Can I Take Prolia Shot Before Test Again

Prolia®

Denosumab(rch) den''-os''-u''-mab

---

Consumer Medicine Information

What is in this CMI

• What Prolia is used for
• Earlier you are given it
  When you must non be given it
  Before y'all are given it
  Taking other medicines
• How it is given
• Instructions for injecting Prolia when supplied in a pre-filled syringe with an automatic needle guard
  Important
  Step 1: Set up
  Stride 2: Get Ready
  Step iii: Inject
  Step 4: Finish
• While y'all are using it
  How much is given
  When to utilise it
  How long to use it
  If you lot miss a dose
  If you are given too much (overdose)
  Things you must practice
  Things you must non do
  Things to be conscientious of
• Side effects
• After using it
  Storage
  Disposal
• Production clarification
  What it looks like
  Ingredients
  Sponsor

This leaflet answers some common questions about Prolia (pronounced – PRO-lia).

It does non comprise all the bachelor information. Information technology does not take the place of talking to your physician, nurse or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it volition have for you.

If you take whatsoever concerns about using this medicine, inquire your doctor, nurse or chemist.

Keep this leaflet with the medicine. Yous may need to read information technology again.

What Prolia is used for

Prolia is used to:

• Treat osteoporosis in women later on the menopause, to reduce the risk of spinal, non-spinal and hip fractures.
• Treat bone loss in men with osteoporosis at increased risk of fracture.
• Treat bone loss that results from a reduction in testosterone level acquired past surgery or treatment with drugs in men with prostate cancer.
• Improve os density in patients treated with corticosteroids.

Bone is a living tissue and is renewed all the time. In women, the ovaries produce the hormone oestrogen which helps continue bones good for you. Afterwards menopause, the oestrogen level drops which affects the bone renewal wheel so that more bone is lost than made, resulting in a lower bone mass. This leaves bones thin and fragile. Osteoporosis is the term used to describe an increased fracture risk, usually with low bone density.

Osteoporosis becomes more common with increasing age. Information technology is more common in women. It tin also occur in patients receiving corticosteroids. Many people with osteoporosis take no symptoms but they are still at risk of breaking basic (developing fractures), especially in the spine, hips and wrists.

Other things that tin can increase the risk of fractures include:

• age
• existence of a previous fracture
• family unit history of hip fractures
• depression trunk weight
• drinking alcohol
• smoking.

Prolia is prescribed to meliorate your bone density and to reduce your chance of fracture.

Surgery or medicines used in the treatment of men with prostate cancer to stop the production of testosterone tin also lead to bone loss. The bones become weaker and interruption more than hands.

Prolia contains the active substance denosumab, which is a protein (monoclonal antibody) that specifically attaches (binds) to another unique protein in the body in gild to treat osteoporosis and bone loss. Treatment with Prolia makes your os stronger and less likely to interruption. Because Prolia works for a long time, you volition not need some other dose of Prolia for half dozen months.

Your md, withal may prescribe Prolia for some other purpose.

Ask your doctor if you accept any questions virtually why this medicine has been prescribed for you.

This medicine is available only with a doctor'due south prescription. It is not addictive.

Before you are given it

When you must non be given it

Do not use Prolia if y'all have an allergy to:

• any medicine containing denosumab
• any of the ingredients listed at the finish of this leaflet
• any medicines that are produced using Chinese Hamster Ovary cells.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the confront, lips, tongue, throat or other parts of the torso
• rash, itching or hives on the skin.

Do not apply Prolia if you have depression levels of calcium in your blood. Your md may do a blood test to bank check your calcium levels before you use Prolia.

Practise not use Prolia if you are pregnant or trying to get pregnant. Prolia may damage your unborn babe.

Do not breast-feed while you are having treatment with Prolia. It is not known if the agile ingredient, denosumab, passes into breast milk.

Do not apply it in a child or adolescent. There is no experience with its employ in children or adolescents aged eighteen years or less.

Do not utilise it after the expiry date [Exp.] printed on the pack. If you use it later the death date has passed, it may not work every bit well.

Do not utilise it if the packaging is torn or shows signs of tampering.

Practise not use it if the Prolia solution is cloudy or discoloured. There may be some translucent to white particles of protein in the solution, nevertheless the medicine can however be used.

If yous are not sure whether y'all should exist given this medicine, talk to your doctor.

Before you lot are given information technology

Tell your doctor if:

• you have allergies to:
  – any other medicines
  – any other substances such equally foods, preservatives or dyes.
• you have allergy to latex.
  – The needle embrace on the pre-filled syringe contains derivative of latex.
• you have calcium deficiency or a vitamin D deficiency.
• you are unable to accept daily calcium or vitamin D supplements.
• you lot have or have had severe kidney issues, kidney failure or have needed dialysis.
  – These conditions may increase your risk of getting low blood calcium, if you do not take calcium supplements.
• you have been told by a medico or healthcare professional person that you take an intolerance to some sugars.
• you become significant during your Prolia treatment, if you think you lot may go significant or plan to become pregnant.
• you are breast-feeding during your Prolia treatment or plan to breast-feed.
  – It is not known whether the active ingredient, denosumab, passes into breast milk.
• yous had or have hurting in the teeth gums or jaw, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a molar.
  – A dental status called jaw osteonecrosis has been rarely reported in patients treated with Prolia. You may demand to have dental treatment completed before starting your medicine.

If you have non told your md almost any of the in a higher place, tell him/her earlier y'all start using Prolia.

Taking other medicines

Tell your doc, nurse or pharmacist if you are taking any other medicines, including whatever that you buy without a prescription from your pharmacy, supermarket or health food store.

Y'all should not accept Prolia with some other medicine containing denosumab.

How information technology is given

Prolia is given as an injection under the skin. This is chosen a subcutaneous injection.

Your Prolia is supplied in a pre-filled syringe with an automatic needle guard.

Your medico may decide that information technology is best for y'all or a carer to inject Prolia. Your medico, nurse or pharmacist will bear witness yous or your carer how to use Prolia. Practice not use Prolia unless proper training has been given.

Follow all directions given to you by your doctor, nurse or pharmacist advisedly. They may differ from the information contained in this leaflet.

Instructions for injecting Prolia when supplied in a pre-filled sy
ringe with an automatic needle baby-sit

This section contains information on how yous, or the person injecting you (your carer), must use the Prolia pre-filled syringe.

To reduce the take a chance of adventitious injury past the needle, each pre-filled syringe is equipped with an automatic needle guard that is automatically activated to cover the needle after complete delivery of the pre-filled syringe contents.

Guide to parts

Before use After Use

Important

Earlier yous or your carer utilise Prolia pre-filled syringe with automated needle baby-sit, read this important data:

• It is of import that yous do not try to give the injection unless training from your doctor, nurse or chemist has been received.
• Prolia is given equally an injection into the tissue merely under the skin (subcutaneous injection).
• Tell your doctor if you have an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex).
• DO NOT remove the grey needle cap from the pre-filled syringe until yous are fix to inject.
• DO NOT use the pre-filled syringe if it has been dropped on a hard surface. Apply a new pre- filled syringe and call your doctor, nurse or pharmacist.
• DO NOT endeavour to activate the pre-filled syringe prior to injection.
• DO Non endeavour to remove the clear pre-filled syringe safety guard from the pre-filled syringe.

Phone call your doctor, nurse or chemist if you have any questions.

Step one: Prepare

A: Remove the pre-filled syringe tray from the package and get together the supplies needed for your injection: alcohol wipes, a cotton wool ball or gauze pad, a plaster and a sharps disposal container (non included).

For a more than comfortable injection, leave the pre-filled syringe at room temperature for nearly 30 minutes before injecting. Wash your easily thoroughly with soap and water.

On a clean, well-lit piece of work surface, place the new pre-filled syringe and the other supplies.

• DO NOT endeavor to warm the syringe by using a oestrus source such as hot water or microwave.
• Practise NOT leave the pre-filled syringe exposed to direct sunlight.
• DO Non shake the pre-filled syringe.
• Keep pre-filled syringes out of the sight and attain of children

B: Open the tray, peeling away the embrace. Grab the pre-filled syringe safe guard to remove the pre- filled syringe from the tray.

For safety reasons:

• DO Non grasp the plunger.
• Exercise Not grasp the grayness needle cap.

C: Inspect the medicine and pre-filled syringe

Practise Non use the pre-filled syringe if:

• the medicine is cloudy or in that location are particles in it. It must be a articulate, colourless to slightly yellow solution.
• any part appears cracked or broken.
• the grey needle cap is missing or not securely attached.
• the decease date printed on the label has passed the last twenty-four hours of the month shown.

In all cases, call your medico, nurse or pharmacist.

Step two: Get ready

A: Launder your hands thoroughly. Prepare and clean your injection site.

You can utilise:

• Upper part of your thigh.
• Belly, except for a 5 cm (2-inch) expanse right around your belly push.
• Outer expanse of upper arm (simply if someone else is giving you the injection).

Clean the injection site with an booze wipe. Let the skin dry.

• Practice Not touch the injection site before injecting.
• Exercise NOT inject into areas where the skin is tender, hobbling, red, or hard. Avoid injecting into areas with scars or stretch marks.

B: Advisedly pull the grey needle cap straight out and away from your torso.

C: Pinch the injection site to create a firm surface.

It is important to keep the skin pinched when injecting.

Step 3: Inject

A: Concur the pinch. INSERT the needle into peel.

• Practice NOT affect the cleaned area of the peel.

B: PUSH the plunger with dull and constant pressure until you feel or hear a "snap". Button all the style downward through the snap.

It is of import to push button downwards through the "snap" to deliver your full dose.

C: RELEASE your thumb. And then LIFT the syringe off skin.

Later on releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.

• Practise NOT put the grey needle cap back on used pre-filled syringes.

Pace 4: Finish

A: Discard the used pre-filled syringe and other supplies in a sharps disposal container.

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

Continue the syringe and sharps disposal container out of sight and reach of children.

• Practise Non reuse the pre-filled syringe.
• DO NOT recycle pre-filled syringes or throw them into household waste.

B: Examine the injection site

If there is claret, printing a cotton fiber brawl or gauze pad on your injection site. DO Non rub the injection site. Apply a plaster if needed.

While you are using information technology

How much is given

The usual dose is threescore mg administered in one case every vi months.

You should also take calcium and vitamin D supplements while receiving Prolia. Your physician, nurse or pharmacist will discuss this with you lot.

When to utilize it

Prolia is injected in one case every 6 months.

Each pack of Prolia contains a reminder card with stickers that tin exist removed from the carton. Use the peel-off stickers to mark the next injection date on your personal calendar and/or the reminder carte to keep a record of the next injection date.

How long to use information technology

Continue using your medicine for every bit long as your doctor tells you.

Prolia can treat osteoporosis and bone loss only for as long every bit you keep having treatment. Please talk to your doctor before you consider stopping treatment.

If you miss a dose

If yous miss a dose, it should be administered every bit soon equally possible.

From so on, it should be scheduled every 6 months from the date of the last injection.

If you are given as well much (overdose)

Immediately telephone your doctor or the Poisons Data Heart (telephone 131126) if you lot think you or anyone else may accept had too much Prolia.

Do this even if there are no signs of discomfort or poisoning.

Things you must do

Tell whatsoever other dr., nurses
and pharmacist who treat you that you are having this medicine.

If you are about to exist started on any other medicine, remind your doctor, nurse or pharmacist that you are existence treated with Prolia.

Take calcium and vitamin D supplements if your doctor has told you lot to. Nigh people exercise not get enough calcium and vitamin D in their nutrition and supplements are needed to assist strengthen bones.

If you become pregnant while using this medicine, tell your doctor immediately. Your md tin discuss with you the risks of having it while you are pregnant.

Females that are menstruating should ensure they have acceptable contraception while taking Prolia.

Attend all of your medico's appointments and then that your progress can be checked. Your doctor may recommend y'all to accept some tests, Ten-rays and/or bone density scans from fourth dimension to time to brand sure the medicine is working.

Tell your physician and dentist immediately about any dental symptoms including pain or unusual feeling in your teeth or gums, or any dental infections.

A dental condition called jaw osteonecrosis has been rarely reported in patients treated with Prolia.

Things y'all must not practice

Exercise non apply Prolia to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they accept the aforementioned status as you.

Practice not stop using your medicine without checking with your doctor.

Prolia tin can treat osteoporosis and bone loss only for equally long as you go along having treatment. Please talk to your physician before you consider stopping treatment.

Things to exist careful of

Be careful driving or using mechanism until you lot know how information technology affects you.

Prolia has no known furnishings on the ability to drive or utilise machines but, as a general precaution, if y'all are driving soon after an injection, arrange to accept someone else bulldoze.

Do skilful dental hygiene. Your routine dental hygiene should include:

• Brushing your teeth and tongue subsequently every meal, including the evening
• Gentle flossing one time a day to remove plaque.

Apply a mirror and cheque your teeth and gums regularly for whatsoever changes such as sores or bleeding gums. If you notice whatsoever problems, tell your doctor and dentist immediately.

Side effects

Tell your doctor, nurse or pharmacist as before long every bit possible if yous practice not feel well after using Prolia.

All medicines can have some unwanted side effects. Sometimes they are serious but well-nigh of the time they are not. Your medico has weighed the risks of using this medicine against the benefits they expect it will have for you.

Exercise not exist alarmed by this listing of possible side effects. You may not experience any of them.

All medicines tin take side effects. Yous may demand medical treatment if you get some of the side effects.

Inquire your doctor, nurse or pharmacist to respond any questions you may have.

If any of the following happen tell your doctor, nurse or pharmacist immediately or go to Accident and Emergency at your nearest hospital:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue, throat or other parts of the body
• rash, itching or hives on the skin.

These are very serious side effects. If you take them, you may be having a serious allergic reaction to the medicine. You may demand urgent medical attention or hospitalisation. These side furnishings are rare.

Tell your doctor, nurse or pharmacist immediately if y'all notice any of the following:

• numbness or tingling in your fingers, toes or effectually the oral cavity
• muscle aches or cramps
• seizures.

These may be serious side effects. You may need urgent medical attention. These serious side effects are rare.

Tell your doctor, nurse or pharmacist as presently as possible if you notice any of the following and they worry you:

• peel infection with swelling and redness, most unremarkably affecting the lower leg, that feels hot and tender
• feeling feverish
• itchy, red or dry out skin
• blurred or cloudy vision
• decreased feeling or sensitivity, especially of the skin
• back, musculus or bone pain
• articulation hurting, most ordinarily affecting the hips, knees and spine
• agonized muscle, musculus tenderness or weakness, not caused by exercise
• pain in the extremities, such as hands and anxiety
• high cholesterol levels in the claret
• pain in upper abdomen (belly) that may be accompanied by back pain, nausea, vomiting, fever and/or sweating
• ear pain, discharge from the ear and/or an ear infection. These could be signs of bone damage in the ear.
• hair loss

These are uncommon or mild mutual side furnishings of the medicine.

Contact your physician if yous feel new or unusual pain in your hip, groin or thigh. This may exist an early indication of a possible fracture of the thigh os. This side effect is very rare.

Tell your doc, nurse or pharmacist if y'all notice anything that is making you feel unwell. Other side furnishings not listed above may also occur in some people.

Contact your dr. if yous plan to stop taking Prolia. After your treatment with Prolia is stopped, it is possible that broken basic in your spine may occur especially if you take a history of broken basic in the spine. If your Prolia treatment is stopped, talk over other available treatment options with your doctor.

Afterwards using it

Storage

If you demand to store your Prolia earlier employ:

• Keep your medicine in the refrigerator, between ii°C and 8°C. Do not freeze.
  – Keep your medicine in the carton in guild to protect it from light. If you remove the medicine from the carton information technology will not keep well.
• Your medicine may be left outside the refrigerator to accomplish room temperature (up to 25°C) before injection. This will make the injection more comfortable.
  – Once your medicine has been left to accomplish room temperature (up to 25°C), it must be used within xxx days.
  – Practise not shake or vigorously agitate the pre-filled syringe.
• Go along it where children cannot accomplish it.

Prolia is for single-use in ane patient merely. Dispose of whatsoever unused or expired medicine as instructed below.

Disposal

Return any unused or expired medicine to your pharmacist.

Production description

What information technology looks like

Your Prolia is supplied in a pre-filled syringe with an automatic needle baby-sit.

Prolia comes in a single pack size containing 60 mg of denosumab in a book of 1.0 mL (60 mg/1.0 mL).

Each pack contains:

• i reminder card with stickers and
• ane set to use pre-filled syringe with an automatic needle guard.

Ingredients

Active ingredient: denosumab.

Inactive ingredients within the pre-filled syringe with an automatic needle guard:

• acetate
• sodium hydroxide
• sorbitol
• Polysorbate 20
• Water for Injection.

This medicine does not incorporate gluten, tartrazine or whatever other azo dyes.

Sponsor

Prolia is supplied in Australia by:

Amgen Australia Pty Ltd
(ABN 31 051 057 428)
Level vii, 123 Epping Road
Northward Ryde NSW 2113

Medical Information: 1800 646 998

This CMI was prepared in February 2019.

Australian Registration Number:

60 mg/i.0 mL pre-filled syringe with an automatic needle baby-sit:
AUST R 159323

Prolia is a registered trademark of Amgen.

Published by MIMS July 2019

altmanuped1943.blogspot.com

Source: https://www.mydr.com.au/medicines/prolia-solution-for-injection/

Share this post