Xanderla

Patient Information Leaflet

Xanderla, 3.6 mg, implant in pre-filled syringe
Goserelin
Please 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, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Leaflet Contents

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

1. What Xanderla is and what it is used for

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

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 normally found only in the lining of the uterus are also found elsewhere in the body (usually in nearby structures);
• to treat benign uterine tumours known as fibroids;
• to thin the lining of the uterus before planned surgery on the uterus;
• as an adjunctive treatment in infertility (together with other medicines). This medicine helps control the release of eggs from the ovaries.

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

2. Information before using Xanderla

When not to use Xanderla

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

Xanderla must not be used if any of the above situations apply.
If in doubt, discuss with a doctor or pharmacist before using Xanderla.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before starting treatment with Xanderla.
If admitted to hospital, inform medical staff that you are using Xanderla.
Before starting treatment with Xanderla, tell your doctor, pharmacist or nurse:

• if the patient has high blood pressure;
• if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or if the patient is taking medicines for these conditions. Treatment with Xanderla may increase the risk of developing heart rhythm disturbances.

Cases of depression, including severe depression, have been reported during treatment with Xanderla. If the patient develops low mood while taking Xanderla, inform the doctor.
Inform your doctor about current or planned anti-doping tests, as treatment with Xanderla may lead to positive results in anti-doping tests.
Information for men
Before starting treatment with Xanderla, discuss with your doctor, pharmacist or nurse:

• if there are difficulties in passing urine or back pain;
• if the patient has diabetes;
• if there are any conditions that may weaken bones, particularly if the patient drinks large amounts of alcohol, smokes, has a family history of osteoporosis (a disease that weakens bones), or if the patient is taking anticonvulsant medicines (medicines used for epilepsy or seizures) or corticosteroids (steroids). These types of medicines may cause reduced calcium content in bones (weakening of bones).

Information for women
Before starting treatment with Xanderla, discuss with your doctor, pharmacist or nurse:

• if there are any conditions that may weaken bones, particularly if the patient drinks large amounts of alcohol, smokes, has a family history of osteoporosis (a disease that weakens bones), has a poor diet, or if the patient is taking anticonvulsant medicines (medicines used for epilepsy or seizures) or corticosteroids (steroids). These types of medicines may cause reduced calcium content in bones (weakening of bones). This condition may improve after stopping treatment.

If Xanderla is used for the treatment of endometriosis, the doctor may recommend also using other medicines that reduce bone loss.
Children
Xanderla must not be used in children.
Xanderla and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Xanderla may affect the action of certain medicines used to treat heart rhythm disorders (such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide and ibutilide) or may increase the risk of heart rhythm disturbances when used together with other medicines [e.g. methadone used for pain relief 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 the patient is pregnant or breastfeeding.
• Do not use Xanderla if the patient plans to become pregnant (unless Xanderla is used as part of infertility treatment).
• Do not take "the pill" (oral contraceptives) while using Xanderla. Use mechanical methods of contraception such as condoms or diaphragm.

Driving and operating machinery
There is a small possibility that Xanderla may affect the ability to drive or operate vehicles or machinery.

3. How to use Xanderla

• The Xanderla 3.6 mg implant will be administered by subcutaneous injection into the abdomen every four weeks (every 28 days). The injection will be given by a doctor or nurse.
• It is important to continue treatment with Xanderla even if the patient feels well.
• Treatment should be continued until the doctor decides it can be discontinued.

Next appointment

• Xanderla should be administered as an injection every 28 days.
• Always remind the doctor or nurse to schedule an appointment for the next injection.
• If the scheduled appointment occurs earlier or later than 28 days after the last injection, inform the doctor or nurse.
• If more than 28 days have passed since the last injection, contact the doctor or nurse to receive the next injection as soon as possible.

Information for women

• If a patient is receiving Xanderla for uterine fibroids and has anaemia (low number of red blood cells or low haemoglobin), the doctor may recommend iron supplements.
• The duration of treatment will depend on the reason for using Xanderla:
• for the treatment of uterine fibroids, Xanderla should not be used for longer than three months.
• for the treatment of endometriosis, Xanderla should not be used for 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur in both men and women:
Allergic reactions:
These reactions are rare. The following symptoms may appear suddenly:

• skin rash, itching or hives
• swelling of the face, lips, tongue or other parts of the body
• breathlessness, wheezing or difficulty breathing. If any of these symptoms occur, seek immediate medical advice.

Injuries at the injection site of Xanderla (including damage to abdominal blood vessels) have been reported. Very rarely, this has led to serious bleeding. Contact a doctor immediately if any of the following symptoms occur:

• abdominal pain
• abdominal distension
• breathlessness
• dizziness
• low blood pressure and (or) any disturbance in consciousness.

Other possible adverse reactions:
Very common (may affect more than 1 in 10 people):

• hot flushes and sweating. Sometimes these adverse reactions may persist for a prolonged period (even several months) after stopping Xanderla.
• reduced libido
• pain, bruising, bleeding, redness or swelling at the injection site of Xanderla.

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

• loss of bone mass
• tingling in 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):

• psychiatric disorders known as psychotic disorders, including possible hallucinations (seeing, feeling or hearing things that are not real), disturbances in thinking and personality changes. These symptoms are very rare.
• development of a pituitary tumour or, if the patient previously had a pituitary tumour, goserelin may cause bleeding from the tumour or pituitary apoplexy. These events are very rare. Pituitary tumours may cause severe headaches, nausea or vomiting, loss of vision and loss of consciousness.

Unknown frequency (cannot be estimated from available data):

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

Information for men
The following adverse reactions may occur in men:
Very common (may affect more than 1 in 10 people):

• impotence.

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

• lower back pain or difficulty passing urine. If these symptoms occur, discuss them with your doctor.
• bone pain at the beginning of treatment. If these symptoms occur, discuss them with your doctor.
• impaired heart function or heart attack
• swelling and tenderness of the breasts
• increased blood sugar levels.

Information for women
The following adverse reactions may occur in women:
Very common (may affect more than 1 in 10 people):

• vaginal dryness
• change in breast size
• acne has been very commonly reported (often within one month of starting treatment).

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

• headaches.

Rare (may affect up to 1 in 1,000 people):

• small ovarian cysts, which may cause pain. These usually resolve without additional treatment.
• in some women, early menopause may occur during goserelin treatment, and menstruation does not return after stopping treatment.

Unknown frequency (cannot be estimated from available data):

• vaginal bleeding. This most commonly occurs during the first month after starting treatment and should resolve spontaneously. If symptoms persist or are bothersome to the patient, discuss them with your doctor.
• slight worsening of symptoms related to fibroids, such as pain.

When goserelin is used to treat endometriosis, uterine fibroids, infertility or to thin the
endometrial lining before surgery, the following adverse reactions may also occur:

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

When goserelin is used to treat breast cancer, the following adverse reactions may occur:

• worsening of breast cancer symptoms at the beginning of treatment. There may be an increase in pain or tumour progression. These symptoms usually do not last long and typically resolve during treatment. However, if symptoms persist or cause discomfort, discuss them with your doctor.
• changes in blood calcium levels. Symptoms may include severe nausea, persistent vomiting or excessive thirst. If these symptoms occur, discuss them with your doctor. Your doctor may order a blood test.

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

• excessive ovarian response. The patient may experience abdominal pain, bloating, nausea or vomiting. If these symptoms occur, inform your doctor immediately.
  This list of possible adverse reactions should not cause undue concern. It is possible that none of them will occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Xanderla

Xanderla will be prescribed to the patient by a doctor. The prescription should be dispensed at a pharmacy, and the medicine should be brought to the next appointment.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The "expiry date (EXP)" or "EXP" refers to the last day of the stated month. The batch number on the packaging can be found 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 packaging.
After first opening: the product should be used immediately after opening the sachet.

6. Contents of the pack and other information

What Xanderla contains

• The active substance is goserelin. One implant contains 3.6 mg goserelin (as goserelin acetate).
• The other component is a copolymer of DL-lactide and glycolide (50:50).

What Xanderla looks like and contents of the pack
White or almost white cylindrical rods (approximate dimensions: diameter 1.2 mm, length 13 mm,
weight 18 mg), embedded in a biodegradable polymer matrix.
The pre-filled syringe containing one implant, placed in a PETP/Aluminium/PE pouch
with a desiccant, inside a cardboard box.
The unit pack contains 1, 2 or 3 pre-filled syringes in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Poland

Manufacturer
AMW GmbH Arzneimittelwerk Warngau
Birkerfeld 11
83627 Warngau
Germany
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany

For further information about this medicinal product and its names in the countries of the
European Economic Area, please contact the Marketing Authorisation Holder.
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.