Sandostatin LAR Depot Text

Signs and Symptoms of
Carcinoid Tumors and
Their Related Syndrome

Why carcinoid tumors are difficult
to diagnose

Two types of tumors

Carcinoid tumors can be active or inactive. This means that sometimes a carcinoid tumor will actively release hormones into the body, resulting in symptoms.

Subtle signs and symptoms of carcinoid tumors

The symptoms associated with active carcinoid tumors can be subtle and common to other types of GI disorders like irritable bowel syndrome. These symptoms are often vague and hard to track.^1-3

Signs and Symptoms of Carcinoid Tumors^{1, 2}

Abdominal mass (tumor)

Abdominal pain

Constipation

Diarrhea

Rectal

Gastrointestinal bleeding

Intestinal obstruction (blockage)

Rectal bleeding

*Sandostatin^® LAR Depot is only indicated to treat the severe diarrhea and flushing associated with Carcinoid Syndrome.

Carcinoid tumors can also be very small in size

Some of them can be less than a centimeter in size.¹ Patients with carcinoid tumors can spend several years without receiving an accurate diagnosis. Many of these patients spend this time being treated for a GI disorder like irritable bowel syndrome.²

Active carcinoid tumors can lead to carcinoid syndrome

"Carcinoid syndrome" refers to the set of symptoms that result from active carcinoid tumors, that release excess hormones into the body. The most commonly overproduced hormone of active carcinoid tumors is serotonin. Serotonin is a hormone that regulates mood and sleep and can inhibit the normal function of the stomach. Serotonin is found abundantly in the gastrointestinal system.^{1, 2, 4}

When carcinoid tumors start to spread or metastasize, they can start producing excess hormones that can lead to these sudden and severe symptoms. In many cases, patients are diagnosed after these symptoms start to develop.^4,5

The Symptoms of Carcinoid Syndrome

Carcinoid syndrome can include a set of symptoms that range in severity. Some patients may experience all or just some of these symptoms. Two of the most common symptoms associated with carcinoid syndrome are severe diarrhea and flushing. When flushing occurs, you may turn red and feel warm. Diarrhea and flushing can occur at the same time or you can experience one without the other.^{1, 2, 5, 6}

Symptoms Associated With Diarrhea¹

• Stools are watery
• The diarrhea can be mild to severe
• Episodes can occur several times a day and can interfere with daily life
• Nocturnal diarrhea

Having excessive diarrhea can drain your body of water, causing dehydration and loss of electrolytes or nutrients and minerals. This can affect your digestion, body weight, and nutrition absorption, leaving you feeling weak and tired.⁷

Symptoms Associated With Flushing^{1, 2}

• Flushing may be temporary or continue, and appears suddenly, primarily on the face or neck and may not be associated with sweating
• With flushing, the skin looks deep red or purple
• You may also feel warm, unpleasant, and have a rapid heartbeat
• The flush can last from a few minutes to several hours

Other Symptoms Associated With Carcinoid Syndrome^{1, 2, 6}

• Abdominal pain
• Arthritis
• Cramping
• Cyanosis (bluish skin)
• Heart valvular lesions
• Pellagra (rash)
• Telangiectasia (red blotches)
• Wheezing

*Sandostatin^® LAR Depot is only indicated to treat the severe diarrhea and flushing associated with Carcinoid Syndrome.

Carcinoid syndrome can make it hard for you to feel comfortable, perform day-to-day tasks, or feel like yourself. It is important to always keep your healthcare team informed if you experience any of these symptoms.

Communication Is Key

If you have carcinoid syndrome, it is especially important that all members of your healthcare team be aware of your condition. This includes doctors and nurses who provide primary or specialized care, as well as emergency care.

The symptoms of carcinoid syndrome can range in severity. It is imperative that you inform your healthcare team about any new symptoms you experience, regardless of their severity. You must also inform your team of any changes in existing symptoms, especially if they become more severe.

Inform your healthcare team immediately if you develop intense diarrhea or flushing with abdominal pain.

INDICATIONS AND USAGE

Sandostatin^® LAR Depot (octreotide acetate for injectable suspension) is a prescription medicine indicated for patients in whom initial treatment with immediate release Sandostatin^® (octreotide acetate) Injection has been shown to be effective and tolerated for:

• Long-term maintenance therapy in acromegalic patients who have had 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 GH and IGF-1 levels to normal).
• Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
• Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors

In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined.

IMPORTANT SAFETY INFORMATION

Warnings and precautions: Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor.

Before taking Sandostatin LAR Depot: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.

Common side effects: Most patients experience side effects at some time. Some common side effects you may experience include:

• Acromegaly: diarrhea, gallstones, abdominal pain, and flatulence
• Carcinoid tumors: back pain, fatigue, headache, abdominal pain, nausea, and dizziness

Other information: Patients with carcinoids tumors and VIPomas should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References