SOMAVERT 10 mg powder and solvent for solution for injection
SOMAVERT 15 mg powder and solvent for solution for injection
SOMAVERT 20 mg powder and solvent for solution for injection
Pegvisomant
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What SOMAVERT is and what it is used for
- 2. Before you use SOMAVERT
- 3. How to use SOMAVERT
- 4. Possible side effects
- 5. How to store SOMAVERT
- 6. Further information
What Somavert Is And What It Is Used For
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders.
SOMAVERT is a product of biotechnology. The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor antagonist. These substances decrease the action of GH and levels of IGF-I circulating in the blood.
Before You Use Somavert
Do not use SOMAVERT
- If you are allergic (hypersensitive) to pegvisomant or to any of the other ingredients of SOMAVERT.
Take special care with SOMAVERT:
- If you experience disturbed vision or headaches while using SOMAVERT you must contact your doctor immediately.
- Your doctor or nurse will monitor the levels of IGF-I (Insulin-like growth factors) circulating in the blood and adjust the dose of SOMAVERT if necessary.
- Your doctor should also monitor your adenoma (benign tumour).
- Your doctor or nurse will monitor the level of liver enzymes in the blood every 4-6 weeks for the first six months of treatment with SOMAVERT. Administration of SOMAVERT should be discontinued if signs of liver disease persist.
- If you are diabetic, your doctor may need to adjust the amount of insulin or other medicines you are using.
- Female patients should use adequate contraception as fertility may be increased. See also the section about Pregnancy below.
Using other medicines
You must tell your doctor if you have previously used other medicines for the treatment of acromegaly or medicines for the treatment of diabetes.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
As part of your treatment you may be given other medicines. It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor or pharmacist.
Pregnancy and breast-feeding:
The effects of SOMAVERT in pregnant women are not known, and so the use of SOMAVERT in pregnant women is not recommended. You are advised to not become pregnant while taking SOMAVERT therapy. In case you become pregnant, you must consult your doctor. Ask your doctor or pharmacist for advice before taking any medicine.
It is not known if SOMAVERT passes into breast milk. You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Driving and using machines:
No studies on the effects on the ability to drive and use machines have been performed.
Important information about some of the ingredients of SOMAVERT
This medicinal product contains less than 1 mmol sodium (23 mg) per 10 mg dose, less than 1 mmol sodium (23 mg) per 15 mg dose, or less than 1 mmol sodium (23 mg) per 20 mg dose i.e. essentially ‘sodium-free’.
How To Use Somavert
Always inject SOMAVERT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
A starting dose of 80 mg of SOMAVERT will be given subcutaneously (just under the skin) by your doctor. Following this, the usual daily dose of SOMAVERT is 10 mg, which is given by subcutaneous injection (just under the skin).
Every four to six weeks your doctor will make appropriate dose adjustments, made in increments of 5 mg pegvisomant/day, based on your so-called serum IGF-I levels to maintain an optimal therapeutic response.
Method and route of administration
SOMAVERT is injected under the skin. The injection can be self-administered or given by another person, for example your doctor or his/her assistant. The detailed instructions on injection procedure provided at the end of this leaflet must be followed. You should continue to inject SOMAVERT for as long as instructed by your doctor.
SOMAVERT must be dissolved before use. The injection must not be mixed in the same syringe or vial as any other medicine.
Fatty tissue of the skin can build-up at the site of injection. To avoid this, use a slightly different place for your injection each time, as described in Step 2 of the ‘Instructions for Preparing and Giving an Injection of Somavert’ section of this leaflet. This gives your skin and the area under your skin time to recover from one injection before it receives another one in the same place.
If you have the impression that the effect of SOMAVERT is too strong or too weak, talk to your doctor or pharmacist.
If you inject more SOMAVERT than you should
If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, but you should contact your doctor or pharmacist immediately.
If you forget to use SOMAVERT
If you forget to give yourself an injection you should inject the next dose as soon as you remember and then continue to inject SOMAVERT as prescribed by your doctor. Do not inject a double dose to make up for forgotten individual doses
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines SOMAVERT can cause side effects, although not everybody gets them
Common side effects (likely to occur in fewer than 1 in 10 patients) include:
- Headache, dizziness, sleepiness, uncontrolled trembling.
- Diarrhoea, constipation, feeling sick, being sick, feeling bloated, indigestion, gas.
- Sweating, itching, rash.
- Joint pain, muscle pain, swelling of the extremities.
- Increased blood cholesterol, weight gain, increased blood glucose, increased appetite.
- Increased blood pressure.
- Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fat below the surface of the skin at injection site.
- Flu-like illness, fatigue.
- Increased levels of substances that measure the function of the liver. These can be seen in the results of blood tests.
- Abnormal dreams, problems sleeping.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
- Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed.
- Decreased sense of touch, abnormal sense of taste, migraine.
- Eyestrain, eye pain, inner ear problems.
- Shortness of breath.
- Dry mouth, increased saliva, tooth problems, hemorrhoids.
- Blood in the urine, protein in the urine, increased urine, kidney problems.
- Facial swelling, dry skin, tendency to bruise, night sweats.
- Arthritis.
- Increased fatty substances in the blood, decreased blood glucose.
- Fever, weakness, feeling abnormal, impaired healing.
- Anger, lack of interest, feeling confused, increased sex drive, panic attack, loss of memory.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
About 17% of patients will develop antibodies to growth hormone during treatment. The antibodies do not seem to stop SOMAVERT from working.
How To Store Somavert
Keep out of the reach and sight of children
Do not use SOMAVERT after the expiry date which is stated on the vial and the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C) Do not freeze. Keep the vials in the outer carton in order to protect from light.
After preparing the SOMAVERT solution it must be used immediately. Carefully dispose of any SOMAVERT solution that has not been injected.
Do not use SOMAVERT if you notice that the solution is cloudy or contains particulate matter.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
Further Information
What SOMAVERT contains
- The active substance is pegvisomant.
- One vial of powder contains either10 mg, 15 mg, or 20 mg. After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant.
- The other ingredients are glycine, mannitol (E421), sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate.
- The solvent is water for injections. One vial of solvent contains 8 ml water for injections.
What SOMAVERT looks like and contents of the pack
SOMAVERT is presented as a powder and a solvent for injection, in a vial. Powder in a vial (either10 mg, 15 mg, or 20 mg pegvisomant) and solvent in a vial (8 ml). Pack sizes of 1 and 30. Not all pack sizes are marketed. The powder is white and the solvent is clear and colourless.
Marketing Authorisation holder:
Manufacturer:
For any information about this medicine product, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved on: December 2007
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments
Instructions For Preparing And Giving An Injection Of Somavert
Introduction
The following instructions explain how to prepare and inject SOMAVERT. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the technique of self-injection. Do not attempt to self-inject until you are sure that you understand how to prepare and give an injection.
The powder must be dissolved with the solvent before use.
This injection should not be mixed in the same syringe or vial with any other medicine.
Step 1. Choosing The Method For Preparing The Somavert Solution
There are 2 methods for preparing the SOMAVERT solution. Please discuss with your healthcare professional which method is best for you:
- a) The Vial Adapter Method (MIXJECT),
- b) The Non-Vial Adapter Method.
a) VIAL ADAPTER METHOD (MIXJECT)
GETTING STARTED
- Wash your hands thoroughly.
- Collect:
- 1 vial of powder (SOMAVERT),
- 1 vial of solvent (Water for Injections),
- 1 luer-lock syringe of 1ml (for both reconstituting the SOMAVERT solution and giving the injection) is recommended. However, other sizes and types of syringes can be used for the preparation and injection of SOMAVERT. Please consult your healthcare professional for further information.
- 2 MIXJECT vial adapters,
- 1 detachable needle (25 to 30 gauge),
- Alcohol or antiseptic swabs and a proper disposal container for used needles and syringes.
- Inspect the expiry dates on both the vial label and the syringe label. They should not be used after the month and year shown.
After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant.
PREPARING THE SOMAVERT DOSE FOR INJECTION
- 1. Remove the protective plastic caps from the tops of both vial of solvent and vial of SOMAVERT (Fig. 1). Take care not to touch the rubber vial stoppers. At this point, the stoppers are clean. If the stoppers are touched or otherwise contaminated, you must clean them with an antiseptic or alcohol swab before inserting a vial adapter through the stopper.
- 2. Open only one of the vial adapters by peeling back the protective cover. Leave the adapter in the plastic packaging and do not touch the spike of the adapter.
- 3. While holding the plastic adapter packaging, place the adapter over the solvent vial and insert the piercing spike of the vial adapter all the way in through the rubber stopper of the solvent vial, using a pushing motion. (Fig. 2). Remove the plastic packaging from the vial adapter and discard.
- 4. Remove the syringe from the protective packaging. Pull the plunger of the syringe out to the 1 ml mark. Hold the solvent vial, placed on a flat surface, with one hand and connect the tip of the syringe to the vial adapter by twisting the syringe on the vial adapter clockwise (Fig. 3). Gently push the plunger until the air is injected into the vial.
ADDING SOLVENT
- 5. Securely grasp the solvent vial, adapter and syringe assembly. Carefully turn the vial, adapter and syringe assembly upside down. Bring to eye level (Fig. 4).
- 6. Slide one hand carefully down the solvent vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper part of the syringe. With the other hand, slowly pull the syringe plunger down to slightly past the 1 ml mark.
Examine the solution in the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of solvent remains in the syringe.
Carefully turn the solvent vial, adapter and syringe assembly and place them upright on a clean surface. Do not remove the syringe from the adapter at this point.
- 7. As explained for the first vial adapter, open now the second vial adapter by peeling back the protective cover. Do not touch the vial adapter. Do not remove the adapter from the plastic packaging. While holding the plastic adapter packaging, place the adapter over the SOMAVERT vial and insert the piercing spike of the vial adapter all the way in through the rubber stopper of the SOMAVERT vial, using a pushing motion (Fig. 5). Remove the plastic packaging from the vial adapter and discard.
- 8. Disconnect the syringe from the solvent vial adapter and attach it to the vial adapter on the vial of SOMAVERT. Tilt the vial of SOMAVERT, adapter and syringe assembly to the side and gently inject the solvent down the inner side of the vial of SOMAVERT (Fig 6). Discard the solvent vial as directed by your healthcare provider.
- 9. Hold the vial of SOMAVERT with the adapter and syringe still attached upright between your hands and gently roll it to dissolve the powder (Fig. 7). DO NOT SHAKE THE VIAL. The solution should be clear after the powder is dissolved. If the solution is cloudy or hazy, do not inject it. Notify your pharmacy and request a replacement vial. Do not throw the vial away because the pharmacy may request that you return it.
PREPARING THE INJECTION
- 10. Securely grasp the vial containing the SOMAVERT reconstituted solution, vial adapter and syringe assembly. Carefully turn the vial, adapter and syringe assembly upside down. Bring to eye level.
- 11. As before, slide one hand carefully down the vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper portion of the syringe. With the other hand, slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml). (Fig.8).
Visually inspect the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of the solution remains in the syringe. Carefully turn the vial containing the SOMAVERT reconstituted solution, adapter and syringe assembly and place them upright on a clean surface. Do not remove the syringe from the adapter at this point.
- 12. Open the needle packaging so that only the end of the needle to be connected to the syringe is exposed. The needle should be partially left in its protective packaging. Lay the needle with its protective packaging on the tabletop. Disconnect the syringe from the vial. Discard the protective packaging and attach the needle to the syringe. Keep the plastic cap on the needle while preparing the site for injection (Fig. 9). Once reconstituted, SOMAVERT should be used immediately. Please proceed to “STEP 2. GIVING THE INJECTION”
b) NON VIAL ADAPTER METHOD
Getting Started
- Wash your hands thoroughly.
- Collect one vial of powder (SOMAVERT) and one vial of solvent (Water for Injections), one 3-ml syringe with a 21-gauge, 1-inch detachable needle, one standard 1 ml insulin syringe, alcohol or antiseptic swabs and a proper disposal container for used needles.
- Inspect the expiry dates on both the vial label and the syringe label. They should not be used after the month and year shown.
After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant.
Preparing the SOMAVERT dose for injection
Remove the protective plastic caps from the tops of both vials. Take care not to touch the rubber vial stoppers. At this point, the stoppers are clean. If the stoppers are touched or otherwise contaminated, you must clean them with an antiseptic or alcohol swab before inserting a needle through the stopper.
Carefully remove the cap from the needle of the larger syringe (3 ml) and set the cap aside. This is the solvent syringe.
- 1. Pull the plunger of the solvent syringe down to the 1 ml mark. With one hand, securely hold the vial of solvent and, with the other hand, insert the needle of the solvent syringe straight through the center of the rubber stopper and deep into the vial. Gently push the plunger until the air is injected into the vial. (Fig. 1)
ADDING SOLVENT
- 2. Securely grasp the solvent vial and syringe assembly, with the needle still deeply inserted into the vial. Carefully turn the vial and syringe assembly upside down. Bring to eye level. (Fig. 2)
- 3. Slide one hand carefully down the solvent vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper part of the syringe. With the other hand, slowly pull the syringe plunger down to slightly past the 1 ml mark.
Examine the solution in the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of solvent remains in the syringe, then withdraw the needle from the vial. (Fig 3)
- 4. Insert the needle of the solvent syringe straight through the stopper of the vial with the powder (SOMAVERT). Tilt the syringe to the side and gently inject the solvent down the inner side of the vial of SOMAVERT. When the solvent syringe is empty, withdraw it from the vial. Discard the solvent vial, syringe, and needle as directed by your healthcare provider. To minimise accidental injury, recap the needle only if instructed to do so by your healthcare provider, and in the manner demonstrated to you by your healthcare provider. (Fig 4)
- 5. Hold the vial of SOMAVERT upright between your hands and gently roll it to dissolve the powder. DO NOT SHAKE THE VIAL. The solution should be clear after the powder is dissolved. If the solution is cloudy or hazy, do not inject it. Notify your pharmacy and request a replacement vial. Do not throw the vial away because the pharmacy may request that you return it. Inject SOMAVERT immediately. (Fig. 5)
PREPARING THE INJECTION
- 6. Clean the rubber stopper of the vial of SOMAVERT with an antiseptic or alcohol swab. Remove the cap from the syringe (1 ml). Pull the syringe plunger down to the 1-ml mark. With one hand, securely hold the vial. With the other hand, insert the needle straight through the center of the rubber stopper and deep into the vial. Gently push the plunger until the air is injected into the vial. Securely grasp the vial and syringe assembly, with the needle still deeply inserted into the vial. Carefully turn the vial and syringe assembly upside down. Bring to eye level. (Fig. 6)
- 7. As before, slide one hand carefully down the vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper portion of the syringe. With the other hand, slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml). To keep the needle tip within the liquid, you may have to slowly back it out of the stopper as you draw out the liquid.
Visually inspect the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of the solution remains in the syringe, then withdraw the needle from the vial.
Recap the needle as directed by your health care provider to minimise accidental injury while preparing the site for injection. (Fig. 7)
GIVING THE INJECTION
Choose an injection site on the upper arm, upper thigh, abdomen or buttocks. Always move on to a different area with each day’s injection. It may be helpful to keep a record of each day’s injection site as you take your daily dose of SOMAVERT. Do not use an area that has a rash or broken skin, or is bruised or lumpy.
Clean the site with an antiseptic or alcohol swab, let the skin dry before injecting the product. Uncap the needle if previously recapped.
- 8. With one hand, gently pinch up the skin at the site of injection. Hold the syringe with the other hand, and in a single, smooth motion, push the needle completely into the skin straight down (at a 90-degree angle). (Fig. A)
- 9. Be sure to keep the needle all the way into the skin while you slowly push the syringe plunger down until the barrel is empty.
Release the pinched skin and pull the needle straight out. (Fig. B)
- 10. Do not rub the injection area. A small amount of bleeding may occur. If necessary, apply a clean, dry cotton swab over the area and press gently for 1 or 2 minutes, or until the bleeding has stopped. (Fig. C)
Disposing of Supplies
The syringe and needle should NEVER be reused. Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
All questions should be handled by a doctor, nurse or pharmacist familiar with SOMAVERT.
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