Lutetium oxodotreotide lu-177
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Dosing in kidney impairment
GBq (100 mCi) in patients with resolution or return to baseline. If reduced dose does not result in renal toxicity, administer LUTATHERA at
GBq (200 mCi) as next dose. Permanently discontinue LUTATHERA for renal toxicity requiring a dosing interval beyond 16 weeks. Recurrent renal toxicity Permanently discontinue LUTATHERA. Hepatotoxicity [see Warnings and Precautions] First occurrence of: Bilirubinemia greater than 3 times the upper limit of normal (Grade 3 or 4), or Serum albumin less than 30 g/L with international normalized ratio (INR) > 1.5.
Withhold dose until resolution or return to baseline. Resume LUTATHERA at
Kidneys 0.654 0.295 19.4
Kidneys 0.773 0.288 22.9
| aGrading of severity is defined in the most current Common Terminology Criteria for Adverse Events (CTCAE). bIncluding allergic reaction and anaphylaxis. cNo dose modification required for hematological toxicities Grade 3 or Grade 4 solely due to lymphopenia. | ||
| Adverse reaction | Severity of adverse reactiona | Dose modification |
| Thrombocytopenia [see Warnings and Precautions (5.2)] | First occurrence of 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) as next dose. Permanently discontinue LUTATHERA for Grade 2 or higher thrombocytopenia requiring a dosing interval beyond 16 weeks. |
| Recurrent Grade 2, 3, or 4 | Permanently discontinue LUTATHERA. | |
| Anemia and Neutropenia [see Warnings and Precautions (5.2)] | First occurrence of 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) as next dose. Permanently discontinue LUTATHERA for Grade 3 or higher anemia or neutropenia requiring a dosing interval beyond 16 weeks. |
| Recurrent Grade 3 or 4 | Permanently discontinue LUTATHERA. | |
| Renal Toxicity [see Warnings and Precautions (5.4)] | First occurrence of:Creatinine clearance less than 40 mL/min; calculated using Cockcroft-Gault formula with actual body weight, or40% increase from baseline serum creatinine, or40% decrease from baseline creatinine clearance; calculated using Cockcroft-Gault formula with actual body weight. | Withhold dose until resolution or return to baseline. Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with resolution or return to baseline. If reduced dose does not result in renal toxicity, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose. Permanently discontinue LUTATHERA for renal toxicity requiring a dosing interval beyond 16 weeks. |
| Recurrent renal toxicity | Permanently discontinue LUTATHERA. | |
| Hepatotoxicity [see Warnings and Precautions (5.5)] | First occurrence of:Bilirubinemia greater than 3 times the upper limit of normal (Grade 3 or 4), orSerum albumin less than 30 g/L with international normalized ratio (INR) > 1.5. | Withhold dose until resolution or return to baseline. Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with resolution or return to baseline. If reduced LUTATHERA dose does not result in hepatotoxicity, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose. Permanently discontinue LUTATHERA for hepatotoxicity requiring a dosing interval beyond 16 weeks. |
| Recurrent hepatotoxicity | Permanently discontinue LUTATHERA. | |
| Hypersensitivity Reactionsb [see Warnings and Precautions (5.6)] | First occurrence of Grade 3 or 4 | Permanently discontinue LUTATHERA. |
| Any Other Adverse Reactionsc [see Adverse Reactions (6.1)] | First occurrence of 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) as next dose. Permanently discontinue LUTATHERA for Grade 3 or higher adverse reactions requiring a dosing interval beyond 16 weeks. |
| Recurrent Grade 3 or 4 | Permanently discontinue LUTATHERA. | |
| aN = 18 (two patients excluded because the liver absorbed dose was biased by the uptake of the liver metastases). bN = 9 (female patients only). cRed marrow dosimetry estimates were determined using blood radioactivity. dN = 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 |
| Livera | 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 |
| Ovariesb | 0.031 | 0.013 | 0.9 | 0.4 |
| Pancreas | 0.038 | 0.016 | 1.1 | 0.5 |
| Red marrowc | 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 |
| Testesd | 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 |
| Uterusb | 0.032 | 0.013 | 1.0 | 0.4 |
| aData are pooled for 8 pediatric patients with somatostatin receptor-positive (SSTR+) tumors, including 4 patients with GEP-NETs. bN = 5 (female patients only). cN = 7 (3 GEP-NET, 4 SSTR+ tumors). Pituitary dosimetry estimates were only performed when pituitary uptake was clearly observed on the planar images. Due to the small size of the pituitary gland, availability for quantification only from planar images and interference from activity in the nasal mucosa, estimates can be associated with a large uncertainty. Pituitary gland absorbed dose estimate includes absorbed dose contributions from activity within the pituitary only, dose contributions from other tissues are not included. dN = 3 (male patients only). eRed marrow dosimetry estimates were determined either using blood radioactivity or by imaging and scaling of a representative region of the lumbar spine. | ||||
| Absorbed dose per unit activity (Gy/GBq)(N = 8a) | Calculated absorbed dose for 4 x 7.4 GBq(29.6 GBq cumulative activity)(Gy) | |||
| Organ | Mean | SD | Mean | SD |
| Adrenals | 0.045 | 0.011 | 1.3 | 0.3 |
| Brain | 0.021 | 0.006 | 0.6 | 0.2 |
| Breastsb | 0.018 | 0.006 | 0.5 | 0.2 |
| Esophagus | 0.024 | 0.006 | 0.7 | 0.2 |
| Eyes | 0.021 | 0.006 | 0.6 | 0.2 |
| Gallbladder wall | 0.031 | 0.011 | 0.9 | 0.3 |
| Heart wall | 0.024 | 0.006 | 0.7 | 0.2 |
| Kidneys | 0.773 | 0.288 | 22.9 | 8.5 |
| Left colon | 0.265 | 0.081 | 7.8 | 2.4 |
| Liver | 0.216 | 0.231 | 6.4 | 6.8 |
| Lungs | 0.024 | 0.006 | 0.7 | 0.2 |
| Osteogenic cells | 0.046 | 0.019 | 1.4 | 0.6 |
| Ovariesb | 0.026 | 0.007 | 0.8 | 0.2 |
| Pancreas | 0.027 | 0.007 | 0.8 | 0.2 |
| Pituitaryc | 1.053 | 0.348 | 31.2 | 10.3 |
| Prostated | 0.026 | 0.006 | 0.8 | 0.2 |
| Rectum | 0.272 | 0.085 | 8.0 | 2.5 |
| Red marrow (blood)e | 0.027 | 0.005 | 0.8 | 0.2 |
| Red marrow (image) e | 0.055 | 0.026 | 1.6 | 0.8 |
| Right colon | 0.152 | 0.045 | 4.5 | 1.3 |
| Salivary glands | 0.036 | 0.017 | 1.1 | 0.5 |
| Small intestine | 0.046 | 0.013 | 1.3 | 0.4 |
| Spleen | 0.733 | 0.304 | 21.7 | 9.0 |
| Stomach wall | 0.027 | 0.007 | 0.8 | 0.2 |
| Testesd | 0.021 | 0.005 | 0.6 | 0.2 |
| Thymus | 0.022 | 0.006 | 0.7 | 0.2 |
| Thyroid | 0.022 | 0.006 | 0.6 | 0.2 |
| Total body | 0.042 | 0.010 | 1.2 | 0.3 |
| Urinary bladder wall | 0.573 | 0.088 | 17.0 | 2.6 |
| Uterusb | 0.031 | 0.008 | 0.9 | 0.2 |
Dosing in liver impairment
Liver a 0.299 0.226 8.9
Liver 0.216 0.231 6.4
Preparation and administration
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Preparation and Administration Preparation Instructions Use aseptic technique and radiation shielding when handling or administering the LUTATHERA solution. Use tongs when handling the vial to minimize radiation exposure. Inspect the product visually under a shielded screen for particulate matter and discoloration prior to administration.
Discard the vial if particulates and/or discoloration are present. Do not inject the LUTATHERA solution directly into any other intravenous solution. Confirm the amount of radioactivity of LUTATHERA delivered to the patient with an appropriate dose calibrator prior to and after each LUTATHERA administration. Dispose of any unused medicinal product or waste material in accordance with local and federal laws.
Administration Instructions Prior to administration, flush the intravenous catheter used for LUTATHERA administration with ≥ 10 mL of 0.9% Sodium Chloride Injection, USP to ensure patency and to minimize the risk of extravasation. Manage cases of extravasation as per institutional guidelines. The gravity method, peristaltic pump method, or the syringe pump method may be used for the administration of the recommended dosage.
Do not administer LUTATHERA as an intravenous bolus. When using the gravity or peristaltic pump method, infuse LUTATHERA directly from its original container. Use the peristaltic pump or syringe pump method when administering a reduced dose of LUTATHERA following a dosage modification for an adverse reaction. When using the gravity method for a reduced dose, adjust the LUTATHERA dose before the administration to avoid the delivery of an incorrect volume of LUTATHERA.
Intravenous Methods of Administration Instructions for the 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% Sodium Chloride Injection, USP (used to transport the LUTATHERA solution 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 the 0.9% Sodium Chloride Injection, USP to flow into the LUTATHERA vial prior to the initiation of the LUTATHERA infusion and do not inject the LUTATHERA solution directly into the 0.9% Sodium Chloride Injection, USP. 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 pre-filled with 0.9% Sodium Chloride Injection, USP and that is used for the LUTATHERA infusion into the patient. Use a clamp or an infusion pump to regulate the flow of the 0.9% Sodium Chloride Injection, USP 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 0.9% Sodium Chloride Injection, USP entering the vial through the short needle will carry the LUTATHERA solution from the vial to the patient via the intravenous 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 0.9% Sodium Chloride Injection, USP 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% Sodium Chloride Injection, USP through the intravenous catheter to the patient.
Instructions for the Peristaltic Pump Method Insert a filtered 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 to the peristaltic pump. Insert a second needle that is 9 cm, 18 gauge (long needle) into the LUTATHERA vial ensuring that the 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% Sodium Chloride Injection, USP 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 pump according to manufacturer’s instructions. Prime 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.
Prime the intravenous catheter that will be connected to the patient by opening the 3-way stopcock valve to the 0.9% Sodium Chloride Injection, USP and pumping the 0.9% Sodium Chloride Injection, USP until it exits the end of the catheter tubing. Connect the primed intravenous catheter to the patient and set the 3-way stopcock valve such that the LUTATHERA solution is in line with the peristaltic pump.
Infuse an appropriate volume of LUTATHERA solution over a 30-40 min period to deliver the desired radioactivity. When the desired LUTATHERA radioactivity has been delivered, stop the peristaltic pump and then change the position of the 3-way stopcock valve so that the peristaltic pump is in line with the 0.9% Sodium Chloride Injection, USP.
Restart the peristaltic pump and infuse an intravenous flush of 25 mL of 0.9% Sodium Chloride Injection, USP through the intravenous catheter to the patient. Instructions for the Syringe Pump Method Withdraw an appropriate volume of LUTATHERA solution to deliver the desired radioactivity by using a disposable syringe fitted with a syringe shield and a disposable sterile needle that is 9 cm, 18 gauge (long needle).
To aid the withdrawal of the solution, a filtered 2.5 cm, 20-gauge needle (short venting needle) can be used to reduce the resistance from the pressurized vial. Ensure that the short needle does not touch the LUTATHERA solution in the vial. Fit the syringe into the shielded pump and include a 3-way stopcock valve between the syringe and an intravenous catheter pre-filled with 0.9% Sodium Chloride Injection, USP and used for LUTATHERA administration to the patient.
Infuse an appropriate volume of LUTATHERA solution over a 30-40 min period to deliver the desired radioactivity. When the desired LUTATHERA radioactivity has been delivered, stop the syringe pump and then change the position of the 3-way stopcock valve to flush the syringe with 25 mL of 0.9% Sodium Chloride Injection, USP.
Restart the syringe pump. After the flush of the syringe has been completed, perform an intravenous flush with 25 mL of 0.9% Sodium Chloride Injection, USP through the intravenous catheter to the patient.
| Item | Specification |
| aequivalent to 14.4 to 20 g L-lysine. bequivalent to 14.9 to 20.7 g L-arginine. | |
| L-lysine HCl | Between 18 and 25 ga |
| L-arginine HCl | Between 18 and 25 gb |
| Volume | 1 to 2 L |
| Osmolality | < 1200 mOsmol/kg |
Drug interactions
Check lutetium oxodotreotide lu-177 against a medication listLabel text (3 paragraphs)
Somatostatin Analogs : Discontinue long-acting analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. ( 2.3 , 7.1 )
7.1 Somatostatin Analogs Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of LUTATHERA. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. Administer short- and long-acting octreotide during LUTATHERA treatment as recommended [see Dosage and Administration ( 2.3 )] .
7.2 Glucocorticoids Glucocorticoids can induce down-regulation of subtype 2 somatostatin receptors (SSTR2). Avoid repeated administration of high doses of glucocorticoids during treatment with LUTATHERA.
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, LUTATHERA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on LUTATHERA use in pregnant women. No animal studies using lutetium Lu 177 dotatate have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from LUTATHERA, can cause fetal harm. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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