Conexxence 60 mg – patient leaflet, side effects, dosage

1. What Conexxence is and what it is used for

What Conexxence is and how it works

Conexxence contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis. Treatment with Conexxence makes bone stronger and less likely to break.

Bone is a living tissue and is renewed all the time. Oestrogen helps keep bones healthy. After the menopause, oestrogen level drops which may cause bones to become thin and fragile. This can eventually lead to a condition called osteoporosis. Osteoporosis can also occur in men due to a number of causes including ageing 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 they are still at risk of breaking bones, especially in the spine, hips and wrists.

Surgery or medicines that stop the production of oestrogen or testosterone used to treat patients with breast or prostate cancer can also lead to bone loss. The bones become weaker and break more easily.

What Conexxence is used for

Conexxence is used to treat:

• osteoporosis in women after the menopause (postmenopausal)

  and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal and hip fractures.

• bone loss that results from a reduction in hormone

  (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.

• bone loss that results from long-term treatment with

  glucocorticoids in patients who have an increased risk of fracture.

2. What you need to know before you use Conexxence

Do not use Conexxence

• if you have low calcium levels in the blood (hypocalcaemia).

• 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 Conexxence.

Whilst being treated with Conexxence you may develop a skin infection with symptoms such as a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever. Please tell your doctor immediately if you develop any of these symptoms.

You should also take calcium and vitamin D supplements while being on treatment with Conexxence. Your doctor will discuss this with you.

You may have low levels of calcium in your blood while receiving Conexxence. Please tell your doctor immediately if you notice any of the following symptoms: spasms, twitches, or cramps in your muscle, and/or numbness or tingling in your fingers, toes or around your mouth, and/or seizures (fits), confusion, or loss of consciousness.

Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis or are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), which may increase your risk of getting low blood calcium if you do not take calcium supplements.

Problems with your mouth, teeth or jaw

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1 000

people) in patients receiving Conexxence for osteoporosis. 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 ONJ developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, take the following precautions:

Before receiving treatment, tell your doctor or nurse (health care professional) if you:

• have any problems with your mouth or teeth such as poor dental

  health, gum disease, or a planned tooth extraction.

• don’t receive routine dental care or have not had a dental check-

  up for a long time.

• are a smoker (as this may increase the risk of dental problems).

• have previously been 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 undergo a dental examination before you start treatment with Conexxence.

While being treated, you should maintain good oral hygiene and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Conexxence.

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 of sores or discharge, as these could be signs of ONJ.

Unusual thigh bone fractures

Some people have developed unusual fractures in their thigh bone while being treated with Conexxence. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.

Children and adolescents

Conexxence should not be used in children and adolescents under 18 years of age.

Other medicines and Conexxence

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

You should not use Conexxence together with another medicine

containing denosumab.

Pregnancy and breast-feeding

Conexxence has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant; or plan to get pregnant. Conexxence is not recommended for use if you are pregnant. Women of child-bearing potential should use effective methods of contraception while being treated with Conexxence and for at least 5 months after stopping treatment with Conexxence.

If you become pregnant during treatment with Conexxence or less than 5 months after stopping treatment with Conexxence, please inform your doctor.

It is not known whether Conexxence is excreted in breast milk. It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-

feeding, or whether to stop using Conexxence, considering the benefit of breast-feeding to the baby and the benefit of Conexxence to the mother.

If you are breast-feeding during Conexxence treatment, please inform your doctor.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

Conexxence has no or negligible influence on the ability to drive and use machines.

Conexxence contains sorbitol

This medicine contains 47 mg sorbitol in each ml of solution.

Conexxence contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodium-free’.

Conexxence contains polysorbate 20

This medicine contains 0.1 mg of polysorbate 20 in each pre-filled

syringe which is equival allergic reactions. Tell y

3. How to use Conexxe

The recommended dose administered once ever skin (subcutaneous). Th thighs and the abdomen of your upper arm. Plea potential next injection.

You should also take cal being on treatment with with you.

Your doctor may decide

ent to 0.1 mg/mL. Polysorbates may cause our doctor if you have any known allergies.

nce

is one pre-filled syringe of 60 mg y 6 months, as a single injection under the e best places to inject are the top of your . Your carer can also use the outer area se consult your doctor on the date for a

cium and vitamin D supplements while Conexxence. Your doctor will discuss this

that it is best for you or a carer to inject

Conexxence. Your docto your carer how to use C Conexxence, please read

Do not shake.

If you forget to use Co

If a dose of Conexxence administered as soon as scheduled every 6 mont

If you stop using Cone

To get the most benefit of fractures, it is import doctor prescribes it for contacting your doctor.

4. Possible side effect

r or healthcare provider will show you or onexxence. For instructions on how to inject the section at the end of this leaflet.

nexxence

is missed, the injection should be possible. Thereafter, injections should be hs from the date of the last injection.

xxence

from your treatment in reducing the risk ant to use Conexxence for as long as your you. Do not stop your treatment without

s

Like all medicines, this m not everybody gets the

Uncommonly, patients r infections (predominant immediately if you deve on treatment with Cone commonly in the lower l with symptoms of fever.

Rarely, patients receivin mouth and/or jaw, swelli or jaw, discharge, numb loosening of a tooth. Th jaw (osteonecrosis). Tell if you experience such s

edicine can cause side effects, although m.

eceiving Conexxence may develop skin ly cellulitis). Please tell your doctor lop any of these symptoms while being xxence: swollen, red area of skin, most eg, that feels hot and tender, and possibly

g Conexxence may develop pain in the ng or non-healing of sores in the mouth ness or a feeling of heaviness in the jaw, or ese could be signs of bone damage in the your doctor and dentist immediately ymptoms while being treated with

Conexxence or after sto

Rarely, patients receivin in the blood (hypocalcae or cramps in your muscl fingers, toes or around y or loss of consciousness doctor immediately. Lo change in heart rhythm electrocardiogram (ECG

Rarely unusual fracture receiving Conexxence. C or unusual pain in your indication of a possible f

Rarely, allergic reaction Conexxence. Symptoms

pping treatment.

g Conexxence may have low calcium levels mia). Symptoms include spasms, twitches, es, and/or numbness or tingling in your our mouth and/or seizures, confusion, . If any of these apply to you, tell your w calcium in the blood may also lead to a called QT prolongation which is seen by ).

s of the thigh bone may occur in patients ontact your doctor if you experience new hip, groin or thigh as this may be an early racture of the thigh bone.

s may occur in patients receiving include swelling of the face, lips, tongue,

throat or other parts of the body; rash, itching or hives on the skin, wheezing or difficulty breathing. Please tell your doctor if you develop any of these symptoms while being treated with Conexxence.

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

• bone, joint, and/or muscle pain which is sometimes severe,
• arm or leg pain (pain in extremity).

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

• painful urination, frequent urination, blood in the urine, inability to hold your urine,
• upper respiratory tract infection,
• pain, tingling or numbness that moves down your leg (sciatica),
• constipation,
• abdominal discomfort,
• 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 discom

  fort (diverticulitis),

• ear infection,

• rash that may occur on the skin or sores in th

  e mouth (lichenoid drug eruptions).

Very rare side effects (may affect up to 1 in 10 0

00 people):

• allergic reaction that can damage blood vess

  els mainly in the skin (e.g. purple or brownish-red spots, hives

  or skin sores)

  (hypersensitivity vasculitis).

Not known (frequency cannot be estimated from

the available data):

• talk to your doctor if you have ear pain, disch

  arge from the ear and/or an ear infection. These could be signs

  of bone damage in the ear.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Conexxence

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 carton 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 container in the outer carton in order to protect from light.

Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25 °C) before injection. This will make the injection more comfortable. Once your syringe has been left to reach room temperature (up to 25 °C), it must be used within 30 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to prote

ct the environment.

6. Contents of the pack and other information

What Conexxence contains

• The active substance is denosumab. Each 1 m

  l pre-filled syringe contains 60 mg of denosumab (60 mg/ml).

• The other ingredients are acetic acid, sodium

  acetate trihydrate, sorbitol (E420), polysorbate 20 (E432), and w

  ater for injections.

What Conexxence looks like and contents of t

he pack

Conexxence is a clear, colourless to slightly yello

w solution for injection provided in a ready to use pre-filled syr

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

rd.

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court

Eastgate Way, Manor Park Runcorn, Cheshire, WA7 1NT United Kingdom

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

8055 Graz

Austria

This leaflet was last revised in May 2025.

Solution for injection in pre-filled syringe denosumab

Subcutaneous use.

60 mg/mL

Conexxence®

Solution for injection in pre-filled syringe

denosumab

Subcutaneous use.

60 mg/mL

Conexxence®

1. 7. Instructions for use

Guide to parts:

Before you use a Conexxence pre-filled syringe with automatic needle guard, read this important information:

• It is important that you do not try to give yourself the injection

unless you have received training from your doctor or healthcare provider.

• Conexxence is given as an injection into the tissue just under

  the skin (subcutaneous injection).

• Do not remove the grey needle cap from the pre-filled syringe

  until you are ready to inject.

• Do not use the pre-filled syringe if the carton is damaged or the

  seal is broken.

• Do not use the pre-filled syringe if it has been dropped on a

hard surface. Use a new pre-filled syringe and call your doctor or healthcare provider.

• Do not try to push the plunger rod of the pre-filled syringe

  before the injection.

• Do not shake the pre-filled syringe.

• Important: Keep the pre-filled syringe out of the sight and

  reach of children.

Storing Conexxence pre-filled syringe

• Store Conexxence in a refrigerator between 2 °C to 8 °C in the

  original carton. Do not freeze.

• Before giving the injection, Conexxence may be allowed to reach

  room temperature up to 25 °C in the original container. This takes 15 to 30 minutes. Do not warm Conexxence in any other way.

• After Conexxence is removed from the refrigerator, it must be

  used within 30 days. If not used in 30 days, it should be thrown away (discarded).

• Do not use Conexxence after the expiration date printed on the

  label.

• Protect Conexxence from direct light and heat.

Call your doctor or healthcare provider if you have any questions.

Prepare to inject Step 2

2.1 Choose an injection site

You can inject into (see Figure H):

• upper thighs
• belly, except for a 5 cm area around the belly button
• outer area of upper arm (if you are injecting into someone else) Do not inject into areas where the skin is tender, bruised, red, or hard.

e plunger rod.

in your sharps

way your pre-filled

e pre-filled syringe.

Inject medicine Step 3

3.1 Pinch the skin

Pinch your injection site to create a firm surface (see Figure K).

Note: It is important to keep the skin pinched when injecting.

3.2 Insert the needle

Quickly insert the needle straight

Do not lift the pre-filled syringe off the skin.

3.4 Release plunger

Slowly release the plunger and allow the needle to come out of the skin at the same angle it was inserted. The clear needle guard will safely cover the needle (see Figure O).

Do not put the needle cap back on the needle.

Throw away your pre-filled syringe Step 4

4.1 Dispose

Put your used pre-filled syringe and needle cap in a sharps disposal container right away after use (see

Figure Q).

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Do not reuse the pre-filled syringe.

Do not throw away (dispose of) used syringes in your household trash.

Do not recycle your used sharps disposal container.

Keep Conexxence pre-filled syringes, sharps disposal container and all medicines out of the reach and sight of children. Prepare materials Step 1

1.1 Gather supplies

On a clean, well-lit work surface,

gather the supplies needed for your

injection (see Figure A):

• alcohol wipes
• cotton ball or gauze pad
• adhesive bandage

• sharps disposal container (see

  Step 4 Throw away your pre-filled syringe)

in direct sunligh

Do not shake t

Keep the pre-fi

children.

1.3 Wash your han

Wash your han

and water and

clean towel (se

1.4 Remove pre-fil

Place two finge

in the middle of

guard. Pull the

straight up and

(see Figure E).

Do not grasp th

Do not grasp th

1.5 Inspect pre-fill

Check the pre-f

make sure that:

• The name o

Conexxence

• The expirati

has not pas

• The pre-fille

cracked or

Check the liqui

any particles or

Figure G).

Do not use the

• The name o

Conexxence

• The expirati

has passed.

• Any part ap

• The needle cap is missing or not firmly attached.

• The medicine is cloudy or there are particles in it. It must be a clear, colourless to slightly yellow solution. In all cases, use a new pre-filled syringe and call your doctor or healthcare provider.

  M0xxxxx/X0 UK Figure A

Figure H

Figure J

Figure K

Figure N

Figure O

Figure Q

After Use

Clear needle guard

Plunger

Needle covered Needle guard

spring extended

Conexxence® 60 mg/ml

Solution for injection in pre-filled syringe denosumab

Subcutaneous use.