reactions have been reported following the administration of sodium iodide (131I), including nausea, vomiting and unspecified possible allergic phenomena. Nausea and vomiting are more frequent after administration by oral route especially after therapeutic doses and the risks of contamination following the occurrence of vomiting have to be considered.
Some cases of allergoid reactions following the administration of sodium iodide (131I) have been reported (European system for reporting of adverse reactions and drug defects). These reactions are most probably related to hypersensitivity against the gelatine of the capsules or their metabolites.
Therapeutic quantities of sodium iodide (131I) may worsen existing hyperthyroidism temporarily. In the course of a toxic multinodular goitre treatment, (131I) may induce Graves’ disease or thyroid associated ophtalmopathy (incidence 1 to 5 %). This side effect has been reported in a single case of differentiated thyroid cancer.
High levels of radioactivity may lead to gastrointestinal disturbance usually within the first hours or days after administration. The incidence of gastrointestinal upset can be as high as 67 %. This can easily be prevented or counteracted by means of symptomatic treatment.
With high dose radioiodine treatment, 1-3 days after administration, the patient may experience transient inflammatory thyroiditis (and tracheitis), with a possibility of severe tracheal constriction, especially where there is existing tracheal stenosis.
Sialadenitis may occur, with swelling and pain in the salivary glands, partial loss of taste and dry mouth. Incidence varies from 10 % (with precautions) and 60 %
(without precautions). Sialadenitis is usually reversible spontaneously or with antiinflammatory treatment but cases have occasionally been described of dose-dependent persistent loss of taste and dry mouth, followed by loss of teeth. The radiation exposure of the salivary glands should be reduced by stimulating saliva excretion with acidic substances.
The destruction of thyroid follicles caused by the radiation exposure of sodium iodide (I-131) may lead to exacerbation of an already existing hyperthyroidism or even to thyrotoxic crisis.
Malfunction of the lachrymal glands, such as ocular dryness and nasolacrimal duct obstruction may occur after radioiodine treatment. Although these symptoms are in the majority of cases transient, they may persist for a longer period or appear late in some patients.
High levels of uptake of radioiodine given to the patients can be associated with local pain, discomfort and oedema in the tissue taking up the radionuclide.
After radioiodine therapy of thyroid carcinoma, a dose dependent impairment of fertility may occur in men and women.
Radiation induced pneumonia and pulmonary fibrosis have been observed in patients with diffuse pulmonary metastases from differentiated thyroid carcinoma, due to destruction of metastatic tissue. This occurs mainly after high dose radioiodine therapy.
In the treatment of metastasising thyroid carcinomas with CNS involvement, the possibility of local cerebral oedema and/or an increasing existing cerebral oedema must also be born in mind.
Late consequences
Dose dependent hypothyroidism may occur as a late consequence of radioiodine treatment of hyperthyroidism. This may manifest itself weeks or years after treatment, requiring suitable timed measurement of thyroid function and appropriate thyroid replacement. The incidence of hypothyroidism, generally not seen until 6-12 weeks, following radioiodine has been variously reported as between 2-70 %.
Occasionally cases of transient hypoparathyroidism have been observed after radioiodine; they must be monitored accordingly and treated with replacement therapy.
As a late consequence a single administration of over 5000 MBq or in interval of below 6 months are more likely to be associated with reversible or in very rare cases irreversible bone marrow depression may develop, with isolated thrombocytopenia or erythrocytopenia, which may be fatal.
Transient leucocytosis is frequently observed.
Epidemiological studies report a higher incidence of stomach cancer in patients receiving (131I).
After higher activities, typically those used in the treatment of thyroid malignancies, an increased incidence of leukaemia has been observed. There may also be a small increase in bladder and breast cancers.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations. In all cases it is necessary to ensure that the risks of the radiation are less than from the disease itself. The effective dose is 284 Sv when the maximal recommended activity of 11 100 MBq is administered and the thyroid uptake is at 35 %.
Types of adverse reactions in children are expected to be the same as in adults. Based on greater radiation sensitivity of child tissue (see section 11) and the greater life expectancy frequency and severity may be different.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and by forced diuresis. Additionally, the blockade of the thyroid gland should be recommended (e.g. with potassium iodide or perchlorate) immediately following suspected overexposure in order to reduce the radiation exposure of the thyroid gland. Emetics can also be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Radiopharmaceutical product for therapeutic use. ATC code: V10XA01
Mechanism of action
The pharmacological active substance is iodine-131 in the form of sodium iodide that is taken up by the thyroid. It decays mainly there during its long residence time and in this manner induces a selective irradiation of this organ.
The P irradiation will dose-dependently decrease cell function and cell division leading to cell destruction.
Pharmacodynamic effects
Iodide in the amount used for therapeutic indications, is not known to have any pharmacological effect. More than 90 % of the radiation effects result from beta radiation which has a mean range of 0.5 mm.
5.2
Pharmacokinetic properties
After oral administration sodium iodide (131I) is absorbed rapidly from the upper gastrointestinal tract (90 % in 60 minutes).
The absorption is influenced by gastric emptying. It is increased by hyperthyroidism and decreased by hypothyroidism.
Distribution and organ uptake
The pharmacokinetics follows that of unlabelled iodide. After entering the blood stream it is distributed in the extra thyroidal compartment. From here it is predominantly taken up by the thyroid or excreted through the kidneys. Small amounts of iodide (131I) are taken up by salivary glands, gastric mucosa and would also be localised in breast milk, the placenta and choroid plexus.
Half-life
The effective half-life of radioiodine in plasma is in the order of 12 hours whereas that for radioiodine taken up by the thyroid gland is about 6 days. Thus after administration of sodium iodide (131I) approximately 40 % of the activity has an effective half-life of 0.4 days and the remaining 60 %, 8 days.
Elimination
Elimination is mainly via the urine. Urinary excretion is 37-75 %, faecal excretion is about 10 % with almost negligible excretion in the sweat.
5.3 Preclinical safety data
Because of the small quantities of substance administered compared with the normal food intake of iodine (40-500 pg/day) no acute toxicity is expected or observed.
There are no data available on the toxicity of repeated doses of sodium iodide nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anhydrous sodium pyrophosphate Sodium thiosulphate Gelatin capsule
upper part: green (titanium dioxide, yellow iron oxide, indigotine), lower part: orange (titanium dioxide, red iron oxide, yellow iron oxide).
6.2.
Incompatibilities
None known
6.3 Shelf life
21 days following manufacture.
The expiry date is indicated on each vial and on the outer packaging.
6.4 Special precautions for storage
Do not store above 25 °C. Store in the original package.
Storage should be in accordance with national regulations for radioactive materials.
6.5 Nature and contents of container
15 mL colourless glass (type I of European Pharmacopoeia) penicillin-type vial, closed with polypropylene device (centring element and perforator), and sealed with aluminium flip-off capsule.
Pack size: One capsule from 50 to 3700 MBq at calibration date per vial.
6.6 Special precautions for disposal
General warning
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.
The capsule is ready for use.
Sodium iodide [131I] capsule is packed in such a way that patients can swallow the capsule unaided.
It is advised to open the packaging under a ventilated hood.
The activity of the capsule should be checked prior to administration to the patient. For method of administration, see section 4.2.
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.
This preparation is likely to result in a relatively high radiation dose to most patients. The administration of sodium iodide (131I) may result in significant environmental hazard.
This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered. Suitable precautions in accordance with national regulations should be taken concerning the activity eliminated by the patients in order to avoid any contaminations.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
CIS bio international B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE
Tel. : +33-(0)1.69.85.70.70
Fax : +33-(0)1.69.85.70.71
8 . MARKETING AUTHORISATION NUMBER
PL 11876/0015
9. DATE OF FIRST AUTHORISATION/ RENEWAL OF
AUTHORISATION 5 October 2000
10 DATE OF REVISION OF THE TEXT
14/06/2016
11 DOSIMETRY (IF APPLICABLE)
Tabulated radiation dosimetry data, as reported in ICRP publication No. 53 (1987), are reported hereafter.
The ICRP model refers to intravenous administration. Since absorption of radioiodide is rapid and complete, this model is applicable in case of oral administration also but there is a further radiation dose to the stomach wall in addition to that due to gastric and salivary excretion. Assuming that the mean residence time in the stomach is 0.5 hours, the absorbed dose to the stomach wall increases by about 30 % for (131I) iodine.
Radiation dose to specific organs, which may not be the target organ of therapy, can be influenced significantly by pathophysiological changes induced by the disease process.
As part of the risk-benefit assessment it is advised that the EDE (Effective Dose Equivalent) and likely radiations doses to individual target organ(s) be calculated prior to administration. The activity might then be adjusted according to thyroid mass, biological half-life and the "re-cycling" factor which takes into account the physiological status of the patient (including iodine depletion) and the underlying pathology.
Radiation exposure (Thyroid blocked, uptake 0 %)
|
Organ |
Absorbed (mGy/MB |
dose per unit activity administered q) | |||
|
Adult |
15 years |
10 years |
5 years |
1 year | |
|
Adrenals |
0.037 |
0.042 |
0.067 |
0.11 |
0.20 |
|
Bladder wall |
0.61 |
0.75 |
1.1 |
1.8 |
3.4 |
|
Bone surfaces |
0.032 |
0.038 |
0.061 |
0.097 |
0.19 |
|
Breast |
0.033 |
0.033 |
0.052 |
0.085 |
0.17 |
|
GI-tract Stomach wall |
0.034 |
0.040 |
0.064 |
0.10 |
0.19 |
|
Small intest |
0.038 |
0.047 |
0.075 |
0.12 |
0.22 |
|
ULI wall |
0.037 |
0.045 |
0.070 |
0.12 |
0.21 |
|
LLI wall |
0.043 |
0.052 |
0.082 |
0.13 |
0.23 |
|
Kidneys |
0.065 |
0.080 |
0.12 |
0.17 |
0.31 |
|
Liver |
0.033 |
0.040 |
0.065 |
0.10 |
0.20 |
|
Lungs |
0.031 |
0.038 |
0.060 |
0.096 |
0.19 |
|
Ovaries |
0.042 |
0.054 |
0.084 |
0.13 |
0.24 |
|
Pancreas |
0.035 |
0.043 |
0.069 |
0.11 |
0.21 |
|
Red marrow |
0.035 |
0.042 |
0.065 |
0.10 |
0.19 |
|
Spleen |
0.034 |
0.040 |
0.065 |
0.10 |
0.20 |
|
Testes |
0.037 |
0.045 |
0.075 |
0.12 |
0.23 |
|
Thyroid |
0.029 |
0.038 |
0.063 |
0.10 |
0.20 |
|
Uterus |
0.054 |
0.067 |
0.11 |
0.17 |
0.30 |
|
Other tissue |
0.032 |
0.039 |
0.062 |
0.10 |
0.19 |
|
Effective dose equivalent |
0.072 |
0.088 |
0.14 |
0.21 |
0.4 |
|
(mSv/MBq) | |||||
According to ICRP 80, the Effective Dose for adults is 0.064 mSv/MBq. Bladder wall contributes to 47.6 % of the effective dose.
After ingestion of 11,100 MBq, the Effective Dose is about 710 mSv. The absorbed doses are 322 mGy and 6,770 mGy for thyroid and bladder wall, respectively.
Incomplete blockage
Effective dose equivalent (mSv/MBq) at small uptake in the thyroid
|
uptake: 0.5 % |
0.3 |
0.45 |
0.69 |
1.5 |
2.8 |
|
uptake: 1.0 % |
0.52 |
0.81 |
1.2 |
2.7 |
5.3 |
|
uptake: 2.0 % |
0.97 |
1.5 |
2.4 |
5.3 |
10 |
|
Organ |
Absorbed (mGy/MB |
dose per unit activity administered q) | |||
|
Adults |
15 years |
10 years |
5 years |
1 year | |
|
Adrenals |
0.036 |
0.043 |
0.071 |
0.11 |
0.22 |
|
Bladder wall |
0.52 |
0.64 |
0.98 |
1.5 |
2.9 |
|
Bone surfaces |
0.047 |
0.067 |
0.094 |
0.14 |
0.24 |
|
Breast |
0.043 |
0.043 |
0.081 |
0.13 |
0.25 |
|
Gl-tract Stomach wall |
0.46 |
0.58 |
0.84 |
1.5 |
2.9 |
|
Small intest |
0.28 |
0.35 |
0.62 |
1.0 |
2.0 |
|
ULI wall |
0.059 |
0.065 |
0.10 |
0.16 |
0.28 |
|
LLI wall |
0.042 |
0.053 |
0.082 |
0.13 |
0.23 |
|
Kidneys |
0.060 |
0.075 |
0.11 |
0.17 |
0.29 |
|
Liver |
0.032 |
0.041 |
0.068 |
0.11 |
0.22 |
|
Lungs |
0.053 |
0.071 |
0.12 |
0.19 |
0.33 |
|
Ovaries |
0.043 |
0.059 |
0.092 |
0.14 |
0.26 |
|
Pancreas |
0.052 |
0.062 |
0.10 |
0.15 |
0.27 |
|
Red marrow |
0.054 |
0.074 |
0.099 |
0.14 |
0.24 |
|
Spleen |
0.042 |
0.051 |
0.081 |
0.12 |
0.23 |
|
Testes |
0.028 |
0.035 |
0.058 |
0.094 |
0.18 |
|
Thyroid |
210 |
340 |
510 |
1100 |
2000 |
|
Uterus |
0.054 |
0.068 |
0.11 |
0.17 |
0.31 |
|
Other tissue |
0.065 |
0.089 |
0.14 |
0.22 |
0.40 |
|
Effective dose equivalent |
6.6 |
10 |
15 |
34 |
62 |
|
(mSv/MBq) | |||||
|
Organ |
Absorbed c (mGy/MBq |
lose per unit activity administered ) | |||
|
Adult |
15 years |
10 years |
5 years |
1 year | |
|
Adrenals |
0.042 |
0.050 |
0.087 |
0.14 |
0.28 |
|
Bladder wall |
0.40 |
0.50 |
0.76 |
1.2 |
2.3 |
|
Bone surfaces |
0.076 |
0.12 |
0.16 |
0.23 |
0.35 |
|
Breast |
0.067 |
0.066 |
0.13 |
0.22 |
0.40 |
|
GI-tract Stomach wall |
0.46 |
0.59 |
0.85 |
1.5 |
3.0 |
|
Small intest |
0.28 |
0.35 |
0.62 |
1.0 |
2.0 |
|
ULI wall |
0.058 |
0.065 |
0.10 |
0.17 |
0.30 |
|
LLI wall |
0.040 |
0.051 |
0.080 |
0.13 |
0.24 |
|
Kidneys |
0.056 |
0.072 |
0.11 |
0.17 |
0.29 |
|
Liver |
0.037 |
0.049 |
0.082 |
0.14 |
0.27 |
|
Lungs |
0.090 |
0.12 |
0.21 |
0.33 |
0.56 |
|
Ovaries |
0.042 |
0.057 |
0.090 |
0.14 |
0.27 |
|
Pancreas |
0.054 |
0.069 |
0.11 |
0.18 |
0.32 |
|
Red marrow |
0.086 |
0.12 |
0.16 |
0.22 |
0.35 |
|
Spleen |
0.046 |
0.059 |
0.096 |
0.15 |
0.28 |
|
Testes |
0.026 |
0.032 |
0.054 |
0.089 |
0.18 |
|
Thyroid |
500 |
790 |
1200 |
2600 |
4700 |
|
Uterus |
0.050 |
0.063 |
0.10 |
0.16 |
0.30 |
|
Other tissue |
0.11 |
0.16 |
0.26 |
0.41 |
0.71 |
|
Effective dose equivalent |
15 |
24 |
36 |
78 |
140 |
|
(mSv/MBq) | |||||
According to ICRP 80, the Effective Dose for adults is 25.6 mSv/MBq.
After ingestion of 11,100 MBq, the Effective Dose is about 284 Sv. The absorbed doses are 5,550 Gy and 4.5 Gy for thyroid and bladder wall, respectively.
|
Organ |
Absorbed c (mGy/MBq |
lose per unit activity administered ) | |||
|
Adult |
15 years |
10 years |
5 years |
1 year | |
|
Adrenals |
0.049 |
0.058 |
0.11 |
0.17 |
0.34 |
|
Bladder wall |
0.29 |
0.36 |
0.54 |
0.85 |
1.6 |
|
Bone surfaces |
0.11 |
0.17 |
0.22 |
0.32 |
0.48 |
|
Breast |
0.091 |
0.089 |
0.19 |
0.31 |
0.56 |
|
Gl-tract Stomach wall |
0.46 |
0.59 |
0.86 |
1.5 |
3.0 |
|
Small intest |
0.28 |
0.35 |
0.62 |
1.0 |
2.0 |
|
ULI wall |
0.058 |
0.067 |
0.11 |
0.18 |
0.32 |
|
LLI wall |
0.039 |
0.049 |
0.078 |
0.13 |
0.24 |
|
Kidneys |
0.051 |
0.068 |
0.10 |
0.17 |
0.29 |
|
Liver |
0.043 |
0.058 |
0.097 |
0.17 |
0.33 |
|
Lungs |
0.13 |
0.18 |
0.30 |
0.48 |
0.80 |
|
Ovaries |
0.041 |
0.056 |
0.090 |
0.15 |
0.27 |
|
Pancreas |
0.058 |
0.076 |
0.13 |
0.21 |
0.38 |
|
Red marrow |
0.12 |
0.18 |
0.22 |
0.29 |
0.46 |
|
Spleen |
0.051 |
0.068 |
0.11 |
0.17 |
0.33 |
|
Testes |
0.026 |
0.031 |
0.052 |
0.087 |
0.17 |
|
Thyroid |
790 |
1200 |
1900 |
4100 |
7400 |
|
Uterus |
0.046 |
0.060 |
0.099 |
0.16 |
0.30 |
|
Other tissue |
0.16 |
0.24 |
0.37 |
0.59 |
1.0 |
|
Effective dose equivalent |
24 |
37 |
56 |
120 |
220 |
|
(mSv/MBq) | |||||
12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)
Not applicable.