Somatuline Depot

Acromegaly

Somatuline Depot is used for the long-term treatment of adults with acromegaly, a hormonal disorder that results from too much growth hormone in the body. It is typically prescribed when other treatments, such as surgery or radiation, have not worked well enough or are not an option for the patient.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

This medication is used to treat a specific type of cancer known as gastroenteropancreatic neuroendocrine tumors. It is indicated for tumors that meet the following criteria:

• They are located in the pancreas or the digestive tract (stomach, intestines, or rectum).
• They are well or moderately differentiated.
• They are locally advanced or metastatic, meaning they cannot be removed by surgery or have spread to other parts of the body.

In these patients, the medication is used to help improve progression-free survival by slowing the growth of the tumors.

Carcinoid Syndrome

Somatuline Depot is also used to treat adults with carcinoid syndrome. In these cases, the medication helps manage the condition by reducing the need for short-acting "rescue" medications that are used to treat symptoms like severe diarrhea and skin flushing.

Hormone Regulation

Somatuline Depot contains the active ingredient lanreotide, which is a synthetic version of a natural hormone called somatostatin. Somatostatin is responsible for regulating several processes in the body, including the release of other hormones.

When injected, the medication binds to specific receptors on cells throughout the body. This action helps to:

• Reduce growth hormone levels: In people with acromegaly, it blocks the pituitary gland from releasing too much growth hormone and insulin-like growth factor-1 (IGF-1).
• Control tumor growth: For certain neuroendocrine tumors (NETs), it interferes with the signals that tell tumor cells to grow and multiply.
• Manage symptoms: It can help reduce symptoms like flushing and diarrhea by preventing the release of hormones that cause these reactions.

Depot Formulation

The "depot" part of the name refers to how the medication is released. After it is injected deep under the skin, the medicine forms a small reservoir that slowly releases lanreotide into the bloodstream over several weeks. This allows for long-lasting effects between doses.

Common Side Effects

• Pain, redness, itching, or a lump at the injection site
• Diarrhea or loose stools
• Stomach pain, nausea, or vomiting
• Gas and bloating
• Constipation
• Headache or dizziness
• Joint or muscle pain
• Hair loss
• Weight loss

Serious Side Effects

• Gallbladder problems, such as gallstones or gallbladder inflammation
• Changes in blood sugar levels (high or low blood sugar)
• Slow heart rate (bradycardia)
• Underactive thyroid (hypothyroidism)
• Severe abdominal pain
• Yellowing of the skin or eyes (jaundice)

Seek immediate medical attention if you experience signs of a severe allergic reaction, such as hives, swelling of the face or throat, or difficulty breathing.

Gallbladder Issues

Treatment with Somatuline Depot is associated with the development of gallstones (cholelithiasis) and related complications, such as gallbladder inflammation or bile duct blockage. Healthcare providers may perform periodic gallbladder ultrasounds to monitor for these conditions.

Blood Sugar Regulation

Lanreotide can interfere with the hormones that regulate blood sugar, leading to both high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Individuals with diabetes should monitor their blood glucose levels closely, as adjustments to insulin or other diabetes medications may be necessary.

Cardiovascular and Endocrine Effects

• Heart Rate: A reduction in heart rate (bradycardia) has been observed in some patients. Caution is generally advised for those with underlying heart conditions.
• Thyroid Function: The medication may suppress thyroid-stimulating hormone, which can lead to decreased thyroid function (hypothyroidism).

Kidney and Liver Considerations

In patients with severe kidney or liver impairment, the medication is cleared from the body more slowly. Healthcare providers typically adjust the starting dose for individuals with these conditions.

Pregnancy and Reproduction

Based on animal studies, Somatuline Depot may cause harm to an unborn baby. It is recommended that individuals who can become pregnant use effective contraception during treatment and for six months after the final dose. The medication may also impact fertility in both males and females.

Pregnancy

There are no adequate and well-controlled studies of Somatuline Depot in pregnant women. Based on findings from animal studies, this medication may cause harm to an unborn baby. In animal research, high doses were associated with increased pregnancy loss and lower fetal body weight. It is currently unknown if the drug increases the risk of birth defects or miscarriage in humans.

If you are pregnant or planning to become pregnant, it is important to discuss the potential risks to the fetus with your doctor before starting or continuing this treatment.

Breastfeeding

It is not known whether Somatuline Depot passes into human breast milk or how it might affect a nursing infant or milk production. Because of the potential for serious side effects in a breastfed child, healthcare providers typically advise that you do not breastfeed during treatment and for 6 months after the final dose.

Fertility

Based on animal studies, Somatuline Depot may reduce fertility in females. If you have concerns about how this medication might affect your ability to have children in the future, talk with your healthcare team.

Available Forms

Somatuline Depot is available as a sterile, extended-release solution for deep subcutaneous injection. It is supplied in the following form:

• Single-dose pre-filled syringe: This delivery system is ready to use and includes an automatic needle guard that covers the needle after the injection is complete.

The medication is designed to be administered by a healthcare professional, although in some cases, patients or caregivers may be trained to give the injection. Because it is a prolonged-release formulation, the active ingredient is released slowly into the body over time.

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Somatuline Depot in 2007 for the treatment of acromegaly. In 2014, the FDA expanded its approval to include certain types of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In 2017, it received further approval for the treatment of carcinoid syndrome.

Approved Uses

Somatuline Depot is currently FDA-approved for the following indications:

• Acromegaly: Long-term treatment for patients who have not responded well to or are unable to undergo surgery or radiation.
• Neuroendocrine Tumors: Treatment of adults with unresectable, well or moderately differentiated, locally advanced or metastatic GEP-NETs to improve the length of time a patient lives without the disease worsening.
• Carcinoid Syndrome: To reduce the frequency of rescue medication use in adults with this condition.

Regulatory Requirements

There are no boxed warnings or Risk Evaluation and Mitigation Strategy (REMS) programs associated with Somatuline Depot. The medication is available only by prescription and is typically administered by a healthcare professional.

Insurance and Coverage

Somatuline Depot is a specialty medication that is typically administered by a healthcare professional in a clinical setting. Because of this, it is often covered under the medical benefit portion of an insurance plan rather than the pharmacy benefit. Out-of-pocket costs, such as copayments or deductibles, vary significantly between private insurance, Medicare, and Medicaid plans.

Financial Assistance Programs

The manufacturer may offer programs to help reduce the cost for eligible patients. These options often include:

• Copay Cards: These may lower out-of-pocket expenses for patients with commercial (private) insurance.
• Patient Assistance Programs: These programs may provide the medication at a reduced cost or for free to individuals who are uninsured or underinsured and meet specific income criteria.

Generic Alternatives

Generic versions of lanreotide may be available, which can offer a lower-cost alternative to the brand-name Somatuline Depot. The availability and price of these generics depend on your pharmacy and specific insurance coverage.

Administration Costs

In addition to the price of the medication itself, there may be costs associated with the healthcare provider's office visit and the professional administration of the injection. It is recommended to contact your insurance provider and your doctor's office to get a complete estimate of the total treatment cost.