Prolia

What is Prolia?

• Prolia (Denosumab) is a RANK ligand (RANKL) inhibitor used for the treatment of osteoporosis, treatment-induced bone loss.

What are the uses of this medicine?

Prolia is a prescription medicine used to: Treat osteoporosis (thinning and weakening of bone) in women after menopause ("change of life") who:

• are at high risk for fracture (broken bone)
• cannot use another osteoporosis medicine or other osteoporosis medicines did not work well
• Increase bone mass in men with osteoporosis who are at high risk for fracture.
• Treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
• Treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
• Treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

How does this medicine work?

• Prolia binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption.
• Prolia prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors.
• Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have been told by your doctor that your blood calcium level is too low.
• are pregnant or plan to become pregnant.
• are allergic to denosumab or any of the ingredients in Prolia.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Prolia.

Is this medicine FDA approved?

• On 2 June 2010, denosumab was approved by the FDA for use in postmenopausal women with risk of osteoporosis under the trade name Prolia.

How should this medicine be used?

• Pregnancy must be ruled out prior to administration of Prolia.

Recommended dosage:

• The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months.
• Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen.
• All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily.

Administration:

• Prolia is an injection that will be given to you by a healthcare professional. Prolia is injected under your skin (subcutaneous).
• You will receive Prolia 1 time every 6 months.
• You should take calcium and vitamin D as your doctor tells you to while you receive Prolia.
• If you miss a dose of Prolia, you should receive your injection as soon as you can.
• Take good care of your teeth and gums while you receive Prolia. Brush and floss your teeth regularly.
• Tell your dentist that you are receiving Prolia before you have dental work.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-dose prefilled syringe containing 60 mg in a 1 mL solution

This medicine is available in fallowing brand namesː

• Prolia

What side effects can this medication cause?

The most common side effects of this medicine include: The most common side effects of Prolia in women who are being treated for osteoporosis after menopause are:

• back pain
• pain in your arms and legs
• high cholesterol
• muscle pain
• bladder infection

The most common side effects of Prolia in men with osteoporosis are:

• back pain
• joint pain
• common cold (runny nose or sore throat)

The most common side effects of Prolia in patients with glucocorticoid-induced osteoporosis are:

• back pain
• high blood pressure
• lung infection (bronchitis)
• headache

The most common side effects of Prolia in patients receiving certain treatments for prostate or breast cancer are:

• joint pain
• back pain
• pain in your arms and legs
• muscle pain

Prolia may cause serious side effects include:

• Serious allergic reactions
• Low calcium levels in your blood (hypocalcemia)
• Severe jaw bone problems (osteonecrosis)
• Unusual thigh bone fractures
• Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia
• Serious infections
• Skin problems
• Bone, joint, or muscle pain

What special precautions should I follow?

• Prolia contains the same active ingredient (denosumab) found in Xgeva. Patients receiving Prolia should not receive Xgeva.
• Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia.
• Hypocalcemia may be exacerbated by the use of Prolia. Must be corrected before initiating Prolia. May worsen, especially in patients with renal impairment. Adequately supplement patients with calcium and vitamin D.
• Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. Monitor for symptoms.
• Atypical low energy or low trauma fractures of the shaft have been reported in patients receiving Prolia. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
• Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Patients should be transitioned to another antiresorptive agent if Prolia is discontinued.
• Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with Prolia. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
• Epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate with Prolia. Consider discontinuing Prolia if severe symptoms develop.
• In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia. Discontinue use if severe symptoms develop.
• Treatment with Prolia resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. Monitor for consequences of bone over-suppression.

What to do in case of emergency/overdose?

• There is no experience with overdosage with Prolia.

Can this medicine be used in pregnancy?

• Prolia is contraindicated for use in pregnant women because it may cause harm to a fetus.
• There are insufficient data with denosumab use in pregnant women to inform any drug-associated risks for adverse developmental outcomes.

Can this medicine be used in children?

• Prolia is not recommended in pediatric patients younger than age 4 years because of the high rates of skeletal growth and the potential for Prolia to negatively affect long-bone growth and dentition.
• The safety and effectiveness of Prolia in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: denosumab
• Inactive ingredients: sorbitol, acetate, polysorbate 20, Water for Injection (USP), and sodium hydroxide

Who manufactures and distributes this medicine?

• Manufactured by:

Amgen Inc. One Amgen Center Drive Thousand Oaks, California

What should I know about storage and disposal of this medication?

• Keep Prolia in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton.
• Do not freeze Prolia.
• When you remove Prolia from the refrigerator, Prolia must be kept at room temperature [up to 77°F (25°C)] in the original carton and must be used within 14 days.
• Do not keep Prolia at temperatures above 77°F (25°C). Warm temperatures will affect how Prolia works.
• Do not shake Prolia.
• Keep Prolia in the original carton to protect from light.

• Dailymed label info on Prolia
• FDA Prolia

Prolia Resources
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