Octreotide Solution for Injection (Prefilled Pen)

What is this medication?

OCTREOTIDE (ok TREE oh tide) treats high levels of growth hormone (acromegaly). It works by reducing the amount of growth hormone your body makes. This reduces symptoms and the risk of health problems caused by too much growth hormone, such as diabetes and heart disease. It may also be used to treat diarrhea caused by neuroendocrine tumors. It works by slowing down the release of serotonin from the tumor cells. This reduces the number of bowel movements you have.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Bynfezia Pen

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Gallbladder disease
• Heart disease
• Kidney disease
• Liver disease
• An unusual or allergic reaction to octreotide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It can be given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are not able to keep your appointment.

If you give yourself this medication at home: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Bromocriptine
• Cyclosporine
• Lutetium Lu 177 dotatate
• Medications for diabetes, such as insulin, metformin, semaglutide
• Some medications for blood pressure, heart disease, irregular heartbeat

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may affect blood sugar (glucose) levels. Tell your care team if you take medications for diabetes. They may need to help you adjust your dose.

You should make sure you get enough vitamin B12 while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

This medication may increase your chances of becoming pregnant. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Low vitamin B12 level—pain, tingling, or numbness in the hands or feet, muscle weakness, dizziness, confusion, trouble concentrating
• Oily or light-colored stools, diarrhea, bloating, weight loss
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Headache
• Nausea
• Pain, redness, or irritation at injection site
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Before first use: Store in the refrigerator. Do not freeze. Keep this medication in the original carton until you are ready to take it. Protect from light.

After first use: Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after 28 days or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of it safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.