Pegvisomant is used to treat a certain condition called acromegaly. Acromegaly occurs when the body makes too much growth hormone and other natural substances such as insulin-like growth factor-I (IGF-I). Pegvisomant is usually used if you have not responded to other treatments (such as surgery, radiation, other medications). Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Pegvisomant works by blocking the action of growth hormone and by reducing the amount of IGF-I to normal levels.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using pegvisomant and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once daily. The injection is given in the upper arm, upper thigh, stomach area, or buttock. The dosage is based on your medical condition, lab tests, and response to treatment. The first dose is usually given by a health care professional.

Take the medication out of the refrigerator at least 10 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Gently roll the vial back and forth in your palms to dissolve the powder in the mixing solution. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Do not shake the medication. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is bruised, lumpy, or irritated. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Lumps may occur under the skin if the same injection site is used often. To reduce the chance of this side effect, change the injection site daily. Redness/swelling at the injection site, pain, diarrhea, or nausea may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including:

• signs of liver problems (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the product packaging), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems

If you have diabetes, pegvisomant may help improve symptoms of diabetes, such as lowering high blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• somatostatin analogs (such as lanreotide, octreotide)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: increased tiredness.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, IGF-I levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Use this medication immediately after mixing or within the time period indicated in the product instructions. Discard any unused portion remaining in the vial. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.