Lutathera

Last updated on RxList: 6/11/2020
Lutathera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lutathera?

Lutathera (lutetium Lu 177 dotatate) Injection is a radiolabeled somatostatin analog indicated for the treatment of somatostatin receptor-positive gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

What Are Side Effects of Lutathera?

Common side effects of Lutathera include:

Dosage for Lutathera

The dose of Lutathera is 7.4 GBq (200 mCi) administered every 8 weeks for a total of 4 doses.

What Drugs, Substances, or Supplements Interact with Lutathera?

Lutathera may interact with somatostatin analogs. Tell your doctor all medications and supplements you use.

Lutathera During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Lutathera; it may harm a fetus. Because of the potential risk for serious adverse reactions in breastfed infants, breastfeeding is not recommended while using Lutathera and for 2.5 months after the final dose.

Additional Information

Our Lutathera (lutetium Lu 177 dotatate) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Lutathera Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • little or no urination;
  • flushing (warmth, redness, or tingly feeling);
  • diarrhea;
  • a light-headed feeling, like you might pass out;
  • wheezing, chest tightness, trouble breathing;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, vomiting;
  • high blood sugar;
  • low potassium; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lutathera (Lutetium Lu 177 dotatate Injection )

Lutathera Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling.

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Secondary Myelodysplastic Syndrome and Leukemia [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Neuroendocrine Hormonal Crisis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in Warnings and Precautions reflect exposure to LUTATHERA in 111 patients with advanced, progressive midgut neuroendocrine tumors (NETTER-1). Safety data in Warnings and Precautions were also obtained in an additional 22 patients in a non-randomized pharmacokinetic substudy of NETTER-1 and in a subset of patients (811 of 1214) with advanced somatostatin receptor-positive tumors enrolled in ERASMUS [see WARNINGS AND PRECAUTIONS].

NETTER-1

The safety data of LUTATHERA with octreotide was evaluated in NETTER-1 [see Clinical Studies] Patients with progressive, somatostatin receptor-positive midgut carcinoid tumors to receive LUTATHERA 7.4 GBq (200 mCi) administered every 8 to 16 weeks concurrently with the recommended amino acid solution and with long-acting octreotide (30 mg administered by intramuscular injection within 24 hours of each LUTATHERA dose) (n = 111), or high-dose octreotide (defined as long-acting octreotide 60 mg by intramuscular injection every 4 weeks) (n = 112) [see Clinical Studies]. Among patients receiving LUTATHERA with octreotide, 79% received a cumulative dose > 22.2 GBq (> 600 mCi) and 76% of patients received all four planned doses. Six percent (6%) of patients required a dose reduction and 13% of patients discontinued LUTATHERA. Five patients discontinued LUTATHERA for renal-related events and 4 discontinued for hematological toxicities. The median duration of follow-up was 24 months for patients receiving LUTATHERA with octreotide and 20 months for patients receiving high-dose octreotide.

Table 4 and Table 5 summarize the incidence of adverse reactions and laboratory abnormalities, respectively. The most common Grade 3-4 adverse reactions occurring with a greater frequency among patients receiving LUTATHERA with octreotide compared to patients receiving high-dose octreotide include: lymphopenia (44%), increased GGT (20%), vomiting (7%), nausea and elevated AST (5% each), and increased ALT, hyperglycemia and hypokalemia (4% each).

Table 4. Adverse Reactions Occurring at Higher Incidence in Patients Receiving LUTATHERA and Long-Acting Octreotide Compared to Long-Acting Octreotide (Between Arm Difference of ≥ 5% All Grades or ≥ 2% Grades 3-4)1

Adverse Reaction1LUTATHERA and Long-Acting Octreotide (30 mg)
(N = 111)
Long-Acting Octreotide (60 mg)
(N = 112)
All Grades
%
Grades 3-4
%
All Grades
%
Grades 3-4
%
Gastrointestinal disorders
Nausea655122
Vomiting537100
Abdominal pain263193
Diarrhea263181
Constipation10050
General disorders
Fatigue381262
Peripheral edema16091
Pyrexia8030
Metabolism and nutrition disorders
Decreased appetite210113
Nervous system disorders
Headache17050
Dizziness17080
Dysgeusia8020
Vascular disorders
Flushing14190
Hypertension12272
Musculoskeletal and connective tissue disorders
Back pain132100
Pain in extremity11050
Myalgia5000
Neck Pain5000
Renal and urinary disorders
Renal failure*13341
Radiation-related urinary tract toxicity**8030
Psychiatric disorders
Anxiety12150
Skin and subcutaneous tissue disorders
Alopecia12020
Respiratory, thoracic and mediastinal disorders
Cough11160
Cardiac disorders
Atrial fibrillation5100
1 National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Only displays adverse reactions occurring at a higher incidence in LUTATHERA-treated patients [between arm difference of ≥5% (all grades) or ≥2% (grades 3-4)]
* Includes the terms: Glomerular filtration rate decreased, acute kidney injury, acute prerenal failure, azotemia, renal disorder, renal failure, renal impairment
** Includes the terms: Dysuria, micturition urgency, nocturia, pollakiuria, renal colic, renal pain, urinary tract pain and urinary incontinence

Table 5. Laboratory Abnormalities Occurring at Higher Incidence in Patients Receiving LUTATHERA and Long-Acting Octreotide Compared to Long-Acting Octreotide (Between Arm Difference of ≥ 5% All Grades or ≥ 2% Grades 3-4)*1

Laboratory Abnormality1LUTATHERA and Long-Acting Octreotide (30 mg)
(N = 111)
Long-Acting Octreotide (60 mg)
(N = 112)
All Grades
%
Grades 3-4
%
All Grades
%
Grades 3-4
%
Hematology
Lymphopenia9044395
Anemia810551
Leukopenia552200
Thrombocytopenia531170
Neutropenia263110
Renal/Metabolic
Creatinine increased851730
Hyperglycemia824672
Hyperuricemia346306
Hypocalcemia320140
Hypokalemia264212
Hyperkalemia190110
Hypernatremia17070
Hypoglycemia15080
Hepatic
GGT increased66206716
Alkaline phosphatase increased655559
AST increased505350
ALT increased434340
Blood bilirubin increased302280
*Values are worst grade observed after randomization
1National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Only displays laboratory abnormalities occurring at a higher incidence in LUTATHERA-treated patients [between arm difference of ≥5% (all grades) or ≥2%(grades 3-4)]

ERASMUS

Safety data are available from 1214 patients in ERASMUS, an international, single-institution, single-arm, open-label trial of patients with somatostatin receptor-positive tumors (neuroendocrine and other primaries). Patients received LUTATHERA 7.4 GBq (200 mCi) administered every 6 to 13 weeks with or without octreotide. Retrospective medical record review was conducted on a subset of 811 patients to document serious adverse reactions. Eighty-one (81%) percent of patients in the subset received a cumulative dose ≥ 22.2 GBq (≥ 600 mCi). With a median follow-up time of more than 4 years, the following rates of serious adverse reactions were reported: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%).

Read the entire FDA prescribing information for Lutathera (Lutetium Lu 177 dotatate Injection )

© Lutathera Patient Information is supplied by Cerner Multum, Inc. and Lutathera Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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