Prolia

Prolia (Denosumab)

What is Prolia (Denosumab)?

Prolia is a medication prescribed to increase bone mass in cases of osteoporosis or cancer. Prolia contains the active ingredient Denosumab and belongs to a class of drugs called Antineoplastics.

Dosage

The typical dosage of Prolia is a single 60mg subcutaneous injection every six months, administered to the upper arm, thigh, or abdomen. You should also take calcium and vitamin D supplements regularly while receiving Prolia injections. Prolia is supplied in a pre-prepared syringe with a needle guard. Typically, Prolia is administered by a healthcare professional, however, in certain circumstances, it may be appropriate for you or your carer to administer it. You must follow the directions provided by your doctor carefully.

Storage

If have doses of Prolia that require storing prior to use, keep them in the refrigerator between 2°C and 8°C. Do not allow them to freeze. Keep Prolia injections in their original packaging out of direct light. You can allow the medication to come to room temperature prior to injection to make it more comfortable. Once it has warmed to room temperature, it must be injected within 30 days. Keep out of reach of children and pets. Do not use expired product. Dispose of expired or surplus medication responsibly, by returning it to your pharmacist. Do not dispose of this medication in household rubbish. Do not share this medication with anyone else. Do not use if the packaging shows signs of tampering (such as tearing), or if the solution is cloudy or discolored.

Side Effects

Common Side Effects

All medication comes with a risk of side effects. It is important to recognize that your doctor has determined that your risk of side effects is outweighed by the potential benefit this medication can provide. Side effects will vary between individuals, and it is possible you will not experience any side effects at all. Prolia use is commonly associated with the following:

• Fever
• Red, itchy skin
• Muscle tenderness or weakness
• Pain in the extremities
• Bladder infection
• Painful/difficult urination
• Back pain

If you experience any of the above side effects and they worry you, contact your healthcare provider, especially if they worsen or do not resolve on their own.

Severe Side Effects

Occasionally, Prolia can be associated with severe side effects that should be taken seriously. If you experience any serious side effects, contact emergency medical assistance immediately. Severe side effects include:

• Difficulty breathing
• Shortness of breath
• Facial swelling
• Rash or itching
• Numbness or tingling of the mouth, fingers or toes
• Seizures
• Unexplained muscle cramps

Warnings & Precautions

Allergies

Do not use Prolia if you are allergic to it or any of its ingredients. Ensure your doctor is aware of all your allergies (including an allergy to latex) and if you have had an allergic reaction to medication in the past.

Pregnancy

Prolia injections must not be given to pregnant people. If you think you could be pregnant, plan on becoming pregnant, or become pregnant while receiving Prolia injections, tell your doctor. Prolia injections can harm the unborn baby, and are therefore not recommended for pregnant people.

Breastfeeding

It is unknown whether Prolia can pass into breast milk. To reduce the risk to the nursing infant, it is not recommended to breastfeed while receiving Prolia injections.

Pediatric Use

Prolia is not recommended for anyone under the age of 18. Do not use it in children or adolescents.

Medical History

Ensure your doctor is aware of your entire personal and family medical history before starting Prolia injections. This includes the following:

• If are deficient in calcium or vitamin D
• If you cannot take supplements for calcium or vitamin D
• If you have a history of kidney problems (including dialysis)
• If you are intolerant to any sugars
• If you have ever had anemia
• If you have cancer
• If you have had dental surgery
• Clotting disorders
• Nutrient absorption problems
• Diabetes

Fractures

Prolia can sometimes lead to a fracture in the femur in the absence of trauma. If you experience new or worsening hip, groin, or thigh pain, contact your doctor immediately.

Infections

This medication can lead to infections that may need hospitalization. If you develop symptoms of infection (such as fever, earache, abdominal discomfort, blood in urine, or tender, swollen skin), seek medical attention at once. People on immunosuppressant drugs may be at higher risk of developing infection.

Jawbone Problems

Denosumab can lead to osteonecrosis of the jaw, particularly after dental surgery while receiving Prolia injections. You should have a dental check-up prior to starting Prolia and ensure to maintain good dental hygiene while receiving the injections.

Interactions & Contraindications

Medications taken concurrently can interact with one another in the body, leading to changes in the way one or both medications act and increasing the risk of unwanted side effects. It is important to keep track of all medications you take on a regular basis (non-prescription and prescription) and share this with your doctor. They may want to alter your medication schedule to accommodate Prolia injections. Do not stop, start, or change the dosage of any medication without first consulting your doctor.

Denosumab may interact with the following medications:

• Anakinra
• Anticancer drugs
• Baricitinib
• Corticosteroids
• Cyclosporine
• Monoclonal antibodies
• Protein kinase inhibitors
• Tacrolimus
• Tofacitinib

If you are taking any of these medications, consult your doctor.

Frequently Asked Questions