Pegvisomant

Dosage Forms & Strengths

powder for injection

• 10mg
• 15mg
• 20mg

Acromegaly

Load: 40 mg SC under physician supervision

Maintenance: 10 mg SC qDay; titrate by 5 mg increments q4-6Weeks according to IGF-1 levels

No more than 30 mg/day maintenance

Monitor: Growth hormone (GH), IGF-1, LFTs (see cautions)

Administration

• Reconstitiute with 1 mL supplied diluent (sterile water for injection)
• Inject within 6 hours of reconstitution
• Rotate injection sites daily

Hepatic Impairment

Obtain baseline LFTs

• WNL: monitor qMonth for 6 months, then quarterly for 6 months, then bianually for 1yr
• Elevated, but ≤ 3 times ULN: monitor qMonth for 1 yr, then bianually for 1 yr
• >3 times ULN: Do not use pegvisomant until full workup for cause of liver dysfunction; if decision made to initiate treatment, monitor LFTs very closely

LFTs During Treatment

• ≥3 times, but less than 5 times ULN: continue treatment; monitor LFTs qWk and perform comprehensive hepatic workup
• ≥5 times ULN: Discontinue pegvisomant; perform hepatic workup & monitor serial LFTs; if LFTs normalize, may re-initiate treatment with frequent monitoring
• Signs or symptoms of hepatitis or other liver injury: hepatic workup; if liver injury confirmed, discontinue pegvisomant

Safety and efficacy not established

Mechanism of Action

Recombinant human growth hormone receptor antagonist, with several polyethylene glycol (PEG) polymers covalently bound

Pharmacokinetics

Half-Life: 6 days

Onset: within 2 wk

Peak Plasma Time: 33-77 hr

Bioavailability: 57% (SC)

Vd: 7 L

Clearance: Total body: 28-36 mL/hr

Excretion: unknown

SOMAVERT®
 (SOM-ah-vert)
(pegvisomant) for Injection

What is SOMAVERT?

SOMAVERT is a prescription medicine used to treat people who have too much growth hormone (acromegaly). SOMAVERT is used to treat people who are not able to be treated or have not already been helped by surgery or radiation.

It is not known if SOMAVERT is safe and effective in children.

What should I tell my healthcare provider before I us e SOMAVERT?

Before you us e SOMAVERT, tell your healthcare provider if you:

• are allergic to pegvisomant or any of the ingredients in SOMAVERT. Do not take SOMAVERT if you are allergic to pegvisomant or any of the ingredients in SOMAVERT. See the end of this leaflet for a complete list of ingredients in SOMAVERT.
• have diabetes
• have or have had liver problems
• are pregnant or plan to become pregnant. It is not known if SOMAVERT will harm your unborn baby. Tell your healthcare provider if you become pregnant while using SOMAVERT.
• are breastfeeding or plan to breastfeed. It is not known if SOMAVERT passes into your breast milk. You and your health care provider should decide if you will take SOMAVERT or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

SOMAVERT may affect the way other medicines work, and other medicines may affect how SOMAVERT works. Especially tell your healthcare provider if you take:

• insulin or other medicines used to treat diabetes
• narcotics (opioid medicines). Your healthcare provider may change your dose of SOMAVERT if you take opioids.

If you are not sure, ask your healthcare provider or pharmacist whether you take these medicines.

Know the medicines you take. Keep a list of all the medicines you take to show your healthcare providers and pharmacists when you get a new medicine.

How should I use SOMAVERT?

• Read the Instructions for Us e at the end of this Patient Information for information about the right way to use SOMAVERT.
• Your healthcare provider should do blood tests to check your liver and insulin-like growth factor-I (IGF-I) levels before you start and while you use SOMAVERT. Your healthcare provider may need to change your dose of SOMAVERT.
• SOMAVERT is given 1 time each day as an injection under your skin (subcutaneous). Some people may need to give 2 injections for their dose each day. Your healthcare provider will tell you if you need to give 2 injections for your dose.
• Your first injection of SOMAVERT should be given by your healthcare provider.
• Your healthcare provider will teach you or your caregiver how to use SOMAVERT.
• If you use too much SOMAVERT, call your healthcare provider right away.
• If you miss a dose of SOMAVERT, just take the next dose at the regular time. Do not take 2 doses at the same time. If you are not sure about your dosing, ask your healthcare provider.

What are the possible side effects of SOMAVERT?

SOMAVERT may cause serious side effects , including:

• changes in your blood sugar level. Your healthcare provider may change your dose of diabetes medicine while you take SOMAVERT.
• liver problems. Stop injecting SOMAVERT right away and call your healthcare provider if you have any of the following symptoms of liver problems:
  • yellowing of your eyes (jaundice)
  • dark, amber-colored urine
  • feeling very tired (fatigue or exhaustion)
  • nausea and vomiting
  • pain in your stomach area (abdomen)
  • generalized swelling
  • bruising easily
• skin thickening at your injection site that could lead to lumps (lipohypertrophy)
• allergic reactions. Call your healthcare provider right away if you have any of the following symptoms of a serious allergic reaction:
  • swelling of your face, tongue, lips, or throat
  • wheezing or trouble breathing
  • skin rash, redness, or swelling
  • severe itching
  • dizziness or fainting

The most common side effects of SOMAVERT include:

• pain
• infection
• nausea
• flu syndrome
• injection site reaction
• diarrhea
• abnormal liver tests. If your liver test results are too high you may have to have more frequent liver tests.

These are not all of the possible side effects of SOMAVERT. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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

How should I store SOMAVERT?

• Before you mix the SOMAVERT powder and the liquid:
  • Store SOMAVERT in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze SOMAVERT.
• After you mix the SOMAVERT powder and liquid:
  • Keep the mixed SOMAVERT at room temperature between 59°F to 77°F (15°C to 25°C).
  • Keep SOMAVERT inside the vial or the syringe until you are ready to inject it.
  • You must use the mixed SOMAVERT within 6 hours after you mix it.
  • If you have not used the mixed SOMAVERT within 6 hours, throw the SOMAVERT away.

Keep SOMAVERT and all medicines out of the reach of children.

General Information about the safe and effective us e of SOMAVERT.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOMAVERT for a condition for which it was not prescribed. Do not give SOMAVERT to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about SOMAVERT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SOMAVERT that is written for health professionals.

For more information, go to www.Somavert.com or call 1-800-645-1280.

What are the ingredients in SOMAVERT?

Active ingredient: pegvisomant, including polyethylene glycol

Inactive ingredients: glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate

Instructions for Use

SOMAVERT®
(SOM-ah-vert)
(pegvis omant for injection)

Note:

• SOMAVERT is for use under the skin only (subcutaneous).
• Do not share your SOMAVERT syringes or needles with anyone else. You may give an infection to them or get an infection from them.

Supplies you need to give each injection of SOMAVERT. See Figure A.

• 1 package of SOMAVERT that contains:
  • 1 vial of powdered SOMAVERT medicine (powder vial)
  • 1 vial of liquid (diluent) labeled “Sterile Water for Injection, USP” to mix the powdered medicine
    The vials in the package of SOMAVERT have stoppers that are not made with natural rubber latex.
    The SOMAVERT package does not come with s yringes and needles .
• a 1 mL syringe with a 21 gauge to 27 gauge needle that is at least 1 inch long. This is the syringe and needle needed to mix the medicine (diluent syringe).
• a 1 mL insulin syringe with attached needle. This is the syringe needed for your injection.
• 2 alcohol swabs
• 1 small clean, dry cotton pad
• 1 sharps disposal container for throwing away used needles and syringes. See “Disposing of used needles and syringes ” at the end of these instructions.
• a clean, flat surface to work on, like a table

Figure A

Preparing and mixing your SOMAVERT medicine

The SOMAVERT medicine comes as a dry powder. Before you use SOMAVERT, you must mix the dry powder with the vial of diluent that comes in the SOMAVERT package.

Do not us e any other liquid to mix the medicine.

Note: If you need to give 2 injections for your SOMAVERT dos e, you need 2 packages of SOMAVERT to prepare 2 separate vials of medicine.

Step 1. Remove 1 package of SOMAVERT from the refrigerator about 10 minutes before you plan to give your SOMAVERT injection. Let the SOMAVERT stand at room temperature to warm up the medicine.

Step 2. Wash your hands with soap and warm water. Dry your hands well.

Step 3. Remove the plastic caps from the tops of the powder vial and the diluent vial. See Figure B.

Do not touch the rubber vial stoppers. The stoppers are clean. If the stoppers are touched by anything, you must clean them with an alcohol swab before use.

Figure B

Step 4. Carefully remove the cap from the diluent syringe with the larger needle and set the cap aside on the table. See Figure C.

Figure C

Step 5. Pull the plunger of the diluent syringe out to the 1 mL mark. With 1 hand, firmly hold the vial of diluent. With the other hand, push the needle of the diluent syringe straight through the center of the rubber stopper and deep into the vial. Gently push the plunger in until the air is injected into the vial. See Figure D.

Figure D

Step 6. Firmly hold the diluent vial and syringe together, with the needle still deeply inserted into the vial. Carefully turn the vial and diluent syringe together upside down. Hold them at eye level. See Figure E.

Figure E

Step 7. Slide 1 hand carefully down the diluent vial so you can firmly hold the neck of the vial with your thumb and forefinger. Hold the upper part of the syringe with your other fingers. With the other hand, slowly pull the plunger out to the 1 mL mark on the diluent syringe. See Figure F.

Figure F

Step 8. Check the diluent syringe for air bubbles. If you see bubbles, tap the diluent syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger in to push only the air bubbles back into the vial. See Figure G. If you push too much of the liquid back into the vial, pull the plunger out again to the 1 mL mark.

Figure G

Step 9. Make sure that 1 mL of diluent remains in the diluent syringe. Pull the needle out of the vial. The vial should still have diluent in it. Do not use the leftover diluent in the vial.

Step 10. Push the needle of the diluent syringe straight through the stopper of the vial of powdered SOMAVERT.

Tilt the diluent syringe to the side and gently push the plunger in to inject the diluent down the inner side of the SOMAVERT powder vial. Be sure the diluent does not fall directly on the powder, but flows down the inside wall of the vial. See Figure H.

Figure H

Step 11. When the diluent syringe is empty, pull the needle out of the powder vial.

Throw away the diluent vial with the leftover liquid in it. Throw away the diluent syringe and needle in the sharps container as your healthcare provider told you. See “Disposing of used needles and syringes ” at the end of these instructions.

Step 12. Hold the medicine vial of SOMAVERT upright between your hands and gently roll it to dissolve the powder into a solution. See Figure I.

Figure I

• Do not s hake the medicine vial. Shaking may des troy the medicine.
• The liquid medicine should be clear after the powder is dissolved. Do not use the vial if:
  • the liquid medicine looks cloudy, hazy, or slightly colored or
  • you see solid particles in the liquid medicine or
  • you see foam in the vial
    Tell your pharmacist and ask for another vial. Do not throw the vial away because the pharmacist may ask that you return it.
• Inject SOMAVERT within 6 hours of mixing it. If you wait more than 6 hours , you must throw away the medicine without injecting it.
• Each mixed medicine vial contains 1 dos e of SOMAVERT. Do not split the liquid medicine into multiple doses.

Preparing your SOMAVERT injection syringe:

Step 13. Clean the rubber stopper of the vial of SOMAVERT with an alcohol swab.

• Carefully remove the cap from the insulin syringe and set the cap on the table.
• Pull the insulin syringe plunger out to the 1 mL mark. With 1 hand, firmly hold the vial. With the other hand, push the needle straight through the center of the rubber stopper and deep into the vial. Gently push the plunger in until the air is injected into the medicine vial. See Figure J.

Figure J

Step 14. Firmly hold the medicine solution vial and insulin syringe together, with the needle still deeply inserted into the vial. Carefully turn the vial and syringe together upside down. Hold them at eye level. See Figure K.

Figure K

Step 15. Slide 1 hand carefully down the medicine solution vial so you can firmly hold the neck of the vial with your thumb and forefinger. Hold the upper part of the syringe with your other fingers. With the other hand, slowly pull the plunger out to the 1 mL mark on the insulin syringe. See Figure L.

Figure L

Step 16. Check the insulin syringe for air bubbles. If you see bubbles, tap the insulin syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger in to push only the air bubbles back into the vial. See Figure M.

Figure M

Step 17. Withdraw the entire 1 mL of medicine solution from the vial. If your dose of SOMAVERT is less than 1 mL, your healthcare provider will tell you how much medicine solution to withdraw. Slowly withdraw the needle to keep the tip in the liquid until you get all the medicine solution you need out of the vial. See Figure N.

Note:

• If your dose of SOMAVERT is less than 1 mL, your healthcare provider will tell you how much medicine solution to withdraw.
• If your dose of SOMAVERT is more than 1 mL, your healthcare provider will tell you how much more medicine solution to withdraw from a second vial into another syringe, and where to give your second injection.

Set the syringe and needle on the table without anything touching the needle.

Figure N

Selecting your SOMAVERT injection site:

Step 18. SOMAVERT is injected under the skin (subcutaneous). Injection sites may include your upper arm, upper thigh, stomach area (abdomen) and buttocks. See Figure O.

Figure O

• Choose your injection site from 1 of the areas your healthcare provider told you to use.
• Choose a different injection site each day so lumps do not develop in your skin. Keep a record of each day's injection site as you inject your daily dose of SOMAVERT.
• Do not use an area of your body that has:
  • a rash
  • broken skin
  • bruising
  • lumps in your skin
• If you need to give 2 injections for your dose of SOMAVERT, choose a different site for your second injection.

Giving your SOMAVERT injection:

Step 19. Clean your injection site with an alcohol swab. See Figure P.

Let your skin dry before you inject your medicine.

Figure P

Step 20. With 1 hand, gently pinch up your skin at your injection site. See Figure Q.

Figure Q

• Step 21. Carefully pick up the insulin syringe with your other hand and hold it like a pen. In a single, smooth motion, push the needle straight down and completely into your skin (at a 90-degree angle). Keep the needle pushed all the way into your skin while you slowly push the syringe plunger in with the index finger of your other hand. See Figure R.
• Keep the needle all the way into your skin until all of the medicine is injected under your skin and the insulin syringe is empty.

Figure R

Step 22. Release your pinched skin and pull the needle straight out. See Figure S.

Figure S

Step 23. Do not rub your injection area. A small amount of bleeding may happen.

If you have a small amount of bleeding, press a small clean, dry cotton pad over the area and press gently for 1 or 2 minutes, or until the bleeding has stopped. See Figure T.

Figure T

Disposing of used needles and syringes :

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. See Figure U. Do not throw away (dispose of) loose needles and syringes in your household trash.

Figure U

• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Your doctor or pharmacist can provide more information about pegvisomant.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Pegvisomant is a medicine used to treat patients who have acromegaly. Acromegaly is a disease caused by the body making too much growth hormone.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Use pegvisomant exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The recommended dose range of Somavert (Pegvisomant) is 10 to 30 mg once daily.

• Before you mix the pegvisomant powder and the liquid:
  • Store pegvisomant in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze pegvisomant.
• After you mix the pegvisomant powder and liquid:
  • Keep the mixed pegvisomant at room temperature between 59°F to 77°F (15°C to 25°C).
  • Keep pegvisomant inside the vial or the syringe until you are ready to inject it.
  • You must use the mixed pegvisomant within 6 hours after you mix it.
  • If you have not used the mixed pegvisomant within 6 hours, throw the pegvisomant away.

Keep pegvisomant and all medicines out of the reach of children.

Selective, competitive somatotropin receptor antagonist; biosynthetic analog of human growth hormone (somatotropin).1 3 5 6 7

Acromegaly

Treatment of acromegaly in patients who have had inadequate responses to or are not candidates for surgical resection, pituitary irradiation, and/or other medical therapies (e.g., bromocriptine mesylate, octreotide).1 3 4 4

Improves certain manifestations of acromegaly (decreases in ring size and a composite measure of soft tissue swelling, arthralgia, headache, excessive perspiration, and fatigue).1 3 6

General

• The goal of therapy in patients with acromegaly is to reduce serum insulin growth factor-I (IGF-I) concentrations to normal levels.1 3 4 Monitor serum IGF-I concentrations at least semiannually after such concentrations have normalized.1 10

Administration

Sub-Q Administration

Administer by sub-Q injection into the upper arm, upper thigh, abdomen, or buttocks.1 2

Reconstitute by adding 1 mL of the manufacturer-supplied diluent (sterile water for injection) to a vial labeled as containing 10, 15, or 20 mg of pegvisomant protein to provide a solution containing 10, 15, or 20 mg/mL, respectively.1 2 Roll vial gently between the palms until powder is completely dissolved and a clear solution is attained;1 2 discard any unused diluent.2 10 Do not shake vial since denaturation of the protein may occur.1 2 10

Dosage

Dosage of pegvisomant is expressed in terms of pegvisomant protein.1 Each mg of pegvisomant protein contains approximately 1 unit of activity.1 10

Adults

Loading dose: 40 mg; administer under medical supervision.1 2 6 Subsequently, self-inject 10 mg once daily.1 2 6

Adjust dosage in 5-mg increments (or 5-mg decrements, if serum IGF-I concentrations are below normal) at intervals of no less than 4–6 weeks until the desired effect on serum IGF-I concentrations is observed or a maximum dosage of 30 mg daily is reached.1 5 6

Not known if an increased dosage would be of benefit in patients who continue to have symptoms after achieving normal IGF-I levels.1

Prescribing Limits

Adults

Maximum daily dosage 30 mg.1 5 6

Special Populations

No special population recommendations at this time.1 10

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about pegvisomant, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pegvisomant. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using pegvisomant.

Review Date: October 4, 2017

Refer to adult dosing.

Adverse events have been observed in some animal reproduction studies.

Initial dose: 40 mg by subcutaneous injection.
Maintenance dose: 10 to 30 mg by subcutaneous injection daily.