OSVYRTI 60 mg /Ml Injectable Solution In Pre-Filled Syringe

Зміст інструкції

1. Osvyrti 60 mg injectable solution in pre-filled syringe
   1. What is Osvyrti and what is it used for What is Osvyrti and how does it work
   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 What Osvyrti contains

Osvyrti 60 mg injectable solution in pre-filled syringe

denosumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Your doctor will give you a patient reminder card containing important safety information that you need to know before and during treatment with Osvyrti.

Contents of this leaflet

• 1. What Osvyrti is and what it is used for
• 2. What you need to know before you use 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 is Osvyrti and what is it used for What is Osvyrti and how does it work

OSVYRTI contains denosumab, a protein (monoclonal antibody) that interferes with the action of
another protein, for the treatment of bone loss and osteoporosis. Treatment with Osvyrti
makes bones stronger and less likely to fracture.
Bone is a living tissue that is constantly being renewed. Estrogens help to keep bones
healthy. After menopause, a decrease in estrogen levels can make bones thin and fragile, which
can lead to the development of a condition called osteoporosis. Osteoporosis can also
occur in men for various reasons including aging and/or a low
level of the male hormone, testosterone. It can also occur in patients receiving
glucocorticoids. Many patients with osteoporosis have no symptoms, but are still at
risk of bone fractures, especially in the spine, hip and wrists.
Surgical procedures or medications that stop the production of estrogen or testosterone,
used to treat patients with breast or prostate cancer, can also cause
bone loss. Bones thus become more fragile and fracture more easily.

What type of treatment is Osvyrti used for
Osvyrti is used for the treatment of:

• osteoporosis in women after menopause (postmenopausal osteoporosis) and in men who have an increased risk of fractures (broken bones), to reduce the risk of vertebral, non-vertebral and hip fractures.
• bone loss in men resulting from a decrease in hormone levels (testosterone) due to surgery or drug therapy in patients with prostate cancer.
• bone loss due to long-term treatment with glucocorticoids in patients at increased

risk of fracture.

2. What you need to know before using Osvyrti

Do not use Osvyrti

• if you have reduced levels of calcium in the 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 using Osvyrti.
During treatment with Osvyrti you may develop a skin infection with symptoms such as
swelling, redness, most commonly in the lower leg, with a feeling of warmth and
pain (cellulitis) and with possible feverish symptoms. Tell your doctor immediately if you
experience any of these symptoms.
During treatment with Osvyrti you must also take calcium and vitamin D supplements. Your doctor
will discuss this with you.
During treatment with Osvyrti you may have low levels of calcium in the blood. Tell your
doctor immediately if you notice any of the following symptoms: spasms, contractions or cramps in the
muscles, and/or numbness or tingling in the fingers, toes or around the mouth, and/or
convulsions, confusion or loss of consciousness.
In rare cases, severely low levels of calcium in the blood have been reported that have led
to hospitalization and even life-threatening reactions. Before each dose and in patients
prone to developing hypocalcemia within two weeks of the initial dose, blood calcium levels will therefore be checked (by blood test).
Tell your doctor if you suffer from or have ever suffered from severe kidney problems, kidney impairment or if you have been
undergoing dialysis or are taking medicines called glucocorticoids (such as prednisolone or
dexamethasone), which may increase your risk of having low levels of calcium in the blood if you do not
take calcium supplements.
Problems with the mouth, teeth or jaw/jawbone
An undesirable effect called osteonecrosis of the jaw/jawbone (severe degeneration of the
bone tissue of the jaw/jawbone) has been reported rarely (may occur in up to 1 in 1,000 patients) in patients receiving Osvyrti for osteoporosis. The risk of osteonecrosis of the
jaw/jawbone increases in patients treated for a long period (may occur in up to 1
in 200 patients if treated for 10 years). Osteonecrosis of the jaw/jawbone can also occur
even after treatment is stopped. It is important to try to prevent the development of osteonecrosis
of the jaw/jawbone as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the
jaw/jawbone, take the following
precautions:
Before receiving treatment, tell your doctor or nurse (healthcare professional) if you:

• have any problems with your mouth or teeth, such as poor dental hygiene, gum disorders, or are planning to have a tooth extracted;
• do not undergo regular dental care or have not had a dental check-up for a long period;
• are a smoker (as this may increase the risk of dental disorders);
• have been previously treated with a bisphosphonate (used to treat or prevent bone disorders);
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• have cancer.

Your doctor may ask you to have a dental check-up (from the dentist) before starting
treatment with Osvyrti.
During treatment, it is necessary to maintain good oral hygiene and undergo periodic dental
check-ups. If you wear dentures, you must make sure that they are fitted correctly. If
you are undergoing dental treatment or are planning to have dental surgery (e.g. tooth extractions), tell your doctor about the dental treatment and tell your dentist that you are in
treatment with Osvyrti.
Contact your doctor and dentist immediately if you notice the appearance of problems with your mouth or teeth
such as tooth loss, pain or swelling or failure to heal mouth sores or the presence of
discharge, as these may be signs of an undesirable effect called osteonecrosis of the
jaw/jawbone (ONJ).
Atypical femoral fractures
Some people have developed atypical fractures of the femur during treatment with Osvyrti.
Contact your doctor if you experience new or unusual pain in the hip, groin or thigh.

Children and adolescents
Osvyrti must not be used in children and adolescents under 18 years of age.

Other medicines and Osvyrti
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. It is particularly important that you tell your doctor if you are taking other
medicines that contain denosumab.

Pregnancy and breastfeeding
Osvyrti has not been studied in pregnant women. It is important that you tell your doctor if you are
pregnant; if you think you may be pregnant; or if you are planning a pregnancy. The use of Osvyrti is not recommended if you are pregnant. Women of childbearing potential
must use effective contraceptive methods while taking Osvyrti and for at least 5 months after
stopping treatment with Osvyrti.
If you become pregnant during treatment with Osvyrti or within 5 months of stopping
treatment with Osvyrti, please tell your doctor.
It is not known whether Osvyrti passes into breast milk. It is important that you tell your doctor if you are breastfeeding or
planning to breastfeed. Your doctor will then help you decide whether to stop breastfeeding or
taking Osvyrti, considering the benefit of breastfeeding for the baby and the benefit of
taking Osvyrti for the mother.
If you are breastfeeding during treatment with Osvyrti, tell your doctor.
Ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Osvyrti does not alter or negligibly alters the ability to drive vehicles or use machines.

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 pre-filled 1 mL syringe. Polysorbates
can cause allergic reactions. If you have any known allergies, tell your doctor.

Osvyrti contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg, i.e. essentially ‘sodium-free’.

3. How to use Osvyrti

The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a
single injection under the skin (subcutaneous). The most suitable injection sites are the upper
thighs and the abdomen. If someone is assisting you with the injection, they can also use the upper
outer part of the arm. Consult your doctor regarding the date of the possible next injection.
Each pack of Osvyrti contains a detachable label, which can be removed from the blister and used to
keep track of the date of the next injection.
During treatment with Osvyrti, you must also take calcium and vitamin D supplements. Your doctor
will discuss this with you.
Your doctor may decide whether it is better for you or the person assisting you to administer the injection with
Osvyrti. Your doctor or nursing staff will show you or the person assisting you how to
administer Osvyrti. For instructions on how to inject Osvyrti, refer to the paragraph at the end of this
Do not shake.

If you forget to use Osvyrti
If you have forgotten a dose of Osvyrti, the injection should be given as soon as possible.
Subsequently, injections should be given every 6 months from the date of the last injection.

If you stop using Osvyrti
To get the maximum benefit from treatment in reducing the risk of fractures, it is important
to take Osvyrti for the entire period prescribed by your doctor. Do not stop treatment without
consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommonly, patients treated with Osvyrti may develop skin infections
(especially cellulitis). Tell your doctor immediatelyif any of these symptoms occur
while you are taking Osvyrti: redness and swelling of the skin, most commonly in the
lower leg, with a feeling of warmth and pain and with possible feverish symptoms.
Rarely, patients treated with Osvyrti may develop pain in the mouth and/or
jaw/mandible, swelling or sores that do not heal in the mouth or
jaw/mandible, presence of secretions, numbness or feeling of heaviness in the
jaw/mandible, or loosening of a tooth. These could be signs of a serious
degeneration of the bone tissue of the jaw/mandible (osteonecrosis). Tell your doctor and
dentist immediatelyif you experience these symptoms during treatment with Osvyrti or after stopping
treatment.
Rarely, patients treated with Osvyrti may have low levels of calcium in the blood
(hypocalcemia). Symptoms include spasms, contractions or muscle cramps, and/or numbness or
tingling in the fingers of the hands, feet or around the mouth and/or convulsions, confusion, or loss of
consciousness. Tell your doctor immediatelyif any of these symptoms occur. Low levels of
calcium in the blood can also lead to a change in the heart rhythm called a prolonged
QT interval, which is detected with an electrocardiogram (ECG).
Rarely, atypical fractures of the femur can occur in patients treated with Osvyrti.

Contact your doctorif you experience new or unusual pain in the hip, groin or thigh, as
this could be an early sign of a possible femur fracture.
Rarely, allergic reactions can occur in patients treated with Osvyrti. Symptoms
include swelling of the face, lips, tongue, throat or other parts of the body; rash,
itching, hives, wheezing or difficulty breathing. Tell your doctorif you experience any
of these 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 the arms or legs (limb pain).

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

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

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

• fever, vomiting and abdominal pain or abdominal disorders (diverticulitis),
• ear infections,
• rash that may occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions).

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

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

Not known(frequency cannot be estimated from available data):

• tell your doctor if you experience ear pain, ear discharge, and/or an ear infection. These could be signs of damage to the ear bone.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Osvyrti

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
The pre-filled syringe can be left out of the refrigerator in such a way as to reach
room temperature (up to 25 °C) before the injection. This will make the injection more comfortable.
Once the syringe has reached room temperature (up to 25 °C), it must be used
within 30 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information What Osvyrti contains

• The active ingredient is denosumab. Each pre-filled syringe of 1 mL contains 60 mg of denosumab (60 mg/mL).
• The other ingredients 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).

Description of the appearance of Osvyrti and contents of the pack
Osvyrti is a clear, injectable solution (injection), from colourless to light yellow, in a pre-filled syringe ready for use.
Each pack contains one pre-filled syringe with needle protection.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6a Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
Ul. Lutomierska 50, 95-200,
Pabianice, Poland
For further information on this medicinal product, 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

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/
Instructions for use:
Guide to the parts

Before use
After use

Important
Before using a pre-filled syringe of Osvyrti with automatic needle protection, read these important instructions:

• - It is important that you do not attempt to administer the injection unless you have received adequate instructions from your doctor or healthcare professional.
• - Osvyrti is administered as an injection into the tissue just below the skin (subcutaneous injection). Do notremove the grey cap/needle cover from the pre-filled syringe until you are

ready for the injection.

Do notuse the pre-filled syringe if it has been dropped onto a hard surface. Use a new pre-filled syringe

and contact your doctor or healthcare professional.

Do notattempt to activate the pre-filled syringe before the injection.

Do nottouch the activation clips of the needle protection before use; otherwise, the

needle protection of the syringe may activate prematurely.

Do notattempt to remove the transparent safety cover from the pre-filled syringe.
Contact your doctor or healthcare professional for any questions.

B Open the wrapper by tearing it open. Grasp the safety cover of the pre-filled syringe to remove the pre-filled syringe from the wrapper.

Grasp here
For safety reasons:

Do notgrasp the plunger.

Do notgrasp the grey cap/needle cover.

C Check the medicinal product and the pre-filled syringe.

Medicine window

Do notuse the pre-filled syringe if:

• The medicinal product is cloudy or there are particles inside. It should be a clear solution, from colourless to light yellow.
• Any parts appear cracked or broken.
• The grey cap/needle cover is missing or is not securely attached.
• The expiry date printed on the label has passed the last day of the month indicated. In all cases, contact your doctor or healthcare professional.

Step 2: Preparation
A Wash your hands thoroughly. Prepare and clean the injection site.

Upper arm
Abdomen
Upper thigh

You can use:

• The upper thigh.
• The abdomen, except for the area of 5 centimetres directly around the navel.
• The outer upper arm (only if someone else is giving you the injection). Clean the injection site with an alcohol swab. Let the skin dry. Do nottouch the injection site before the injection. Do notinject into areas where the skin is sensitive, wounded, reddened, or hardened. Avoid injecting into areas with scars or stretch marks.

B	Carefully remove the grey cap/needle cover outwards and away from your body.
o c a m r a F Do not twist and do not bend the cap/needle cover. Do not hold the pre-filled syringe by the plunger rod. Dispose of the cap/needle cover in a sharps disposal container. l Do not touch the needle and avoid contact of the needle with any surface. e Do not put the cap back on the needle.

C	d Lift the injection site to create a firm surface.
a n a i l a t It is important to keep the skin lifted during the injection.

Step 3: Injection
A	Keeping the skin lifted, INSERT the needle into the skin.
i z n e g A Do not touch the clean skin area.

B	PUSH the plunger with a slow and steady pressure until you feel or hear a “click”. Push all the way down until the click.
o c a m r a It is important to push all the way down to the “click” to inject the entire dose.

C	RELEASE your thumb. Then WITHDRAW the syringe from the skin.
l e d a n a i l a t I After releasing the plunger, the safety cover of the pre-filled syringe will cover the injection needle safely. Do not put the grey cap back on used pre-filled syringes.

Step 4: End
A Dispose of the used pre-filled syringe and other materials in a sharps disposal container.

Medicines should be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
Keep the syringe and the sharps disposal container out of the sight and reach of children.

Do notreuse the pre-filled syringe.

Do notrecycle pre-filled syringes or throw them in household waste.