Prolia – Currently Unavailable

PROLIA 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 by a health professional or by a trained injector, with or without food.

Your prefilled 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 PROLIA, away from children.

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

Usual dose:

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

Overdose

In case of drug overdose, contact a health professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no 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.

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).
• Skin condition with itching, redness and/or dryness (eczema). Injection site reactions were uncommon.
• 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 PROLIA (multiple vertebral fractures).

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 doctor.

PROLIA contains the same medicine as another drug called XGEVA, but at a different dose. If you are being treated with PROLIA, you should not be taking XGEVA or vice versa.

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

BEFORE you use PROLIA talk to your doctor or pharmacist 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 PROLIA
• Plan to have dental surgery or teeth removed
• Have a history of cancer
• Could become pregnant
• Are allergic to rubber or latex

Tell your doctor and pharmacist about all the medicines you take, including prescription and nonprescription drugs, vitamins, and herbal supplements, and keep an up-to-date list of all of them.

The needle cover on the single use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons allergic to it.

PROLIA may interfere with normal bone and tooth development in fetuses, nursing babies, and children under 18 years of age. Children under 18 years of age should not take PROLIA.

Women who are pregnant or could become pregnant should not take PROLIA. If you become pregnant while taking PROLIA, stop taking PROLIA and tell your doctor right away.

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

PROLIA may lower levels of calcium in the blood. Low blood calcium should be treated before receiving PROLIA. 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 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 PROLIA:

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

In a drug interaction study, PROLIA (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 PROLIA 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 PROLIA.