Odensify: Uses, Side Effects and Dosage

What Odensify is used for:

Odensify is used for the treatment

• of osteoporosis (thinning and weakening of the bone) in women after menopause who

  • have an increased risk for fractures or;
  • cannot use other osteoporosis medicines, or other osteoporosis medicines did not work well.
• to increase bone mass in men with osteoporosis at high risk for fracture.
• to increase bone mass and may reduce fractures that occur when medication to reduce testosterone levels are taken for the treatment of prostate cancer that has not spread to other parts of the body (nonmetastatic).
• to increase bone mass in women who are receiving certain treatments for breast cancer, which has not spread to other parts of the body (nonmetastatic) and at high risk of fracture.
• to increase bone mass to treat osteoporosis in both women and men at high risk for fracture related to the use of corticosteroid medicines, such as prednisone.
• to increase bone mass to prevent osteoporosis in both women and men at high risk for fracture related to starting corticosteroid medicines, such as prednisone.

What is osteoporosis?

Bone is constantly changing. There are special cells in the body called osteoclasts whose primary function is to remove bone. There is another type of cell called osteoblasts, which are bone-forming cells. In normal bone, there is a balance between the actions of these two cells. In people with osteoporosis, this balance no longer exists. Instead, the cells that remove bone work overtime, removing bone faster than new bone can be created. The result is bone that is thinner, weaker and more likely to break. Osteoporosis may occur without any pain or other symptoms. Sometimes the first symptom of osteoporosis is a fragility fracture, a broken bone that may be caused by a minor fall, or simple activities such as lifting groceries or getting out of bed. A fragility fracture can significantly increase the risk of future fractures. Aside from prescribing Odensify, your doctor can guide you in other ways to manage your bone health.

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

Corticosteroids, like prednisone, can also cause thinning and weakening of the bone increasing your chance of broken bones.

How Odensify works:

Odensify works differently than other osteoporosis medications. It is a RANK ligand inhibitor. RANK ligand is a protein which activates the cells that break down bone (osteoclasts). Odensify blocks RANK ligand to stop the cells that break down bone. This action strengthens your bones by increasing bone mass and lowers the chance of breaking bones of the hip, spine, and nonspinal sites.

The ingredients in Odensify are:

Medicinal ingredient: Denosumab

Non-medicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, poloxamer 188, sucrose and water for injection. The needle cover on the pre-filled syringe is not made with natural rubber latex.

Odensify comes in the following dosage form(s):

Odensify is a liquid for injection, available in a pre-filled syringe.

Odensify is a practically free of visible particles, clear, colourless to slightly yellow solution. Do not use if the solution is cloudy.

Do not use Odensify if:

• You are allergic to denosumab or any other ingredient of Odensify. Allergic reactions (e.g., rash, hives, or in rare cases, swelling of the face, lips, tongue, throat, or trouble breathing) have been reported.
• You have low calcium levels in your blood (hypocalcemia).
• You are less than 18 years of age (see also What is Odensify used for above and Other warnings you should know about below).

• You are pregnant or breastfeeding.

• You are a woman before menopause [unless you have been diagnosed with breast cancer or are taking Odensify for the treatment or prevention of osteoporosis related to the use of corticosteroid medicines (see also What is Odensify used for above and Other warnings you should know about below)].
• You are currently taking denosumab for oncology.
• You do not have access to a healthcare professional or trained injector.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Odensify. Talk about any health conditions or problems you may have, including if you:

• Have low blood calcium.
• Cannot take daily calcium and vitamin D.
• Had parathyroid or thyroid surgery (glands located in your neck).
• Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome).
• Have kidney problems or are on kidney dialysis.
• Have ever had an allergic reaction to Odensify.
• Plan to have dental surgery or teeth removed.
• Have a history of cancer.
• Are pregnant or could become pregnant.

Odensify may interfere with normal bone and tooth development in fetuses, nursing babies, and children under 18 years of age. Odensify is not indicated for use in patients under 18 years of age.

Do not take Odensify if you are pregnant or could become pregnant as Odensify may harm your unborn baby. Your healthcare professional should do a pregnancy test before you start treatment with Odensify. You should use an effective method of birth control (contraception) during treatment with Odensify and for at least 5 months after your last dose of Odensify. If you become pregnant while taking Odensify, stop taking Odensify and tell your doctor right away.

Nursing mothers should not take Odensify. It may also interfere with breastfeeding.

Odensify may lower levels of calcium in the blood. If you are prone to low calcium levels, your doctor will monitor your blood, especially in the first few weeks after starting Odensify. Severe low blood calcium levels may lead to hospitalization, life-threatening events, and death. Low blood calcium should be treated before receiving Odensify. Symptoms of low blood calcium may include muscle spasms, twitches, cramps, numbness or tingling in hands, feet or around the mouth, and weakness. Some patients may not have any symptoms of low calcium. Tell your doctor if you have any of these symptoms. Tell your doctor if you have or have had severe kidney problems as this may increase your risk of getting low blood calcium.

Tell your doctor right away if you have symptoms of infection, including:

• Fever or chills
• Skin that looks red, swollen, hot or tender to touch
• Severe abdominal pain
• Frequent or urgent need to urinate or burning feeling when you urinate

Tell your doctor if you have any of the following symptoms of skin problems that do not go away or get worse:

• Redness
• Itching
• Rash
• Dry or leathery skin
• Open, crusted or peeling skin
• Blisters

After you start Odensify:

• Take good care of your teeth and gums, and see your dentist regularly.
• If you have a history of dental problems (such as poorly fitting dentures or gum disease), see your dentist before starting Odensify.
• Tell your dentist that you are taking Odensify, especially if you are having dental work.

A dental condition called osteonecrosis of the jaw (ONJ) which can cause tooth and jawbone loss has been reported in patients treated with denosumab injection. The risk of ONJ may increase with length of time on Odensify. Tell your doctor and dentist immediately about any dental symptoms, including pain or unusual feeling in your teeth or gums, or any dental infections.

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

After your treatment with Odensify is stopped, it is possible that broken bones in your spine may occur especially if you have a history of broken bones in the spine. Do not stop taking Odensify without first talking with your doctor. If your Odensify treatment is stopped, discuss other available treatment options with your doctor.

Other warnings you should know about:

Odensify contains the same medicine as another denosumab drug for oncology, but at a different dose. If you are being treated with Odensify, you should not be taking denosumab for oncology or vice versa.

There is an increased risk of skin infection (cellulitis) with Odensify therapy, most commonly on the leg. See a doctor urgently if you develop swollen, red, hot or painful skin, with or without fever.

You should take calcium and vitamin D supplements as recommended by your healthcare professional.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Odensify:

In a drug interaction study, denosumab (60 mg) did not interfere with the action of a drug called midazolam which is metabolized (broken down) by a certain liver enzyme called cytochrome P450 3A4. No drug interactions are expected with Odensify and other drugs metabolized by this enzyme in women with postmenopausal osteoporosis.

You should discuss with your doctor any medications or vitamins or herbal products you are taking before using Odensify.

How to take Odensify:

Odensify is administered as a single injection under the skin (subcutaneous) every 6 months. The injection can be in your upper arm, upper thigh, or abdomen. It can be given anytime with or without food by a healthcare professional, by a trained injector, or a patient may self-inject if a healthcare professional determines that is appropriate.

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. See instructions for injection.

Keep all medicines, including Odensify, away from children.

Do not share a Odensify product with others, even if they have a similar disease.

Usual dose:

The usual dose of Odensify is 60 mg administered once every 6 months. You should also take supplements of calcium and vitamin D.

Overdose:

If you think you, or a person you are caring for, have taken too much Odensify, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose you should receive your next dose as soon as convenient. Schedule your next dose 6 months from the date of your last injection.

The following instructions are for preparing and giving an injection of Odensify using a single-use pre-filled syringe with a manual needle guard:

Guide to parts

Important: The needle is covered by the grey needle cap before use.

Important:

Before you use a Odensify pre-filled syringe, read this important information:

Using the pre-filled syringe

• Administration should be performed by an individual who has been trained in injection techniques. This includes patients who have been deemed appropriate by their healthcare professional to administer Odensify.
• Make sure the name Odensify appears on the carton and pre-filled syringe label.
• Check the carton and pre-filled syringe label to make sure the dose strength is 60 mg.
• Do NOT use a syringe after the expiration date on the label.
• Do NOT shake the syringe.
• Do NOT remove the grey needle cap from the syringe until you are ready to inject.
• Do NOT use the syringe if the carton is open or damaged.
• Do NOT use a syringe if it has been dropped on a hard surface. Part of the syringe may be broken even if you cannot see the break. Use a new syringe.

The needle cover on the pre-filled syringe is not made with natural rubber latex.

Call your healthcare professional if you have any questions.

Step 1: Prepare

1. A. Remove the pre-filled syringe carton from the refrigerator.

Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature for 15-30 minutes before you give an injection.

• Do NOT use the pre-filled syringe if the carton is damaged.
• Do NOT try to warm the pre-filled syringe by using a heat source such as hot water or a microwave.
• Do NOT leave the pre-filled syringe in direct sunlight.
• Do NOT shake the pre-filled syringe.

Open the tray by peeling away the cover. Hold the transparent safety guard to remove the pre-filled syringe from the tray.

For safety reasons:

• Do NOT hold the plunger rod.
• Do NOT hold the grey needle cap.
• Inspect the medicine and pre-filled syringe.

Always hold the syringe by the syringe barrel.

Make sure the medicine in the pre-filled syringe is clear and colourless to pale yellow.

Do NOT use the pre-filled syringe if:

• The medicine is cloudy or discoloured.
• Any part appears cracked or broken.
• The pre-filled syringe has been dropped.
• The grey needle cap is missing or not securely attached.
• The expiration date printed on the label has passed.

In all cases, use a new pre-filled syringe and call your healthcare professional.

1. C. Gather all materials needed for the injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the:

• Pre-filled syringe
• Alcohol wipe (not included)
• Cotton ball or gauze pad (not included)
• Adhesive bandage (not included)
• Sharps disposal container (not included)

Step 2: Get ready

1. D.

   Prepare and clean the injection site.

   

You can use:

• Upper thigh
• Stomach area (abdomen), except for a 5 cm (2-inch) area right around the navel (belly button)
• Outer area of upper arm (only if someone else is giving you the injection).

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

• Do NOT touch this area again before injecting.
• Do NOT inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

• Hold the pre-filled syringe by the syringe barrel. Carefully pull the grey needle cap straight off and away from the body.

  

• Do NOT remove the grey needle cap from the pre-filled syringe until you are ready to inject.
• Do NOT twist or bend the grey needle cap.
• Do NOT hold the pre-filled syringe by the plunger rod.
• Do NOT put the grey needle cap back onto the pre-filled syringe.

Important: Throw the grey needle cap into the sharps disposal container.

Step 3: Subcutaneous (under the skin) injection.

1. F. Pinch the injection site to create a firm surface.

Important: Keep skin pinched while injecting.

1. G.

   Hold the pinch. Insert the needle into the skin at 45 to 90 degrees.

   

2. H. Using slow and constant pressure, push the plunger rod until it reaches the bottom.
3. • Do NOT pull back the plunger rod while the needle is inserted.

When done, gently pull the syringe off of the skin.

Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare professional right away.

Step 4: Finish

1. I. Before you finish!

With the syringe still in place, allow the pre-filled syringe to retract the needle from the skin.

• Slowly lift your finger from the plunger.
• The plunger will move up with your finger and retract the needle from the site, into the transparent safety guard.

• The needle will not be retracted unless all the liquid is injected. Speak to your doctor, pharmacist, or nurse if you think you have not been given a full dose.

  

It is normal to see a spring around the plunger rod after the needle is retracted.

Keep your hands away from the needle at all times.

1. J.

   Discard (throw away) the used pre-filled syringe.

   

2. • Put the used pre-filled syringe in a sharps disposal container right away after use. Do NOT throw away (dispose of) the syringe in the household trash.
3. •

   If you do not have a sharps disposal container, you may use a household container that is:

   • made of a heavy-duty plastic,
   • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
   • upright and stable during use,
   • leak-resistant, and
   • properly labelled to warn of hazardous waste inside the container.
4. • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be provincial or local laws about how you should throw away used needles and syringes.
5. • Do NOT reuse the pre-filled syringe.
6. • Do NOT recycle the pre-filled syringe or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of reach of children.

1. K. Examine the injection site.

If there is blood, press a cotton ball or gauze pad on the injection site. Do NOT rub the injection site. Apply an adhesive bandage if needed.

Possible side effects from using Odensify:

These are not all the possible side effects you may have when using Odensify. If you experience any side effects not listed here, tell your healthcare professional.

Possible side effects include:

• Pain, sometimes severe, in the muscles, joints, arms, legs or back.
• Low blood calcium (hypocalcemia). Symptoms of low blood calcium may include muscle spasms, twitches, cramps, numbness or tingling in fingers, toes or around the mouth.
• Allergic reactions (e.g., rash, hives, or in rare cases, swelling of the face, lips, tongue, throat, or trouble breathing).
• Allergic reaction that can damage blood vessels mainly in the skin (e.g., purple or brownish-red spots, hives or skin sores).
• Severe allergic reaction (drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome) with skin rash / blisters, fever and / or increase in a type of white blood cell (eosinophils) with possible organ damage, such as liver, kidney, or lung.
• Skin condition with itching, redness and / or dryness (eczema). Injection site reactions were uncommon.
• Rash that may occur on the skin or sores in the mouth (lichenoid drug eruption).
• Hair loss (alopecia).
• Skin infection with swollen, red area of skin, that feels hot and tender and may be accompanied by fever (cellulitis).
• Common cold (runny nose or sore throat).
• Broken bones in the spine after stopping Odensify (multiple vertebral fractures).

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

When prescribed Odensify, you will likely need to fill your prescription at a pharmacy. Store Odensify in your refrigerator at 2°C to 8°C until your injection appointment with your healthcare professional or trained injector. Do not freeze.

When removed from the refrigerator, Odensify must be kept at room temperature (up to 25°C) in the original carton and must be used within 30 days.

Store in original carton in order to protect from light.

Do not use Odensify after the expiry date which is printed on the carton and label. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required.

Keep out of reach and sight of children.

If you want more information about Odensify:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.

Date of Authorization: 2026-07-10