Fulvestrant Vipharm

Package Leaflet: Information for the User

Fulvestrant Vipharm, 250 mg/ 5 mL, Solution for Injection in a Prefilled Syringe

Fulvestrant

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medication Has Been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Any Possible Side Effects Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 1. What is Fulvestrant Vipharm and What is it Used for
• 2. Important Information Before Using Fulvestrant Vipharm
• 3. How to Use Fulvestrant Vipharm
• 4. Possible Side Effects
• 5. How to Store Fulvestrant Vipharm
• 6. Package Contents and Other Information

1. What is Fulvestrant Vipharm and What is it Used for

Fulvestrant Vipharm Contains the Active Substance Fulvestrant, Which Belongs to a Group of Medications Known as Estrogen Receptor Antagonists. Estrogens, Female Sex Hormones, May Sometimes Influence the Development of Breast Cancer.

Fulvestrant Vipharm is Used:

• As a Single Medication, in the Treatment of Postmenopausal Women with a Certain Type of Breast Cancer Known as Hormone Receptor-Positive Breast Cancer, Which is Locally Advanced or Has Spread to Other Parts of the Body (Metastasized) or
• In Combination with Palbociclib in the Treatment of Women with a Certain Type of Breast Cancer Known as 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 (Metastasized). Women Who Have Not Yet Reached Menopause Will Also Receive a Medication Called a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist.

When Fulvestrant Vipharm is Used in Combination with Palbociclib, it is Also Important to Read the Package Leaflet for Palbociclib. If You Have Any Questions About Palbociclib, Ask Your Doctor.

2. Important Information Before Using Fulvestrant Vipharm

When Not to Use Fulvestrant Vipharm

• If You are Allergic to Fulvestrant or Any of the Other Ingredients of this Medication (Listed in Section 6)
• If You are Pregnant or Breastfeeding
• If You Have Severe Liver Function Disorders

Warnings and Precautions

Tell Your Doctor or Pharmacist or Nurse Before Using Fulvestrant Vipharm if You Have Ever Had Any of the Following Health Problems:

• If You Have Ever Had Kidney or Liver Disease
• If You Have Ever Had a Low Platelet Count (Which Allows Blood to Clot) or Bleeding Disorders
• If You Have Ever Had a Blood Clot Disorder
• If You Have Ever Had Problems with Bone Mineral Density (Osteoporosis)
• Alcohol Dependence

Children and Adolescents

Fulvestrant Vipharm is Not Recommended for Use in Children and Adolescents Under 18 Years of Age.

Fulvestrant Vipharm and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.

Pregnancy and Breastfeeding

Fulvestrant Vipharm Should Not be Used During Pregnancy. If You Can Become Pregnant, You Should Use Effective Contraception During Treatment with Fulvestrant Vipharm and for 2 Years After the Last Dose.

Driving and Using Machines

Fulvestrant Vipharm Has Not Been Shown to Affect the Ability to Drive or Use Machines. If You Experience Fatigue After Using Fulvestrant Vipharm, Do Not Drive or Use Machines.

This Medication Contains 500 mg of Alcohol (Ethanol) per Injection, Which is Equivalent to 100 mg/mL (10% w/v). The Amount of Alcohol in this Medication is Equivalent to 13 mL of Beer or 5 mL of Wine.

The Amount of Alcohol in this Medication is Unlikely to Have an Effect on Adults and Adolescents.

The Alcohol in this Medication May Affect the Action of Other Medications. If You are Taking Other Medications, Consult Your Doctor or Pharmacist.

Fulvestrant Vipharm Contains 500 mg of Benzyl Alcohol per Injection, Which is Equivalent to 100 mg/mL.

Benzyl Alcohol May Cause Allergic Reactions.

Fulvestrant Vipharm Contains 750 mg of Benzyl Benzoate per Injection

per Injection, Which is Equivalent to 150 mg/mL.

3. How to Use Fulvestrant Vipharm

This Medication Should Always be Used Exactly as Prescribed by Your Doctor or Pharmacist. If You are Unsure, Consult Your Doctor or Pharmacist.

The Recommended Dose is 500 mg of Fulvestrant (Two Injections of 250 mg/5 mL), Administered Once a Month, and an Additional Dose of 500 mg Administered 2 Weeks After the First Dose.

Fulvestrant Vipharm is Administered by a Doctor or Nurse. The Medication Will be Injected Slowly Into the Muscle in Two Consecutive Injections of 5 mL Each, in Different Buttocks.

If You Have Any Further Questions About the Use of this Medication, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like All Medications, Fulvestrant Vipharm Can Cause Side Effects, Although Not Everybody Gets Them.

If You Experience Any of the Following Side Effects, Contact Your Doctor Immediately:

• Allergic Reactions (Hypersensitivity), Including Swelling of the Face, Lips, Tongue, and/or Throat, Which May be Symptoms of Anaphylaxis
• Blood Clot Disorders (Increased Risk of Venous Thromboembolism)*
• Hepatitis
• Liver Failure

If You Experience Any of the Following Side Effects, Tell 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
• 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 Liver Pigment)
• Blood Clot Disorders (Increased Risk of Venous Thromboembolism)*
• Low Platelet Count (Thrombocytopenia)
• Vaginal Bleeding
• Lower Back Pain Radiating to the Leg on One Side of the Body (Sciatica)
• Sudden Weakness, Numbness, Tingling, or Loss of Mobility in the 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)
• Bluish Discoloration and Bleeding at the Injection Site
• Increased Activity of the Liver Enzyme Gamma-Glutamyltransferase, Measured in Blood Tests
• Hepatitis (Liver Inflammation)
• Liver Failure
• Numbness, Tingling, and Pain
• Anaphylactic Reactions * Includes Side Effects for Which the Impact of Fulvestrant Cannot be Assessed Due to the Presence of the Underlying Disease.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Possible Side Effects Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects Can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49-21-301, Fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl .

5. How to Store Fulvestrant Vipharm

Keep the Medication Out of the Sight and Reach of Children.

Do Not Use this Medication After the Expiration Date Stated on the Box or Label on the Syringe After the Abbreviation: EXP. The Expiration Date Refers to the Last Day of the Specified Month.

Store and Transport in a Refrigerator (2°C - 8°C).

Avoid Storing the Product at a Temperature Other Than 2°C - 8°C. Avoid Storing at a Temperature 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, the Recommended Storage Conditions Should be Applied Immediately (Store and Transport in a Refrigerator at 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 Within 2 Years of the Expiration Date of Fulvestrant Vipharm. Exposure to a Temperature Below 2°C Does Not Damage the Product if it is Not Stored at a Temperature Below -20°C.

Store the Prefilled Syringe in its Original Packaging to Protect it from Light.

Medical Personnel are Responsible for the Proper Storage, Use, and Disposal of the Packaging After the Medication has Been Used.

This Medication May Pose a Risk to the Aquatic Environment. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications That are No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Fulvestrant Vipharm Contains

• The Active Substance is Fulvestrant. Each Prefilled Syringe (5 mL) Contains 250 mg of Fulvestrant.
• The Other Ingredients are: Ethanol (96%), Benzyl Alcohol, Benzyl Benzoate, and Purified Castor Oil.

What Fulvestrant Vipharm Looks Like and What the Package Contains

Fulvestrant Vipharm is a Clear, Colorless to Yellowish, Viscous Solution in a Prefilled Syringe Made of Colorless Glass Type I, with a Piston Made of Polystyrene Terminated with a Rubber Stopper, with a Protective Cap in a Cardboard Box, Containing 5 mL of Fulvestrant Solution for Injection. To Administer the Recommended Monthly Dose of 500 mg, Two Prefilled Syringes Should be Injected.

Fulvestrant Vipharm is Available in 3 Different Package Sizes, Containing 1, 2, or 6 Prefilled Syringes. The Packages Also Contain 1, 2, or 6 Needles with a Safety System (BD Safety Glide), Respectively. Not All Package Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Vipharm S.A.

ul. A. i F. Radziwiłłów 9

05-850 Ożarów Mazowiecki

Manufacturer:

Laboratorios Farmalán, S.A.

Calle La Vallina s/n, Edificio 2

Polígono Industrial Navatejera

24193, Villaquilambre, León

Spain

This Medicinal Product Has Been Authorized in the Member States of the European Economic Area Under the Following Names:

Netherlands

Fulvefar 250 mg Solution for Injection in a Prefilled Syringe

Austria

Fulvestrant +pharma 250 mg Injection Solution in a Prefilled Syringe

Czech Republic

Fulvestrant Vipharm

Hungary

Fulvestrant Vipharm 250 mg Solution for Injection in a Prefilled Syringe

Poland

Fulvestrant Vipharm

Slovakia

Fulvestrant Vipharm 250 mg

Date of Last Revision of the Package Leaflet:

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Information Intended for Healthcare Professionals Only:

Fulvestrant Vipharm 250 mg/ 5 mL, Solution for Injection in Prefilled Syringes Should be Administered Using Two Prefilled Syringes (See Section 3).

Administration Instructions

Caution – Do Not Place the Needle with the Safety System (BD SafetyGlide Shielding Hypodermic Needle) in an Autoclave Before Use. When Handling the Medication and Disposing of Residues, Avoid Contact Between Your Hands and the Needle.

For Both Syringes:

• Remove the Glass Prefilled Syringe from the Container and Check if it is Not Damaged.
• Open the Outer Packaging of the Needle with the Safety System (SafetyGlide).
• Before Administering Parenteral Solutions, Visually Inspect them for the Presence of Particulate Matter and Changes in Color.
• Hold the Syringe Upright in the Striped Part (C). With Your Other Hand, Grasp the Cap (A) and Carefully Tilt it Forward and Backward Until the Cap Separates and Can be Removed, Do Not Twist (See Figure 1).

Figure 1

• Remove the Cap (A) While Holding the Syringe Upright. To Maintain Sterility, Do Not Touch the Tip of the Syringe (B) (See Figure 2).

Figure 2

• Attach the Needle with the Safety System to the Luer-Lock Tip and Tighten to Secure it (See Figure 3).
• Check if the Needle is Connected to the Luer-Lock Tip Before Proceeding to the Upright Position.
• When Tightening the Needle, Avoid Damaging its Sharp End.
• Bring the Needle with the Safety System Close to the Injection Site.
• Remove the Needle Cap.
• Remove Any Air from the Syringe.

Figure 3

• Administer the Medication Intramuscularly, Slowly (1-2 Minutes/Injection), into the Buttock Muscle (Buttock Site). For the Convenience of the Person Administering the Medication, the Needle Cut is on the Same Surface as the Safety System Locking Mechanism (See Figure 4).

Figure 4

• Immediately After Administering the Medication, Activate the Needle Safety System by Pushing its Locking Mechanism Forward (See Figure 5).

CAUTION: Proceed in a Way that Ensures Your Safety and the Safety of Others. Listen for the Click and Visually Confirm that the Needle Tip is Completely Hidden.

Figure 5

Disposal of Residues

The Prefilled Syringes are Intended Exclusivelyfor Single Use.

This Medication May Pose a Risk to the Aquatic Environment. Any Unused Product or Waste Material Should be Disposed of in Accordance with Local Requirements.