Fulvestrant Ever Pharma

Package Leaflet: Information for the User

Fulvestrant EVER Pharma, 250 mg/ 5 ml, Solution for Injection in a Pre-filled Syringe

Fulvestrant

Read All of 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 Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicine Has Been Prescribed for You Only. Do Not Pass It on to Others. It May Harm Them, Even if Their Signs of Illness Are the Same as Yours.
• If You Get Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

• 1. What Fulvestrant EVER Pharma Is and What It Is Used For
• 2. Before You Use Fulvestrant EVER Pharma
• 3. How to Use Fulvestrant EVER Pharma
• 4. Possible Side Effects
• 5. How to Store Fulvestrant EVER Pharma
• 6. Contents of the Pack and Other Information

1. What Fulvestrant EVER Pharma Is and What It Is Used For

Fulvestrant EVER Pharma Contains the Active Substance Fulvestrant, Which Belongs to a Group of Medicines Called Estrogen Receptor Antagonists. Estrogens, Female Sex Hormones, Can Sometimes Influence the Growth of Breast Cancer.

Fulvestrant EVER Pharma Is Used:

• Alone to Treat Postmenopausal Women with a Certain Type of Breast Cancer That Has Spread or Can't Be Operated On, Known as Hormone Receptor-Positive Breast Cancer, or
• In Combination with Palbociclib to Treat Women with a Certain Type of Breast Cancer Known as Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced or Metastatic Breast Cancer. Women Who Have Not Yet Reached Menopause Will Also Receive a Luteinizing Hormone-Releasing Hormone Agonist.

When Fulvestrant EVER Pharma Is Given 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. Before You Use Fulvestrant EVER Pharma

Do Not Use Fulvestrant EVER Pharma

• If You Are Allergic to Fulvestrant or Any of the Other Ingredients of This Medicine (Listed in Section 6);
• If You Are Pregnant or Breast-Feeding;
• If You Have Severe Liver Problems.

Warnings and Precautions

Before Starting Fulvestrant EVER Pharma, Discuss with Your Doctor, Pharmacist, or Nurse If You:

• Have Kidney or Liver Disease;
• Have a Low Platelet Count (Which Helps the Blood to Clot) or Bleeding Disorder;
• Have Had Blood Clotting Problems in the Past;
• Have Osteoporosis (Thinning of the Bones);
• Are Alcohol-Dependent.

Children and Adolescents

Fulvestrant EVER Pharma Is Not Intended for Use in Children and Adolescents Under 18 Years of Age.

Fulvestrant EVER Pharma and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking Now or Have Recently Taken, and About Any Medicines You Plan to Take. In Particular, Inform Your Doctor If You Are Taking Anticoagulant Medicines (Medicines That Prevent Blood Clots).

Pregnancy and Breast-Feeding

Fulvestrant EVER Pharma Must Not Be Used During Pregnancy. If You Are Able to Become Pregnant, You Should Use Effective Contraception During Treatment with Fulvestrant EVER Pharma and for 2 Years After the Last Dose. You Must Not Breast-Feed During Treatment with Fulvestrant EVER Pharma.

Driving and Using Machines

Fulvestrant EVER Pharma Is Not Expected to Affect Your Ability to Drive or Use Machines. However, If You Feel Tired After Receiving Fulvestrant EVER Pharma, Do Not Drive or Use Machines.

Fulvestrant EVER Pharma Contains Ethanol

This Medicine Contains 500 Mg of Ethanol (Alcohol) in Each Pre-Filled Syringe, Which Is Equivalent to 10% V/V. The Amount of Alcohol in Each Pre-Filled Syringe of This Medicine Is Equivalent to Less Than 10 Ml of Beer or 4 Ml of Wine. The Small Amount of Alcohol in This Medicine Will Not Have a Noticeable Effect. However, You Should Consider This If You Are in a High-Risk Group, Such as Patients with Liver Disease or Epilepsy.

Fulvestrant EVER Pharma Contains Benzyl Alcohol

This Medicine Contains 500 Mg of Benzyl Alcohol in Each Pre-Filled Syringe, Which Is Equivalent to 100 Mg/Ml. Benzyl Alcohol May Cause Allergic Reactions. Patients with Liver or Kidney Disease Should Contact Their Doctor Before Receiving Fulvestrant EVER Pharma, as Large Amounts of Benzyl Alcohol May Accumulate in Their Body and Cause Side Effects (So-Called "Metabolic Acidosis").

Fulvestrant EVER Pharma Contains Benzyl Benzoate

This Medicine Contains 750 Mg of Benzyl Benzoate in Each Pre-Filled Syringe, Which Is Equivalent to 150 Mg/Ml.

3. How to Use Fulvestrant EVER Pharma

This Medicine Should Always Be Used Exactly as Your Doctor or Pharmacist Has Told You. If You Are Not Sure, Ask Your Doctor or Pharmacist. The Recommended Dose Is 500 Mg of Fulvestrant (Two 250 Mg/5 Ml Injections), Given Once a Month, and an Additional 500 Mg Dose Given 2 Weeks After the First Dose. Fulvestrant EVER Pharma Will Be Given to You by a Doctor or Nurse. The Medicine Will Be Injected Slowly into a Muscle, with Each Injection Given in a Different Buttock. If You Have Any Further Questions on the Use of This Product, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like All Medicines, Fulvestrant EVER Pharma 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 Anaphylactic Reactions;
• Blood Clots in the Veins (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)

• Pain and/or Inflammation at the Injection Site;
• Changes in Liver Enzyme Activity (in Blood Tests)*;
• Nausea;
• Feeling Weak, Tired*;
• Pain in the Joints and Musculoskeletal 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 Infection;
• Back Pain*;
• Increased Bilirubin Levels (a Liver Pigment);
• Blood Clots in the Veins (Increased Risk of Venous Thromboembolism)*;
• Low Platelet Count (Thrombocytopenia);
• Vaginal Bleeding;
• Pain in the Lower Back 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);
• Bruising and Bleeding at the Injection Site;
• Increased Activity of the Liver Enzyme Gamma-Glutamyltransferase in Blood Tests;
• Hepatitis;
• Liver Failure;
• Numbness, Tingling, and Pain;
• Anaphylactic Reactions.*

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Fulvestrant EVER Pharma

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 Carton or Syringe Label After "EXP". The Expiry Date Refers to the Last Day of That Month. There Are No Special Storage Conditions for This Medicine. Medical Professionals Are Responsible for the Proper Storage, Use, and Disposal of the Packaging of Fulvestrant EVER Pharma After Use. This Medicine May Pose a Risk to the Aquatic Environment. 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 Protect the Environment.

6. Contents of the Pack and Other Information

What Fulvestrant EVER Pharma Contains

• The Active Substance Is Fulvestrant. One Pre-Filled Syringe (5 Ml) Contains 250 Mg of Fulvestrant.
• The Other Ingredients Are Ethanol 96%, Benzyl Alcohol, Benzyl Benzoate, and Purified Castor Oil. Each Pre-Filled Syringe Contains 10% V/V Ethanol (Alcohol), I.E., Up to 500 Mg of Ethanol. Each Pre-Filled Syringe Contains 500 Mg of Benzyl Alcohol, Which Is Equivalent to 100 Mg/Ml. Each Pre-Filled Syringe Contains 750 Mg of Benzyl Benzoate, Which Is Equivalent to 150 Mg/Ml.

What Fulvestrant EVER Pharma Looks Like and Contents of the Pack

Fulvestrant EVER Pharma Is a Clear, Colorless to Yellowish, Viscous Solution, Free from Visible Particles, in a Pre-Filled Syringe Made of Colorless Glass Type I, with a Piston Made of Polystyrene and a Bromobutyl Rubber Stopper, with a Needle Shield and a Needle Protection System, Containing 5 Ml of Solution for Injection in a Pre-Filled Syringe. To Administer the Recommended Monthly Dose of 500 Mg, Two Pre-Filled Syringes Should Be Injected. Fulvestrant EVER Pharma Is Available in Two Types of Packaging: a Pack Containing 1 Pre-Filled Syringe or a Pack Containing 2 Pre-Filled Syringes. The Packaging Also Includes 21 G x 1.5 Inch (BD SafetyGlide) Needles with a Needle Protection System, Intended for Attachment to the Syringe Barrel. A Multipack Containing 4 (2 Packs of 2) or 6 (3 Packs of 2) Pre-Filled Syringes (5 Ml Each). Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder

EVER Valinject GmbH, Oberburgau 3, 4866 Unterach am Attersee, Austria

Manufacturer

EVER Pharma Jena GmbH, Otto-Schott-Straße 15, 07745 Jena, Germany, EVER Pharma Jena GmbH, Brüsseler Straße 18, 07747 Jena, Germany

For Further Information on This Medicine, Contact the Local Representative of the Marketing Authorization Holder:

EVER Pharma Poland Sp. z o.o., E-Mail: [email protected]

This Medicine Is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Leaflet:

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Information Intended for Healthcare Professionals Only:

Fulvestrant EVER Pharma, 500 Mg (2 X 250 Mg/5 Ml Solution for Injection in a Pre-Filled Syringe), Should Be Administered Using Two Pre-Filled Syringes, See Section 3. BD SafetyGlide Is a Trademark of Becton Dickinson and Company and Has the CE Mark: CE 0050. Administration Instructions: Administer the Injection According to Local Guidelines for Performing Intramuscular Injections of Large Volume. CAUTION: Care Should Be Taken If Fulvestrant EVER Pharma Is Administered in the Upper-Outer Quadrant of the Buttock, Due to the Proximity of the Sciatic Nerve. Note - Do Not Autoclave the Needle with the Safety Shield (BD SafetyGlide Shielding Hypodermic Needle) Before Use. When Handling the Medicinal Product and Disposing of Residues, Avoid Hand Contact with the Needle.

• Carefully Remove the Needle and Syringe from the Packaging and Check for Damage.
• Open the Outer Packaging of the Needle with the Safety Shield (BD SafetyGlide).
• Before Administering Parenteral Medicines, Visually Inspect Them for Particulate Matter and Color Changes.
• Remove the Shield from the Syringe Tip. To Maintain Sterility, Do Not Touch the Syringe Tip.
• Attach the Needle to the Luer-Lock Tip.
• Tighten to Secure with the Luer Connector.
• By Pulling, Remove the Needle Shield So as Not to Damage the Sharp Point.

• Remove the Needle Cap.
• Holding the Syringe with the Needle Upwards, Gently Press the Plunger to Bring the Medicinal Product Up into the Syringe. There Should Be No Air in the Syringe.
• Administer the Medicinal Product Slowly Intramuscularly (Injection Time 1-2 Minutes), into the Buttock Muscle. For the Convenience of the Person Administering the Medicinal Product, the Needle Bevel Is on the Same Surface as the Trigger of the Needle Protection System.

• Immediately After Administering the Medicinal Product, Activate the Needle Protection System by Pushing the Trigger Forward with Your Finger.
• CAUTION: Proceed in Such a Way as to Ensure Your Safety and the Safety of Others. Listen for the Click and Visually Verify That the Needle Tip Is Fully Enclosed.

Disposal of Residues: Pre-Filled Syringes Are for Single Use Only. This Medicinal Product May Pose a Risk to the Aquatic Environment. Any Unused Medicinal Product or Waste Material Should Be Disposed of in Accordance with Local Requirements.