Osvyrti 60 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Osvyrti 60 mg solution for injection in pre-filled syringe

denosumab

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

Read the 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient alert card containing important safety information that you should know before and during treatment with Osvyrti.

Leaflet contents

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

1. What Osvyrti is and what it is used for

What Osvyrti is and how it works

OSVYRTI contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein in order to treat bone loss and osteoporosis. Treatment with Osvyrti strengthens bones and reduces the risk of fracture.

Bone is a living tissue that is continuously renewed. Oestrogens contribute to maintaining bone health. After menopause, oestrogen 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 can also occur in patients receiving glucocorticoid therapy. Many patients with osteoporosis do not have symptoms, although they still remain at risk of bone fractures, particularly in the spine, hip, and wrists.

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

What Osvyrti is used for

Osvyrti is used to treat:

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

2. What you need to know before using Osvyrti

Do not use Osvyrti:

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

Warnings and precautions

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

While being treated with Osvyrti, 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. Contact your doctor immediately if you experience any of these symptoms.

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

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

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

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 your risk of low blood calcium levels if you do not take calcium supplements.

Problems with mouth, teeth or jaw

In patients receiving Osvyrti for osteoporosis, a rare adverse effect called osteonecrosis of the jaw (ONJ) (damage to the jaw bone) 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 may also occur after stopping treatment. It is important to try to prevent ONJ from developing, 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 Osvyrti.

While being treated with Osvyrti, 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 Osvyrti.

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 oozing sores, as these could be symptoms of ONJ.

Unusual femur fractures

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

Children and adolescents

Osvyrti should not be used in individuals under 18 years of age.

Using Osvyrti with other medicines

Tell 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 Osvyrti together with another medicine containing denosumab.

Pregnancy and breastfeeding

Osvyrti 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. Osvyrti is not recommended during pregnancy. Women of childbearing potential must use effective contraception during treatment with Osvyrti and for at least 5 months after stopping treatment with Osvyrti.

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

It is unknown whether Osvyrti 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 discontinue Osvyrti, taking into account the benefits of breastfeeding for the child and the benefits of Osvyrti for the mother.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The influence of Osvyrti on the ability to drive and use machines is negligible or none.

Osvyrti contains sorbitol

This medicine contains 46 mg of sorbitol per ml of solution.

Osvyrti contains polysorbate 20

This medicine contains 0.1 mg of polysorbate 20 in each 1 ml pre-filled syringe. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

Osvyrti contains sodium

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

3. How to use Osvyrti

The recommended dose is one 60 mg prefilled syringe administered under the skin (subcutaneous route) as a single injection every 6 months. The best places to give the injection are the upper thigh and abdomen. If the injection is administered by a caregiver, it may also be given on the outer side of the upper arm. Consult your doctor for the date of your next possible injection. Each Osvyrti package contains a detachable label that can be removed from the blister and used to keep a record of the date of your next injection.

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

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

Do not shake.

If you forget to use Osvyrti

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

If you stop treatment with Osvyrti

To get the maximum benefit from your treatment and reduce the risk of fractures, it is important that you use Osvyrti for the entire period prescribed by your doctor. Do not stop treatment without first talking to your doctor.

4. Possible side effects

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

Patients treated with Osvyrti may occasionally develop skin infections (mainly cellulitis). Contact your doctor immediately if any of the following symptoms occur during treatment with Osvyrti: 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 Osvyrti may develop mouth and/or jaw pain, swelling or non-healing ulcers in the mouth or jaw, pus 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 Osvyrti or after stopping treatment.

Rarely, patients receiving Osvyrti may develop low levels of calcium in the blood (hypocalcemia). Symptoms include 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. If you experience any of these, contact your doctor immediately. Low calcium levels in the blood may also cause a change in heart rhythm called QT prolongation, which can be detected by performing an electrocardiogram (ECG).

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

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

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

Common side 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 side 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).

Very rare side 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):

• consult 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Osvyrti

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 carton after "CAD" or "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.

Before injection, the pre-filled syringe may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) to make the injection less uncomfortable. Once the syringe has reached room temperature (up to 25 °C), it must be used within 30 days.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Osvyrti

• The active substance is denosumab. Each 1 ml pre-filled syringe contains 60 mg of denosumab (60 mg/ml).
• The other components are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20, and water for injections (see section 2, Osvyrti contains sorbitol, Osvyrti contains polysorbate 20 and Osvyrti contains sodium).

Appearance of Osvyrti and contents of the pack

Osvyrti is a ready-to-use, clear, colourless to slightly yellowish injectable solution, supplied in a pre-filled syringe.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z.o.o.

Ul. Lutomierska 50, 95-200,

Pabianice, Poland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Τηλ: +30 210 74 88 821

Date of the most recent review of this leaflet: <{MM/YYYY}><{month YYYY}>.

Other sources of information

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