pegvisomant for injection
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.
Before you use 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 non-prescription 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.
- Read the Instructions for Use 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.
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:
- flu syndrome
- injection site reaction
- 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.
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 use 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.
Active ingredient: pegvisomant, including polyethylene glycol
Inactive ingredients: glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate
INSTRUCTIONS FOR USE
(pegvisomant for injection)
- 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 syringes 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
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 use any other liquid to mix the medicine.
Note: If you need to give 2 injections for your SOMAVERT dose, 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.
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.
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.
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.
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.
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.
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.
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.
- Do not shake the medicine vial. Shaking may destroy 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 dose 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.
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.
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.
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.
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.
- 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.
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.
- 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
- 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.
Step 20. With 1 hand, gently pinch up your skin at your injection site. See 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.
Step 22. Release your pinched skin and pull the needle straight out. See 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.
- 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.
- 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.