Denosumab

What is Denosumab (prolia)?

It is known as the Prolia version of the drug denosumab and can be used by adult patients to manage osteoporosis or loss of bone for those who:

• Are at risk of fractured bones, and
• Those who are unable to use an alternative osteoporosis medication or whose drugs have not worked as expected.

Prolia can be used for those whose fractured bones are the result of certain medications as well as treatment for cancer. Treatments. This medication guide gives information on the Prolia Denosumab brand. Xgeva will be a different version of denosumab to treat bone fractures as well as other skeletal problems in patients who have tumors that have spread to bone. Denosumab can also be used for other purposes not covered in this medication guide.

Side effects of Prolia

Seek medical attention immediately. If you notice symptoms that indicate an allergy, such as hives, irritation, rash, difficulty breathing, feeling lightheaded, or swelling of your lips, face, and tongue,

Denosumab could cause severe adverse effects. Contact your physician immediately. If you suffer from:

• New or unusual pain in your hip, thigh, or groin area;
• intense discomfort in joints, muscles, bones, or joints;
• skin issues like redness, dryness, peeling, or blisters. bumps, oozing, and crusting
• low calcium levels; muscle spasms or contractions; numbness or sensation (around your mouth or on your toes and fingers).

The risk of developing serious infections is increased in the course of treatment for Prolia. Contact your physician right now if you are showing symptoms of infection, like:

• fever, chills;
• the sensation of tenderness, swelling, pain, warmth, redness, or swelling anywhere on your body;
• burning and pain when you pee; painful urine;
• an increased or urgent urgency to urge urination;
• severe stomach pain; or
• cough, wheezing, and shortness of breath.

Common adverse effects of denosumab could be:

• Bladder infections (painful or painful to urinate);
• Lung inflammation (cough or shortness of breath);
• Headache;
• The back muscle and joint discomfort;
• Raised blood pressure.
• Symptoms of the cold, like nasal stuffiness, sneezing, and a sore throat;
• Excessive cholesterol or
• Discomfort in your arms or legs.

This isn't a complete list of possible side effects, and others could happen. Contact your doctor for advice regarding medical effects. You can report any side effects to the FDA at 1-800-FDA-1088.

Warnings

This guideline provides details about the Prolia Denosumab brand. Xgeva is a different brand of denosumab, which is used to prevent bone fractures as well as other skeletal problems in patients with tumors that are spreading into the bone.

Prolia may cause dangerous adverse effects. Call your doctor immediately if you notice an illness that causes chills, fever, burning or pain after you urinate, extreme stomach discomfort and cough, shortness or no breath, skin issues and tingling or numbness, intense or unusual pain, or skin issues.

Do not take it when you are pregnant. Use effective birth control when using Prolia and for a minimum of 5 months after the last dose. Consult your physician when you are pregnant.

Before taking this medication

It is not recommended to take Prolia. If you are sensitive to denosumab or if you suffer from:

• The calcium levels are low in the blood (hypocalcemia), as well as
• If you are pregnant.

When you're using Prolia, it is not recommended to get Xgeva. Another brand of denosumab

Speak to your doctor if you were ever diagnosed with:

• Renal disease (or if you're taking dialysis);
• An immune system that is weak (caused by illness or taking certain medications);
• Hypoparathyroidism (decreased function of parathyroid glands);
• Parathyroid or thyroid operation;
• Any illness that makes it difficult for your body to take in the nutrients in the food you eat (malabsorption);
• If you're scheduled to undergo a procedure at the dentist,
• If you are unable to take your daily vitamin D and calcium, for example,
• If you are taking medication that lowers your blood calcium levels,

This medicine can lead to jaw bone issues (osteonecrosis). The highest risk is in patients with blood cell disorders, cancer, or pre-existing dental issues, or in patients receiving chemotherapy, steroids, or radiation. Signs of jaw pain or numbness, swelling or red gums, gum infections, loose teeth, or a slow healing process following dental procedures Consult your dentist about the risks you face.

It is possible that you will need to take a pregnancy test that is negative prior to commencing this treatment.

Do not take Prolia in the event that you are expecting. It could harm the unborn baby or cause birth defects. Make sure you use effective birth control when taking Prolia for at least five months following the last dose. Inform your doctor when you fall pregnant.

It is not recommended to breastfeed during treatment with denosumab.

What is Prolia?

Denosumab is injected beneath the skin. The healthcare professional will administer the injection. Prolia is generally only given every six months.

Your doctor might suggest that you take additional vitamin D and calcium while you're being treated with denosumab. Only take the amount of vitamin D and calcium the doctor has recommended. If you require any dental surgery (especially surgery), inform your dentist prior to the appointment that you're receiving denosumab.

Make sure you pay attention to your hygiene. Cleanse and brush your teeth on a regular basis while you are taking this drug. It's possible to need an examination of your teeth prior to beginning the treatment process with Prolia. Follow the instructions of your dentist.

The risk of sustaining bone fractures may increase if you discontinue, pause, or delay the use of Prolia. Don't stop taking Prolia without consulting your physician. If you store this medication at home, you can store it in its original container in the refrigerator. Keep it away from sunlight, and don't freeze. Do not shake the prefilled syringe.

The carton can be taken from the refrigerator and left at room temperature prior to the injection. Once you've taken Prolia from the fridge, you can keep it at room temperature for up to fourteen days. Place it inside the container that you purchased it from, away from light and heat.

Toss out a syringe filled with prefilled medicine after use, even if there's remaining medicine inside. Don't reuse needles or syringes. Put them in an impervious-to-punch "sharps" container and dispose of it in accordance with the laws of your state or municipality. Keep them out of the reach of children and pets. Don't share this medication with anyone else, even if they suffer from similar symptoms as you do.

Do I be concerned if I miss a dose?

Contact your physician for advice in case you missed the dose or failed to make an appointment to receive the Prolia injector. You must get your delayed injection as soon as possible.

What will happen if I take excessively?

For medical emergencies, seek emergency medical attention or contact the Poison Help Line toll-free at 1-800-222-1222.

What should be avoided?

Follow the doctor's advice regarding any dietary restrictions, drinks, food, or any activity.

Interaction with other drugs

Other medications may interact with Prolia, including prescription and non-prescription medicines, vitamins, and herbal products. Inform your physician about any other medications you take.