Ponlimsi 60 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ponlimsi 60mg solution for injection in pre-filled syringe

denosumab

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient reminder card containing important safety information you should know before and during treatment with Ponlimsi.

Contents of the leaflet

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

1. What Ponlimsi is and what it is used for

What Ponlimsi is and how it works

Ponlimsi contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, aimed at treating bone loss and osteoporosis. Treatment with Ponlimsi strengthens bones and reduces the risk of fractures.

Bone is living tissue that is continuously renewed. Estrogens contribute to maintaining bone health. After menopause, estrogen levels decrease, which may cause bones to become thinner and more fragile. Over time, this can lead to a condition called osteoporosis. Osteoporosis can also occur in men due to various causes, including age and/or low levels of the male hormone testosterone. It may also occur in patients receiving glucocorticoid treatment. Many patients with osteoporosis do not have symptoms, yet they still remain at risk of bone fractures, particularly in the spine, hip, and wrists.

Surgical procedures or medications that suppress the production of estrogen or testosterone, used to treat patients with prostate or breast cancer, can also cause bone loss. As a result, bones become weaker and more prone to breaking.

What Ponlimsi is used for

Ponlimsi is used to treat:

• postmenopausal osteoporosis in women and osteoporosis in men at increased risk of fracture (bone breakage), reducing the risk of hip, vertebral, and non-vertebral fractures.
• bone loss caused by reduced hormone levels (testosterone) resulting from surgery or medical treatment in patients with prostate cancer.
• bone loss resulting from long-term glucocorticoid therapy in patients at high risk of fracture.

2. What you need to know before using Ponlimsi

Do not use Ponlimsi

• if you have low levels of calcium in your blood (hypocalcemia).
• if you are allergic to denosumab or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Ponlimsi.

During treatment with Ponlimsi, you may develop a skin infection with symptoms such as a swollen and red area of skin, most commonly on the lower leg, which feels warm and tender to the touch (cellulitis), and which may be accompanied by fever. Inform your doctor immediately if you experience any of these symptoms.

In addition, you must take calcium and vitamin D supplements during treatment with Ponlimsi. Your doctor will discuss this with you.

While receiving Ponlimsi, you may develop low levels of calcium in your blood. Inform your doctor immediately if you notice any of the following symptoms: muscle spasms, contractions or cramps, and/or numbness or tingling in the fingers, toes, or around the mouth, and/or seizures, confusion, or loss of consciousness.

Rarely, cases of very low blood calcium levels have been reported, requiring hospitalization and, in some cases, potentially life-threatening reactions. Therefore, before each dose is administered, and in patients predisposed to hypocalcemia, your blood calcium levels will be checked (through a blood test) within two weeks after the initial dose.

Inform your doctor if you have or have had severe kidney problems, renal failure, if you have required dialysis, or if you are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), as these may increase the risk of low blood calcium levels if you do not take calcium supplements.

Problems in the mouth, teeth, or jaw

In patients receiving Ponlimsi for osteoporosis, a rare adverse effect called osteonecrosis of the jaw (ONJ) (damage to the jawbone) has been reported (may affect up to 1 in 1,000 people). The risk of ONJ increases in patients treated for a long time (may affect up to 1 in 200 people if treated for 10 years). ONJ can also occur after stopping treatment. It is important to try to prevent the development of ONJ, as it can be a painful condition that may be difficult to treat. To reduce the risk of developing ONJ, follow these precautions:

Before receiving treatment, inform your doctor or nurse (healthcare professional) if:

• you have any problems with your mouth or teeth, such as poor dental health, gum disease, or planned dental extraction.
• you do not receive regular dental check-ups or have not had a dental check-up for a long time.
• you are a smoker (as this may increase the risk of dental problems).
• you have previously been treated with a bisphosphonate (used to prevent or treat bone disorders).
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• you have cancer.

Your doctor may ask you to have a dental examination before starting treatment with Ponlimsi.

During treatment with Ponlimsi, you should maintain good oral hygiene and undergo routine dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or are scheduled for dental surgery (e.g., tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Ponlimsi.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as loose teeth, pain or swelling, or non-healing or draining sores, as these could be symptoms of ONJ.

Unusual femur fractures

Some people have developed unusual fractures in the femur while being treated with Ponlimsi. Consult your doctor if you experience new or unusual pain in the hip, groin, or thigh.

Children and adolescents

Ponlimsi must not be used in individuals under 18 years of age.

Other medicines and Ponlimsi

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you inform your doctor if you are being treated with another medicine containing denosumab.

You must not use Ponlimsi together with another medicine containing denosumab.

Pregnancy and breastfeeding

Ponlimsi has not been studied in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. The use of Ponlimsi during pregnancy is not recommended. Women of childbearing potential must use effective contraceptive methods during treatment with Ponlimsi and for at least 5 months after stopping treatment with Ponlimsi.

If you become pregnant during treatment with Ponlimsi or within 5 months after stopping treatment with Ponlimsi, inform your doctor.

It is unknown whether Ponlimsi is excreted in human breast milk. It is important that you inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to discontinue breastfeeding or to stop using Ponlimsi, taking into account the benefits of breastfeeding for the child and the benefits of Ponlimsi for the mother.

If you are breastfeeding during treatment with Ponlimsi, please inform your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The effect of Ponlimsi on the ability to drive and use machines is negligible or none.

Ponlimsi contains sorbitol

This medicine contains 47 mg of sorbitol per ml of solution.

Ponlimsi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg; this is essentially “sodium-free”.

Ponlimsi contains polysorbate 20

This medicine contains 0.1 mg of polysorbate 20 in each syringe, equivalent to 0.1 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Ponlimsi

The recommended dose is one 60 mg pre-filled syringe administered under the skin (subcutaneous route) as a single injection every 6 months. The best places to administer the injection are the upper thighs and the abdomen. If a caregiver (a person who assists you) gives the injection, it may also be administered into the outer side of the upper arm. Please consult your doctor about the date of your next possible injection.

In addition, you must take calcium and vitamin D supplements during treatment with Ponlimsi. Your doctor will discuss this with you.

Your doctor may decide whether it is preferable for you or a caregiver to administer the Ponlimsi injection. Your doctor or healthcare professional will show you or your caregiver how to use Ponlimsi. If you would like instructions on how to inject Ponlimsi, please read the last section of this leaflet.

Do not shake.

If you forget to use Ponlimsi

If you miss a dose of Ponlimsi, the injection should be administered as soon as possible. After that, injections should be scheduled every 6 months starting from the date of the last injection.

If you stop using Ponlimsi

To obtain the maximum benefit from your treatment and to reduce the risk of fractures, it is important to use Ponlimsi for the entire duration prescribed by your doctor. Do not stop treatment without first speaking to your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Patients treated with Ponlimsi may rarely develop skin infections (mainly cellulitis). Contact your doctor immediately if any of the following symptoms occur during treatment with Ponlimsi: swollen, red area of skin, usually on the lower leg, which is warm and tender to the touch and may be accompanied by fever.

Rarely, patients receiving Ponlimsi may develop pain in the mouth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loose teeth. These could be symptoms of bone damage in the jaw (osteonecrosis). Contact your doctor and dentist immediately if you experience such symptoms while being treated with Ponlimsi or after stopping treatment.

Rarely, patients receiving Ponlimsi may develop low levels of calcium in the blood (hypocalcemia); very low calcium levels may require hospitalization and could even be life-threatening. Symptoms include muscle spasms, twitching or cramps, and/or numbness or tingling in the fingers, toes, or around the mouth, and/or seizures, confusion, or loss of consciousness. If you experience any of these, contact your doctor immediately. Low calcium levels in the blood may also cause a change in heart rhythm known as QT prolongation, which can be detected by an electrocardiogram (ECG).

Rarely, unusual femoral fractures may occur in patients receiving Ponlimsi. Consult your doctor if you experience new or unusual pain in the hip, groin, or thigh, as this may be an early sign of a possible femur fracture.

Rarely, allergic reactions may occur in patients receiving Ponlimsi. Symptoms include swelling of the face, lips, tongue, throat, or other body parts; skin rash, itching, or hives; wheezing or difficulty breathing. Contact your doctor if you experience such symptoms while being treated with Ponlimsi.

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

• bone, joint, and/or muscle pain, which may sometimes be severe,
• pain in the legs or arms (limb pain).

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

• painful urination, frequent urination, blood in the urine, urinary incontinence,
• upper respiratory tract infection,
• pain, tingling, or numbness radiating down the lower leg (sciatica),
• constipation,
• abdominal discomfort,
• skin rash,
• skin condition with itching, redness, and/or dryness (eczema),
• hair loss (alopecia).

Uncommon adverse effects (may affect up to 1 in 100 people):

• fever, vomiting, and abdominal pain or discomfort (diverticulitis),
• ear infection,
• skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Rare adverse effects (may affect up to 1 in 10,000 people):

• allergic reaction that may damage blood vessels, mainly in the skin (e.g., purple or reddish-brown spots, hives, or skin ulcers) (hypersensitivity vasculitis).

Frequency not known (cannot be estimated from available data):

• contact your doctor if you have ear pain, ear discharge, and/or an ear infection. These could be symptoms of damage to the ear bones.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ponlimsi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and the carton, following the word "EXP". The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

Keep the pre-filled syringe in the outer packaging to protect it from light.

Prior to injection, the pre-filled syringe may be removed from the refrigerator and allowed to reach room temperature (up to 30 °C) to make the injection less uncomfortable. Once the syringe has reached room temperature (up to 30 °C), it must not be returned to the refrigerator and should be used within 32 days.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ponlimsi

• The active substance is denosumab. Each 1 ml pre-filled syringe contains 60 mg of denosumab (60 mg/ml).
• The other components are sodium acetate trihydrate, glacial acetic acid, sorbitol (E420), polysorbate 20, and water for injections.

Description of the product and contents of the pack

Ponlimsi is an injectable solution, ranging from transparent to opalescent and from colourless to pale yellow, supplied in a ready-to-use pre-filled syringe.

Each pack contains one pre-filled syringe with a needle protector.

Marketing Authorization Holder

TEVA GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Manufacturer responsible for manufacturing

Merckle GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Further information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

Instructions for use