Lanreotide Acetate (lanreotide acetate)

Dosage of lanreotide acetate is expressed in terms of lanreotide.

Lanreotide acetate is administered by deep subcutaneous injection only by a healthcare provider.

The drug is commercially available as a prefilled syringe for subcutaneous injection.

Lanreotide acetate prefilled syringes must be refrigerated at 2-8degreesC and stored in the original carton to protect the drug from light; the product should not be frozen. Prior to administration, the prefilled syringe (in the sealed pouch) should be allowed to reach room temperature for about 30 minutes; the pouch should remain sealed until just prior to injection. Lanreotide in the sealed pouch, left at room temperature (not to exceed 40degreesC) for up to 72 hours, may be returned to the refrigerator for continued storage and later use.

The drug should be inspected visually for particulate matter and discoloration prior to administration. The solution should be gel-like, and white to pale yellow in color, but may have small air bubbles; the drug should be discarded if the solution contains visible particles or is discolored.

Subcutaneous injection of lanreotide acetate should be administered slowly for 20 seconds into the superior external quadrant of the buttock; injection sites should be alternated every 4 weeks between the right and left buttock. Injections should not be made into moles, scars, or areas where the skin is red or hard. The needle should be inserted rapidly to its full length at an angle perpendicular to the skin; the skin should not be pinched prior to administration.

Lanreotide acetate prefilled syringes are intended for single-use only and should be discarded after use.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Long-Acting Somatostatin Analogs/Copper Cu 64 Dotatate

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Both somatostatin analogs and copper Cu 64 dotatate bind to the same somatostatin receptors (SSTR2), resulting in competitive inhibition.(1)

CLINICAL EFFECTS: Concurrent use of copper Cu 64 dotatate and somatostatin analogs may affect the results of the scan.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: In patients receiving somatostatin analogs, perform the image just prior to dosing with long-acting somatostatin analogs. For patients on long-acting somatostatin analogs, a washout period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging.(1)

DISCUSSION: Both somatostatin analogs and copper Cu 64 dotatate bind to the same somatostatin receptors (SSTR2), resulting in competitive inhibition, which can affect the results of the scan.(1)

Long-Acting Somatostatin Analogs/Lutetium Lu 177 Dotatate

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Somatostatin and somatostatin analogs bind to somatostatin receptors and may interfere with the efficacy of lutetium lu 177 dotatate.(1)

CLINICAL EFFECTS: Concurrent administration of lutetium lu 177 dotatate and somatostatin analogs may decrease the efficacy of lutetium lu 177 dotatate.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of lutetium lu 177 dotatate recommends the following: - Before initiating lutetium lu 177 dotatate, discontinue long-acting somatostatin analogs for at least 4 weeks prior to initiation. Administer short-acting somatostatin analogs as needed; discontinue at least 24 hours prior to initiation of lutetium lu 177 dotatate. - During lutetium lu 177 dotatate treatment, administer long-acting octreotide 30 mg intramuscularly between 4 and 24 hours after each lutetium lu 177 dotatate dose. Do not administer long-acting octreotide within 4 weeks of each subsequent lutetium lu 177 dotatate dose. Short-acting octreotide may be given for symptomatic management during lutetium lu 177 dotatate treatment, but must be withheld for at least 24 hours before each lutetium lu 177 dotatate dose. - Following lutetium lu 177 dotatate treatment, continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing lutetium lu 177 dotatate until disease progression or for up to 18 months following treatment initiation.(1)

DISCUSSION: Somatostatin and somatostatin analogs bind to somatostatin receptors and may interfere with the efficacy of lutetium lu 177 dotatate.(1)

Somatostatin Analogs/Gallium Ga 68 Dotatate; Ga 68 Dotatoc

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Both somatostatin analogs and gallium Ga 68 dotatate/ gallium Ga 68 dotatoc bind to the same somatostatin receptors, resulting in competitive inhibition.(1)

CLINICAL EFFECTS: Concurrent use of gallium Ga 68 dotatate/ gallium Ga 68 dotatoc and somatostatin analogs may affect the results of the scan.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: In patients receiving somatostatin analogs, perform the image just prior to dosing with long-acting somatostatin analogs. Short acting somatostatin analogs can be used up to 24 hours before imaging with gallium Ga 68 dotatate or gallium Ga 68 dotatoc. (1)

DISCUSSION: Both somatostatin analogs and gallium Ga 68 dotatate/ gallium Ga 68 dotatoc bind to the same somatostatin receptors, resulting in competitive inhibition, which can affect the results of the scan.(1)

There are no moderate interactions for this drug.

*History of hypersensitivity to lanreotide; angioedema and anaphylaxis have been reported following administration.

• Lactation

• Child-pugh class B hepatic impairment
• Child-pugh class C hepatic impairment
• Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
• Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Disease of liver

• Biliary calculus
• Bradycardia
• Exocrine pancreatic insufficiency
• Gallbladder disease
• Hyperglycemia
• Hypertension
• Hypoglycemic disorder
• Hypothyroidism
• Kidney disease with likely reduction in glomerular filtration rate (GFr)

Adverse effects reported in >5% of patients receiving lanreotide for acromegaly include diarrhea, abdominal pain, nausea, and injection site reactions.

Adverse effects reported in >10% of patients receiving lanreotide for GEP-NET include abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.

Adverse effects reported in >=5% of patients and at least 5% greater than placebo in those receiving lanreotide for carcinoid syndrome include headache, dizziness, and muscle spasm.

More Frequent

• Biliary calculus
• Dysglycemia

Less Frequent

• Bradycardia
• Diabetes mellitus
• Hyperglycemia
• Hypertension
• Hypoglycemic disorder

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Cholangitis
• Cholecystitis
• Eructation
• Exocrine pancreatic insufficiency
• Hypothyroidism
• Pancreatitis

More Frequent

• Acute abdominal pain
• Anemia
• Arthralgia
• Diarrhea
• Flatulence
• Injection site sequelae
• Loose stools
• Musculoskeletal pain
• Myalgia
• Nausea
• Vomiting
• Weight loss

Less Frequent

• Constipation
• Depression
• Dizziness
• Dyspnea
• Headache disorder
• Muscle spasm

Rare or Very Rare

• Discolored feces
• Injection site abscess
• Steatorrhea

No enhanced messaging available.

Safety and efficacy not established in children.

There are no adequate and well-controlled studies using lanreotide in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

In animal studies, embryofetal toxicity (decreased embryofetal survival, fetal skeletal/soft tissue abnormalities) was observed in rats and rabbits receiving lanreotide in dosages resulting in exposures 5- and 2- times the systemic exposures, respectively, achieved in humans at the maximum recommended human dose.

It is not known whether lanreotide is distributed into human milk, affects milk production, or has any effects on breast-fed infants.

Because of the potential for serious adverse reactions (e.g., glucose metabolism, bradycardia) to lanreotide in breast-fed infants, women should be advised not to breast-feed while receiving the drug and for 6 months after the last dose.

Dosage in geriatric patients should be selected with caution (usually at the low end of the dosage range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Although no overall differences in safety or efficacy were observed between geriatric and younger patients with acromegaly receiving lanreotide, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.

There were an insufficient number of patients >=65 years of age with neuroendocrine tumors to determine whether they respond differently from younger patients.