Xanderla La

Package Leaflet: Information for the Patient

Xanderla LA, 10.8 mg, Implant in a Prefilled Syringe

Goserelin

Read All of This Leaflet Carefully Before Using This Medicine Because It Contains Important Information for You.

• You should 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 is Xanderla LA and What is it Used For
• 2. Important Information Before You Use Xanderla LA
• 3. How to Use Xanderla LA
• 4. Possible Side Effects
• 5. How to Store Xanderla LA
• 6. Contents of the Pack and Other Information

1. What is Xanderla LA and What is it Used For

Xanderla LA contains the active substance goserelin. It belongs to a group of medicines called LHRH analogues.
Xanderla LA is used to treat prostate cancer. The medicine works by reducing the amount of testosterone - a hormone produced by the body. Xanderla LA is a long-acting medicine and is given every 12 weeks.

2. Important Information Before You Use Xanderla LA

When Not to Use Xanderla LA

• in women.

Do not use Xanderla LA if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Xanderla LA.

Warnings and Precautions

Before starting treatment with Xanderla LA, tell your doctor, pharmacist, or nurse:

or if you are taking medicines for epilepsy or other conditions that may affect your bones (such as steroids);

There have been reports of depression during treatment with Xanderla LA, including severe depression. If you experience low mood during treatment with Xanderla LA, you should tell your doctor.
Medicines like Xanderla LA can cause a decrease in bone density (weakening of bones).
If you are admitted to hospital, you should tell the medical staff that you are using Xanderla LA.
You should tell your doctor about any current or planned doping tests, as treatment with Xanderla LA may cause positive results in doping tests.

Children

Xanderla LA should not be used in children.

Xanderla LA and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take.
Xanderla LA may affect the way other medicines work, especially those used to treat irregular heartbeats (such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, and ibutilide)
or may increase the risk of irregular heartbeats when used with other medicines [such as methadone (used for pain relief and in drug addiction treatment), moxifloxacin (an antibiotic), and antipsychotic medicines used to treat serious mental illnesses].

Driving and Using Machines

Xanderla LA is unlikely to affect your ability to drive or use machines.

3. How to Use Xanderla LA

Xanderla LA, 10.8 mg, implant will be injected under the skin in the abdomen every 12 weeks.
The injection will be given by a doctor or nurse.

• It is important to continue treatment with Xanderla LA, even if you feel well.
• Continue treatment until your doctor decides it is time to stop.

Next Appointment

• Xanderla LA should be given as an injection every 12 weeks.
• Always remind your doctor or nurse to schedule an appointment for your next injection.
• If the scheduled appointment is earlier or later than 12 weeks after the last injection, tell your doctor or nurse.
• If more than 12 weeks have passed since the last injection, contact your doctor or nurse to get the next injection as soon as possible.

4. Possible Side Effects

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

Allergic Reactions:

These effects are rare. The following symptoms may occur suddenly:

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

There have been reports of injection site injuries with Xanderla LA (including damage to abdominal blood vessels). Very rarely, this has caused serious bleeding. Seek medical attention immediatelyif you experience any of the following symptoms:

• abdominal pain
• abdominal swelling
• shortness of breath
• dizziness
• low blood pressure and/or any changes in consciousness.

Other Possible Side Effects:

Very Common (May Affect More Than 1 in 10 People):

• hot flashes and sweating. These side effects may persist for a long time (even several months) after stopping treatment with Xanderla LA.
• reduced sex drive and impotence.

Common (May Affect Up to 1 in 10 People):

• back pain or difficulty urinating. If you experience these symptoms, talk to your doctor.
• bone pain at the start of treatment. If you experience these symptoms, talk to your doctor.
• bone density loss
• increased blood sugar levels
• tingling in fingers and toes
• skin rashes
• weight gain
• pain, bruising, bleeding, redness, or swelling at the injection site
• heart problems or heart attack
• changes in blood pressure
• breast tenderness or swelling
• mood changes (including depression).

Uncommon (May Affect Up to 1 in 100 People):

• joint pain.

Rare (May Affect Up to 1 in 10,000 People):

• mental health problems called psychotic disorders, including hallucinations (seeing, feeling, or hearing things that are not there), disordered thinking, and changes in personality. These symptoms are very rare.
• the appearance of a pituitary tumor or, if you already have a pituitary tumor, goserelin may cause bleeding from the tumor or pituitary apoplexy. These effects are very rare. Pituitary tumors can cause severe headaches, nausea, vomiting, loss of vision, and loss of consciousness.

Not Known (Frequency Cannot be Estimated from the Available Data):

• hair loss
• blood disorders
• liver problems
• 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 (prolonged QT interval).

The list of possible side effects should not cause undue concern.
It is possible that none of them will occur.

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Drug Safety 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.
Side effects can also be reported 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 Xanderla LA

Xanderla LA will be prescribed to you by your doctor. You should have the prescription filled at a pharmacy and bring the medicine with you to your 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. "Expiry Date" or "EXP" means the last day of the month stated.
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. Contents of the Pack and Other Information

What Xanderla LA Contains

• The active substance is goserelin. One implant contains 10.8 mg goserelin (as goserelin acetate).
• The other ingredients are: DL-lactic acid polymer and DL-lactic acid and glycolic acid copolymer (75:25).

What Xanderla LA Looks Like and Contents of the Pack

White or almost white cylindrical rods (approximate dimensions: diameter 1.5 mm, length 20 mm, weight 44 mg), embedded in a biodegradable polymer matrix.
A prefilled syringe containing one implant, placed in a PETP/Aluminum/PE pouch containing a desiccant, in a cardboard box.
The single pack contains 1, 2, or 3 prefilled 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

For More Information on This Medicine, Including Its Name in Other European Economic Area Countries, Contact the Marketing Authorization Holder.

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.
Date of Last Revision of the Leaflet:March 2022