What is Prolia?

Denosumab is a monoclonal antibody that affects the actions of the body’s immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
Denosumab is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.
Denosumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Prolia?

You should not receive denosumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia).
Before you receive this medication, tell your doctor if you have kidney disease (or if you are on dialysis), a weak immune system, a history of hypoparathyroidism or thyroid surgery, a history of intestinal surgery; or if you are allergic to latex.
Serious infections may occur during treatment with denosumab. Call your doctor right away if you have signs of infection such as: severe skin irritation; swelling or redness anywhere on your body; pain or burning when you urinate; severe stomach cramps, diarrhea, or vomiting; ear pain, trouble hearing; cough, feeling short of breath; purple or red spots under your skin; or fever, chills, night sweats, flu symptoms, or weight loss.
Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving denosumab. You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before taking Prolia?

You should not receive denosumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia).
If you have any of these other conditions, you may need a denosumab dose adjustment or special tests:

kidney disease (or if you are on dialysis)
a weak immune system (caused by disease or by using certain medicines)
a history of hypoparathyroidism (decreased functioning of the parathyroid glands)
a history of thyroid surgery
a history of surgery to remove part of your intestine; or
if you are allergic to latex

FDA pregnancy category C. It is not known whether denosumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. However, this medication may slow the production of breast milk. You should not breast-feed while receiving denosumab.
Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Prolia Side Effects

What are the possible side effects of Prolia?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious infections may occur during treatment with denosumab. Call your doctor right away if you have signs of infection such as:

severe itching, burning, rash, or dryness of the skin
swelling, pain, tenderness, or redness anywhere on your body
pain or burning when you urinate
severe stomach cramps, diarrhea, vomiting
ear pain or drainage, trouble hearing
fever, chills, night sweats
cough, feeling short of breath
pinpoint purple or red spots under your skin; or
flu symptoms, weight loss

Call your doctor at once if you have a serious side effect such as:

numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate

Less serious side effects may include:

back pain
constipation
pain in your arms or legs; or
muscle or joint pain

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Prolia Interactions

What other drugs affect Prolia?

Tell your doctor about all other medicines you use, especially:

drugs that weaken your immune system (such as cancer medicine or steroids)
cyclosporine (Neoral, Sandimmune, Gengraf)
sirolimus (Rapamune), tacrolimus (Prograf)
basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone)
mycophenolate mofetil (CellCept); or
azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel)

This list is not complete and other drugs may interact with denosumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I avoid while taking Prolia?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Prolia Dosage

How should I take Prolia?

Denosumab is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Denosumab is usually given once every 6 months. Follow your doctor’s instructions.
Your doctor may have you take extra calcium and vitamin D while you are being treated with denosumab. Take only the amount of calcium and vitamin D that your doctor has prescribed.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving denosumab. You may need to stop using the medicine for a short time.

What happens if I overdose on Prolia?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What happens if I miss a dose of Prolia?

Call your doctor for instructions if you miss an appointment for your denosumab injection.
Sourced from everydayhealth.com

Prolia