Pronunciation:

peg-VI-soe-mant

Brand Names:

• Somavert

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Growth Hormone Receptor Antagonist

Uses of This Medicine:

Pegvisomant is used to treat a condition called acromegaly, which is caused by too much growth hormone in the body, in patients who cannot be treated with surgery or radiation. Too much growth hormone produced in adults causes the hands, feet, and parts of the face to become large, thick, and bulky. Other problems such as arthritis also can develop. Pegvisomant works by binding to the growth hormone receptor and preventing the actions of too much growth hormone .

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pegvisomant in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegvisomant in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dose in patients receiving pegvisomant .

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Octreotide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes—Use with caution. May cause changes in the blood sugar .

• Kidney disease or
• Liver disease, or a history of—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Tumors that produce growth hormone—Use with caution. May increase risks for more serious side effects .

Proper Use of This Medicine:

This medicine is given as a shot under your skin. Pegvisomant may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected .

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject on an area that has a rash, bruise, lump, or a broken skin .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For treating acromegaly:
    • Adults—At first, 40 milligrams (mg) will be injected under your skin by your doctor. Then, you will inject the next doses of 10 milligrams (mg) once a day under your skin . Higher doses may be needed, as determined by your doctor.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unopened vials of this medicine in the refrigerator. Do not freeze. Store the medicine that has been mixed at room temperature and use it within 6 hours. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution .

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets .

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects .

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin .

The cover of the vials of this medicine contains latex, which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine .

Make sure your doctor knows if you are using this medicine before taking any tests. This medicine may affect the results of some medical tests (e.g., liver tests), especially if you also use other medicines to treat acromegaly (e.g., octreotide, Sandostatin®) .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding, blistering, burning, coldness, or discoloration of skin at site of injection

bloating or swelling of face, arms, hands, lower legs, or feet

blurred vision

chest pain

chills

cough

dizziness

feeling of pressure

fever

headache

hives

hoarseness

infection, inflammation, itching, or lump at site of injection

nervousness

lower back or side pain

painful or difficult urination

pounding in the ears

rapid weight gain

slow or fast heartbeat

tingling of hands or feet

unusual weight gain or loss

Less common

Thickening of the skin

Incidence not known

Abdominal pain or tenderness

clay colored stools

dark urine

decreased appetite

fever

itching

loss of appetite

nausea and vomiting

skin rash

unusual tiredness or weakness

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Accidental injury

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

diarrhea

general feeling of discomfort or illness

joint pain

muscle aches and pains

pain

pain or tenderness around eyes and cheekbones

runny or stuffy nose

shivering

shortness of breath or troubled breathing

sore throat

sweating

tightness of chest or wheezing

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.