Special Warnings Precautions and FollowUp

224RaCl may only be administered to women of childbearing age or to patients with increased infectious susceptibility (e.g., chronic obstructive diseases) in justified cases (Table 7).

Table 7 Patient Preparation and Treatment Procedure

Obtain history of pretreatment and drug history; review results of previous imaging and confirm appropriateness of indication for 224Ra therapy You should also check

Blood parameters (leukocytes, erythrocytes, platelets)

History of administration of drugs toxic to the bone marrow or bone marrow radiation Liver function Renal function Hematopoietic diseases

Add missing imaging procedures, such as radiographs of the axis skeleton, three-phase bone scanning, MRI if necessary Obtain written informed consent; provide written and verbal information on 224RaCl treatment

Pregnancy testing in women of childbearing age

Vein puncture and intravenous administration (inline catheter) according to the rules of asepsis in a dedicated room for the use of radionuclides according to national law and local regulations

Before injection of the radiopharmaceutical, check for the correct radionuclide and activity

After injection of 224RaCl flush the needle with 0.9% saline

Table 8 Treatment Monitoring and Patient Follow-Up

Before, during, and after treatment, blood counts of leukocytes, erythrocytes, and platelets are required weekly A check-up for side effects or other complications is recommended at every time point of weekly administration Clinical follow-up examinations to assess treatment response and blood counts are recommended 3, 6, and 12 months after therapy, and then in annual intervals thereafter for 25 years

A relative contraindication exists for women of childbearing age. Contraception during and up to six months after the end of the therapy with 224RaCl must be planned. The reason is that 224RaCl crosses the placenta and deposits in the skeleton of the unborn child. In cases in which radioactive drug treatment of women in childbearing age is necessary, pregnancy must be excluded. Data concerning the transmission to breast milk are not available. Breastfeeding must be discontinued in cases where the drug is to be administered to a breastfeeding mother.

Fluid intake and frequent voiding should be encouraged for the first 24 hours following treatment. Owing to the excretion of 224RaCl in urine and feces, patients should be instructed to empty their bladder and colon at least once during the 24 hours following treatment. The toilet should be flushed two or three times. Handwashing should be performed routinely and frequently (Table 9). Sharing food and eating utensils is prohibited.

Before, during, and after the treatment, peripheral blood counts (leukocytes, erythrocytes, and platelets) are required. The counts must be performed weekly before each administration during the total period of treatment. If leukocyte counts decrease below 4.000/ml, lymphocyte counts below 500/ml, or neutrophil granulocyte counts below 1000/ml, the therapy has to be stopped. Treatment must be stopped also in the case of a decrease in thrombocytes below 50,000/ml or hemoglobin value below 9.0 g/dl.

Owing to the potential damage to the bone marrow and the potentially long latent period between treatment with 224RaCl and myelotoxic effects or possible induction of leukemia, regular complete blood counts (three months, six months, and one year after the end of treatment, and then in one-year intervals, up to 25 years) have to be performed. After administration of 224RaCl, no effects on the ability to drive or handle machines are to be expected.

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