Generic Name: denosumab (Prolia) (den OH sue mab)
Brand Names: Prolia

What is Prolia?

Prolia (denosumab) is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Prolia is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.

Prolia is also used for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy.

Prolia is also used to increase bone mass in men with osteoporosis at high risk for fracture.

This medication guide provides information about the Prolia brand of denosumab. Xgeva is another brand of denosumab used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone.

Prolia may also be used for purposes not listed in this medication guide.

Important information

Prolia can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not receive Prolia if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).

Before you receive Prolia, 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, a condition that makes it hard for your body to absorb nutrients from food, or if you are allergic to latex.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Serious infections may occur during treatment with Prolia. 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 pain; 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 Prolia 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 Prolia. You may need to stop using the medicine for a short time.

Before receiving Prolia

You should not receive Prolia if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).

To make sure you can safely use Prolia, tell your doctor if you have any of these other conditions:

  • 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;

  • any condition that makes it hard for your body to absorb nutrients from food (malabsorption); or

  • if you are allergic to latex.

Some people using Prolia 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.

FDA pregnancy category X. Prolia can harm an unborn baby or cause birth defects. Do not use Prolia if you are pregnant. Tell your doctor right away if you become pregnant during treatment. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Prolia on the baby. It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. However, Prolia may slow the production of breast milk. You should not breast-feed while receiving Prolia.

See also: Pregnancy and breastfeeding warnings (in more detail)

How is Prolia given?

Prolia is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.

Prolia 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 Prolia. Take only the amount of calcium and vitamin D that your doctor has prescribed.

Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving Prolia. You may need to have a dental exam before you begin treatment with Prolia. Follow your doctor's instructions.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Prolia. You may need to stop using the medicine for a short time. If you keep your medication at home, store it in the original container in a refrigerator. Protect from light and do not freeze.

You may take the medicine out of the refrigerator and allow it to reach room temperature before the injection is given. Do not heat the medicine before using.

After you have taken Prolia out of the refrigerator, you may keep it at room temperature for up to 14 days. Store in the original container away from heat and light. Do not shake the prefilled syringe or you may ruin the medicine. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

Each prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Do not share Prolia with another person, even if they have the same symptoms you have.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Prolia injection. You should receive your missed injection as soon as possible.

What happens if I overdose?

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

What should I avoid?

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

Prolia side effects

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

  • severe itching, burning, rash, blistering, peeling, or dryness of the skin;

  • swelling, pain, tenderness, warmth, or redness anywhere on your body;

  • pain or burning when you urinate, blood in your urine;

  • severe stomach pain;

  • 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 or in your fingers or toes, fast or slow heart rate, muscle cramps or contraction, overactive reflexes; or

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious Prolia side effects may include:

  • weakness;

  • constipation;

  • back pain, muscle pain; or

  • pain in your arms or legs.

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.

See also: Side effects (in more detail)

What other drugs will affect Prolia?

Tell your doctor about all other medicines you use, especially drugs that weaken your immune system such as:

  • steroids or cancer medicine;

  • cyclosporine (Neoral, Sandimmune, Gengraf);

  • sirolimus (Rapamune), tacrolimus (Prograf);

  • basiliximab (Simulect), muromonab-CD3 (Orthoclone);

  • mycophenolate mofetil (CellCept); or

  • azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel).

This list is not complete and other drugs may interact with Prolia. 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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Prolia.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Prolia only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 9.01. Revision Date: 2012-07-06, 4:44:54 PM.

Hide
(web1)