Patient Medication Information: uses, side effects, how to take - Jubbonti

What is Jubbonti used for?

Jubbonti 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 Jubbonti, 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 does Jubbonti work?

Jubbonti 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). Jubbonti 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 non spinal sites.

What are the ingredients in Jubbonti?

Medicinal ingredient: denosumab.

Non-medicinal ingredients: acetic acid, hydrochloric acid, polysorbate 20, sodium hydroxide, sorbitol, water for injection. The prefilled syringe with safety guard is not made with natural rubber latex.

Jubbonti comes in the following dosage forms:

Jubbonti is a liquid for injection, available in a prefilled syringe with safety guard.

Jubbonti is a clear, colourless to slightly yellowish or slightly brownish solution. Do not use if the solution is cloudy or if the solution contains visible particles.

Do not use Jubbonti if you:

are allergic to denosumab or any other ingredient of Jubbonti. Allergic reactions (eg, rash, hives, or in rare cases, swelling of the face, lips, tongue, throat, or trouble breathing) have been reported.
have low calcium levels in your blood (hypocalcemia).
are less than 18 years of age (see also What is Jubbonti used for above and Other warnings you should know about below).
are pregnant or breastfeeding.
are a woman before menopause [unless you have been diagnosed with breast cancer or are taking Jubbonti for the treatment or prevention of osteoporosis related to the use of corticosteroid medicines (see also What is Jubbonti used for above and Other warnings you should know about below)].
are currently taking other denosumab-containing medicinal products.
do not have access to a health professional or trained injector.

Other warnings you should know about:

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

There is an increased risk of skin infection (cellulitis) with Jubbonti 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.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Jubbonti. 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 Jubbonti.
Plan to have dental surgery or teeth removed.
Have a history of cancer.
Are pregnant or could become pregnant.

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

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

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

Denosumab 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 Jubbonti. Severe low blood calcium levels may lead to hospitalization, life-threatening events, and death. Low blood calcium should be treated before receiving Jubbonti. 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 Jubbonti:

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 Jubbonti.
Tell your dentist that you are taking Jubbonti, 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. The risk of ONJ may increase with length of time on Jubbonti. 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 Jubbonti 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 Jubbonti without first talking with your doctor. If your Jubbonti treatment is stopped, discuss other available treatment options with your doctor.

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 Jubbonti:

In a drug interaction study, Jubbonti (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 Jubbonti and other drugs metabolised 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 Jubbonti.

How to take Jubbonti:

Jubbonti 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 25^oC) before injection. This takes about 15 to 30 minutes and will make the injection more comfortable. See instructions for use.

Keep the prefilled syringe in the original carton until ready to use in order to protect from light.

Keep all medicines, including Jubbonti, away from children.

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

Usual dose:

The usual dose of Jubbonti 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:

If you think you, or a person you are caring for, have taken too much Jubbonti, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

The following “Instructions for Use” contain information on how to inject Jubbonti.

If your doctor decides that you or your caregiver may be able to give your injections of Jubbonti at home, ensure that your doctor or nurse shows you or your caregiver how to prepare and inject with the Jubbonti prefilled syringe before you use it for the first time.

Be sure that you read and understand these Instructions for Use before injecting with the Jubbonti prefilled syringe. Talk to your doctor if you have any questions.

Important information you need to know before injecting Jubbonti

Jubbonti is for subcutaneous injection only (inject directly into fatty layer under the skin).
Do not use the prefilled syringe if any of the safety seals on the outer carton or the seal of the plastic tray is broken.
Do not shake the prefilled syringe at any time.
Do not use if the prefilled syringe has been dropped onto a hard surface or dropped after removing the needle cap.
The prefilled syringe has a safety guard that activates to cover the needle after the injection is finished. The safety guard helps to prevent needle stick injuries to anyone who handles the prefilled syringe after injection.
Be careful not to touch the safety guard wings before use. Touching them may cause the safety guard to activate too early.
Do not attempt to re-use or disassemble the prefilled syringe.
Do not pull back on the plunger.

Prepare to inject Jubbonti

Step 1. Bring to room temperature

Take the carton containing the prefilled syringe out of the refrigerator and leave it unopened for about 15 to 30 minutes so that it reaches room temperature.

Step 2. Gather supplies

Ensure that you have the following (not included in the carton):

Alcohol wipe
Cotton ball or gauze pad
Sharps disposal container
Adhesive plaster

Step 3. Unpack

Open the plastic tray by peeling away the cover. Remove the prefilled syringe by holding it in the middle as shown.

Do not remove the needle cap until you are ready to inject.

Step 4. Perform safety checks

Look through the viewing window of the prefilled syringe. The liquid inside should be a clear, colourless to slightly yellowish or slightly brownish solution. You may see air bubbles in the liquid, which is normal.

Do not attempt to remove the air.

Do not use the prefilled syringe if liquid is cloudy or contains visible particles.
Do not use the prefilled syringe if it appears to be damaged or if it has leaked.
Do not use the prefilled syringe after the expiry date (EXP), which is printed on the prefilled syringe label and carton.

In all of these cases, contact your doctor, nurse or pharmacist.

Step 5. Choose injection site

You should inject into the front of the thighs or the lower stomach area but not the area 5 cm around the belly button.

Do not inject into skin that is tender, bruised, red, scaly, hard or into areas with scars or stretch marks.

If your caregiver, doctor or nurse is giving you the injection, they may also inject into the upper arm.

Inject with Jubbonti

Step 6. Clean injection site

Wash your hands with soap and water.

Clean the chosen injection site with an alcohol wipe. Leave it to dry before injecting.

Do not touch or blow on the cleaned area before injecting.

Step 7. Remove needle cap Firmly pull straight to remove the needle cap from the prefilled syringe. You may see a drop of liquid at the end of the needle. This is normal. Do not put the needle cap back on. Throw away the needle cap.
Step 8. Insert needle Gently pinch the skin at the injection site and hold the pinch throughout the injection. With the other hand insert the needle into the skin at an angle of approximately 45 degrees as shown. Do not press the plunger while inserting the needle.
Step 9. Start injection Continue to pinch the skin. Slowly press the plunger as far as it will go. This will ensure that a full dose is injected.
Step 10. Complete injection Confirm that the plunger head is between the safety guard wings as shown. This will ensure that the safety guard has been activated and will cover the needle after the injection is finished.

Step 11. Release plunger

Keeping the prefilled syringe at the injection site, slowly release the plunger until the needle is covered by the safety guard.

Remove the prefilled syringe from the injection site and release the pinch.

There may be a small amount of blood at the injection site. You can press a cotton ball or gauze pad over the injection site until any bleeding stops.

Do not rub the injection site. If needed, cover the injection site with a small adhesive plaster.

After the injection

Step 12. Dispose of the prefilled syringe

Put the prefilled syringe in a sharps disposal container immediately after use. Do not throw away the prefilled syringe into household waste.

Talk to your doctor or pharmacist about proper disposal of the sharps disposal container. There may be local regulations for disposal.

What are possible side effects from using Jubbonti?

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

These are not all the possible symptoms or side effects you may experience; if you are concerned about any effects you experience you should contact 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 Jubbonti (multiple vertebral fractures).

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
COMMON (≥ 1%, in 1 to 10% of patients)
Skin condition with itching, redness and/or dryness (eczema)	X
UNCOMMON (≥ 0.1%, < 1%)
Skin infection (mainly cellulitis) leading to hospitalization, erysipelas (serious and rapid skin infection commonly on the face or legs)		X
Bladder infection, pancreatitis (inflamed pancreas causing severe stomach pains), and ear infection		X
Broken bones in the spine after stopping Jubbonti treatment (multiple vertebral fractures)		X
RARE (≥ 0.01%, < 0.1%)
Low calcium levels in the blood (muscle spasms, twitches, cramps, numbness or tingling in hands, feet or around the mouth, and weakness)		X
Endocarditis (inflammation of the inner lining of the heart)		X	X
Sore in mouth involving gums or jaw bones (osteonecrosis of the jaw)		X	X
Allergic reaction (feeling faint, trouble breathing/wheezing, throat tightness, swelling of face, lips or tongue, rash, hives)		X	X
Unusual thigh bone fractures (atypical femoral fracture)		X

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) 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:

Store in a refrigerator between 2°C and 8°C. Do not freeze.

Prior to administration, Jubbonti may be allowed to reach room temperature (up to 25°C) in the original carton. Once removed from the refrigerator, Jubbonti must not be exposed to temperatures above 25°C and must be used within 30 days. If not used within the 30 days, Jubbonti should be discarded.