DENOSUMAB - INJECTION

DENOSUMAB - INJECTION

PHONETIC PRONUNCIATION: (den-OH-sue-mab)

COMMON BRAND NAME(S): Prolia

GENERIC NAME(S): denosumab

Uses

USES: Denosumab is used to treat bone loss (osteoporosis) in women who are at high risk for bone fracture after menopause. It is also used to treat bone loss in men who are at high risk for bone fracture. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take corticosteroid medications (such as prednisone) for long periods. Denosumab is also used to treat bone loss in women who are at high risk for bone fracture while receiving certain treatments for breast cancer. Denosumab is also used to treat bone loss in men who are at high risk of bone fracture while receiving certain treatments for prostate cancer that has not spread to other parts of the body. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Denosumab belongs to a class of drugs called monoclonal antibodies. It prevents certain cells in the body (osteoclasts) from breaking down bone.


How to use DENOSUMAB - INJECTION

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using denosumab and before each injection. If you have any questions, ask your doctor or pharmacist. Your healthcare provider will inject this medication under your skin in the upper arm, upper thigh, or abdomen as directed by your doctor, usually every 6 months. Take calcium and vitamin D as directed by your doctor, usually 1000 milligrams of calcium and at least 400 IU of vitamin D daily. Use this medication regularly in order to get the most benefit from it. It is important to keep receiving this medication even if you feel well. Most people with osteoporosis do not have symptoms. Remember to receive it every 6 months. It may help to mark your calendar with a reminder. Continue to take other medications for your condition as directed by your doctor.

Side Effects

SIDE EFFECTS: See also Precautions section. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Denosumab may cause low calcium levels, especially if you have kidney problems. Take calcium and vitamin D as directed by your doctor. (See also How to Use section.) Your doctor will order calcium blood tests before your first injection and during treatment. Tell your doctor right away if you have any symptoms of low calcium such as: muscle spasms/cramps, mental/mood changes (such as irritability or confusion), numbness/tingling (especially around lips/mouth or in fingers/toes), fast/irregular heartbeat, severe dizziness/fainting, seizures. Denosumab can affect your immune system. You may be more likely to get a serious infection, such as a skin, ear, stomach/gut, or bladder infection. Tell your doctor right away if you develop any signs of infection, such as: fever/chills, red/swollen/tender/warm skin (with or without pus), severe abdominal pain, ear pain/discharge, trouble hearing, frequent/painful/burning urination, pink/bloody urine. Tell your doctor right away if you have any serious side effects, including: jaw pain, new or unusual thigh/hip/groin pain, bone/joint/muscle pain. After your treatment with denosumab is stopped, you may be at increased risk for bone fracture, including bones in your spine. Do not stop using this medication without first talking with your doctor. If your treatment is stopped, talk with your doctor about other medicines you can take. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Denosumab can cause skin problems such as dryness, peeling, redness, itching, small bumps/patches, or blisters. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash or if any of these symptoms persist or worsen. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using denosumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood calcium levels (hypocalcemia), thyroid/parathyroid problems/surgery, stomach/intestinal problems (such as malabsorption, surgery), kidney problems, recent or planned dental surgery/tooth removal. Some people using denosumab may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away. Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Denosumab is not recommended for use in children. It may slow down a child's growth and affect tooth development. This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication and for at least 5 months after treatment. Therefore, females must use reliable forms of birth control during treatment and for at least 5 months after treatment. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for DENOSUMAB - INJECTION

Denosumab is used to treat osteoporosis in postmenopausal women, as well as to prevent skeletal-related events in patients with advanced cancer.

Denosumab is a monoclonal antibody that works by inhibiting a protein called RANKL, which is involved in the breakdown of bone. By blocking RANKL, denosumab helps to increase bone density and reduce the risk of fractures.

Denosumab is administered as an injection under the skin (subcutaneous) once every six months for the treatment of osteoporosis. For cancer patients, the recommended dose may vary based on individual circumstances.

Common side effects of denosumab include back pain, muscle pain, joint pain, nausea, diarrhea, and skin rash. In rare cases, it may also increase the risk of serious infections, jawbone problems, and low levels of calcium in the blood.

Denosumab is not recommended for use during pregnancy as its effects on the developing fetus are not well-known. It is also not known whether denosumab passes into breast milk, so breastfeeding mothers should consult their healthcare provider before using it.

It is important to inform your healthcare provider about all the medications you are taking, including over-the-counter drugs and supplements, as they may interact with denosumab. Certain medications, such as glucocorticoids or other bone-building medications, may affect its efficacy or increase the risk of side effects.

The duration of denosumab treatment for osteoporosis depends on individual factors and should be determined by your healthcare provider. It is generally recommended to evaluate the need for continued treatment after five years.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.