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Lutathera

Lutathera Dosage/Direction for Use

Manufacturer:

Novartis

Distributor:

Global Medical Solutions
Full Prescribing Info
Dosage/Direction for Use
Lutathera should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see Special precautions for disposal and other handling under Cautions for Usage) and after evaluation of the patient by a qualified physician.
Before starting treatment with Lutathera, somatostatin receptor imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of these receptors in the tumour tissue with the tumour uptake at least as high as normal liver uptake (tumour uptake score ≥ 2).
Posology: Adults: The recommended treatment regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each. The recommended interval between each administration is 8 weeks which could be extended up to 16 weeks in case of dose modifying toxicity (DMT) (see Table 10).
For renal protection purpose, an amino acid solution must be administered intravenously during 4 hours. The infusion of the amino acid solution should start 30 minutes prior to start of Lutathera infusion.
Amino acid solution: The amino acid solution can be prepared as a compounded product, in compliance with the hospital's sterile medicinal product preparation good practices and according to the composition specified in Table 6. (See Table 6.)

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Alternatively, some commercially available amino acid solutions can be used if compliant with the specification described in Table 7. (See Table 7.)

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Considering the high quantity of amino acids and the significant volume that commercially available solutions may require to meet the previously mentioned specifications, the compounded solution is considered the medicinal product of choice, due to its lower total volume to be infused and lower osmolarity.
Treatment monitoring: Before each administration and during the treatment, biological tests are required to re-assess the patient's condition and adapt the therapeutic protocol if necessary (dose, infusion interval, number of infusions).
The minimum laboratory tests needed before each infusion are: Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin, bilirubin); Kidney function (creatinine and creatinine clearance); Haematology (Haemoglobin [Hb], white blood count, platelet count).
These tests should be performed at least once within 2 to 4 weeks prior to administration and shortly before the administration. It is also recommended to perform these tests every 4 weeks for at least 3 months after the last infusion of Lutathera and every 6 months thereof, in order to be able to detect possible delayed adverse reactions (see Adverse Reactions). Dosing may need to be modified based on the tests results.
Dose modification: In some circumstances, it might be necessary to temporarily discontinue treatment with Lutathera, adapt the dose after the first administration or even discontinue the treatment (see Tables 8, 9 and 10 and Figure 3).

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Special populations: Elderly: Clinical experience has not identified differences in responses between the elderly and younger patients. However, since increased risk of presenting haematotoxicity has been described in elderly patients (≥ 70 years old), a close follow up allowing for prompt dose adaptation (DMT) in this population is advisable.
Renal impairment: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients. The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe renal impairment (creatinine clearance < 30 mL/min) has not been studied, therefore treatment with Lutathera in those patients is contraindicated (see Contraindications). As this medicinal product is known to be substantially excreted by the kidneys, patients with mild to moderate impaired renal function should be more frequently monitored during the treatment.
For additional details about the treatment of patient with renal impairment see Table 10 and Precautions.
Hepatic impairment: Careful consideration of the activity to be administered to patients with hepatic impairment is required since an increased radiation exposure is possible in these patients. The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe hepatic impairment has not been studied, therefore treatment with Lutathera in those patients is not recommended.
For additional details about the treatment of patient with mild to moderate hepatic impairment, see Table 10 and Precautions.
Paediatric population: The safety and efficacy of Lutathera have not been established in pediatric patients.
Method of administration: Lutathera is for intravenous use. It is a ready to use radiopharmaceutical medicinal product for single use only.
Lutathera must be administered by slow intravenous infusion over approximately 30 minutes, concomitantly with amino acid solution administered by contralateral intravenous infusion. This medicinal product must not be injected as a bolus.
Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion.
The recommended infusion method for administration of Lutathera is the gravity method. During the administration the recommended precaution measures should be undertaken (see Special precautions for disposal and other handling under Cautions for Usage).
Lutathera should be infused directly from its original container. The vial must not be opened or the solution transferred to another container. During the administration only disposable materials should be used.
The medicinal product should be infused through an intravenous catheter placed in the vein exclusively for its infusion.
Requirements: Storage of the vial: Either in a container made of polymethyl methacrylate (PMMA), a transparent radioprotection container that allows a direct visual inspection of the vial; Or in the lead container in which Lutathera is delivered.
Room and equipment preparation: Administration room: The floor and the furniture should be covered with tissue paper to avoid any accidental contamination.
Medicinal products to be administered: One vial of Lutathera; One bag of sodium chloride 9 mg/mL (0.9%) solution for injection (500 mL); Amino acid solution bag(s); Antiemetics.
Care supplies and equipment: Two (2) infusion poles; One (1) Long needle (90 - 100 mm); One (1) Short needle; Two (2) gravity intravenous infusion sets with a clamp to regulate or stop the flow (one for Lutathera, one for amino acid solution administration); Two (2) peripheral intravenous plastic catheters; One (1) sterile tubing line with a clamp to regulate or stop the flow; A pair of tongs (for Lutathera vial handling); Calibrated radioactivity measurement system and Geiger counter to monitor the radioactivity of Lutathera.
Lutathera vial tubing connections procedure: The tubing line should be pre-filled with sodium chloride 9 mg/mL (0.9%) solution for injection and then connected with a venous catheter previously inserted to the patient's arm.
The infusion set should be connected to the bag of sodium chloride 9 mg/mL (0.9%) solution for injection and pre-filled by opening the clamp.
The short needle should be inserted into the Lutathera vial, so that it does not touch the radiopharmaceutical solution. This will equilibrate pressure thus reducing any risk of leakage.
The short needle should be then connected to the pre-filled infusion set.
The long needle should be connected to the pre-filled tubing line and then inserted into the Lutathera vial, so that it touches the bottom of the vial. This will allow for the complete extraction of the radiopharmaceutical solution.
The flow of the radiopharmaceutical solution should be regulated with the clamps.
Administration procedure (gravity method): During the infusion, the flow of sodium chloride 9 mg/mL (0.9%) solution for injection increases the pressure in the Lutathera vial, facilitating the flow of Lutathera into the catheter inserted in the patient's peripheral vein.
Careful monitoring of the vital signs during the infusion is recommended.
1. Two intravenous plastic catheters should be inserted into patient's peripheral veins, one on each arm.
2. The catheters should be connected to the infusion sets (one for Lutathera, one for amino acid solution).
3. Antiemetic premedication should be administered 30 minutes before start of amino acid solution infusion.
4. Administration of the amino acid solution should be initiated 30 minutes before Lutathera infusion, with an infusion rate of 250 to 550 mL/h (depending on the solution type). Amino acid solution should be administered over 4 hour time span. Rates lower than 320 mL/h are not recommended for commercial solutions. In case of severe nausea or vomiting during amino acid solution infusion, an antiemetic of a different pharmacological class can be administered.
5. Radioactivity in the Lutathera vial should be measured immediately before infusion using a calibrated radioactivity measurement system.
6. Lutathera infusion should start 30 minutes after the beginning of the amino acid solution infusion, with the infusion rate of approximately 400 mL/h (this infusion rate is the reference rate and can be adapted depending on the patient's venous status). Lutathera should be administered over 20 to 30 minute time span. Constant intra-vial pressure should be maintained during the entire infusion.
Lutathera administration should be initiated by opening first the tubing line connected to the patient's peripheral vein, and then, by opening the infusion set connected to the bag of sodium chloride 9 mg/mL (0.9%) solution for injection. The pole height should be adjusted in order to compensate any increase or reduction of pressure inside the vial. Moving the patient's arm position should be avoided if possible (extreme flexion or extension which could lead to vein compression).
7. The flow of Lutathera from the vial to the patient should be monitored during the entire infusion. Soon after the start of the infusion, the radioactivity emission over the patient's thorax should be measured using Geiger counter to verify the presence of Lutathera in the bloodstream. Subsequent checks of the radioactivity emission should be performed approximately every 5 minutes at the level of the patient's thorax and vial. During the infusion, the radioactivity emission from the patient's thorax should steadily increase while the one from the Lutathera vial should decrease.
8. To ensure complete administration, the Lutathera vial should be kept under even pressure. The level of solution in the vial should remain constant during the entire infusion.
Visual controls of the solution levels should be repeated during the administration by direct visual control (when PMMA container is used) or using a pair of tongs to handle the vial when the lead shipping container is used.
9. The infusion should be stopped once the radioactivity emission from the vial becomes stable for several minutes (or during two consecutive measurements). This is the only parameter to determine the procedure completion. The volume of sodium chloride 9 mg/mL (0.9%) solution for injection necessary to complete the infusion may vary.
10. Total activity administered is equal to the activity in the vial before infusion minus the activity remaining in the vial after the infusion. The measurements should be performed using a calibrated system.
The following table summarises the required procedures during a treatment course with Lutathera using the gravity method: See Table 11.

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For instructions on the medicinal product before administration, see Instructions for preparation of radiopharmaceuticals under Cautions for Usage.
For patient preparation, see Precautions.
For recommendations in case of extravasation, see Precautions.
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