Why is this medication prescribed?

Prolia (denosumab) is a medication prescribed for the treatment of osteoporosis in postmenopausal women, men with osteoporosis, and in certain patients at high risk of fractures. It belongs to a class of drugs known as monoclonal antibodies and works by inhibiting the activity of a protein called RANKL, which plays a role in bone breakdown. By reducing bone resorption, Prolia helps increase bone mass and reduce the risk of fractures.

How should this medicine be used?

Here are some general guidelines on how Prolia should be used, but it’s important to follow the specific instructions provided by your healthcare provider:

• Administration: Prolia is administered as a subcutaneous injection (under the skin) by a healthcare professional.
• Dosage: The typical dosing schedule is once every six months. Your doctor will determine the appropriate dosage based on your individual health status.
• Injection Site: Prolia injections are usually given in the upper arm, upper thigh, or abdomen. The injection site may vary, and your healthcare provider will choose the best location.
• Monitoring: Your doctor may order regular blood tests to monitor your calcium levels during the course of treatment.
• Supplements: Your healthcare provider may recommend calcium and vitamin D supplements if your dietary intake is insufficient. It’s important to maintain an adequate intake of calcium and vitamin D to support bone health.
• Follow-Up: Attend all scheduled follow-up appointments with your healthcare provider to monitor your response to treatment and assess any potential side effects.

It’s crucial to inform your healthcare provider about your medical history, including any other medications or supplements you are taking, before starting Prolia. Also, let them know if you have any allergies or a history of infections.

As with any medication, Prolia may have potential side effects, and it’s important to discuss these with your healthcare provider. If you have any questions or concerns about the use of Prolia, it’s advisable to consult your healthcare provider for personalized advice.

Other uses for this medicine

Prolia (denosumab) is primarily prescribed for the treatment of osteoporosis, but it may also be used in certain other medical conditions. Here are some additional uses of Prolia:

• Giant Cell Tumor of Bone (GCTB): Prolia is approved for the treatment of giant cell tumor of bone in adults and skeletally mature adolescents.
• Bone Loss Due to Hormonal Therapy for Breast or Prostate Cancer: In some cases, Prolia may be used to prevent bone loss in individuals undergoing hormonal therapy for breast or prostate cancer.

What special precautions should I follow?

Special precautions should be taken when using Prolia, and your healthcare provider will consider your medical history and potential risk factors. Here are some general precautions:

• Hypocalcemia (Low Calcium Levels): Prolia can lead to low blood calcium levels. It’s essential to ensure an adequate intake of calcium and vitamin D, and your doctor may recommend supplements.
• Infections: Prolia may increase the risk of infections. Inform your healthcare provider if you have a history of infections, and monitor for signs of infection during treatment.
• Dental Issues: There have been reports of osteonecrosis of the jaw (ONJ) associated with Prolia. Inform your dentist about your Prolia treatment, and practice good oral hygiene. It’s advisable to undergo dental examinations and, if needed, preventive dental procedures before starting Prolia.
• Pregnancy and Breastfeeding: Prolia should not be used during pregnancy unless the potential benefits outweigh the risks. It is not known whether Prolia passes into breast milk, so breastfeeding women should consult their healthcare provider.
• Allergies: Inform your healthcare provider of any allergies you may have, especially to proteins, as Prolia is a monoclonal antibody.
• Other Medications: Inform your doctor about all medications, including over-the-counter drugs and supplements, that you are taking. Some medications may interact with Prolia.

Always follow your healthcare provider’s instructions and attend regular check-ups to monitor your response to Prolia and address any concerns or potential side effects. If you experience any unusual symptoms or side effects while taking Prolia, contact your healthcare provider promptly.

What special dietary instructions should I follow?

While there are no specific dietary restrictions for Prolia, it is important to ensure an adequate intake of calcium and vitamin D. Your healthcare provider may recommend supplements to support bone health.

What should I do if I forget a dose?

If you miss a dose of Prolia, it’s important to contact your healthcare provider as soon as possible to discuss the best course of action. The timing of Prolia injections is critical for its effectiveness, so your healthcare provider will guide you on whether to reschedule the missed dose or adjust your treatment plan accordingly.

Do not double the dose to make up for a missed one. Always follow your healthcare provider’s instructions and attend regular appointments to monitor your response to Prolia and address any concerns. If you have any questions or uncertainties about your treatment, consult your healthcare provider for personalized advice.

What side effects can this medication cause?

Prolia (denosumab) may cause side effects, and it’s important to be aware of potential adverse reactions. Common side effects and less common but more serious side effects associated with Prolia include:

Common Side Effects:

• Back Pain: Pain in the back, muscles, or joints.
• Pain in Extremities: Discomfort or pain in the arms or legs.
• Hypercholesterolemia: Increased levels of cholesterol in the blood.
• Bladder Infection: Inflammation or infection of the bladder.
• Elevated Blood Pressure: An increase in blood pressure.
• Headache: Mild to moderate headaches.
• Dermatological Reactions: Skin reactions such as dermatitis or eczema.
• Gastrointestinal Symptoms: Nausea, abdominal pain, and diarrhea.

Less Common but Serious Side Effects:

• Hypocalcemia: Low levels of calcium in the blood, which can lead to symptoms such as muscle spasms, numbness, or tingling in fingers, toes, or around the mouth.
• Serious Infections: There is an increased risk of serious infections, including skin, urinary tract, and respiratory infections.
• Osteonecrosis of the Jaw (ONJ): A rare but serious condition involving the death of jawbone tissue. Symptoms may include jaw pain, swelling, and infection.
• Atypical Femoral Fractures: Unusual fractures of the thigh bone.
• Allergic Reactions: Severe allergic reactions, though rare, may occur. Seek medical attention if you experience symptoms like difficulty breathing, swelling of the face or throat, or severe itching.
• Dermatologic Reactions: Rare cases of severe skin reactions have been reported.

It’s important to report any unusual or severe symptoms to your healthcare provider promptly. Your doctor will weigh the potential benefits of Prolia in treating osteoporosis or other conditions against the possible risks and monitor you for adverse effects during the course of treatment.

Remember that this is not an exhaustive list of side effects, and individual responses can vary. If you have concerns or experience any unexpected symptoms while taking Prolia, contact your healthcare provider for guidance. Additionally, always follow your healthcare provider’s instructions and attend regular check-ups to monitor your response to the medication.

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

Storage of Prolia:

• Refrigeration: Prolia should be stored in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C).
• Protect from Light: Keep the Prolia syringe in the original carton to protect it from light.
• Do Not Freeze: Do not freeze Prolia. Freezing can damage the medication.
• Keep Out of Reach of Children: Store Prolia in a place where children cannot reach it.

Disposal of Prolia:

• Consult Healthcare Provider: Ask your healthcare provider or pharmacist about the proper way to dispose of Prolia syringes. They may provide specific instructions for safe disposal.
• Authorized Collection Centers: In some regions, there are authorized collection centers or programs for the disposal of medications. Check with local authorities for information on medication disposal in your area.
• Do Not Dispose in Household Waste: Do not dispose of Prolia syringes in your household trash or flush them down the toilet.

In case of emergency/overdose

In case of an emergency or overdose, contact your local poison control center at 1-800-222-1222 or seek emergency medical attention. Provide them with information about the medication you have taken, including the name (Prolia) and the amount.

What other information should I know?

• Regular Follow-Up: Attend all scheduled appointments with your healthcare provider to monitor your response to Prolia and discuss any concerns or side effects.
• Inform Healthcare Providers: Make sure all healthcare providers you see, including dentists, are aware that you are taking Prolia. This is important, especially before undergoing dental procedures.
• Dental Care: Practice good oral hygiene and inform your dentist about your Prolia treatment. Consider undergoing dental examinations before starting Prolia.
• Calcium and Vitamin D: Ensure an adequate intake of calcium and vitamin D through diet and/or supplements as recommended by your healthcare provider.
• Medication Interactions: Inform your doctor about all medications, including over-the-counter drugs and supplements, that you are taking to avoid potential interactions.
• Pregnancy and Breastfeeding: Discuss with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. The use of Prolia during pregnancy and breastfeeding should be carefully considered.

Always follow your healthcare provider’s advice and instructions for the proper use, storage, and disposal of Prolia. If you have any questions or concerns, consult your healthcare provider or pharmacist for clarification.