Xanderla

Leaflet attached to the packaging: patient information

Xanderla, 3.6 mg, implant in a syringe

Goserelin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Xanderla and what is it used for
• 2. Important information before using Xanderla
• 3. How to use Xanderla
• 4. Possible side effects
• 5. How to store Xanderla
• 6. Package contents and other information

1. What is Xanderla and what is it used for

Xanderla contains the active substance goserelin. It belongs to a group of medicines called LHRH analogs.

Use of Xanderla in men

In men, Xanderla is used to treat prostate cancer. The medicine works by reducing the amount of testosterone - a hormone produced by the patient's body.

Use of Xanderla in women

In women, Xanderla is used:

• to treat breast cancer;
• to treat a condition called endometriosis. In endometriosis, cells that normally occur only in the lining of the uterus are also found in other parts of the body (usually in structures near the uterus);
• to treat benign tumors of the uterus, called uterine fibroids;
• to thin the lining of the uterus before a planned uterine surgery;
• as an adjunct in the treatment of infertility (in combination with other medicines). This medicine helps control the release of egg cells from the ovaries.

In women, Xanderla works by reducing the amount of estrogen - a hormone produced by the patient's body.

2. Important information before using Xanderla

When not to use Xanderla

• if the patient is allergic to goserelin or any other component of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding (see "Pregnancy and breastfeeding" below).

Xanderla should not be used if any of the above situations occur. In case of doubts before using Xanderla, consult your doctor or pharmacist.

Warnings and precautions

Before starting Xanderla, discuss it with your doctor, pharmacist, or nurse.

• if the patient has high blood pressure;
• if the patient has any heart or blood vessel diseases, including rhythm disorders (arrhythmia), or if the patient is taking medicines for these diseases. During Xanderla treatment, the risk of rhythm disorders may increase.

Depression has been reported during Xanderla treatment, including severe depression. If the patient experiences low mood during Xanderla treatment, they should inform their doctor.

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Children

Xanderla should not be used in children.

Xanderla and other medicines

Xanderla may affect the action of certain medicines used to treat rhythm disorders (such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, and ibutilide) or may increase the risk of rhythm disorders when used with other medicines [e.g., methadone used to relieve pain and in detoxification therapy for addiction, moxifloxacin (an antibiotic), and antipsychotic medicines used to treat serious mental illnesses].

Pregnancy, breastfeeding, and fertility

• Do not use Xanderla if you are pregnant or breastfeeding.
• Do not use Xanderla if you plan to become pregnant (unless Xanderla is used as part of infertility treatment).
• Do not take "pills" (oral contraceptives) while using Xanderla. Use mechanical methods of contraception, such as condoms or diaphragms.

Driving and operating machinery

There is a small likelihood that Xanderla will affect your ability to drive or operate machinery.

3. How to use Xanderla

• Xanderla, 3.6 mg, implant will be injected subcutaneously into the abdomen every four weeks (every 28 days). The injection will be performed by a doctor or nurse.
• It is essential to continue Xanderla treatment, even if you feel well.
• Continue treatment until your doctor decides it can be stopped.

Next visit

• Xanderla should be used in the form of an injection every 28 days.
• Always remind your doctor or nurse to schedule a visit to receive the next injection.
• If the scheduled visit is earlier or later than 28 days after the last injection, inform your doctor or nurse.
• If more than 28 days have passed since the last injection, contact your doctor or nurse to receive the next injection as soon as possible.

Information for women

• If you are receiving Xanderla for uterine fibroids and have anemia (low red blood cell count or low hemoglobin), your doctor may recommend taking iron supplements.
• The duration of treatment will depend on the reason for using Xanderla:
• for uterine fibroids, Xanderla treatment should not last longer than three months.
• for endometriosis, Xanderla treatment should not last longer than six months.
• to thin the uterine lining before surgery, Xanderla should be used for no longer than one or two months (four or eight weeks).

4. Possible side effects

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

The following side effects may occur in men and women:

Allergic reactions:

These reactions are rare. The following symptoms may appear suddenly:

• rash, itching, or hives on the skin
• swelling of the face, lips, or tongue, or other parts of the body
• shortness of breath, wheezing, or difficulty breathing. If any of these symptoms occur, seek medical attention immediately.

There have been reports of injuries at the Xanderla injection site (including damage to abdominal blood vessels). Very rarely, this has led to severe bleeding. Seek medical attention immediatelyif you experience:

• abdominal pain
• abdominal swelling
• shortness of breath
• dizziness
• low blood pressure and (or) any disturbance of consciousness.

Other possible side effects:

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

• hot flashes and sweating. Sometimes these side effects may persist for a longer period (even several months) after stopping Xanderla treatment.
• reduced sex drive
• pain, bruising, bleeding, redness, or swelling at the Xanderla injection site.

Common (may affect up to 1 in 10 people):

• bone loss
• tingling in the fingers and toes
• skin rashes
• hair loss
• weight gain
• joint pain
• changes in blood pressure
• mood changes (including depression).

Very rare (may affect up to 1 in 10,000 people):

• psychotic disorders, including hallucinations (seeing, feeling, or hearing things that are not there), disordered thinking, and personality changes. These symptoms are very rare.
• the occurrence of a pituitary tumor or, if a pituitary tumor was present before, goserelin may cause bleeding from the tumor or pituitary apoplexy. These reactions are very rare. Pituitary tumors can cause severe headaches, nausea, or vomiting, vision loss, and loss of consciousness.

Unknown (frequency cannot be estimated from available data):

• blood changes
• liver disorders
• blood clots in the lungs, causing chest pain or shortness of breath
• pneumonia; symptoms may be typical of pneumonia (such as shortness of breath and cough)
• changes in ECG (QT interval prolongation).

Information for men

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

• impotence.

Common (may affect up to 1 in 10 people):

• back pain or difficulty urinating. If these symptoms occur, consult your doctor.
• bone pain at the start of treatment. If these symptoms occur, consult your doctor.
• heart failure or heart attack
• breast tenderness or swelling
• increased blood sugar levels.

Information for women

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

• vaginal dryness
• breast changes
• acne (very common, often within a month of starting treatment).

Common (may affect up to 1 in 10 people):

• headaches.

Rare (may affect up to 1 in 1000 people):

• small ovarian cysts, which may cause pain. They usually resolve without additional treatment.
• in some women treated with goserelin, early menopause may occur, and menstrual periods may not return after stopping treatment.

Unknown (frequency cannot be estimated from the available data):

• vaginal bleeding. This usually occurs in the first month after starting treatment and should resolve on its own. If symptoms persist or bother you, consult your doctor.
• mild worsening of symptoms related to uterine fibroids, such as pain.

When using goserelin to treat endometriosis, uterine fibroids, infertility, or to thin the uterine lining before surgery, the following side effects may also occur:

• body hair changes
• dry skin
• weight gain
• increased blood fat levels (cholesterol). This can be determined by a blood test.
• vaginal inflammation and discharge
• nervousness
• sleep disturbances and fatigue
• swelling of the feet and ankles
• muscle pain
• sudden, painful muscle cramps in the legs
• abdominal symptoms, such as nausea or vomiting, diarrhea, and constipation
• voice changes
• in the treatment of uterine fibroids, mild worsening of symptoms related to uterine fibroids, such as pain.

When using goserelin to treat breast cancer, the following side effects may occur:

• worsening of breast cancer symptoms at the start of treatment. This may lead to increased pain or growth of the tumor. These symptoms usually do not last long and resolve during treatment. However, if symptoms persist or cause discomfort, consult your doctor.
• changes in blood calcium levels. Symptoms may include severe nausea, persistent vomiting, or severe thirst. If these symptoms occur, consult your doctor.Your doctor may order a blood test.

When using goserelin to treat infertility,in combination with another medicine called gonadotropin, the following may occur:

• overstimulation of the ovaries. You may experience abdominal pain, bloating, nausea, or vomiting. If these symptoms occur, inform your doctor immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in this 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

5. How to store Xanderla

Xanderla will be prescribed to you by your doctor. Have the prescription filled at a pharmacy and bring the medicine with you to your next visit.

Store Xanderla in a place out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. "Expiry date" or "EXP" means the last day of the month shown. The batch number on the packaging is located after "Batch number (Lot)" or "Lot".

Do not store above 30°C.

Store in the original packaging to protect from moisture. Do not open the foil pouch.

After first opening: the product should be used immediately after opening the pouch.

6. Package contents and other information

What Xanderla contains

• The active substance is goserelin. One implant contains 3.6 mg of goserelin (as goserelin acetate).
• The other ingredient is a copolymer of DL-lactic acid and glycolic acid (50:50).

What Xanderla looks like and what the package contains

White or almost white cylindrical rods (approximate dimensions: diameter 1.2 mm, length 13 mm, mass 18 mg), embedded in a biodegradable polymer matrix.

A pre-filled syringe containing one implant, placed in a PETP/Aluminum/PE pouch containing a desiccant, in a cardboard box.

A single pack contains 1, 2, or 3 pre-filled syringes in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Manufacturer

AMW GmbH Arzneimittelwerk Warngau

Birkerfeld 11

83627 Warngau

Germany

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany