Prolia (Denosumab Injection)
What is Prolia (Denosumab Injection)?
Prolia (denosumab) is a monoclonal antibody that is designed for the treatment of osteoporosis in individuals that are at a high risk of experiencing bone fractures. It may both increase bone mass and reduce bone loss in individuals with long-term corticosteroid use or receiving certain cancer treatments.
How is Prolia Used?
Prolia is a subcutaneous medication that is injected once every six months into a patient’s abdomen, upper thigh, or upper arm. Patients using Prolia should also consume daily vitamin D and calcium supplements during treatment to prevent the occurrence of low blood calcium levels.
Prolia should be stored in the refrigerator between the temperatures of 36°F (2°C) and 46°F (8°C) before use. It is also noted that this medication should be stored in its original carton. It should not be exposed to heat or light, and it should not be frozen. Prolia should also not be vigorously shaken.
When is removed from refrigeration, it should be used within 14 days and not exposed to temperatures exceeding 77°F (25°C), or else it will need to be discarded.
Keep this medication out of the reach of pets and children at all times.
Prolia should be safely disposed of in a “sharps” container to avoid accidental injury. Since this injection is often administered in a professional medical setting, your healthcare provider will be able to safely dispose of the used syringe for you.
Prolia is prescribed for the treatment of the following conditions associated with osteoclast-related health concerns:
- giant cell tumors of bone
- hypercalcemia of a malignancy
- osteolytic bone metastases of solid tumors
How Does Prolia Work?
As a monoclonal antibody, Prolia is made from living cells found in the body. This medication functions by inhibiting certain cells known as osteoclasts, preventing them from causing further damage that results in bone breakdown. It does this by affecting the RANKL protein within the body, which limits osteoclasts’ capabilities. By slowing down the activities of these cells, Prolia is able to assist in preventing fractures from occurring in those who are at high risk for such events due to osteoporosis.
Prolia is available as a single-dose prefilled syringe. This syringe contains 1 mL of a 60 mg/mL denosumab solution.
Overdoses involving Prolia have not been reported or observed. This medication is typically administered in a medical setting by a medical professional. However, if an overdose of Prolia somehow occurs or is suspected, please seek out emergency medical assistance.
Prolia is associated with a number of different side effects that range in severity. Although this medication is likely to cause side effects in many patients, a doctor will still prescribe it if the benefits to the patient’s health outweigh the risks associated with using this medication for treatment.
The most common side effects of taking Prolia are as follows:
- arm pain
- back pain
- bronchitis (and other similar lung infections)
- hair loss
- high blood pressure
- high cholesterol levels
- joint pain
- leg pain
- more susceptible to catching colds
- musculoskeletal pain
- stomach pain
- swelling in the legs or arms
- urinary tract infections (UTIs)
- weight gain (due to swelling)
Most of these typically resolve within a few weeks. However, consult with your prescribing physician if any of these side effects persist or worsen over time.
Some of the more severe following side effects may also occur and require medical attention:
- atypical femur fracture (thigh bone)
- delayed healing after experiencing a fracture
- dental problems
- difficulty walking
- jaw-related problems
- spinal fractures
- pain in the thigh, hip, groin, or back
- severe allergic reactions
- severe pain in muscles, bones, or joints
- skin infections
- unusual bone fractures
- urinary tract infections (severe)
Please seek immediate emergency medical care if you experience any of the following symptoms of a severe allergic reaction when using Prolia:
- low blood pressure
- rash on the skin
- swelling of the feet, hands, lips, or eyelids
- swelling of the throat, tongue, or mouth
Warnings & Precautions
Prolia has been linked to some serious health conditions. Patients at risk of experiencing or developing any of the following conditions or complications should be sure to discuss these risks with their doctor before beginning treatment.
Dental Side Effects
Prolia has been associated with serious dental and jaw-related side effects. This medication causes a significant increase in patients experiencing loose teeth, oral infections, or numbness or pain in their jaw. For those that remain on this medication for a long period of time, there is also a risk of jaw necrosis, in which the tissues of the jawbone die. Removal of the patient’s teeth may be required when this occurs.
Patients at the highest risk of developing osteonecrosis of the jaw include those using Prolia alongside receiving significant dental procedures, those with poor oral hygiene practices, those diagnosed with cancer and receiving certain treatments (such as chemotherapy or the use of certain medications), and those with preexisting dental conditions.
Patients with low blood calcium, or hypocalcemia, are required to improve their condition before beginning treatment with Prolia. Prolia has been linked to a worsening of this condition, and patients are often advised to take daily calcium and vitamin D to counter dropping blood calcium levels. A patient’s doctor will check their blood calcium levels before treatment begins and will also perform regular bloodwork through the duration of treatment with Prolia to monitor these levels. Those who have renal impairment are at a higher risk of experiencing hypocalcemia-related issues when using Prolia.
Infections are a common side effect in those who use Prolia, and some of these may become severe. Endocarditis, ear infections, abdominal infections, skin infections, and urinary tract infections have all been reported. Some of these infections have become severe enough to require hospitalization. Patients that use Prolia alongside immunosuppressant medications or when they have impaired immunity are at a higher risk of experiencing serious infections.
Prolia is not safe for use by pregnant individuals. Patients currently using Prolia should be sure to use effective methods of birth control while taking this medication and for a period of at least five months after having received their last dose of Prolia. This medication poses a serious risk to an unborn child, and patients that become pregnant while using Prolia should inform their physician immediately.
Although stopping Prolia has not been linked to any patients experiencing withdrawal symptoms, those who discontinue the use of the medication are at significant risk of fractures occurring. Whether a patient has received numerous doses of Prolia or just one initial dose, their fracture risk is greatly increased when not continuing to use the medication afterward. Spinal fractures are the most commonly reported injuries that have occurred after stopping treatment with Prolia.
Although actual fluctuations in a patient’s weight are not considered a true side effect of using Prolia, many people have reported weight gain due to the swelling that this medication causes. Swelling of a patient’s arms and legs is more common in those using Prolia who have also gone through menopause, and this swelling has resulted in higher weights in these individuals.
Additional Medical Conditions
Individuals with the following medical conditions should exercise caution when using Prolia and be sure to discuss these conditions with their doctor before beginning treatment:
- blood cell disorders
- impaired immunity
- inability to take vitamin D and calcium daily
- latex allergy
- kidney disease
- a history of thyroid surgery
- an upcoming dental procedure
Those with the following medical conditions should not be allowed to use Prolia until their condition is resolved:
- individuals with hypocalcemia (low blood calcium levels)
- those who are pregnant
Speak to your doctor about any medications or herbal supplements you are currently taking before beginning treatment with Prolia. Discuss any concerns you may have with your doctor or a trusted pharmacist.
Drugs That May Interact with Prolia
These medications may potentially interact with Prolia and increase your chances of experiencing adverse side effects:
- monoclonal antibodies
- protein kinase inhibitors
- Xgeva (another brand of denosumab)
For patients who are unable to take Prolia or experiencing significant adverse side effects, alternative medications may be used to treat some of the associated conditions for which this medication is commonly prescribed:
- abaloparatide (Tymlos)
- alendronate (Fosamax)
- ibandronic acid (Boniva)
- risedronic acid (Actonel)
- teriparatide (Forteo)
- zoledronic acid (Reclast)