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Drug overview for LANREOTIDE ACETATE (lanreotide acetate):
Generic name: LANREOTIDE ACETATE (lan-REE-oh-tide)
Drug class: Somatostatic Agents
Therapeutic class: Endocrine
Lanreotide acetate is a synthetic octapeptide pharmacologically related to somatostatin.
No enhanced Uses information available for this drug.
Generic name: LANREOTIDE ACETATE (lan-REE-oh-tide)
Drug class: Somatostatic Agents
Therapeutic class: Endocrine
Lanreotide acetate is a synthetic octapeptide pharmacologically related to somatostatin.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for LANREOTIDE ACETATE (lanreotide acetate) have been approved by the FDA:
Indications:
Acromegaly
Carcinoid syndrome
Malignant gastroenteropancreatic neuroendocrine tumor
Professional Synonyms:
Acromegalia
Malignant carcinoid syndrome
Malignant neuroendocrine gastroenteropancreatic tumor
Marie's disease
Marie's syndrome
Metastatic carcinoid syndrome
Indications:
Acromegaly
Carcinoid syndrome
Malignant gastroenteropancreatic neuroendocrine tumor
Professional Synonyms:
Acromegalia
Malignant carcinoid syndrome
Malignant neuroendocrine gastroenteropancreatic tumor
Marie's disease
Marie's syndrome
Metastatic carcinoid syndrome
The following dosing information is available for 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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LANREOTIDE 120 MG/0.5 ML SYRNG | Maintenance | Adults inject 0.5 milliliter (120 mg) by subcutaneous route every 4 weeks |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LANREOTIDE 120 MG/0.5 ML SYRNG | Maintenance | Adults inject 0.5 milliliter (120 mg) by subcutaneous route every 4 weeks |
The following drug interaction information is available for LANREOTIDE ACETATE (lanreotide acetate):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Gallium Ga 68 Dotatate; Gallium Ga 68 Dotatoc/Somatostatin analogs 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) |
GALLIUM GA-68 DOTATOC, NETSPOT |
| Lutetium Lu 177 dotatate/Long-Acting Somatostatin Analogs 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) |
LUTATHERA |
| DETECTNET |
There are 0 moderate interactions.
The following contraindication information is available for LANREOTIDE ACETATE (lanreotide acetate):
Drug contraindication overview.
*History of hypersensitivity to lanreotide; angioedema and anaphylaxis have been reported following administration.
*History of hypersensitivity to lanreotide; angioedema and anaphylaxis have been reported following administration.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| 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 |
There are 9 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Biliary calculus |
| Bradycardia |
| Exocrine pancreatic insufficiency |
| Gallbladder disease |
| Hyperglycemia |
| Hypertension |
| Hypoglycemic disorder |
| Hypothyroidism |
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for LANREOTIDE ACETATE (lanreotide acetate):
Adverse reaction overview.
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.
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.
There are 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Biliary calculus Dysglycemia |
Bradycardia Diabetes mellitus Hyperglycemia Hypertension Hypoglycemic disorder |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Cholangitis Cholecystitis Eructation Exocrine pancreatic insufficiency Hypothyroidism Pancreatitis |
There are 21 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anemia Arthralgia Diarrhea Flatulence Injection site sequelae Loose stools Musculoskeletal pain Myalgia Nausea Vomiting Weight loss |
Constipation Depression Dizziness Dyspnea Headache disorder Muscle spasm |
| Rare/Very Rare |
|---|
|
Discolored feces Injection site abscess Steatorrhea |
The following precautions are available for LANREOTIDE ACETATE (lanreotide acetate):
Safety and efficacy not established in children.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
The following prioritized warning is available for LANREOTIDE ACETATE (lanreotide acetate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for LANREOTIDE ACETATE (lanreotide acetate)'s list of indications:
| Acromegaly | |
| E22.0 | Acromegaly and pituitary gigantism |
| Carcinoid syndrome | |
| E34.0 | Carcinoid syndrome |
| E34.00 | Carcinoid syndrome, unspecified |
| E34.01 | Carcinoid heart syndrome |
| E34.09 | Other carcinoid syndrome |
| Malignant gastroenteropancreatic neuroendocrine tumor | |
| C25.4 | Malignant neoplasm of endocrine pancreas |
| C7A.01 | Malignant carcinoid tumors of the small intestine |
| C7A.010 | Malignant carcinoid tumor of the duodenum |
| C7A.011 | Malignant carcinoid tumor of the jejunum |
| C7A.012 | Malignant carcinoid tumor of the ileum |
| C7A.019 | Malignant carcinoid tumor of the small intestine, unspecified portion |
| C7A.02 | Malignant carcinoid tumors of the appendix, large intestine, and rectum |
| C7A.020 | Malignant carcinoid tumor of the appendix |
| C7A.021 | Malignant carcinoid tumor of the cecum |
| C7A.022 | Malignant carcinoid tumor of the ascending colon |
| C7A.023 | Malignant carcinoid tumor of the transverse colon |
| C7A.024 | Malignant carcinoid tumor of the descending colon |
| C7A.025 | Malignant carcinoid tumor of the sigmoid colon |
| C7A.026 | Malignant carcinoid tumor of the rectum |
| C7A.029 | Malignant carcinoid tumor of the large intestine, unspecified portion |
| C7A.092 | Malignant carcinoid tumor of the stomach |
| C7A.094 | Malignant carcinoid tumor of the foregut, unspecified |
| C7A.095 | Malignant carcinoid tumor of the midgut, unspecified |
| C7A.096 | Malignant carcinoid tumor of the hindgut, unspecified |
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