VASTALOMA 250 mg /5 Ml Solution

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: information for the patient
3. Vastaloma, 250 mg/5 ml, solution for injection in a pre-filled syringe
   1. Please read carefully the contents of the leaflet before using the medicine, as it contains
   2. Table of contents of the leaflet
4. What is Vastaloma and what is it used for
5. Important information before taking Vastaloma
   1. When NOT to take Vastaloma
   2. Warnings and precautions
   3. Children and adolescents
   4. Vastaloma and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Vastaloma contains ethanol (alcohol)
   8. Vastaloma contains 500 mg of benzyl alcohol
   9. Vastaloma contains 750 mg of benzyl benzoate
6. How to take Vastaloma
7. Possible side effects
   1. Severe side effects
   2. In case of the following side effects, please contact your doctor immediately:
   3. If you experience any of the following side effects, please inform your doctor, pharmacist, or nurse:
   4. All other side effects:
   5. Reporting side effects
8. How to store Vastaloma
9. Contents of the pack and other information
   1. What Vastaloma contains
   2. What Vastaloma looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the following EU member states under the names:
   6. European Union:
   7. Date of last revision of the leaflet:
   8. Information intended for healthcare professionals only:
   9. Administration instructions

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the patient

Vastaloma, 250 mg/5 ml, solution for injection in a pre-filled syringe

Fulvestrant

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• Please keep this leaflet, you may need to read it again.
• In case of any doubts, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Vastaloma and what is it used for
• 2. Important information before taking Vastaloma
• 3. How to take Vastaloma
• 4. Possible side effects
• 5. How to store Vastaloma
• 6. Contents of the pack and other information

1. What is Vastaloma and what is it used for

Vastaloma contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes influence the development of breast cancer.
Vastaloma is used:

• as a single medicine, in the treatment of postmenopausal women with a certain type of breast cancer called hormone receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastases) or
• in combination with palbociclib in the treatment of women with a certain type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer, which is locally advanced or has spread to other parts of the body (metastases). Women who have not yet reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Vastaloma is given in combination with palbociclib, it is also important to read the patient information leaflet accompanying the packaging of palbociclib. If you have any questions about palbociclib, please consult your doctor.

2. Important information before taking Vastaloma

When NOT to take Vastaloma

• if you are allergic to fulvestrant or any of the other ingredients of Vastaloma (listed in section 6)
• if you are pregnant or breastfeeding
• if you have severe liver function disorders

Warnings and precautions

Please inform your doctor or pharmacist or nurse before taking Vastaloma if you have ever had the following health problems:

• if you have ever had kidney or liver disease
• if you have had a reduced platelet count (which enables blood to clot) or bleeding disorder
• if you have ever had a blood clotting disorder
• if you have ever had problems with reduced bone mineral density (osteoporosis)
• alcohol dependence.

Children and adolescents

Vastaloma is not used in children and adolescents under 18 years of age.

Vastaloma and other medicines

Please tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, please inform your doctor if you are taking anticoagulant medicines (medicines that prevent blood clots).

Pregnancy and breastfeeding

Vastaloma must not be used during pregnancy. If you may become pregnant, you should use effective contraception during treatment with Vastaloma and for 2 years after the last dose.
Do not breastfeed during treatment with Vastaloma.

Driving and using machines

It has not been shown that Vastaloma affects the ability to drive or use machines. If you feel tired after taking Vastaloma, do not drive or use machines.

Vastaloma contains ethanol (alcohol)

Vastaloma contains 500 mg of ethanol in each injection, which corresponds to 100 mg/ml (10% m/v). This amount in each injection of this medicine corresponds to 13 ml of beer or 5 ml of wine.
It is unlikely that the amount of alcohol in this medicine will have an effect on adults and adolescents.
The alcohol in this medicine may affect the action of other medicines. If you are taking other medicines, please discuss this with your doctor or pharmacist.
If you are pregnant or breastfeeding, please inform your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, please inform your doctor or pharmacist before taking this medicine.

Vastaloma contains 500 mg of benzyl alcohol

Vastaloma contains 500 mg of benzyl alcohol in each pre-filled syringe,
which corresponds to 100 mg/ml. Benzyl alcohol may cause allergic reactions.

Vastaloma contains 750 mg of benzyl benzoate

Vastaloma contains 750 mg of benzyl benzoate in each pre-filled syringe, which corresponds to
150 mg/ml.

3. How to take Vastaloma

Vastaloma is given by a doctor or nurse. The medicine will be slowly injected intramuscularly in two consecutive injections of 5 ml, each into a different buttock.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), given once a month
and an additional dose of 500 mg given 2 weeks after the first dose.
If you have any further doubts about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

In case of the following side effects, please contact your doctor immediately:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat, which may be symptoms of anaphylactic reactions
• blood clotting disorders (increased risk of venous thrombosis)*
• hepatitis
• liver failure

If you experience any of the following side effects, please inform your doctor, pharmacist, or nurse:

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

• injection site reactions, such as pain and/or inflammation
• changes in liver enzyme activity (in blood tests)*
• nausea
• feeling weak, fatigue*
• joint and muscle pain
• hot flashes
• skin rash
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat

All other side effects:

Common side effects(may affect up to 1 in 10 people)

• headache
• vomiting, diarrhea or loss of appetite*
• urinary tract infections
• back pain*
• increased bilirubin levels (a pigment produced by the liver)
• blood clotting disorders (increased risk of venous thrombosis)*
• reduced platelet count (thrombocytopenia)
• vaginal bleeding
• lower back pain radiating to one leg (sciatica)
• sudden weakness, numbness, tingling or loss of mobility in a leg, especially on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy)

Uncommon side effects(may affect up to 1 in 100 people)

• thick, white vaginal discharge and vaginal candidiasis (infection)
• bruising and bleeding at the injection site
• increased activity of the liver enzyme gamma-glutamyltransferase, measured in blood tests
• hepatitis
• liver failure
• numbness, tingling and pain
• anaphylactic reactions

* Includes side effects for which the impact of Vastaloma cannot be assessed due to the underlying disease.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, please inform your doctor, pharmacist, or nurse. Department of Adverse Reaction Monitoring of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vastaloma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label on the syringe after EXP. The expiry date refers to the last day of the month.
Store and transport in a cool place (2°C - 8°C).
Limit storage of the product at a temperature other than 2°C - 8°C. Avoid storing above 30°C and do not exceed 28 days with an average storage temperature below 25°C (but above the range 2°C - 8°C). If the temperature range is exceeded, please apply the recommended storage conditions immediately (store and transport in a cool place 2°C - 8°C). Exceeding the recommended storage temperature may have a cumulative effect on the quality of the product and the 28-day period must not be exceeded during the shelf life of Vastaloma. Exposure to temperatures below 2°C does not damage the product if it is not stored below -20°C.
Store the pre-filled syringe in its original packaging to protect it from light.
Medical personnel are responsible for proper storage, use, and disposal of the packaging after using Vastaloma.
This medicine may pose a risk to the aquatic environment. Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vastaloma contains

The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
The other ingredients (excipients) are: ethanol (96 percent), benzyl alcohol (E1519),
benzyl benzoate, purified castor oil.

What Vastaloma looks like and contents of the pack

Vastaloma is a clear, colorless to yellowish, viscous solution in a pre-filled syringe made of colorless glass type I, with a plunger made of polystyrene ended with a rubber stopper, with a protective cap in a cardboard box, containing 5 ml of fulvestrant solution. Two pre-filled syringes should be used to administer the recommended monthly dose of 500 mg.
Three pack sizes of the medicinal product Vastaloma are available, containing 1, 2 or 6 pre-filled syringes. The packs also contain 1, 2 or 6 needles for administering the medicinal product with a safety system (BD SafetyGlide).

Marketing authorization holder

Alvogen Pharma Trading Europe EOOD
86 Bulgaria blvd.,
1680 Sofia
Bulgaria

Manufacturer

Laboratorios Farmalán, S.A.
Calle La Vallina, s/n, Edificio 2
Polígono Industrial Navatejera
24193 Villaquilambre, León
Spain

This medicine is authorized in the following EU member states under the names:

European Union:

Netherlands
Vastaloma 250 mg oplossing voor injectie in een voorgevulde spuit
Bulgaria
Васталома 250 mg инжекционен разтвор в предварително напълнена
спринцовка
Hungary
Vastaloma 250mg oldatos injekció előretöltött fecskendőben
Iceland
Vastaloma
Poland
Vastaloma
Romania
Vastaloma 250 mg soluție injectabilă seringa preumpluta

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Vastaloma,500 mg (2 x 250 mg/5 ml, solution for injection) should be administered using
two pre-filled syringes (see section 3).

Administration instructions

Caution– Do not put the needle with a safety system (BD SafetyGlide, Safety Hypodermic Needle) in an autoclave before use. When handling the medicine and disposing of its remains, avoid hand contact with the needle.
Applicable to both syringes:

• Remove the glass syringe from the container and check if it is damaged.
• Open the outer packaging of the needle with a safety system (BD SafetyGlide).
• Before administering parenteral solutions, visually inspect them for the presence of particulate matter and color change.
• Hold the syringe vertically in the striped part (C). With the other hand, grasp the cap (A) and carefully twist the rigid plastic cap of the tip counterclockwise (see Figure 1).

Figure 1

• Remove the rigid plastic cap of the tip (A) in a vertical position upwards. To maintain sterility, do not touch the tip of the syringe (B) (see Figure 2).

Figure 2

• Attach the needle with a safety system to the Luer-Lock tip and tighten it securely (see Figure 3).
• Check if the needle is connected to the Luer-Lock tip before moving to a vertical position.
• Bring the filled needle close to the injection site.
• Remove the needle cap.
• Remove any excess air from the syringe.

Figure 3

• The medicine should be administered intramuscularly, slowly (1-2 minutes/injection), into the buttock muscle (the site on the buttock). For the convenience of the person administering, the needle bevel is on the same surface as the safety needle guard (see Figure 4)

Figure 4

• Immediately after injection, activate the safety needle guard by moving the arm of the guard forward with one finger motion (see Figure 5).

Note: proceed in such a way as to ensure your safety and the safety of others. Listen for the click and visually confirm that the needle tip is fully covered.

Figure 5
Disposal of remains
The pre-filled syringe is for single use.
This medicine may pose a risk to the aquatic environment. Any unused residues or its waste should be disposed of in accordance with local regulations.