Pegvisomant, Injection

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KEY POINTS

• This medicine is given by injection to treat acromegaly. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause liver damage or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: growth hormone receptor antagonist

Generic and brand names: pegvisomant, injection; Somavert

What is this medicine used for?

This medicine is given by injection (shot) to treat acromegaly. Acromegaly is a disease caused when the body makes too much growth hormone.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Liver disease

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

The shots are given just under the skin. Your healthcare provider will determine the exact dosage. If your healthcare provider is giving you the shots, keep all your appointments.

If you give yourself these shots or have someone at home give them to you, your provider will teach you how to use this medicine. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions in the medicine package for preparing and using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

If you miss a shot, skip the missed shot and give the next one as directed. Do not give double doses. If you are not sure of what to do if you miss a shot, or if you miss more than one shot, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: tiredness.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine can cause liver damage. If you develop a fever, rash, or yellowing of your eyes and skin, contact your healthcare provider right away.

The injections of this medicine may cause thick or lumpy skin at the injection site. Choose a different injection site each day so lumps do not develop. Talk with your healthcare provider about this.

This medicine may cause dizziness. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes, dark urine, light-colored bowel movements, chest pain, swelling of hands or feet, extreme unexplained tiredness, severe stomach pain, severe nausea or vomiting, loss of appetite that lasts for several days, numbness or tingling.

Other: Back pain, dizziness, injection site reactions (redness, rash, pain), fever, headache, muscle or joint pain, diarrhea, mild nausea, sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Diabetes medicines such as alogliptin (Nesina), canagliflozin (Invokana), dapagliflozin (Farxiga), empagliflozin (Jardiance), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, linagliptin (Tradjenta), metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Before you mix the powder and the liquid, store the medicine in a refrigerator. Do not freeze. After mixing the powder and liquid, you must inject the medicine within 6 hours. You may keep mixed medicine at room temperature. If you have not used it within 6 hours, throw it away.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.