Bosaya: Uses, Side Effects and Dosage

What BOSAYA is used for:

• 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.

How BOSAYA works:

BOSAYA 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). BOSAYA 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 BOSAYA are:

Medicinal ingredients: denosumab.

Nonmedicinal ingredients: Acetate, polysorbate 20, sorbitol, acetic acid, sodium hydroxide and water for injection. The prefilled syringe is not made with natural rubber latex.

BOSAYA comes in the following dosage forms:

BOSAYA is a liquid for injection, available in a prefilled syringe.

BOSAYA is a clear to slightly opalescent, colourless to pale yellow solution. Do not use if the solution is cloudy.

Do not use BOSAYA if:

• you are allergic to denosumab or any other ingredient of BOSAYA. Allergic reactions (eg, 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 BOSAYA 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 BOSAYA for the treatment or prevention of osteoporosis related to the use of corticosteroid medicines (see also What is BOSAYA used for above and Other warnings you should know about below)].
• you are currently taking denosumab-containing medicinal products.
• 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 BOSAYA. 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 BOSAYA.
• Plan to have dental surgery or teeth removed.
• Have a history of cancer.
• Are pregnant or could become pregnant.

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

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

BOSAYA may lower levels of calcium in the blood. If you are prone to low calcium levels, your healthcare professional will monitor your blood, especially in the first few weeks after starting BOSAYA. Severe low blood calcium levels may lead to hospitalization, life-threatening events, and death. Low blood calcium should be treated before receiving BOSAYA. 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 healthcare professional if you have any of these symptoms. Tell your healthcare professional if you have or have had severe kidney problems as this may increase your risk of getting low blood calcium.

Tell your healthcare professional 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 healthcare professional 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 BOSAYA:

• 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 BOSAYA.
• Tell your dentist that you are taking BOSAYA, 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 BOSAYA. The risk of ONJ may increase with length of time on BOSAYA. Tell your healthcare professional 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 healthcare professional if you experience new or unusual pain in your hip, groin, or thigh.

After your treatment with BOSAYA 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 BOSAYA without first talking with your healthcare professional. If your BOSAYA treatment is stopped, discuss other available treatment options with your healthcare professional.

Other warnings you should know about:

If you are being treated with BOSAYA, you should not be taking denosumab containing medicinal products.

There is an increased risk of skin infection (cellulitis) with BOSAYA therapy, most commonly on the leg. See a healthcare professional 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 BOSAYA:

In a drug interaction study, BOSAYA (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 BOSAYA and other drugs metabolised by this enzyme in women with postmenopausal osteoporosis.

You should discuss with your healthcare professional any medications or vitamins or herbal products you are taking before using BOSAYA.

How to take BOSAYA:

BOSAYA 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 any time 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 prefilled syringe may be left outside the refrigerator to reach room temperature (up to 25ºC) before injection. This will make the injection more comfortable. See instructions for injection.

Keep all medicines, including BOSAYA, away from children.

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

The following instructions are for preparing and giving an injection of BOSAYA using a single-use prefilled syringe with an automatic needle safety guard:

Guide to parts

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

Important:

Before you use a BOSAYA prefilled syringe, read this important information:

Using the prefilled 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 BOSAYA.
• The prefilled syringe has a needle safety guard that will be activated to cover the needle after the injection is given. The needle guard will help prevent needlestick injuries to anyone who handles the prefilled syringe after the injection has been given.
• Make sure the name BOSAYA appears on the carton and prefilled syringe label.
• Check the carton and prefilled 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 prefilled syringe is not made with natural rubber latex.

  Call your healthcare professional or Biocon Biologics Canada Inc. at 1-833-986-1468if you have any questions.

Step 1: Prepare

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

Open the tray by peeling away the cover. Grab the safety guard to remove the prefilled syringe from the tray.

Grab here

Figure B

For safety reasons:

• Do NOT grab the plunger rod.
• Do NOT grab the grey needle cap.

B. Inspect the medicine and prefilled syringe.

Figure C

Always hold the syringe by the needle safety guard.

Make sure the medicine in the prefilled syringe is clear to slightly opalescent,colourless to pale yellow solution.

Do NOT use the prefilled syringe if:

• The medicine is cloudy or discoloured.
• Any part appears cracked or broken.
• The prefilled 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 prefilled syringe and call your healthcare professional or Biocon Biologics Canada Inc. at 1-833-986-1468.

C. Gather all materials needed for the injection.

Take the prefilled syringe carton out of the refrigerator and place it on your clean work surface. Allow it to reach room temperature for 30 minutes before giving an injection.

Wash your hands thoroughly with soap and water.

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

• Prefilled syringe
• Alcohol wipe
• Cotton ball or gauze pad
• Adhesive bandage
• Sharps disposal container

Figure D

Step 2: Get ready

D. Prepare and clean the injection site

Figure E

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 prefilled syringe by the needle safety guard. When ready carefully pull the grey needle cap straight off and away from the body.

Figure F

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

Figure G

Important: Keep skin pinched while injecting.

1. G. Hold the pinch. Insert the needle into the skin.

Figure H

1. H . Using slow and constant pressure, push the plunger rod until it reaches the bottom. PUSH the plunger with slow and constant pressure until you feel or hear a "snap". Push all the way down through the snap (Figure I).

Figure I

• Do NOT pull back the plunger rod while the needle is inserted.

I. Once the entire dose has been injected, the needle safety guard will be triggered. You can do either of the following: (Refer figure J)

Release the plunger until the entire needle is covered and then remove the needle from the injection site.

or

Gently remove the needle from the injection site and release the plunger until the entire needle is covered by the needle safety guard.

Figure J

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

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.

• If the needle safety guard is not activated or only partially activated, discard the product (without replacing the needle cap). See “Step J: Disposing of used prefilled syringes”

.

Figure K

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

• 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 labeled to warn of hazardous waste inside the container.
• 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 state or local laws about how you should throw away used needles and syringes.
• Do NOT reuse the prefilled syringe.
• Do NOT recycle the prefilled syringe or sharps disposal container or throw them into household trash.

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

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.

Usual dose:

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

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.

Overdose:

Possible side effects from using BOSAYA:

Like all medicines, BOSAYA can cause side effects, although not everybody gets them.

These are not all the possible side effects you may have when taking BOSAYA. 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 (eg, 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 (eg, 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 BOSAYA (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:

Keep out of reach and sight of children.

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

When removed from the refrigerator, BOSAYA 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 BOSAYA 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.

If you want more information about BOSAYA:

• 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); the manufacturer’s website https://www.bioconbiologics.ca ; or by calling 1-833-986-1468. .

Manufactured by:

Biocon Biologics Canada Inc.

1 First Canadian Place

100 King Street West, Suite 6200

Toronto, ON, M5X 1B8 Canada

Distributed by:

Accuristix Vaughan, ON L4H 3C5

Date of Authorization: 2026-08-28

BOSAYA™ is a trademark of Biocon Biologics Limited.