Somavert 25 mg polvo y disolvente para solucion inyectable

Prospect: information for the user

SOMAVERT 10 mg powder and solvent for injectable solution

SOMAVERT 15 mg powder and solvent for injectable solution

SOMAVERT 20 mg powder and solvent for injectable solution

SOMAVERT 25mg powder and solvent for injectable solution

SOMAVERT 30mg powder and solvent for injectable solution

pegvisomant

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section4.

SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from an increase in growth hormone (GH) secretion and IGF‑I (insulin-like growth factor), and is characterized by excessive growth of bones, thickening of soft tissues, heart disease, and related disorders.

The active ingredient of SOMAVERT, pegvisomant, is known as a growth hormone receptor antagonist. These substances reduce the action of GH and circulating IGF‑I levels.

Do not use SOMAVERT

• If you are allergic to pegvisomant or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use SOMAVERT.

• If you experience vision problems or headaches, tell your doctor immediately.

• Your doctor or nurse will monitor your IGF‑I (insulin-like growth factor) levels in the blood and adjust the SOMAVERT dose as needed.

• Your doctor will also monitor your adenoma (benign tumor).

• Your doctor will perform liver function tests before starting and during treatment with SOMAVERT. If the test results are not normal, your doctor will discuss treatment options with you. Once treatment begins, your doctor or nurse will monitor your liver enzyme levels in the blood every 4‑6 weeks for the first 6months of treatment with SOMAVERT. SOMAVERT administration should be suspended if liver disease symptoms persist.

• If you are diabetic, your doctor may need to adjust the amount of insulin or other medications you are taking.

• Fertility in patients may increase as the disease improves. This medication is not recommended for pregnant women, and women of childbearing age should use a contraceptive method. See also the section on Pregnancy below.

Other medications and SOMAVERT

Tell your doctor if you have previously used another medication for the treatment of acromegaly or any medication for the treatment of diabetes.

Inform your doctor or pharmacist if you are using or have recently used any other medication. As part of your treatment, you may be treated with other medications. It is essential to continue using all medications, including SOMAVERT, unless you receive other instructions from your doctor, pharmacist, or nurse.

Pregnancy, breastfeeding, and fertility

This medication is not recommended for pregnant women. If you are of childbearing age, use a contraceptive method during treatment.

It is not known whether pegvisomant passes into breast milk. Do not breastfeed while taking SOMAVERT unless you have discussed this with your doctor.

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

SOMAVERT contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will administer an initial dose of 80 mg of pegvisomant subcutaneously (under the skin). After that, the usual daily dose is 10 mg of pegvisomant administered subcutaneously (under the skin).

Every 4-6 weeks, your doctor will make the necessary dose adjustments by increasing the dose by 5 mg of pegvisomant per day, according to your blood levels of the mentioned IGF-I, in order to achieve an optimal therapeutic response.

Form and Route of Administration

SOMAVERT is injected under the skin. The injection can be given by yourself or another person, such as your doctor or assistant. You must follow the detailed instructions on the injection process, which are included at the end of this leaflet. You should continue injecting this medication for as long as your doctor tells you to.

This medication must be dissolved before use. The injection should not be mixed in the same syringe or vial with another medication.

The fatty tissue of the skin may increase at the injection site. To avoid this, use slightly different injection points each time, as described in step 2 of the section of this leaflet “Instructions for Preparation and Administration of a SOMAVERT Injection”.This will give your skin and the area under the skin time to recover between injections before injecting in the same place again.

If you think the effect of this medication is too strong or too weak, talk to your doctor, pharmacist, or nurse.

If you inject more SOMAVERT than you should

If you accidentally inject more SOMAVERT than your doctor told you to, it is unlikely to be serious but you should tell your doctor, pharmacist, or nurse 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 continue injecting SOMAVERT as prescribed by your doctor. Do not inject a double dose to make up for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe allergic reactions (anaphylactic) have been reported in some patients taking SOMAVERT. Symptoms of a severe allergic reaction may include one or more of the following: swelling of the face, tongue, lips, or throat; ringing or difficulty breathing (laryngospasm); generalized skin rash, urticaria, or itching; or dizziness. Contact your doctor immediately if you experience any of these symptoms.

Very common: may affect more than 1 in 10 people:

• Headache.
• Diarrhea.
• Joint pain.

Common: may affect up to 1 in 10 people:

• Difficulty breathing.
• Increases in substances that determine liver function. May be seen in blood test results.
• Blood in the urine.
• High blood pressure.
• Constipation, discomfort, feeling sick, feeling bloated, indigestion, flatulence.
• Dizziness, drowsiness, uncontrolled tremor, decreased sense of touch.
• Cardinal signs or bleeding at the injection site, pain or swelling at the injection site, increased subcutaneous fat at the injection site, swelling of the extremities, weakness, fever.
• Sweating, itching, rash, tendency to have cardinal signs.
• Muscle pain, arthritis.
• Increased cholesterol in the blood, weight gain, increased blood glucose, decreased blood glucose.
• Flu-like symptoms, fatigue.
• Abnormal dreams.
• Eye pain.

Uncommon: may affect up to 1 in 100 people:

• Allergic reaction after administration (fever, rash, pruritus, and, in severe cases, difficulty breathing, rapid skin swelling, which require urgent medical attention). May occur immediately or several days after administration.
• Proteins in the urine, increased urine output, kidney problems.
• Lack of interest, feeling of confusion, increased libido, panic attacks, memory loss, difficulty sleeping.
• Reduced platelets in the blood, increased or decreased white blood cells in the blood, tendency to bleed.
• Abnormal sensation, alteration in wound healing.
• Eye heaviness, inner ear problems.
• Swelling of the face, skin dryness, nocturnal sweating, skin redness (erythema), itching, and raised skin rashes (urticaria).
• Increased fatty substances in the blood, increased appetite.
• Mouth dryness, increased salivation, dental problems, hemorrhoids.
• Abnormal sense of taste, migraines.

Unknown: cannot be estimated from available data:

• Irritability.
• Severe difficulty breathing (laryngospasm).
• Rapid skin swelling, underlying tissue, and internal lining (mucosa) of organs (angioedema).

Approximately 17% of patients will develop antibodies against growth hormone during treatment. It appears that antibodies do not affect the action of this medication.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse,even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the vials and on the packaging after EXP. The expiration date is the last day of the month indicated.

Store the powder vial(s) in the refrigerator (between 2°C and 8°C) in its packaging to protect it from light. Do not freeze.

The packaging that contains the powder vial(s) of SOMAVERT can be stored at room temperature up to a maximum of 25°C for a single period of up to 30days. Write the expiration date on the packaging, including the day/month/year (up to 30days from the date of removal from the refrigerator). The vial(s) must be protected from light. Do not put this medication back in the refrigerator.

Discard this medication if it is not used before the new expiration date or the expiration date printed on the packaging, whichever occurs first.

Store the pre-filled syringe(s) at a temperature below 30°C or store in the refrigerator (between 2°C and 8°C). Do not freeze.

After preparing the SOMAVERT solution, it must be used immediately.

Do not use this medication if you observe that the solution is cloudy or contains particles.

Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of SOMAVERT

• The active ingredient is pegvisomant.
• SOMAVERT 10mg: a vial of powder contains 10mg of pegvisomant. After reconstitution with 1 ml of solvent, 1ml of solution contains 10mg of pegvisomant.
• SOMAVERT 15mg: a vial of powder contains 15mg of pegvisomant. After reconstitution with 1 ml of solvent, 1ml of solution contains 15mg of pegvisomant.
• SOMAVERT 20mg: a vial of powder contains 20mg of pegvisomant. After reconstitution with 1 ml of solvent, 1ml of solution contains 20mg of pegvisomant.
• SOMAVERT 25mg: a vial of powder contains 25mg of pegvisomant. After reconstitution with 1 ml of solvent, 1ml of solution contains 25mg of pegvisomant.
• SOMAVERT 30mg: a vial of powder contains 30mg of pegvisomant. After reconstitution with 1 ml of solvent, 1ml of solution contains 30mg of pegvisomant.
• The other components are glycine, mannitol (E-421), anhydrous sodium phosphate, and monohydrate dihydrogen phosphate of sodium (see section 2 “SOMAVERT contains sodium”).
• The solvent is water for injection.

Appearance of the product and contents of the pack

SOMAVERT is presented as a powder and solvent for injection (in a vial of 10 mg, 15 mg, 20 mg, 25 mg, or 30 mg of pegvisomant and 1 ml of solvent in a pre-filled syringe). Pack sizes of 1 and/or 30.Only some pack sizes may be marketed..The powder is white and the solvent is transparent and colourless.

Marketing authorisation holder and responsible person for manufacturing:

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible person for manufacturing

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics: 02/2025.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

INSTRUCTIONS FOR USE

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

pegvisomant for injection

For subcutaneous injection only

Single-dose vial

SOMAVERT is presented as a white powder in a vial. It must be mixed with a liquid (solvent) before use.

The solvent is presented in a pre-filled syringe with the label “Solvent for SOMAVERT”.

Do not mix SOMAVERT with any other liquid.

It is essential that you do not attempt to administer an injection to yourself or another person without having received training from a healthcare professional.

Store the vials of powder in the refrigerator between 2°C and 8°C and away from direct sunlight.

The pack containing the vial of powder of SOMAVERT can be stored at room temperature up to a maximum of 25°C for a single period of up to 30days. Write the expiry date on the pack, including the day/month/year (up to 30days from the date of removal from the refrigerator). The vial must be protected from light. Do not return this medicinal product to the refrigerator.

Dispose of this medicinal product if it is not used before the new expiry date or the expiry date printed on the pack, whichever occurs first.

The pre-filled syringe of solvent can be stored at room temperature. Keep out of the reach of children.

1. What you need

A pack of SOMAVERT containing:

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

You will also need:

• A cotton ball
• Alcohol swab
• A suitable sharps container

1. Preparation

Before starting:

• Prepare to administer the dose.
• Remove one pack of SOMAVERT 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 packaging of the syringe and safety needle to make it easier to handle each component while preparing for the injection.
• Do not use the syringe or vial if:
• • they are damaged or defective;
  • the expiry date has passed;
  • the syringe has frozen, even if it has been thawed afterwards (only the syringe).

1. Choose an injection site

• Choose a different site within each area for injection.
• Avoid bony, red, painful, or hard areas, or areas with ecchymosis, scars, or skin diseases.
• Clean the injection site with an alcohol swab as instructed by your healthcare professional.
• Wait for the injection site to dry.

1. Remove the vial cap

• Remove the vial cap.
• Dispose of the cap; it is not needed again.

Caution:Do not let anything touch the vial cap.

1. Remove the syringe cap

• Remove the syringe cap. You may need more force than expected.
• Dispose of the syringe cap; it is not needed again.
• Hold the syringe in a vertical position to prevent leakage.

Caution:Do not let the syringe tip touch anything once the cap has been removed.

1. Attach the safety needle

• Attach the safety needle to the syringe by turning it firmly as much as possible.

1. Remove the protective cover of the needle

• Doubly outward the protective cover of the needle, separating it from the protective cover of the needle.
• Carefully pull the protective cover of the needle directly outward.
• Dispose of the protective cover of the needle; it is not needed again.

Caution:Do not let the needle touch anything.

1. Insert the needle

• Push the needle through the centre of the vial cap as indicated.
• Hold the syringe while the needle is inserted in the vial cap to prevent the needle from bending.

1. Add the liquid

• Incline the vial and syringe to form an angle as indicated.
• Push the plunger rod slowly until all the liquid is inside the vial.
• Caution:Ensure the liquid does not fall directly onto the powder, as this will form foam. Foam makes the medicinal product unusable.
• Do not remove the needle yet.

1. Mix the medicinal product

• Suspend the syringe and vial with one hand as indicated.
• Mix the liquid gently by rotating the vial on a flat surface.
• Continue mixing the liquid until the powder is completely dissolved.

Nota:This may take up to 5 minutes.

1. Examine the medicinal product

• With the needle still inserted in the vial, inspect the medicinal product carefully. It must be transparent and without particles.
• Do not use it if:
• • the medicinal product is turbid or dark;
  • the medicinal product has a colour;
  • it contains particles or has a foam layer in the vial.

1. Reposition the needle

• Turn the vial so you can see the space in the vial cap, as indicated.
• Pull the needle downwards so the tip of the needle is in the lowest point in the liquid. This will help you extract as much liquid as possible.
• Check that the plunger rod has not moved. If it has, push it back in completely to ensure all air has been removed from the syringe before extracting the dose.

1. Extract the dose

• Pull the plunger rod slowly to extract as much medicinal product as possible from the vial.

Nota:If you see air in the syringe, press the syringe plungerto move thebubbles upwards, and then push the bubbles slowlyinto the vial.

• Remove the needle from the vial.

1. Insert the needle

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

1. Inject the medicinal product

• Pull the plunger rod downwards slowly until the syringe is empty.

Nota:Ensure the needle is inserted completely.

• Release the pinched skin and remove the needle in a straight line.

1. Secure the needle

• Doubly the protective cover of the needle over the needle.
• Carefullypress against a hard surface to close the protective cover of the needle.

Nota:You will hear a click when the protective cover of the needle is closed.

1. Dispose of

• The syringe and needle must never be reusedEVER. Dispose of the needle and syringe as instructed by your doctor, nurse, or pharmacist and in accordance with local health and safety guidelines and legislation.

1. After the injection

• If necessary, press gently with a clean cotton ball on the injection site.
• Do not rub the area.

QUESTIONS AND ANSWERS

What should I do if something has accidentally touched the vial cap?

• Clean the vial cap with a new alcohol swab, and let it dry completely. If you are unable to clean the vial cap, do not use the vial.

What should I do with the syringe if it has fallen?

• Do not use it, even if it appears to be undamaged. Dispose of the syringe in the same way as you dispose of a used syringe.You will need another syringe.

How many times can I safely insert the needle into the vial cap?

• Only once. Extracting and reinserting the needle significantly increases the risk of needle damage and may cause discomfort and increase the risk of skin damage and infection. There is also a risk of losing some of the medicinal product.

Is it okay to shake the vial if the powder does not dissolve?

• No, never shake the vial. Shaking may render the medicinal product unusable and form foam. The powder may take a few minutes to dissolve completely, so continue rotating the vial slowly in a circular motion until the liquid is completely transparent.

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

•Foam appears as a mass of small bubbles that float forming a layer on the liquid. Do not inject SOMAVERT if foam has formed.

How can I avoid foam forming in the medicinal product?

• Pull the plunger rod slowly so the liquid flows smoothly into the vial. Do not let the liquid fall directly onto the powder, as this will form foam. This technique will also reduce the time needed to mix the medicinal product and allow more medicinal product to be extracted.

I can see some air in the syringe. Is that okay?

• The small air bubbles in the liquid are normal, and the injection is safe. However, it is possible to accidentally suck in some air into the syringe, which must be removed before the injection. The air bubbles or spaces floating on the liquid must be expelled into the vial.

Why can I not extract all the medicinal product from the vial?

• The shape of the vial means that a small amount of medicinal product remains in the vial. This is normal. To ensure that only a small amount of medicinal product remains in the vial, ensure when extracting the dose that the tip of the needle is inserted as far as possible into the vial.

What should I do if I have any doubts about the medicinal product?

• All questions should be directed to a doctor, nurse, or pharmacist with experience with SOMAVERT.