Prolia (Denosumab)
Prolia
Denosumab
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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.

Storage

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.

Uses

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
  • osteoporosis
  • 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.

Dosage

Prolia is available as a single-dose prefilled syringe. This syringe contains 1 mL of a 60 mg/mL denosumab solution.

Overdose

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.

Side Effects

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
  • headaches
  • 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:

  • flushing
  • itching
  • 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.

Hypocalcemia

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.

Severe Infections

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.

Pregnancy

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.

Stopping Prolia

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.

Weight Gain

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
  • cancer
  • hypoparathyroidism
  • impaired immunity
  • inability to take vitamin D and calcium daily
  • latex allergy
  • kidney disease
  • a history of thyroid surgery
  • malabsorption
  • 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

Drug Interactions

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:

  • abatacept
  • anakinra
  • azathioprine
  • baricitinib
  • belimumab
  • bleomycin
  • bosutinib
  • cinacalcet
  • corticosteroids
  • cyclophosphamide
  • cyclosporine
  • dasatinib
  • dexamethasone
  • eculizumab
  • etanercept
  • fingolimod
  • golimumab
  • hydroxyurea
  • idelalisib
  • imatinib
  • infliximab
  • leflunomide
  • methotrexate
  • monoclonal antibodies
  • mycophenolate
  • nilotinib
  • ozanimod
  • prednisone
  • protein kinase inhibitors
  • rituximab
  • siponimod
  • tacrolimus
  • tofacitinib
  • Xgeva (another brand of denosumab)

Alternative Medications

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)

Frequently Asked Questions

There is no required time frame of treatment for patients using Prolia. Multiple studies have followed patients that have used the medication for multiple years, with the longest documented time period of a patient using Prolia consisting of eight years in one study. However, a patient’s fracture risk is greatly decreased the longer they continue to use the injections.

A patient may stop using Prolia after their first injection, but they will still remain at an increased risk of experiencing fractures after receiving their first injection, especially spinal fractures. The longer a patient continues to use Prolia, the lower their overall risk of fractures.

Yes. Prolia has been shown to reverse osteoporosis by increasing bone density and reversing bone loss in those using the medication. This has resulted in improved bone density and a reduced risk of fractures of the femoral neck, hips, and lumbar spine.

Prolia improves a person’s bone health by reducing bone loss and increasing bone density, but a patient using the medication will not feel the medication actively working within the body. However, they will experience a reduced risk of bone fractures while using Prolia, and the patient’s test results when their doctor checks their level of bone strength and bone mineral density should greatly improve over time.

Most patients using Prolia will be required to take additional supplements of calcium and vitamin D as directed by their doctor. Taking these supplements daily will help prevent hypocalcemia, or low levels of calcium in the blood, while using Prolia. The most commonly recommended dosage of daily calcium during treatment with Prolia is 1000 mg per day, and about 400 IU of vitamin D should be taken along with the calcium to ensure proper absorption.

Studies involving Prolia did not report hair loss as a common side effect in those using the medication. However, some patients using Prolia reported hair loss after these studies were conducted, but it has not been determined if the hair loss is directly tied to Prolia use. It is often used in individuals who are already receiving other therapies and treatments for cancer, and these types of treatments are known to cause hair loss, meaning that the hair loss experienced is not a direct result of use.

Prolia should be given exactly six months after the patient’s last injection. If an injection has been missed, it should be given as soon as possible. Patients that have already received one or more injections have a significantly high risk of fractures after using this medication when its use is not continued.

Prolia carries a risk of osteonecrosis of the jaw for those using the medication that may need to have certain dental procedures performed. Patients that need any type of dental work performed should consult with both their prescribing physician and their dentist to determine the safety of the necessary procedure while using this medication. Some minor procedures may carry less of a risk associated with Prolia use, but procedures such as tooth extractions are known to cause significant adverse responses when a patient is actively using Prolia.

Patients using Prolia may experience abnormal heart rhythms due to the lower levels of calcium in the blood that are caused by this medication. This risk is why doctors will often monitor a patient’s blood calcium levels during treatment and recommend that they take daily doses of calcium and vitamin D to avoid hypocalcemia.

Prolia is not available in pill form. It is currently only available as a prefilled syringe containing a denosumab solution for a twice-yearly injection. Certain medications are unable to be consumed in a pill form due to them being unable to be absorbed by a patient’s digestive tract, and this is when injectable medications are the only options available.

Osteonecrosis of the jaw is most common in those who are elderly or female and using Prolia. About 80% of female patients developed this condition, whereas only 73.3% of other patients in a study experienced this issue. The development of ONJ appears to be impacted by the presence of other comorbid conditions in these patients, yet it does not seem to be impacted by the duration of treatment or how many doses a patient has received.