Lanreotid Zentiva (Lanreotide)
Somatostatin analogue for acromegaly and neuroendocrine tumors
Lanreotid Zentiva contains lanreotide, a synthetic somatostatin analogue used to treat acromegaly (excess growth hormone) and gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It is given as a deep subcutaneous injection every 28 days and works by inhibiting growth hormone secretion and slowing tumor cell growth. This page provides comprehensive, evidence-based information about its uses, dosage, side effects, and important precautions.
Quick Facts
Key Takeaways
- Lanreotid Zentiva is a long-acting somatostatin analogue that reduces growth hormone and IGF-1 levels in acromegaly and slows tumor growth in neuroendocrine tumors.
- The injection is given every 28 days as a deep subcutaneous injection, usually in the upper outer buttock. Self-injection is possible after proper training.
- Common side effects include gastrointestinal symptoms (diarrhea, abdominal pain) and gallstones, which should be monitored with periodic ultrasound.
- Blood glucose levels may be affected — patients with diabetes require careful monitoring and possible dose adjustments of their antidiabetic medications.
- The pre-filled syringe must be stored refrigerated (2–8°C) and should be brought to room temperature before injection for patient comfort.
What Is Lanreotid Zentiva and What Is It Used For?
Lanreotid Zentiva contains the active substance lanreotide, a synthetic octapeptide that closely resembles the naturally occurring hormone somatostatin. Somatostatin is produced in several organs throughout the body, including the hypothalamus, gastrointestinal tract, and pancreas. It plays a critical role in regulating the release of several hormones, particularly growth hormone (GH) from the pituitary gland, as well as insulin, glucagon, and various gastrointestinal hormones.
As a somatostatin analogue, lanreotide binds primarily to somatostatin receptor subtypes 2 (SSTR2) and 5 (SSTR5), which are the predominant receptor subtypes found on both pituitary somatotroph adenomas (the tumors that cause acromegaly) and neuroendocrine tumor cells. This receptor binding triggers a cascade of intracellular events that suppress hormone secretion and, importantly, exert antiproliferative effects that can slow or halt tumor growth.
Acromegaly
Acromegaly is a chronic hormonal disorder caused by excessive production of growth hormone (GH), almost always by a benign pituitary adenoma. Left untreated, acromegaly leads to enlarged hands and feet, coarsened facial features, joint pain, and serious systemic complications including cardiovascular disease, diabetes mellitus, and increased mortality. Lanreotid Zentiva is indicated for the long-term treatment of acromegaly when surgery has not been curative or is not possible, and in patients who have not responded adequately to radiotherapy. Clinical trials have demonstrated that lanreotide effectively normalizes GH and insulin-like growth factor 1 (IGF-1) levels in approximately 50–70% of patients, with significant improvement in symptoms and quality of life.
Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Neuroendocrine tumors (NETs) arise from neuroendocrine cells found throughout the body, most commonly in the gastrointestinal tract and pancreas. These tumors may be functioning (secreting hormones that cause clinical syndromes) or non-functioning. Lanreotid Zentiva is approved for the treatment of grade 1 and a subset of grade 2 (Ki-67 index up to 10%) unresectable, locally advanced, or metastatic GEP-NETs. The landmark CLARINET trial (Caplin et al., 2014) demonstrated that lanreotide 120 mg every 28 days significantly prolonged progression-free survival compared to placebo (median not reached vs. 18 months; hazard ratio 0.47), establishing lanreotide as a first-line antiproliferative therapy for these tumors.
Carcinoid Syndrome
In patients with functioning neuroendocrine tumors, somatostatin analogues including lanreotide are used to control symptoms of carcinoid syndrome, particularly debilitating flushing and diarrhea caused by excessive serotonin secretion. By inhibiting the release of serotonin and other vasoactive peptides, lanreotide can substantially improve quality of life in these patients. While symptom control is achieved in approximately 60–80% of patients, the antiproliferative benefit provides an additional rationale for treatment.
What Should You Know Before Taking Lanreotid Zentiva?
Contraindications
Lanreotid Zentiva must not be used if you have a known hypersensitivity to lanreotide, to other somatostatin analogues (such as octreotide), or to any of the excipients in the formulation. Allergic reactions, though rare, can range from mild skin reactions to severe anaphylaxis. If you have experienced a previous allergic reaction to any somatostatin analogue, this must be communicated to your prescribing physician before treatment begins.
Warnings and Precautions
Several important precautions apply to the use of lanreotide:
- Gallbladder complications: Somatostatin analogues reduce gallbladder motility and increase the risk of gallstone formation (cholelithiasis). Gallstones develop in approximately 10–20% of patients during long-term treatment. Periodic ultrasound monitoring of the gallbladder is recommended, typically every 6–12 months. Complications such as cholecystitis (inflammation of the gallbladder), cholangitis, or pancreatitis may occur.
- Blood glucose changes: Lanreotide inhibits both insulin and glucagon secretion. Patients with diabetes mellitus may experience changes in blood glucose levels, requiring adjustment of insulin or oral antidiabetic medication doses. Regular glucose monitoring is essential, particularly at the start of treatment or when the dose is changed.
- Thyroid function: Lanreotide may decrease thyroid-stimulating hormone (TSH) levels and potentially affect thyroid function. Thyroid function tests should be monitored periodically, especially in patients with pre-existing thyroid conditions.
- Cardiac effects: Somatostatin analogues may reduce heart rate (bradycardia). Caution is required in patients with underlying cardiac conditions, particularly those taking medications that also reduce heart rate (beta-blockers, calcium channel blockers). An ECG may be advisable before starting treatment.
Pregnancy and Breastfeeding
There are limited data on the use of lanreotide during pregnancy. Animal studies have not shown direct harmful effects on fertility or fetal development at clinically relevant doses; however, as a precautionary measure, lanreotide should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment.
It is not known whether lanreotide is excreted in human breast milk. Because many peptides are excreted in breast milk and because of the potential for adverse effects in the nursing infant, a decision must be made whether to discontinue breastfeeding or to discontinue lanreotide therapy, taking into account the importance of the drug to the mother. Patients should discuss this with their physician.
Elderly Patients
No specific dose adjustment is required for elderly patients. However, elderly patients may have age-related reductions in hepatic and renal function, and a greater prevalence of cardiac and biliary conditions, warranting closer monitoring during therapy. Clinical studies have included patients up to 80 years of age with comparable efficacy and safety profiles to younger adults.
Children and Adolescents
The safety and efficacy of lanreotide in children and adolescents under 18 years of age have not been established. No pediatric indication is currently approved, and the use of lanreotide in this age group is not recommended outside of specialized clinical settings.
How Does Lanreotid Zentiva Interact with Other Drugs?
Drug interactions with lanreotide are primarily related to its pharmacological effects on gastrointestinal motility, hormone secretion, and cardiac conduction. Because lanreotide suppresses various gastrointestinal hormones and reduces gallbladder motility, it can alter the absorption and effectiveness of concomitantly administered medications. Healthcare providers should review the full medication list before initiating lanreotide therapy and monitor for potential interactions throughout treatment.
| Interacting Drug | Effect | Clinical Significance | Recommendation |
|---|---|---|---|
| Insulin & oral antidiabetics | Altered blood glucose regulation due to inhibition of insulin and glucagon secretion | Major | Monitor blood glucose closely; adjust antidiabetic doses as needed |
| Ciclosporin | Decreased intestinal absorption of ciclosporin, leading to reduced blood levels | Major | Monitor ciclosporin trough levels and adjust dose accordingly |
| Bromocriptine | Increased oral bioavailability of bromocriptine | Moderate | Monitor for bromocriptine side effects; dose reduction may be needed |
| Beta-blockers | Additive bradycardic effect; risk of clinically significant heart rate reduction | Moderate | Monitor heart rate; consider ECG monitoring at initiation |
| QT-prolonging drugs | Potential additive effect on QT interval prolongation | Moderate | ECG monitoring recommended; avoid combination if possible |
| Calcium channel blockers | Additive heart rate-lowering effect | Moderate | Monitor heart rate and blood pressure regularly |
Major Interactions
The most clinically significant interactions involve insulin and oral antidiabetic medications. Since lanreotide affects both insulin and glucagon secretion, blood glucose levels can become unpredictable, particularly in patients with pre-existing diabetes mellitus. Hyperglycemia is more common, but hypoglycemia can also occur. Frequent blood glucose monitoring is mandatory when starting, adjusting, or discontinuing lanreotide in diabetic patients.
Ciclosporin absorption is reduced because lanreotide decreases gastrointestinal motility, which can lead to subtherapeutic blood levels of ciclosporin in transplant patients. This is a potentially serious interaction that requires close monitoring of ciclosporin trough levels and appropriate dose adjustments to prevent graft rejection.
Minor Interactions
Lanreotide may alter the absorption of other orally administered medications due to its effects on gastrointestinal motility and gastric acid secretion. Drugs with narrow therapeutic indices that are absorbed primarily in the upper gastrointestinal tract should be monitored more carefully. Additionally, because lanreotide can suppress thyroid-stimulating hormone (TSH), patients on thyroid replacement therapy should have their thyroid function monitored periodically to ensure adequate dosing of levothyroxine.
What Is the Correct Dosage of Lanreotid Zentiva?
Lanreotid Zentiva is available as a pre-filled syringe containing a supersaturated solution of lanreotide that forms a slow-release depot upon injection. The injection is administered by deep subcutaneous injection into the upper outer quadrant of the buttock. The depot formulation provides sustained therapeutic lanreotide levels over the entire 28-day dosing interval, eliminating the need for daily injections. After appropriate training by a healthcare professional, patients or their caregivers may self-administer the injection at home.
Adults
Acromegaly
The recommended starting dose is 60 mg or 90 mg every 28 days. The dose is then adjusted based on GH and IGF-1 levels, measured after at least 3 months of treatment at the same dose. The target is normalization of GH (<2.5 ng/mL) and age- and sex-adjusted IGF-1 levels. If GH levels remain elevated, the dose may be increased to a maximum of 120 mg every 28 days. If GH levels are well controlled and symptoms have resolved, the dose may be reduced to 60 mg every 28 days. In some patients with well-controlled disease, the injection interval may be extended to every 42–56 days.
Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
The recommended dose is 120 mg every 28 days. This is based on the CLARINET trial, which used only the 120 mg dose and demonstrated significant antiproliferative benefit. Treatment should be continued as long as there is clinical benefit (stable disease or tumor response) and the treatment is tolerated. Disease progression should be evaluated periodically with imaging.
Carcinoid Syndrome
For symptom control in patients with carcinoid syndrome, the dose is individualized starting at 60–120 mg every 28 days, adjusted based on symptom response. Higher doses (120 mg) and shorter intervals may be considered in patients with breakthrough symptoms, though intervals shorter than 21 days are not recommended.
| Indication | Starting Dose | Maintenance Dose | Interval |
|---|---|---|---|
| Acromegaly | 60–90 mg | 60–120 mg (based on GH/IGF-1) | Every 28 days |
| GEP-NETs | 120 mg | 120 mg | Every 28 days |
| Carcinoid syndrome | 60–120 mg | 60–120 mg (symptom-based) | Every 28 days |
Children
Lanreotid Zentiva is not approved for use in children and adolescents under 18 years of age. Safety and efficacy data in pediatric populations are insufficient, and no pediatric dosing recommendations can be made. If there is a clinical need in exceptional circumstances (such as pediatric neuroendocrine tumors), treatment should only be initiated and supervised by an experienced pediatric endocrinologist or oncologist in a specialized center.
Elderly
No dose adjustment is required based on age alone. Elderly patients should be monitored more frequently for gallbladder complications, cardiac effects (bradycardia), and blood glucose changes, given the higher prevalence of comorbidities in this population. Renal and hepatic function should be assessed before starting treatment, as these can affect drug clearance.
Renal and Hepatic Impairment
No dose adjustment is required for patients with mild to moderate renal or hepatic impairment. However, patients with severe renal or hepatic impairment should be monitored closely, as the pharmacokinetics of lanreotide may be altered. Dose reductions may be considered on a case-by-case basis if adverse effects are significant.
Missed Dose
If an injection is missed, it should be administered as soon as possible. The next injection should then be given 28 days after the missed dose was administered. Do not double the dose to compensate for a missed injection. If the delay is longer than two weeks, consult your physician before administering the next dose, as the treatment schedule may need to be reassessed.
Overdose
There is limited experience with overdose of lanreotide in clinical settings. Based on its pharmacological profile, overdose symptoms may include severe gastrointestinal effects (diarrhea, abdominal cramping, nausea), marked bradycardia, flushing, and hypoglycemia. Treatment is supportive and symptomatic — there is no specific antidote. If accidental overdose is suspected, monitor cardiac function, blood glucose, and gastrointestinal symptoms, and provide appropriate medical care. Because lanreotide has a long half-life and depot formulation, effects may persist for several weeks.
What Are the Side Effects of Lanreotid Zentiva?
Like all medicines, Lanreotid Zentiva can cause side effects, although not everyone experiences them. The majority of adverse effects are related to the pharmacological action of the drug — specifically, its inhibition of gastrointestinal hormones and effects on gallbladder motility. Most side effects are mild to moderate in severity and tend to improve with continued use as the body adjusts to the medication. The following side effects have been reported in clinical trials and post-marketing surveillance, classified by frequency.
Very Common
- Diarrhea (reported in up to 37% of patients in clinical trials)
- Abdominal pain or discomfort
- Gallstones (cholelithiasis) — often asymptomatic, detected on routine ultrasound
Common
- Nausea and vomiting
- Flatulence and abdominal bloating
- Injection site reactions (pain, redness, induration, nodule at injection site)
- Steatorrhea (fatty stools)
- Headache and dizziness
- Fatigue and asthenia
- Hyperglycemia
- Weight loss or weight gain
- Loose stools or constipation
Uncommon
- Bradycardia (slow heart rate)
- Hypoglycemia
- Cholecystitis (gallbladder inflammation)
- Gallbladder dilatation
- Biliary sludge
- Pancreatitis
- Elevated liver enzymes (ALT, AST, bilirubin)
- Hypothyroidism
- Alopecia (hair loss)
- Skin rash or pruritus
Rare
- Severe allergic reactions (anaphylaxis, angioedema)
- Severe pancreatitis
- Intestinal obstruction
- QT prolongation on ECG
Contact your doctor immediately if you experience severe abdominal pain (which could indicate pancreatitis or gallbladder complications), significant changes in heart rate, symptoms of an allergic reaction (rash, swelling, difficulty breathing), or persistent severe diarrhea causing dehydration. Seek emergency medical attention if you experience signs of severe anaphylaxis.
It is worth noting that gastrointestinal side effects are typically most pronounced during the first few months of treatment and tend to decrease in both frequency and severity with continued therapy. Gallstone formation is a particular concern with long-term use, occurring in 10–20% of patients. However, most gallstones remain asymptomatic and are detected incidentally during routine monitoring. In some cases, complications such as cholecystitis may develop, potentially requiring cholecystectomy (surgical removal of the gallbladder). Prophylactic ursodeoxycholic acid may be considered in patients with a history of gallbladder disease, though this is not routinely recommended for all patients.
Injection site reactions are generally mild and localized, consisting of transient pain, redness, or a small nodule at the injection site. Proper injection technique — including ensuring the syringe is at room temperature before injection and using the correct depth of subcutaneous injection — can help minimize these reactions.
How Should You Store Lanreotid Zentiva?
Proper storage of Lanreotid Zentiva is essential to maintain the integrity and efficacy of the medication. The pre-filled syringe contains a supersaturated solution that forms a gel depot upon injection. If stored incorrectly, the formulation may be compromised, potentially affecting drug release and therapeutic effect.
- Temperature: Store in a refrigerator at 2–8°C. Do not freeze the product. Freezing may damage the syringe and alter the formulation.
- Light protection: Keep the pre-filled syringe in its original packaging (sealed pouch) to protect from light until ready for use.
- Room temperature allowance: The syringe may be kept at room temperature (up to 25°C) for a single period of up to 24 hours before injection. This allows patients to bring the syringe to a comfortable temperature for injection. Once removed from refrigeration for this purpose, the product should not be returned to the refrigerator.
- Before injection: Remove the syringe from the refrigerator approximately 30 minutes before injection to allow it to reach room temperature. Injecting cold solution can increase injection site pain.
- Shelf life: Do not use the product after the expiry date stated on the package. The expiry date refers to the last day of that month.
- Disposal: Do not dispose of used syringes in household waste. Return them to a pharmacy or use a sharps disposal container as directed by local regulations.
What Does Lanreotid Zentiva Contain?
Lanreotid Zentiva is formulated as a supersaturated aqueous solution of lanreotide acetate in a pre-filled syringe with an automatic needle safety system. The formulation is designed to form a slow-release depot upon deep subcutaneous injection, ensuring sustained drug release over the 28-day dosing interval.
Active Ingredient
The active ingredient is lanreotide, present as lanreotide acetate. Lanreotide is a synthetic cyclic octapeptide analogue of the natural hormone somatostatin. Its molecular formula is C54H69N11O10S2 (as the free base), and it has a molecular weight of approximately 1,096 g/mol. The peptide is synthesized using solid-phase peptide synthesis and purified to pharmaceutical grade. Available strengths are:
- 60 mg: Each 0.3 mL pre-filled syringe contains lanreotide acetate equivalent to 60 mg of lanreotide.
- 90 mg: Each 0.3 mL pre-filled syringe contains lanreotide acetate equivalent to 90 mg of lanreotide.
- 120 mg: Each 0.5 mL pre-filled syringe contains lanreotide acetate equivalent to 120 mg of lanreotide.
Excipients
The excipients used in the formulation are:
- Water for injections — the solvent
- Glacial acetic acid — used for pH adjustment to ensure stability and optimal depot formation
The formulation does not contain preservatives, antimicrobial agents, or latex. The pre-filled syringe includes an automatic needle safety system to help prevent needlestick injuries after use. The needle cover of the syringe may contain natural rubber latex derivatives; patients with known latex allergies should inform their healthcare provider.
Physical Appearance
Lanreotid Zentiva is a white to slightly yellow, semi-solid preparation. Upon visual inspection before use, the syringe should be checked for any particles or discoloration. Do not use the product if the seal of the pouch has been broken, if the solution appears cloudy, or if visible particles are observed.
Frequently Asked Questions
Lanreotid Zentiva is a somatostatin analogue used to treat acromegaly (when surgery or radiation therapy has not been adequate), gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and the symptoms of carcinoid syndrome. It works by inhibiting excessive growth hormone secretion and has antiproliferative effects that can slow tumor growth.
Lanreotid Zentiva is given as a deep subcutaneous injection, typically into the upper outer quadrant of the buttock. The injection is administered once every 28 days using a pre-filled syringe. After proper training by a healthcare professional, patients or their caregivers may self-inject at home. It is important to allow the syringe to reach room temperature (approximately 30 minutes out of the refrigerator) before injection to reduce discomfort.
The most common side effects include diarrhea, abdominal pain, gallstones (cholelithiasis), injection site reactions, nausea, and flatulence. Gallstones develop in approximately 10–20% of patients during long-term treatment but are often asymptomatic. Most gastrointestinal side effects tend to improve over time. Contact your doctor if you experience severe or persistent symptoms.
Yes. Lanreotide can affect blood glucose regulation because somatostatin analogues inhibit both insulin and glucagon secretion. This may lead to hyperglycemia (more common) or, less frequently, hypoglycemia. Patients with diabetes may need adjustment of their insulin or oral antidiabetic medication. Regular blood glucose monitoring is recommended, especially when starting treatment or changing the dose.
Store Lanreotid Zentiva in a refrigerator at 2–8°C in its original sealed pouch to protect from light. Do not freeze. The syringe may be kept at room temperature (up to 25°C) for up to 24 hours before injection. Remove from the refrigerator approximately 30 minutes before use to allow it to reach room temperature, which reduces injection site discomfort.
Lanreotid Zentiva and Somatuline Autogel both contain the same active ingredient (lanreotide) in the same formulation and strengths. Lanreotid Zentiva is a generic or biosimilar equivalent approved by the European Medicines Agency. They are considered therapeutically equivalent and can be used interchangeably under medical supervision, though patients should always follow their prescribing physician’s guidance regarding any product switch.
References
- European Medicines Agency (EMA). Lanreotide-containing products — Summary of Product Characteristics. Available at: ema.europa.eu. Accessed January 2026.
- Caplin ME, Pavel M, Ćwikła JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors (CLARINET): a randomised, double-blind, placebo-controlled trial. N Engl J Med. 2014;371(3):224-233. doi:10.1056/NEJMoa1316158
- Melmed S, Bronstein MD, Chanson P, et al. A Consensus Statement on acromegaly therapeutic outcomes. Nat Rev Endocrinol. 2018;14(9):552-561.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Neuroendocrine and Adrenal Tumors. Version 2.2025.
- Pavel M, Öberg K, Falconi M, et al. Gastroenteropancreatic neuroendocrine neoplasms: ESMO Clinical Practice Guidelines. Ann Oncol. 2020;31(7):844-860.
- Caron PJ, Bevan JS, Petersenn S, et al. Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial. J Clin Endocrinol Metab. 2014;99(4):1282-1290.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd list, 2023.
- Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951.
About the Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialists in endocrinology, oncology, pharmacology, and clinical medicine. Our content follows the GRADE evidence framework and is based on peer-reviewed research, international clinical guidelines (EMA, FDA, NCCN, Endocrine Society), and established medical standards.
Every article undergoes a rigorous multi-step review: initial research by medical writers, clinical accuracy verification by specialist physicians, editorial review for clarity and accessibility, and final approval by the Medical Review Board.
We prioritize Level 1A evidence from systematic reviews and randomized controlled trials. All medical claims are referenced to peer-reviewed sources. No commercial funding influences our content.
Last medically reviewed: | Published: | Read our editorial standards