Drugplain

Lanreotide Acetate 90 mg/.3mL

lanreotide acetate · INJECTION · Cipla USA Inc.

No Recall History
Plain English

Lanreotide Acetate is a injection containing lanreotide acetate at 90 mg/.3mL, taken subcutaneous. Manufactured by Cipla USA Inc..

Key Facts

Brand Name
Lanreotide Acetate
Generic Name
lanreotide acetate
NDC Code (Product)
69097-890
Manufacturer
Cipla USA Inc.
Strength
90 mg/.3mL
Dosage Form
INJECTION
Route
SUBCUTANEOUS
Marketing Status
Application #
NDA215395
Marketing Start
12/24/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Lanreotide Injection is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly Lanreotide Injection is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal. 1.2 Gastroenteropancreatic Neuroendocrine Tumors Lanreotide Injection is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): For deep subcutaneous injection only. Intended for administration by a healthcare provider. Administer in the superior external quadrant of the buttock. Alternate injection sites. Recommended Dosage ( 2.1 ) Acromegaly : 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen. GEP-NETs : 120 mg every 4 weeks. Carcinoid Syndrome : 120 mg every 4 weeks. If patients are already being treated with Lanreotide Injection for GEP-NET, do not administer an additional dose for carcinoid syndrome. Dosage Adjustment : See full prescribing information for dosage adjustment in patients with acromegaly and renal or hepatic impairment. ( 2.2 , 2.3 ) 2.1 Recommended Dosage Acromegaly The recommended starting dosage of Lanreotide Injection is 90 mg given via the deep subcutaneous route, at 4-week intervals for 3 months. After 3 months, the Lanreotide injection dosage may be adjusted as follows: GH greater than 1 ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain dosage at 90 mg every 4 weeks. GH greater than 2.5 ng/mL, …

Contraindications

4 CONTRAINDICATIONS Lanreotide Injection is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [ see Adverse Reactions ( 6.3 )] . Hypersensitivity to lanreotide. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Cyclosporine : Lanreotide Injection may decrease the absorption of cyclosporine. Dosage adjustment of cyclosporine may be needed. ( 7.2 ) Bromocriptine : Lanreotide Injection may increase the absorption of bromocriptine. ( 7.3 ) Bradycardia-Inducing Drugs (e.g., beta-blockers) : Lanreotide Injection may decrease heart rate. Dosage adjustment of the coadministered drug may be necessary. ( 7.3 ) 7.1 Insulin and Oral Hypoglycemic Drugs Lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Therefore, blood glucose levels should be monitored when Lanreotide Injection treatment is initiated or when the dose is altered, and antidiabetic treatment should be adjusted accordingly [see Warnings and Precautions ( 5.2 )] . 7.2 Cyclosporine Concomitant administration of cyclosporine with Lanreotide Injection may decrease the absorption of cyclosporine, and therefore, may necessitate adjustment of cyclosporine dose to maintain therapeutic drug concentrations. [see Clinical Pharmacology ( 12.3 )] 7.3 Bromocriptine Limited published data indicate that concomitant administration of a somatostatin analog and bromocriptine may…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are: Acromegaly : (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions. ( 6.1 ) GEP-NET : (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. ( 6.1 ) Carcinoid Syndrome : (≥5% and at least 5% greater than placebo): headache, dizziness and muscle spasm. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. Inc. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials …

Frequently Asked Questions

What is Lanreotide Acetate used for?

Lanreotide Acetate contains lanreotide acetate. It is a injection taken subcutaneous. Consult your doctor for specific uses.

Is Lanreotide Acetate a controlled substance?

Lanreotide Acetate is not classified as a controlled substance by the DEA.

What is the generic name for Lanreotide Acetate?

The generic name for Lanreotide Acetate is lanreotide acetate. There are 9 other brand versions of lanreotide acetate.

What is the NDC code for Lanreotide Acetate 90 mg/.3mL?

The NDC (National Drug Code) for Lanreotide Acetate 90 mg/.3mL is 69097-890, listed by Cipla USA Inc..

Product NDC

69097-890

Package NDC

69097-890-67

Other Lanreotide Brands

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