Bynfezia is a prescription medicine that contains octreotide, a man-made protein that is similar to a hormone in the body called somatostatin. Octreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.

Bynfezia is used to reduce the amount of growth hormone and insulin like growth factor 1 in adult patients with acromegaly.

Bynfezia is also used to treat flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIPomas).

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Bynfezia if you are allergic to octreotide.

To make sure Bynfezia is safe for you, tell your doctor if you have ever had:

• diabetes;
• gallbladder disease;
• heart disease, high blood pressure, or heart rhythm disorder;
• thyroid problems;
• pancreatitis;
• liver disease; or
• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

Octreotide can affect certain hormones that may make it easier for you to get pregnant, even if you were unable to get pregnant before. Talk to your doctor about using birth control to avoid unwanted pregnancy.

Bynfezia is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Bynfezia is used to give an injection under the skin. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

You will need frequent medical tests.

Store unused Bynfezia in the original carton in the refrigerator. Protect from light. Do not freeze, and throw the Bynfezia pen away if it has been frozen.

Once you begin using your Bynfezia pen, you may store it at room temperature for up to 28 days. 

Throw the Bynfezia pen away 28 days after your first use, even if there is still medicine left inside.

Use a needle only once and then place it in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You should not use Bynfezia if you are allergic to octreotide.

To make sure Bynfezia is safe for you, tell your doctor if you have ever had:

• diabetes;
• gallbladder disease;
• heart disease, high blood pressure, or heart rhythm disorder;
• thyroid problems;
• pancreatitis;
• liver disease; or
• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

Octreotide can affect certain hormones that may make it easier for you to get pregnant, even if you were unable to get pregnant before. Talk to your doctor about using birth control to avoid unwanted pregnancy.

Bynfezia is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe upper stomach pain, diarrhea, weight loss, warmth or tingling, numbness or cold feeling, unexplained muscle pain, weakness, weak pulse, fainting, or slow breathing (breathing may stop).

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe constipation;
• slow or uneven heartbeats;
• signs of gallstones--fever, chills, nausea, vomiting, severe pain in your upper stomach spreading to your back, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• underactive thyroid--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain.

Common Bynfezia side effects may include:

• gallstones;
• nausea, vomiting, diarrhea, stomach pain, gas;
• headache, back pain; muscle spasm; or
• dizziness, tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• bromocriptine (Cycloset, Parlodel);
• cyclosporine;
• insulin or oral diabetes medicine; or
• heart or blood pressure medication, such as beta-blockers.

This list is not complete. Other drugs may affect Bynfezia, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Tell your healthcare provider about all the medicines you take. Bynfezia may affect the way other medicines work, and other medicines may affect how Bynfezia works. If you have diabetes, your healthcare provider may change your dose of diabetes medication when you first start receiving Bynfezia or if your dose of Bynfezia is changed.