Bomyntra: Uses, Side Effects and Dosage

Serious warnings and precautions box

• Osteonecrosis of the jaw (sore in mouth involving gums or jaw bones)

What BOMYNTRA is used for:

• BOMYNTRA is used for reducing the risk of developing cancer-related complications like broken bones and/or bone pain that need surgery or radiation.
• BOMYNTRA is used for reducing the risk of developing cancer-related complications in patients with multiple myeloma. Multiple myeloma is a cancer of plasma cells (a type of white blood cell).
• BOMYNTRA is used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option in adults and adolescents (aged 13-17 years) whose bones have stopped growing.
• BOMYNTRA is used to reduce high levels of calcium in the blood in cancer patients (hypercalcemia of malignancy) after other drugs called bisphosphonates did not work.

How BOMYNTRA works:

BOMYNTRA works differently than other medications used to treat cancer patients whose disease has spread to their bones. It works as a RANK Ligand (RANKL) inhibitor. RANKL is a protein that promotes the breakdown of bone. BOMYNTRA blocks RANKL to stop the breakdown of bone. This action strengthens your bones by increasing bone mass and lowers the chance of the cancer-causing problems with your bones, such as fractures or severe pain requiring radiation treatment.

BOMYNTRA reduces the amount of calcium in the blood by reducing the breakdown of bones. In patients with hypercalcemia of malignancy, the breakdown of bones can cause too much calcium in the blood.

The ingredients in BOMYNTRA are:

Medicinal ingredients: denosumab

Non-medicinal ingredients: acetic acid, glacial; polysorbate 20, sodium acetate trihydrate, sorbitol and water for injection.

BOMYNTRA comes in the following dosage forms:

BOMYNTRA is a liquid for injection, with enough liquid in it for one shot. Each vial delivers 120 mg of denosumab. BOMYNTRA is supplied in a carton containing 1 vial.

BOMYNTRA is also supplied in a pack containing one prefilled syringe.

Do not use BOMYNTRA if:

• you are allergic to denosumab or any other ingredient of BOMYNTRA. 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 hypocalcemia (low calcium levels in the blood), until your doctor corrects this condition.

What important information do I need to know about taking BOMYNTRA?

BOMYNTRA contains the same medicine as found in other denosumab products. If you are being treated with BOMYNTRA, you should not be taking any other denosumab product or vice versa.

Patients being treated with BOMYNTRA should not be treated concomitantly with bisphosphonates.

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

Hypocalcemia (low calcium levels in the blood)

BOMYNTRA may lower levels of calcium in your blood. In the post-marketing setting, cases of low blood calcium with severe symptoms, including death, have been reported. If you have low blood calcium before you start receiving BOMYNTRA, it may get worse during treatment. Your low blood calcium must be treated before you receive BOMYNTRA. Most people with low calcium levels do not have symptoms, but some people may have symptoms. When the calcium levels in your blood go down, your body tries to correct the calcium levels by increasing the amount of a hormone made by your parathyroid glands (parathyroid hormone) in your blood. Call your doctor right away if you have symptoms of low blood calcium such as:

• Spasms, twitches, or cramps in your muscles.
• Numbness or tingling in fingers, toes or around the mouth.

Conditions which increase the risk of low blood calcium:

• If you cannot take daily calcium and/or vitamin D.
• If you have severe kidney disease or are on dialysis.

Your doctor will tell you to take calcium and vitamin D to help prevent low calcium levels in your blood while you take BOMYNTRA, unless your blood calcium is high. Take calcium and vitamin D as your doctor tells you to.

Osteonecrosis of the Jaw (sore in mouth involving gums or jaw bones)

Severe jaw bone problems may happen when you take BOMYNTRA. Your doctor should examine your mouth before you start BOMYNTRA. Your doctor may tell you to see your dentist before you start BOMYNTRA. It is important for you to practice good mouth care such as brushing and flossing your teeth regularly during treatment with BOMYNTRA.

Tell your doctor immediately about any dental symptoms, including pain or unusual feeling in your teeth or gums, or any dental infections. If possible, you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while you are receiving treatment with BOMYNTRA without talking to your doctor first.

If you do need dental work, tell your dentist that you are receiving BOMYNTRA and tell your doctor that you are having dental work done.

Unusual Thigh Bone Fractures

Unusual fracture in the thigh bone may occur with some medicines, including BOMYNTRA. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.

High Calcium Levels in the Blood after Stopping Treatment with BOMYNTRA

Some patients with giant cell tumour of the bone and some who are still growing during treatment with denosumab injection, have developed high calcium levels in the blood weeks to months after stopping treatment.

Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving BOMYNTRA.

Risk of Broken Bones in the Spine After Stopping Treatment with BOMYNTRA

Do not stop taking BOMYNTRA without first talking with your doctor. After treatment with BOMYNTRA is stopped, there may be an increased risk of having broken bones in your spine especially in people who have had a fracture or who have had osteoporosis (a condition in which bones become thin and fragile).

Skin Infections

Tell your doctor promptly if you develop a swollen, red area on your skin that feels hot and tender with symptoms of fever (cellulitis) while taking BOMYNTRA.

Pregnancy or Breast-Feeding

BOMYNTRA is not recommended for use in women who are pregnant or plan to become pregnant and nursing mothers. BOMYNTRA may interfere with normal bone and tooth development in fetuses and nursing babies, and may interfere with breastfeeding.

BOMYNTRA is not intended for use in pregnant women. You should not be given BOMYNTRA if you are pregnant. A highly effective method of birth control should be used when taking BOMYNTRA, or for at least 5 months after the last dose of BOMYNTRA.

It is not known whether BOMYNTRA is excreted into human milk.

Use in Children

BOMYNTRA is not recommended for anyone under 18 years of age except for adolescents with giant cell tumour of bone whose bones have stopped growing. The use of BOMYNTRA has not been studied in children and adolescents with other cancers that have spread to bone.

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 BOMYNTRA:

Before starting BOMYNTRA, tell your doctor about all the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements.

Interactions between BOMYNTRA and other drugs have not been studied.

How to take BOMYNTRA:

BOMYNTRA is administered as a single injection under the skin (subcutaneous) once every four weeks. You should not inject BOMYNTRA into the muscle (intramuscular), into your veins (intravenous) or between the layers of the skin (intradermal). The injection can be in your upper arm, upper thigh, or abdomen. The injection should be administered under the supervision of your doctor who is familiar with this drug. You may be able to give yourself BOMYNTRA injections only if you have been trained in giving the injection and your doctor thinks you are capable of doing it correctly and if your doctor follows up with you as necessary.

Before injection, remove the vial/prefilled syringe from the refrigerator and allow it to reach room temperature (up to 25°C) in the original container. This will make the injection more comfortable. Do not shake. See instructions for injection.

Keep all medicines, including BOMYNTRA, away from children.

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

Usual dose:

The usual dose of BOMYNTRA is 120 mg administered once every 4 weeks. If you are being treated for giant cell tumour of bone or hypercalcemia of malignancy, you will receive an additional dose 1 week and 2 weeks after the first dose in the first month of treatment only.

You should also take supplements of calcium and vitamin D as instructed by your doctor.

Overdose:

If you think you, or a person you are caring for, have taken too much BOMYNTRA, 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 symptoms.

Missed dose:

If you miss a dose you should try to receive that dose as soon as you can. In order for BOMYNTRA to work properly, BOMYNTRA needs to be given every 4 weeks. Continue to schedule your doses every four weeks.

Possible side effects from using BOMYNTRA:

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

• 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

• Skin infection with swollen, red area of skin that feels hot and tender and may be accompanied by fever (cellulitis)
• Sore in mouth involving gums or jaw bones (osteonecrosis of the jaw)
• Shortness of breath (dyspnea)
• Low phosphate levels in the blood (hypophosphatemia)
• Allergic reactions (e.g., rash, hives, or in rare cases, swelling of the face, lips, tongue, throat, or trouble breathing)
• Unusual thigh bone fractures (atypical femoral fracture)
• Rash that may occur on the skin or sores in the mouth (lichenoid drug eruption)
• Hair loss (alopecia)
• Pain, sometimes severe, in the muscles, joints, arms, legs or back
• High calcium levels in the blood (hypercalcemia) after stopping treatment in patients who are still growing while on treatment with BOMYNTRA
• High calcium levels in the blood (hypercalcemia) after stopping treatment in patients with giant cell tumour of the bone
• Broken bones in your spine (multiple vertebral fractures) after stopping treatment with BOMYNTRA

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 health 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 the reach and sight of children.

BOMYNTRA should be stored in the refrigerator at 2 ^oC to 8 ^oC in the original carton to protect it from light. Do not freeze BOMYNTRA. Do not shake BOMYNTRA.

BOMYNTRA may be removed from the refrigerator and allowed to reach room temperature (up to 25 ^oC) to make the injection more comfortable.

Once removed from the refrigerator, BOMYNTRA must not reach temperatures above 25 ^oC and must be used within 30 days. If not used within 30 days, BOMYNTRA should be discarded.

Do not use BOMYNTRA 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 BOMYNTRA:

• Talk to your healthcare professional
• Find the full product monograph, that is prepared for health professionals and includes this 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.fresenius-kabi.com/en-ca), or by calling: 1-877-821-7724

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd, Suite 100

Toronto, ON M9W 0C8

Date of Authorization: April 18, 2026

Instructions for Use

^PrBomyntra

Denosumab injection

Solution; 120 mg/1.7 mL

Subcutaneous injection

Single use vial

IMPORTANT: TO HELP AVOID CONTAMINATION AND POSSIBLE INFECTION DUE TO INJECTION, PLEASE READ AND FOLLOW THESE INSTRUCTIONS CAREFULLY.

How to prepare for Bomyntra injection

Bomyntra is available as a liquid in vials. When you receive your Bomyntra, always check to see that:

• The name Bomyntra appears on the package and vial label.
• The expiration date on the vial label has not passed. Do not use a vial after the date on the label.
• The Bomyntra liquid in the vial is clear, colourless to slightly yellow.

Only use disposable syringes and needles. Use the syringes only once and dispose of them as instructed by your doctor or nurse.

Setting up for an injection

1. 1. Find a clean flat working surface, such as a table.
2. 2. Remove the vial of Bomyntra from the refrigerator. Allow Bomyntra to reach room temperature (this takes about 15 to 30 minutes). Vials should be used only once. DO NOT SHAKE THE VIAL. Shaking may damage Bomyntra. If the vial has been shaken vigorously, the solution may appear foamy and it should not be used.
3. 3.

   Assemble the supplies you will need for an injection:

   1. • Bomyntra vial and sterile disposable syringe and a 27-gauge needle.
   2. •

      Two alcohol swabs and one cotton ball or gauze pad.

   3. • Puncture-proof disposal container.
4. 4. Clean your work surface thoroughly and wash your hands with soap and warm water.

Selecting and preparing the injection site

1. 1.

   Choose an injection site. The recommended injection sites for Bomyntra are:

   1. • The outer area of your upper arms.
   2. • The abdomen, except for the two-inch (5 cm) area around your navel.
   3. • The top of your thighs.

How to prepare the dose of BOMYNTRA in vials

1. 1. Take the cap off the vial. Clean the stopper with an alcohol swab.
2. 2. Check the package containing the syringe. If the package has been opened or damaged, do not use that syringe. Dispose of that syringe in the puncture-proof disposal container. If the syringe package is undamaged, open the package and remove the syringe.
3. 3. Keep the vial on your flat working surface and insert the needle straight down through the rubber stopper. Do not put the needle through the rubber stopper more than once.
4. 4. Push the plunger of the syringe down and inject the air from the syringe into the vial of Bomyntra. Keeping the needle inside the vial, turn the vial upside down. Make sure that the tip of the needle is in the Bomyntra liquid.
5. 5. Keeping the vial upside down, slowly pull back on the plunger to fill the syringe with Bomyntra liquid. Withdraw the entire content of the vial.
6. 6. Keeping the needle in the vial, turn the syringe needle up and check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Then slowly push the plunger up to force the air bubbles out of the syringe.
7. 7. Remove the syringe from the vial but do not lay it down or let the needle touch anything.

Injecting the dose of Bomyntra

1. 1. Hold the syringe in the hand you will use to inject Bomyntra. With the other hand, clean the injection site with an alcohol swab. Use a circular motion from the inside to the outside of the injection site.
2. 2. Pinch a fold of skin at the cleaned injection site.
3. 3.

   Holding the syringe like a pencil, use a quick “dart-like” motion to insert the needle either straight up and down (90-degree angle) or at a slight angle (45 degrees) into the skin.

   

4. 4. After the needle is inserted, let go of the skin. Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist.
5. 5. When the syringe is empty, pull the needle out of the skin and place a cotton ball or gauze over the injection site and press for several seconds.
6. 6.

   Use a syringe, needle and vial only once. DO NOT put the needle cover (the cap) back on the needle. Discard the vial with any remaining Bomyntra liquid.

   90^o angle

   45^o angle

Disposal of syringes, needles and vials

You should always follow the instructions given by your doctor, nurse, or pharmacist on how to properly dispose of containers with used syringes, needles and vials. There may be special provincial or local laws for disposal of used needles and syringes.

• Place all used needles, needle covers, syringes, and vials (empty or unused contents) into a “Sharps” container given to you by your doctor or pharmacist or in a hard-plastic container with a screw-on cap, or a metal container with a plastic lid, labelled “used syringes.” Do not use glass or clear plastic containers.
• When the container is full, tape around the cap or lid to make sure the cap or lid does not come off. Do not throw the container in the household trash. Do not recycle.
• Always keep the container out of the reach of children.

Instructions for Use

^PrBomyntra

Denosumab injection

Solution; 120 mg/1.7mL

Subcutaneous injection

Single use pre-filled syringe

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

Guide to parts:

Before you use a Bomyntra 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.
• Bomyntra 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 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.

Storing Bomyntra pre-filled syringe

• Store Bomyntra in a refrigerator between 2 °C to 8 °C in the original carton. Do not freeze.
• Before giving the injection, Bomyntra may be allowed to reach room temperature up to 25 °C in the original container. This takes 15 to 30 minutes. Do not warm Bomyntra in any other way.
• After Bomyntra 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 Bomyntra after the expiration date printed on the label.
• Protect Bomyntra from direct light and heat.

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

Step 1: Prepare materials

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)

Figure A

1.2. Wait 15 to 30 minutes

Remove the carton from the refrigerator (see Figure B) and place it on a flat surface.

Figure B

Let it warm at room temperature for 15 to 30 minutes (see Figure C)

Figure C

Do not try to warm the pre-filled syringe by using a heat source such as hot water or microwave.

Do not leave the pre-filled syringe in direct sunlight.

Do not shake the pre-filled syringe

Keep the pre-filled syringe out of sight and reach of children.

1.3. Wash your hands

Wash your hands well with soap and water and dry them with a clean towel (see Figure D).

Figure D

1.4. Remove pre-filled syringe from tray

Place two fingers on either side, in the middle of the clear needle guard. Pull the pre-filled syringe straight up and out of the tray (see Figure E).

Do not grasp the plunger.

Do not grasp the needle cap.

Figure E

1.5. Inspect pre-filled syringe and medicine

Check the pre-filled syringe to make sure that:

• The name on the label says Bomyntra (see Figure F).
• The expiration date on the label has not passed.
• The pre-filled syringe is not cracked or broken.

Figure F

Check the liquid to see if there are any particles or discoloration (see Figure G).

Figure G

Do not use the pre-filled syringe if:

• The name on the label is not Bomyntra.
• The expiration date on the label has passed.
• Any part appears cracked or broken.
• 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.

Step 2: Prepare to inject

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.

Avoid injecting into areas with scars or stretch marks

Figure H

2.2. Clean the injection site

Clean the injection site with an alcohol wipe (see Figure I).

Let your skin air dry.

Do not blow on or touch the injection site after cleaning.

Figure I

2.3. Remove needle cap

Carefully pull the needle cap straight off and away from your body (see Figure J). It may take some force to remove the needle cap.

Do not remove the needle cap from the pre-filled syringe until you are ready to inject.

Do not hold the pre-filled syringe by the plunger rod.

Do not twist or bend the needle cap.

Throw away (dispose of) the needle cap in your sharps disposal container (see Step 4 Throw away your pre-filled syringe).

Do not put the needle cap back onto the pre-filled syringe.

Do not touch the needle or let it touch any surface after removal of the needle cap.

Figure J

Step 3: Inject medicine

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.

Figure K

3.2. Insert the needle

Quickly insert the needle straight into the pinched skin at a 45 to 90-degree angle (see Figure L).

Do not inject into muscle or blood vessel.

Figure L

3.3. Inject

Push the plunger with slow and constant pressure (see Figure M) until you cannot press anymore and have injected all of the liquid under the skin (subcutaneously) (see Figure N).

Figure M

Figure N

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).

Figure O

Do not put the needle cap back on the needle.

3.5. Treat injection site

If there is blood or liquid at the injection site, gently press a cotton ball or gauze on the skin (see Figure P).

You may use an adhesive bandage if needed.

Figure P

Do not rub the injection site.

Step 4: Throw away your pre-filled syringe

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.

Figure Q

Keep Bomyntra pre-filled syringes, sharps disposal container and all medicines out of the reach and sight of children.