Somavert

Package leaflet: Information for the user

SOMAVERT 10 mg powder and solvent for injectable solution, 15 mg powder and solvent for injectable solution, 20 mg powder and solvent for injectable solution, 25 mg powder and solvent for injectable solution, 30 mg powder and solvent for injectable solution

pegvisomant
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What SOMAVERT is and what it is used for
2. What you need to know before using SOMAVERT
3. How to use SOMAVERT
4. Possible side effects
5. How to store SOMAVERT
6. Contents of the pack and other information

1. What SOMAVERT is and what it is used for

SOMAVERT is used for the treatment of acromegaly, a hormonal disorder caused by increased secretion of growth hormone (GH) and IGF-1 (insulin-like growth factors), which is characterized by excessive growth of bones, swelling of soft tissues, heart disease, and related disorders.
The active substance of SOMAVERT, pegvisomant, is known as a growth hormone receptor antagonist. These substances reduce the action of GH and circulating levels of IGF-1 in the blood.

2. What you need to know before using SOMAVERT

Do not use SOMAVERT

• If you are allergic to pegvisomant or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SOMAVERT.

• If you experience visual disturbances or headaches, you must contact your doctor immediately.
• Your doctor or nurse will monitor your circulating levels of IGF-I (insulin-like growth factors), and adjust your dose of SOMAVERT if necessary.
• Your doctor should also continue to monitor your adenoma (benign tumour).
• Your doctor will perform tests to assess your liver function before starting and during treatment with SOMAVERT. If the results of these tests are abnormal, your doctor will discuss treatment options with you. After starting treatment, your doctor or nurse will monitor liver enzyme levels in your blood every 4–6 weeks for the first 6 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 your insulin dose or other antidiabetic medications.
• In female patients, fertility may increase as the disease improves. Use of this medicine during pregnancy is not recommended, and women of childbearing potential should be advised to use contraception. See also the section on Pregnancy below.

Other medicines and SOMAVERT
You must inform your doctor if you have previously used other medicines for the treatment of acromegaly or diabetes.
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines.
During treatment, you may be given other medicines. It is important to continue taking all prescribed medicines, including SOMAVERT, unless otherwise advised by your doctor, pharmacist, or nurse.

Pregnancy, breastfeeding, and fertility
Use of SOMAVERT in pregnant women is not recommended. Women of childbearing potential must use a contraceptive method during treatment.
It is not known whether pegvisomant is excreted in human breast milk. You must not breastfeed while being treated with SOMAVERT unless you have discussed this with your doctor.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No studies on the ability to drive and use machines have been performed.

SOMAVERT contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

3. How to use SOMAVERT

Inject this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
An initial dose of 80 mg of pegvisomant will be administered subcutaneously (just under the
skin) by your doctor. Subsequently, the usual daily dose of pegvisomant, injected subcutaneously (just under the skin), is 10 mg.
Every four to six weeks, based on serum IGF-1 levels, your doctor will adjust the dose appropriately, increasing it in 5 mg increments of pegvisomant/day, to maintain an optimal therapeutic response.
Method and route of administration
SOMAVERT is injected under the skin. The injection may be self-administered or given by another person, for example your doctor or your assistant. Detailed instructions on the injection procedure are provided at the end of this leaflet. You must continue treatment with this medicine as directed by your doctor.
This medicine must be dissolved before use. The solution for injection must not be mixed in the same syringe or vial with other medicines.
Fatty tissue may accumulate at the injection site. To avoid this, a slightly different area should be used for each injection, as described in Step 2 of the section of this leaflet entitled “Instructions for preparing and administering a SOMAVERT injection”. This will allow the skin and underlying tissue sufficient recovery time between injections.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor, pharmacist or nurse.
If you inject more SOMAVERT than you should
If you accidentally inject more SOMAVERT than prescribed by your doctor, it is probably not serious, but you must contact your doctor, pharmacist or nurse immediately.
If you forget to use SOMAVERT
If you forget to give yourself an injection, inject the next dose as soon as you remember, and then continue injecting SOMAVERT as prescribed by your doctor. Do not inject a double dose to make up for a missed single dose.
If you have any questions about how to use this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Allergic (anaphylactic) reactions, ranging from moderate to severe, have been reported in some patients treated with SOMAVERT. Symptoms of a severe allergic reaction may include one or more of the following: swelling of the face, tongue, lips or throat; wheezing or difficulty breathing (laryngeal spasm); generalized rash, hives or itching; or dizziness. Inform your doctor immediately if you notice any of these symptoms.

Very common (may affect more than 1 in 10 people)

• Headache
• Diarrhoea
• Joint pain

Common (may affect up to 1 in 10 people)

• Shortness of breath
• Increased levels of substances measuring liver function. These increases can be seen in blood test results.
• Blood in the urine
• Increased blood pressure
• Constipation, nausea, vomiting, bloating, indigestion, gas in the intestine
• Dizziness, drowsiness, uncontrollable tremor, reduced sensitivity to touch
• Bruising or bleeding at injection site, pain or swelling at injection site, accumulation of fat under the skin at the injection site, swelling of extremities, weakness, fever
• Sweating, itching, rash, tendency to bruise
• Muscle pain, arthritis
• Increased cholesterol in the blood, weight gain, increased blood glucose, decreased blood glucose
• Influenza-like illness, fatigue
• Altered dreams
• Eye pain

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction after administration (fever, rash, itching, and, in severe cases, difficulty breathing, rapid swelling of the skin requiring urgent medical intervention). These may occur immediately or several days after administration.
• Protein in the urine, increased urination, kidney problems
• Loss of interest, feeling confused, increased sexual drive, panic attacks, memory loss, sleep disorders
• Reduced platelets in the blood, increased or decreased white blood cells in the blood, tendency to bleed
• Abnormal sensations, impaired healing
• Eye fatigue, inner ear problems
• Facial swelling, dry skin, night sweats, skin redness (erythema), raised itchy skin welts (urticaria)
• Increased fatty acids in the blood, increased appetite
• Dry mouth, increased salivation, dental problems, haemorrhoids
• Altered sense of taste, migraine

Not known (frequency cannot be estimated from available data)

• Rage
• Severe dyspnoea (laryngospasm)
• Tendency to rapid swelling of the skin and underlying tissue and the internal lining (mucosa) of organs (angioedema)

Approximately 17% of patients undergoing treatment will develop antibodies against growth hormone. It appears that these antibodies do not interfere with the activity of this medicine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOMAVERT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and on the outer packaging after "Exp". The expiry date refers to the last day of that month.
Store the powder vials in the refrigerator (2°C – 8°C) in their original packaging to protect the medicine from light. Do not freeze.
Packages containing SOMAVERT powder vials may be stored at room temperature up to a maximum of 25°C for a period not exceeding 30 days. Write the final use-by date on the package, indicating day/month/year, calculated as 30 days from the date of removal from the refrigerator. The vials must be protected from light. Do not put this medicine back into the refrigerator.
Dispose of this medicine if it is not used by the final use-by date of the vials or by the printed expiry date on the packaging, whichever comes first.
Store the pre-filled syringes at a temperature below 30°C or in the refrigerator (2°C–8°C). Do not freeze.
After reconstitution, the SOMAVERT solution should be used immediately.
Do not use this medicine if you notice that the solution is cloudy or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What SOMAVERT contains

• The active substance is pegvisomant.
• SOMAVERT 10 mg: one vial of powder contains 10 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of solution contains 10 mg of pegvisomant.
• SOMAVERT 15 mg: one vial of powder contains 15 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of solution contains 15 mg of pegvisomant.
• SOMAVERT 20 mg: one vial of powder contains 20 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of solution contains 20 mg of pegvisomant.
• SOMAVERT 25 mg: one vial of powder contains 25 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of solution contains 25 mg of pegvisomant.
• SOMAVERT 30 mg: one vial of powder contains 30 mg of pegvisomant. After reconstitution with 1 mL of solvent, 1 mL of solution contains 30 mg of pegvisomant.
• The other components are: glycine, mannitol (E421), dibasic sodium phosphate anhydrous and monobasic sodium phosphate monohydrate (see section 2 “SOMAVERT contains sodium”).
• The solvent is water for injections.

Description of the appearance of SOMAVERT and contents of the pack
SOMAVERT consists of a white powder and a solvent for injectable solution (10 mg, 15 mg, 20 mg, 25 mg or 30 mg of pegvisomant in a vial and 1 mL of solvent in a pre-filled syringe). Packs are available in pack sizes of 1 and/or 30. Not all pack sizes may be marketed. The powder is white and the solvent is clear and colourless.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: +370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: +359 2 970 4333 Tel.: + 36 1 488 37 00

Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420 283 004 111 Tel: +356 21344610

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς Α.Ε. Pfizer Polska Sp. z o.o.
Τηλ: +30 210 6785800 Tel.: +48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500

France România
Pfizer Pfizer Romania S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: + 385 1 3908 777 Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: 1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: +44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00

Κύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited
Τηλ: +357 22817690 Tel: +44 (0)1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.
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INSTRUCTIONS FOR USE

SOMAVERT powder in vial with solvent in a pre-filled syringe

pegvisomant for injectable solution
for subcutaneous use only
single-dose vial

SOMAVERT is supplied as a white powder layer in a vial. Before use,
SOMAVERT must be mixed with a liquid (diluent).
The liquid is supplied in a pre-filled syringe labelled “Solvent for SOMAVERT”.
Do not mix SOMAVERT with any other liquid.
It is important that you or anyone else does not administer the injections unless properly trained by a healthcare professional.

Store the vial packaging in the refrigerator at a temperature between 2°C and 8°C, protected from direct sunlight.
The packaging containing the SOMAVERT powder vials may be stored at room temperature up to a maximum of 25°C for no longer than 30 days.
Write the expiry date of the vials on the packaging, indicating day/month/year, counting 30 days from the date the vials were removed from refrigeration.
The vials must be protected from light. Do not return this medicine to the refrigerator.
Dispose of this medicine if it is not used by the new expiry date of the vials or by the expiration date printed on the packaging, whichever comes first.

Pre-filled syringes may be stored at room temperature. Keep out of the reach of children.

1. What you will need

A single package of SOMAVERT containing:

• one vial of SOMAVERT powder
• one pre-filled syringe with solvent
• one safety needle

You will also need:

• a cotton ball
• an alcohol swab
• a sharps container

Vial Vial

Syringe

Safety needle

2. Preparation

Before starting:

• Mix SOMAVERT and the solvent only when you are ready to inject your dose.
• Remove one SOMAVERT pack from the refrigerator and allow it to reach room temperature naturally in a safe place.
• Wash your hands with soap and water and dry them thoroughly.
• Open the syringe and safety needle package so that they are easy to access while preparing for the injection.
• Do not use the syringe or vial if:
  - they are damaged or defective;
  - the expiry date has been exceeded;
  - the syringe has been frozen, even if it is now thawed.

3. Choose the injection site

Choose the injection site
3

• For each injection, select a different spot within the injection area.
• Avoid bruised, red, tender, or hard areas, as well as areas with scars or skin conditions.
• Clean the injection site with an alcohol swab according to the healthcare provider's instructions.
• Allow the injection site to dry.

4. Remove the vial cap

Remove the cap
4
of the vial

• Remove the cap from the vial.
• Discard the cap; it will not be used again. Caution: Avoid touching the vial's rubber stopper.

5. Remove the syringe cap

Remove the
5
syringe cap

• Snap off the syringe cap. This may require more force than expected.
• Discard the syringe cap; it will no longer be needed.
• Hold the syringe upright to prevent leakage. Caution: Avoid touching the tip of the syringe once the cap has been removed.

6. Insert the safety needle

Insert the safety needle
6

• Screw the safety needle firmly onto the syringe until it locks into place.

7. Remove the needle cover

Remove the
7
needle cover

• Bend the needle guard to release the needle cover.
• Carefully remove the needle cover.
• Discard the needle cover, as it will no longer be needed. Caution: Avoid contact between the needle and any surface.

8. Insert the needle

Insert the needle
8

• Insert the needle through the center of the rubber stopper of the vial as shown in the figure.
• Hold the syringe while the needle is inserted into the rubber stopper of the vial to prevent it from bending.

9. Adding the liquid

9 Adding the liquid

• Tilt the vial and syringe as shown in the figure.
• Push the plunger slowly until all the liquid has been emptied into the vial.
• Caution: Do not squirt the liquid directly onto the powder, as this will create foam. Foam makes the medicine unusable.
• Do not remove the needle yet.

10. Rotate the vial

10 Rotate the vial

• Hold the syringe and the vial in one hand as shown in the figure.
• Gently swirl the liquid with a rotating motion by moving the vial in a circular movement on a flat surface.
• Continue swirling the liquid until the powder has completely dissolved. Note: this may take up to 5 minutes.

11. Check the medicine

11 Check the medicine

• With the needle inserted into the vial, carefully inspect the medicine. It must be clear and free of particles.
• Do not use if:
  • the medicine is cloudy or not clear;
  • the medicine has any colour;
  • there are particles or a layer of foam in the vial.

12. Reposition the needle

12 Reposition the needle

• Rotate the vial so that the space in the rubber stopper is visible, as shown in the figure.
• Pull the needle downward so that the tip is positioned at the lowest point of the liquid. This will help draw up as much liquid as possible.
• Check that the plunger has not moved; if it has, push it back fully into the syringe. This ensures that all air is expelled from the syringe before drawing up the dose.

13. Draw up the dose

Draw up the dose
13

• Slowly pull back the plunger to draw up as much medication as possible from the vial. Note: if air is visible in the syringe, gently tap the barrel to allow air bubbles to rise to the surface, then gently push them back into the vial.
• Remove the needle from the vial.

14. Insert the needle

Insert the needle
14

• Gently pinch the skin at the injection site.
• Insert the needle completely into the skin.

15. Inject the medicine

15 Inject the medicine

• Push the plunger slowly until the syringe is empty. Note: Make sure the needle remains fully inserted at all times.
• Release the skin and withdraw the needle.

16. Safely secure the needle

Safely secure the needle
16

• Fold the needle guard over the needle.
• Gently apply pressure using a hard surface to close the needle guard. Note: You will hear a click when the needle guard is closed.

17. Disposal

Disposal
17

• The syringe and needle must NEVER be reused. Dispose of the needle and syringe according to the instructions provided by your doctor, nurse, or pharmacist, and in accordance with local regulations regarding health and safety.

18. After Injection

After Injection
18

• If necessary, use a clean cotton ball and gently press it against the injection site.
• Do not rub the area.

QUESTIONS AND ANSWERS
What should I do if I accidentally touch the rubber stopper of the vial?

• Clean the vial’s rubber stopper with a new alcohol wipe and allow it to dry completely. If the rubber stopper cannot be cleaned, do not use the vial.

What should I do if the syringe has fallen?

• Do not use it, even if it does not appear damaged. Dispose of the syringe as you would with a used one. You will need a new syringe.

How many times can I insert the needle into the vial’s rubber stopper?

• Only once. Removing and reinserting the needle greatly increases the risk of damaging it. This may cause discomfort and increase the risk of skin damage and infection. There is also a risk of losing some of the medication.

Can I shake the vial if the powder does not dissolve?

• No, never shake the vial. Shaking may destroy the medication and cause foaming. It may take several minutes for the powder to dissolve completely. Continue gently swirling the vial in a circular motion until the solution is completely clear.

How can I tell if there is foam in the vial?

• Foam is a layer of small bubbles floating on the surface of the liquid. Do not inject SOMAVERT if it is foamy.

How can I prevent foam from forming?

• Push the plunger very slowly so that the liquid flows gently into the vial. Do not spray the liquid directly onto the powder, as this creates foam. This technique will also reduce the swirling time and allow you to draw up more medication.

There is visible air in the syringe. Can I still use it?

• Tiny air bubbles in the liquid are normal and the injection can be administered without problems. However, you may accidentally draw air into the syringe, which must be removed before administering the injection. Any bubbles or air accumulating at the liquid surface should be pushed back into the vial.

Why can't I draw up all the medication from the vial?

• The vial is designed in such a way that a very small amount of medication will remain inside. This is normal. To ensure only traces of medication are left, make sure the tip of the needle is at the lowest point inside the vial while drawing up the dose.

What should I do if I have doubts about my medication?

• For any questions, consult a doctor, nurse, or pharmacist experienced with SOMAVERT.