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Lutathera Dosage

Generic name: LUTETIUM OXODOTREOTIDE LU-177 10mCi in 1mL
Dosage form: injection

Medically reviewed by Drugs.com. Last updated on May 4, 2020.

Important Safety Instructions

LUTATHERA is a radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1)] . Use waterproof gloves and effective radiation shielding when handling LUTATHERA. Radiopharmaceuticals, including LUTATHERA, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.

Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA [see Use in Specific Populations (8.1, 8.3)].

Recommended Dosage

The recommended LUTATHERA dosage is 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses. Administer premedications and concomitant medications as recommended [see Dosage and Administration (2.3)].

Premedication and Concomitant Medications

Somatostatin Analogs

  • Before initiating LUTATHERA: Discontinue long-acting somatostatin analogs (e.g., long-acting octreotide) for at least 4 weeks prior to initiating LUTATHERA. Administer short-acting octreotide as needed; discontinue at least 24 hours prior to initiating LUTATHERA [see Drug Interactions (7.1)] .
  • During LUTATHERA treatment: Administer long-acting octreotide 30 mg intramuscularly between 4 to 24 hours after each LUTATHERA dose. Do not administer long-acting octreotide within 4 weeks of each subsequent LUTATHERA dose. Short-acting octreotide may be given for symptomatic management during LUTATHERA treatment, but must be withheld for at least 24 hours before each LUTATHERA dose.
  • Following LUTATHERA treatment: Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing LUTATHERA until disease progression or for up to 18 months following treatment initiation.

Antiemetic
Administer antiemetics before the recommended amino acid solution.


Amino Acid Solution
Initiate an intravenous amino acid solution containing L-lysine and L-arginine (Table 1) 30 minutes before administering LUTATHERA. Use a three-way valve to administer amino acids using the same venous access as LUTATHERA or administer amino acids through a separate venous access in the patient's other arm. Continue the infusion during and for at least 3 hours after LUTATHERA infusion. Do not decrease the dose of the amino acid solution if the dose of LUTATHERA is reduced [see Warnings and Precautions (5.4)] .

Table 1. Amino Acid Solution

Item

Specification

*
equivalent to 14.4 to 20 g lysine
equivalent to 14.9 to 20.7 g arginine

L-Lysine HCl content

Between 18 g and 25 g*

L-Arginine HCl content

Between 18 g and 25 g

Volume

1 L to 2 L

Osmolarity

< 1050 mOsmol/L

2.4 Dosage Modifications for Adverse Reactions

Recommended dose modifications of LUTATHERA for adverse reactions are provided in Table 2.

Table 2. Recommended Dosage Modifications of LUTATHERA for Adverse Reactions
*
Grading of severity is defined in the most current Common Terminology Criteria for Adverse Events (CTCAE)

Adverse Reaction

Severity of Adverse Reaction*

Dose Modification

Thrombocytopenia [see Warnings and Precautions (5.2)]

Grade 2, 3 or 4

Withhold dose until complete or partial resolution (Grade 0 to 1).


Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. If reduced dose does not result in Grade 2, 3 or 4 thrombocytopenia, administer LUTATHERA at 7.4 GBq (200 mCi) for next dose.


Permanently discontinue LUTATHERA for Grade 2 or higher thrombocytopenia requiring a treatment delay of 16 weeks or longer.

Recurrent Grade 2, 3 or 4

Permanently discontinue LUTATHERA.

Anemia and Neutropenia [see Warnings and Precautions (5.2)]

Grade 3 or 4

Withhold dose until complete or partial resolution (Grade 0, 1, or 2).


Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. If reduced dose does not result in Grade 3 or 4 anemia or neutropenia, administer LUTATHERA at 7.4 GBq (200 mCi) for next dose.


Permanently discontinue LUTATHERA for Grade 3 or higher anemia or neutropenia requiring a treatment delay of 16 weeks or longer.

Recurrent Grade 3 or 4

Permanently discontinue LUTATHERA.

Renal Toxicity [see Warnings and Precautions (5.4)]

Defined as:

  • Creatinine clearance less than 40 mL/min; calculate using Cockcroft Gault with actual body weight, or
  • 40% increase in baseline serum creatinine, or
  • 40% decrease in baseline creatinine clearance; calculate using Cockcroft Gault with actual body weight.

Withhold dose until complete resolution or return to baseline.


Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete resolution. If reduced dose does not result in renal toxicity, administer LUTATHERA at 7.4 GBq (200 mCi) for next dose.


Permanently discontinue LUTATHERA for renal toxicity requiring a treatment delay of 16 weeks or longer.

Recurrent renal toxicity

Permanently discontinue LUTATHERA.

Hepatotoxicity [see Warnings and Precautions (5.5)]

Defined as:

  • Bilirubinemia greater than 3 times the upper limit of normal (Grade 3 or 4), or
  • Hypoalbuminemia less than 30 g/L with a decreased prothrombin ratio less than 70%.

Withhold dose until complete resolution or return to baseline.


Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete resolution or return to baseline. If reduced LUTATHERA dose does not result in hepatotoxicity, administer LUTATHERA at 7.4 GBq (200 mCi) for next dose.


Permanently discontinue LUTATHERA for hepatotoxicity requiring a treatment delay of 16 weeks or longer.

Recurrent hepatotoxicity

Permanently discontinue LUTATHERA.

Other Non-Hematologic Toxicity [see Adverse Reactions (6.1)]

Grade 3 or 4

Withhold dose until complete or partial resolution (Grade 0 to 2).


Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. If reduced dose does not result in Grade 3 or 4 toxicity, administer LUTATHERA at 7.4 GBq (200 mCi) for next dose.


Permanently discontinue LUTATHERA for Grade 3 or higher toxicity requiring treatment delay of 16 weeks or longer.

Recurrent Grade 3 or 4

Permanently discontinue LUTATHERA.

Preparation and Administration

  • Use aseptic technique and radiation shielding when administering the LUTATHERA solution. Use tongs when handling vial to minimize radiation exposure.
  • Do not inject LUTATHERA directly into any other intravenous solution.
  • Confirm the amount of radioactivity of LUTATHERA in the radiopharmaceutical vial with an appropriate dose calibrator prior to and after LUTATHERA administration.
  • Inspect the product visually for particulate matter and discoloration prior to administration under a shielded screen. Discard vial if particulates or discoloration are present.
  • Dispose of any unused medicinal product or waste material in accordance with local and federal laws.

Administration Instructions

The gravity method or infusion pump method may be used for administration of the recommended dosage. Use the infusion pump method when administering a reduced dose of LUTATHERA following a dosage modification for an adverse reaction; using the gravity method to administer a reduced dose of LUTATHERA may result in delivery of the incorrect volume of LUTATHERA, if the dose is not adjusted prior to administration.

Instructions for Gravity Method

  • Insert a 2.5 cm, 20 gauge needle (short needle) into the LUTATHERA vial and connect via a catheter to 500 mL 0.9% sterile sodium chloride solution (used to transport LUTATHERA during the infusion). Ensure that the short needle does not touch the LUTATHERA solution in the vial and do not connect this short needle directly to the patient. Do not allow sodium chloride solution to flow into the LUTATHERA vial prior to the initiation of the LUTATHERA infusion and do not inject LUTATHERA directly into the sodium chloride solution.
  • Insert a second needle that is 9 cm, 18 gauge (long needle) into the LUTATHERA vial ensuring that this long needle touches and is secured to the bottom of the LUTATHERA vial during the entire infusion. Connect the long needle to the patient by an intravenous catheter that is prefilled with 0.9% sterile sodium chloride and that is used exclusively for the LUTATHERA infusion into the patient.
  • Use a clamp or pump to regulate the flow of the sodium chloride solution via the short needle into the LUTATHERA vial at a rate of 50 mL/hour to 100 mL/hour for 5 to 10 minutes and then 200 mL/hour to 300 mL/hour for an additional 25 to 30 minutes (the sodium chloride solution entering the vial through the short needle will carry the LUTATHERA from the vial to the patient via the catheter connected to the long needle over a total duration of 30 to 40 minutes).
  • During the infusion, ensure that the level of solution in the LUTATHERA vial remains constant.
  • Disconnect the vial from the long needle line and clamp the saline line once the level of radioactivity is stable for at least five minutes.
  • Follow the infusion with an intravenous flush of 25 mL of 0.9% sterile sodium chloride.

Instructions for Infusion Pump Method

  • Insert a 2.5 cm, 20 gauge needle (short venting needle) into the LUTATHERA vial. Ensure that the short needle does not touch the LUTATHERA solution in the vial and do not connect this short needle directly to the patient or the infusion pump.
  • Insert a second needle that is 9 cm, 18 gauge (long needle) into the LUTATHERA vial ensuring that this long needle touches and is secured to the bottom of the LUTATHERA vial during the entire infusion. Connect the long needle and a 0.9% sterile sodium chloride solution to a 3-way stopcock valve via appropriate tubing.
  • Connect the output of the 3-way stopcock valve to tubing installed on the input side of the peristaltic infusion pump according to manufacturer’s instruction.
  • Purge the line by opening the 3-way stopcock valve and pumping the LUTATHERA solution through the tubing until it reaches the exit of the valve.
  • Purge the intravenous catheter which will be connected to the patient by opening the 3-way stopcock valve to the 0.9% sterile sodium chloride solution and pumping the 0.9% sterile sodium chloride solution until it exits the end of the catheter tubing.
  • Connect the purged intravenous catheter to the patient and set the 3-way stopcock valve such that the LUTATHERA solution is in line with the infusion pump.
  • Infuse one-half the volume listed on the LUTATHERA vial over a 30 min period (approximately 25 mL/h).
  • When the correct volume of LUTATHERA has been delivered, stop the infusion pump and then change the position of the 3-way stopcock valve so that the infusion pump is in line with the 0.9% sterile sodium chloride solution. Restart the infusion pump and infuse an intravenous flush of 25 mL of 0.9% sterile sodium chloride solution through the intravenous catheter to the patient.

Radiation Dosimetry

The mean and standard deviation (SD) of the estimated radiation absorbed doses for adults receiving LUTATHERA are shown in Table 3. The maximum penetration in tissue is 2.2 mm and the mean penetration is 0.67 mm.

Table 3. Estimated Radiation Absorbed Dose for LUTATHERA in NETTER-1
*
N=18 (two patients excluded because the liver absorbed dose was biased by the uptake of the liver metastases)
N=9 (female patients only)
N=11 (male patients only)

Absorbed dose per unit activity

(Gy/GBq)

(N=20)

Calculated absorbed dose for 4 x 7.4 GBq

(29.6 GBq cumulative activity)

(Gy)

Organ

Mean

SD

Mean

SD

Adrenals

0.037

0.016

1.1

0.5

Brain

0.027

0.016

0.8

0.5

Breasts

0.027

0.015

0.8

0.4

Gallbladder Wall

0.042

0.019

1.2

0.6

Heart Wall

0.032

0.015

0.9

0.4

Kidneys

0.654

0.295

19.4

8.7

Liver *

0.299

0.226

8.9

6.7

Lower Large Intestine Wall

0.029

0.016

0.9

0.5

Lungs

0.031

0.015

0.9

0.4

Muscle

0.029

0.015

0.8

0.4

Osteogenic Cells

0.151

0.268

4.5

7.9

Ovaries

0.031

0.013

0.9

0.4

Pancreas

0.038

0.016

1.1

0.5

Red Marrow

0.035

0.029

1.0

0.8

Skin

0.027

0.015

0.8

0.4

Small Intestine

0.031

0.015

0.9

0.5

Spleen

0.846

0.804

25.1

23.8

Stomach Wall

0.032

0.015

0.9

0.5

Testes

0.026

0.018

0.8

0.5

Thymus

0.028

0.015

0.8

0.5

Thyroid

0.027

0.016

0.8

0.5

Total Body

0.052

0.027

1.6

0.8

Upper Large Intestine Wall

0.032

0.015

0.9

0.4

Urinary Bladder Wall

0.437

0.176

12.8

5.3

Uterus

0.032

0.013

1.0

0.4

Frequently asked questions

Further information

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