Download Prolia (denosumab) treatment for osteoporosis

Prolia (denosumab) treatment
for osteoporosis
Information for patients
This information sheet answers some of the questions you may have
about Prolia treatment for osteoporosis. If you have any other
questions or concerns, please do not hesitate to speak to the doctors
or nurses caring for you.
What is osteoporosis?
Osteoporosis literally means 'porous bones'.
Our bones are made up of a thick outer shell and a strong inner mesh. This mesh looks
like a honeycomb made of tiny struts of bone. If you have osteoporosis, some of these
struts become thin or break, making your bones more fragile and likely to break.
These breaks are often in your wrist, hip or spine (vertebrae), but osteoporosis affects
all of the bones in your body.
You can also break bones very easily if you have this condition. For example, by having
a simple fall or lifting something awkwardly.
You often do not know you have osteoporosis until you break a bone.
Who is at risk of developing osteoporosis?
Hormones, including oestrogen in women and testosterone in men, help keep bones
healthy. Low levels of oestrogen or testosterone can cause your bones to become
weaker as more bone is removed than replaced, increasing your risk of developing
osteoporosis. This can happen can after the menopause as oestrogen levels drop.
Similarly, surgery or medication that stops the production of oestrogen or testosterone
– such as treatment for breast or prostate cancer – can also lead to bone loss and
osteoporosis.
What is Prolia and how does it work?
Prolia is a drug containing a protein called denosumab that interferes with how
another protein works to treat bone loss and osteoporosis.
New bone is constantly added to your bones and the old tissue is taken away to help to
repair damage from everyday activities. This is called bone turnover. These processes are
carried out by special cells. If you have osteoporosis, not enough new bone is added to
make up for the loss of the old bone.
Prolia slows down bone turnover. It stops the cells that break down bone and allows
the cells that rebuild bone to work more effectively and bring the process back into
balance. This improves the strength of your bones and reduces your risk of fractures.
The drug is not used to relieve the pain of fractures caused by osteoporosis.
How is it given?
You have it as an injection, just under your skin.
What are the benefits?
• It improves the strength of your bones
• It reduces your risk of bone fractures
• It makes your bones stronger.
What are the risks?
As with all medications, Prolia may cause side effects. These include:
• Skin infections (cellulitis). An area of your skin – usually on the lower part of your leg
– may become swollen, red and feel hot and tender. You may also have a high
temperature (a fever).
• Jaw osteonecrosis. This is a very rare condition in which the bone in your jaw breaks
down faster than your body can make enough new bone. It can delay healing and
cause problems, usually after major dental work. There have been only a very small
number of cases worldwide in patients with osteoporosis, so the risk is extremely low.
But it is important to have regular dental care and to let your dentist know you are
being treated with Prolia.
Prolia can sometimes cause other side effects. If you have any symptoms that you think
may be caused by your treatment, please talk to your doctor or contact the
Rheumatology Nurse Helpline at Orpington Hospital on 01689 865293. For the Denmark
Hill site, please contact medical secretary Laura Gonzalez on 020 3299 4181.
What are the alternatives?
There are a number of different drugs that you may be able to take. Your doctor will
discuss whether they are suitable for you.
Biphosphonates: these include Alendronic Acid, Alendronate, Risedronate, Ibandronate
and Zolendronic Acid. This may be given to you as a tablet, an injection or a drip in the
arm.
Selective Oestrogen Receptor Modulator (SERM): Raloxifene. We give this to women to
reduce the risk of fracturing their spine after the menopause.
Strontium Ranelate: This reduces the risk of fracturing your spine and comes as a
powder that you mix in water.
Parathyroid Hormone treatment (PTH): Teriparatide. This reduces the risk of fracturing
your spine. This is given as an injection and is only available for patients who have had
a number of fractures.
Consent
We must by law obtain your written consent to any operation and some other
procedures beforehand. Staff will explain the risks, benefits and alternatives before
they ask you to sign a consent form. If you are unsure of any aspect of the treatment
proposed, please do not hesitate to speak with a senior member of the staff again.
How often do I need to have this treatment?
A Rheumatology Nurse will give you your Prolia injection every six months. It is
important that you have each injection as close as possible to six months after the last
one.
Each pack of Prolia has a reminder card and peel-off stickers. Use the stickers to mark
the next injection date on your calendar and/or the reminder card to keep a record of
when it is due.
What happens if I miss a treatment?
If you miss a dose, you should contact the clinical team to arrange an
appointment; we will give you the injection as soon as possible. You need
to have your injection every six months.
What happens if I stop treatment?
To get the most benefit from your treatment, it is important that you use Prolia for as
long as your doctor prescribes it for you. Please talk to your doctor before you consider
stopping treatment.
Who is this treatment suitable for?
Prolia is used to treat:
• Osteoporosis in women after they have gone through the menopause
(postmenopausal) to reduce the risk of spinal, non-spinal and hip fractures.
• Bone loss in women that results from a reduction in oestrogen caused by surgery or
medication for breast cancer.
• Bone loss in men that results from a reduction in testosterone caused by surgery or
medication for prostate cancer.
• Patients with osteoporosis and poor renal function, who are unable to take other
treatment.
Before you start treatment, we will do a test to check the level of calcium and vitamin D
in your blood. If this is low, your GP will treat it with vitamin D or calcium supplements.
You should also have blood tests two – three weeks before each treatment.
Please let us know if you:
• Have an allergy to latex before using this treatment. The needle cover on the prefilled syringe contains a by-product of latex. If you are allergic to latex, please discuss
with your medical practitioner who will offer you an alternative treatment.
Who is this treatment not suitable for?
You cannot have Prolia if you:
• are allergic (hypersensitive) to denosumab or any of Prolia’s other ingredients
• have intolerance to a kind of sugar called sorbitol (E420)
• are breast feeding, pregnant, think you may be pregnant or planning to get
pregnant. Prolia is not recommended for pregnant women.
Do I need to take any extra care while on this treatment?
It is important you maintain good oral hygiene. We may advise you to have a dental
examination before you start treatment. If you are having dental treatment, please tell
your dentist that you are being treated with Prolia.
Do I need to take any extra supplements?
Most people having treatment with Prolia should also take calcium and vitamin D
supplements. Prolia can reduce your calcium levels as it affects the cells that both build
and break down bone. Your doctor will advise you further about this.
Who can I contact with queries and concerns?
If you have any queries, please contact the Rheumatology Nurses at Orpington Hospital
on 01689 865259, Monday – Friday, 9am – 5pm.
If you are a patient at Denmark Hill, please contact medical secretary Laura Gonzalez on
020 3299 4181.
Sharing your information
We have teamed up with Guy's and St Thomas' Hospitals in a partnership known as
King’s Health Partners Academic Health Sciences Centre. We are working together to
give our patients the best possible care, so you might find we invite you for
appointments at Guy's or St Thomas'. To make sure everyone you meet always has the
most up-to-date information about your health, we may share information about you
between the hospitals.
Care provided by students
We provide clinical training where our students get practical experience by treating
patients. Please tell your doctor or nurse if you do not want students to be involved in
your care. Your treatment will not be affected by your decision.
PALS
The Patient Advice and Liaison Service (PALS) is a service that offers support,
information and assistance to patients, relatives and visitors.They can also provide help
and advice if you have a concern or complaint that staff have not been able to resolve
for you. The PALS office is located on the ground floor of the Hambleden Wing, near
the main entrance on Bessemer Road - staff will be happy to direct you.
Tel:
Fax:
Email:
020 3299 3601
020 3299 3626
[email protected]
If you would like the information in this leaflet in a different language or format,
please contact PALS on 020 3299 1844.
www.kch.nhs.uk
PL648.2 Jan 2015
Corporate Comms: 0927
Review date Nov 2017