denosumab injection side effects

Prolia comes with side effects to consider before taking it. Less common side-effects include: low blood calcium - your blood levels will be checked before you start treatment and, rarely: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Call your doctor for medical advice about side effects. Skin problems may occur after receiving Prolia. "Product Information. O 0, 2. The risk of osteonecrosis of the jaw is greater in those who have received chemotherapy, radiation, or steroids. 1998-2022 Mayo Foundation for Medical Education and Research (MFMER). Back pain. We comply with the HONcode standard for trustworthy health information. Feeling sick This is usually mild and gets better after a few days. Do not shake denosumab vigorously. new or unusual pain in your thigh, hip, or groin; severe pain in your joints, muscles, or bones; skin problems such as dryness, peeling, redness, itching, blisters, bumps, oozing, or crusting; or [Ref], Common (1% to 10%): Herpes zoster, serious infections (nonfatal cases), Uncommon (0.1% to 1%): Serious Infections (fatal cases)[Ref], Uncommon (0.1% to 1%): Basal cell carcinoma[Ref], New malignancies were reported in 4.8% of patients receiving this drug (placebo=4.3%); new malignancies included breast (0.9%), reproductive system (0.5%), and gastrointestinal system (0.9%). pain in the arms or legs. new or unusual pain in your thigh, hip or groin, severe pain in joints, muscles, or bones, dry skin, peeling skin, redness, itching, blisters, oozing or crusting, numbness or tingly feeling around your mouth, fingers or toes, muscle tightness or contractions, overactive reflexes , fever, chills, night sweats, swelling, pain, tenderness, warmth, An increased risk of urinary infections and eczema, and rare adverse events involving serious infection and osteonecrosis of the jaw, have been reported in patients receiving denosumab therapy for osteoporosis [ 11 , 15 ]. Tell your doctor right away if you have nausea, vomiting, headache, or decreased alertness. If you have been shown how to self-inject denosumab, administer yourself a dose once every six months, otherwise see your healthcare provider for a dose every six months. It's usually fine to take other medicines alongside denosumab, but check with your doctor or pharmacist before starting any new medications. Is fatigue a side effect of Prolia? Check with your doctor or nurse immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. But nausea may be a symptom of side effects such as vertigo or constipation. Denosumab isn't normally recommended for women of child-bearing age. This may be more common if you use it for a long time. Hospitalizations due to serious infections in the abdomen (0.9% vs 0.7%), urinary tract (0.7% vs. 0.5%), ear (0.1% vs. 0%) and skin, including erysipelas and cellulitis (0.4% vs. less than 0.1%) were reported. (It was honestly that bad) As soon as I stopped taking the pills I was fine again after a couple of weeks. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 3. 3. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported. In comparison, 2.1% of the females taking a placebo had itching. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Common (1% to 10%): Angina pectoris, atrial fibrillation[Ref], Postmarketing reports: Anaphylaxis, rash, urticaria, facial swelling, erythema[Ref], Very common (10% or more): Dyspnea (21%), cough (15%), Common (1% to 10%): Upper respiratory tract infection, pneumonia, pharyngitis, nasopharyngitis[Ref], The most commonly reported side effects were asthenia, fatigue, back pain, hypophosphatemia, hypocalcemia, and nausea. Pain in extremities (e.g., arms, hands, legs, feet) For osteoporosis in people assigned male at birth, common side effects with Prolia may include: 1. Denosumab is a monoclonal antibody that may be used to treat osteoporosis. Tooth extraction, history ofMay cause side effects to become worse. Xgeva (denosumab)." Use of denosumab injection is not recommended in the pediatric population, except for teenagers with giant cell tumor of the bone. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of denosumab injection in the elderly. . [Ref], Very common (10% or more): Asthenia (45%), fatigue (45%), Uncommon (0.1% to 1%): Ear infection[Ref], 1. [Ref], Common (1% to 10%): Herpes zoster, serious infections (nonfatal cases), Uncommon (0.1% to 1%): Serious Infections (fatal cases)[Ref], Uncommon (0.1% to 1%): Basal cell carcinoma[Ref], New malignancies were reported in 4.8% of patients receiving this drug (placebo=4.3%); new malignancies included breast (0.9%), reproductive system (0.5%), and gastrointestinal system (0.9%). Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of denosumab injection in the elderly. Check with your doctor or nurse immediately if any of the following side effects occur while taking denosumab: Some side effects of denosumab may occur that usually do not need medical attention. There are two brands of denosumab, Prolia, and Xgeva. Tell your doctor or nurse right away if you have a rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection. Medically reviewed by Philip Thornton, DipPharm. Doing so may increase your risk for more fractures. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Blood tests may be needed to check for unwanted effects. If you have questions about side effects, call your doctor. If you have questions about side effects, call your doctor. Cerner Multum, Inc. "Australian Product Information." Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given. Drug information provided by: IBM Micromedex. This medicine is to be given only by or under the supervision of your doctor. Hypercalcemia may occur after stopping Xgeva treatment in patients with growing bones. Drug class: miscellaneous bone resorption inhibitors, Osteolytic Bone Metastases of Solid Tumors, Osteolytic Bone Lesions of Multiple Myeloma, blistering, crusting, irritation, itching, or reddening of the skin, muscle cramps in the hands, arms, feet, legs, or face, pain in the lower back, bottom, upper leg, or hips, painful blisters on the trunk of the body, clear or bloody discharge from the nipple, itching, pain, redness, swelling, tenderness, or warmth on the skin, lump or swelling in the abdomen or stomach, pains in the stomach, side, or abdomen, possibly radiating to the back, persistent crusting or scaling of the nipple, raised, firm, and bright red patches of the skin on the arm or leg, sore on the skin of the breast that does not heal, pain, swelling, or numbness in the mouth or jaw, excess air or gas in the stomach or bowels, feeling of constant movement of self or surroundings, redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given. Geriatric . Urinary tract infectionUse with caution. Do not suddenly stop receiving this medicine without checking first with your doctor. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Women should use a highly effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 5 months after the last dose. The risk of serious infections may also be increased. Copyright 2022 IBM Watson Health. The most common side effects of Prolia are fatigue (45%), body weakness and lack of . sensation of spinning or whirling. The risk decreases to pretreatment values within 24 months. May make these conditions worse. Xgeva (denosumab)." Partial fractures are usually confirmed by a special diagnostic scan. Continue reading for a comprehensive list of adverse effects. This decreases bone breakdown and increases bone density and strength both in the outer layer of bone and the inner spongy layer. It is important that you tell all of your doctors that you are receiving denosumab injection, including your dentist. What are the side effects? Once taken out of the refrigerator, use within 14 days. Feeling tired or weak. Check with your doctor right away if you have a dull or aching pain in the thigh, groin, or hips. Severe allergic reactions have been reported with denosumab and symptoms have included low blood pressure, shortness of breath, facial and throat tightness, and rash. PROLIA - the dental significance. Although not all of these side effects may occur, if they do occur they may need medical attention. Although not all of these side effects may occur, if they do occur they may need medical attention. This medicine is also used to treat hypercalcemia of malignancy that has been treated with bisphosphonates (eg, alendronate, ibandronate, risedronate, Fosamax) but did not work well. Bone mineral density was increased by 8.8% in the spine, 6.4% in the hip, and 5.2% in the neck after three years of treatment with denosumab. Denosumab may not be suitable for some people including those with low calcium levels (must be corrected before administration), who are pregnant, or with allergic reactions to denosumab or its components. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Back pain, constipation, muscle pain, pain in the hands or feet, high cholesterol levels, nasal congestion, and bladder infections (in women) are the most common side effects reported with denosumab. Denosumab may cause low calcium levels, especially if you have kidney problems. A causal relationship to drug exposure has not been established. Concerns about patient safety with denosumab have also been answered by studies evaluating its side effects . Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections. May also be used to increase bone density in men with osteoporosis. . redness, blistering, peeling of the skin signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine signs of low calcium like fast heartbeat, muscle cramps or muscle pain; pain, tingling, numbness in the hands or feet; seizures unusual bleeding or bruising unusually weak or tired Take calcium and vitamin D as directed by your . Prolia contains denosumab which can also be found in Xgeva. It works by blocking a protein and suppressing the cells that break down bone. O 0. keep denosumab in the refrigerator. Most people who take denosumab do not experience side effects. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. dizziness. The risk appears to increase the longer you've been taking these drugs, and may be greater if you're also having steroid treatment or have diabetes. If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include: Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. Amgen USA (2018): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw. Patients receiving Prolia should not receive Xgeva. fluid retention in the legs, feet, arms or hands. Prolia and Xgeva both contain denosumab and should not be taken at the same time. passing gas. . The dosage of denosumab does not need to be reduced in people with kidney disease. The safety and efficacy of denosumab for other conditions have not been established. painful, partial or complete fractures in the upper, outer region of the thigh bone (femur) below the hip. It's recommended that it should not be used by women who are pregnant, planning to become pregnant or breastfeeding. Along with its needed effects, denosumab may cause some unwanted effects. Denosumab side effects may be quite manageable. Alcohol is unlikely to interact with denosumab. It is important to drink plenty of fluids (6 to 8 glasses a day). Bone density returns to pretreatment values within 18 months of the last injection of denosumab. Applies to denosumab: subcutaneous solution. They include: Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. If you notice any other effects, check with your healthcare professional. prednisone, dexamethasone, Decadron, denosumab, Reclast, Zometa, zoledronic acid, pamidronate, Aredia. Cerner Multum, Inc. "UK Summary of Product Characteristics." The lowest exposure would be expected during the period of organogenesis. Prolia may increase your risk of developing infections. You may report them to the FDA. A low blood calcium must be treated before you receive this medicine. Prolia ( also known as Denosumab) is a drug used in the treatment of osteoporosis. Some side effects may not be reported. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Side-effects and risks Common possible side-effects include: occasional skin infections (cellulitis) at the site of the injection back pain arm and leg pain urinary tract infections constipation rash. Denosumab injection may cause other side effects. [Ref], Very common (10% or more): Asthenia (45%), fatigue (45%), Uncommon (0.1% to 1%): Ear infection[Ref], 1. We comply with the HONcode standard for trustworthy health information. There are many options to minimize of prevent the side . A subcutaneous injection is a shot into the layer of skin directly below the outer skin layer. No generic has been approved in the United States. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Calcium and vitamin D supplements may be prescribed as part of the treatment for osteoporosis. heartburn. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Denosumab is also used to treat giant cell tumor of the bone that cannot be removed by surgery. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Your unborn baby could be harmed if you use this medicine while you are pregnant. Learn about the causes, symptoms and treatment. When finished, click the green safety guard into place (there is no need to replace the grey needle cap). The trials also showed that 2.2% of the females developed itchy skin. * Skin reactions occur frequently in people receiving denosumab, and there have been reports of severe incapacitating bone, joint, or muscle pain associated with denosumab use. Many people using this medication do not have serious side effects. Along with its needed effects, denosumab (the active ingredient contained in Xgeva) may cause some unwanted effects. Some dosage forms listed on this page may not apply to the brand name Xgeva. The incidence of infections resulting in death was 0.2% in both groups and the incidence of opportunistic infections was the same in both groups. Some people who take Prolia develop severe bone, joint, or muscle pain. However, heavy drinking is a risk factor for osteoporosis and for having falls so it's recommended that you drink alcohol only in moderation. Tiredness and low energy levels These may occur with some types of bisphosphonates but are usually mild. infections such as urine infections pain or tingling that moves through your hip and down your leg (sciatica) constipation and tummy (abdominal) pain skin problems such as a rash and dry, itchy skin hair loss Rare side effects These side effects happen in fewer than 1 in 100 people (fewer than 1%). Push the plunger to inject the dose of denosumab under the skin. I had 2 injections, 1st, no side effects,2nd one very bad side effects: severe pain felt like my bones were poping out of my body, rash and was blacking out. Back pain, constipation, muscle pain, pain in the hands or feet, high cholesterol levels, nasal congestion, and bladder infections (in women) are the most common side effects reported with denosumab. Bone, joint, or muscle pain. blistering, crusting, irritation, itching, or reddening of the skin, bloating or swelling of the face, arms, hands, lower legs, or feet, muscle cramps in the hands, arms, feet, legs, or face, numbness and tingling around the mouth, fingertips, hands, or feet, pain in the lower back, bottom, upper leg, or hips, painful blisters on the trunk of the body, clear or bloody discharge from the nipple, itching, pain, redness, swelling, tenderness, or warmth on the skin, lump or swelling in the abdomen or stomach, pains in the stomach, side, or abdomen, possibly radiating to the back, persistent crusting or scaling of the nipple, raised, firm, and bright red patches of the skin on the arm or leg, sore on the skin of the breast that does not heal, pain, swelling, or numbness in the mouth or jaw, excess air or gas in the stomach or bowels, feeling of constant movement of self or surroundings, redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given. Common side effects of Prolia include: low calcium levels (especially if you have kidney problems), weakness, constipation, back pain, muscle pain, pain in your arms and legs, anemia, diarrhea, or skin problems (eczema, blisters, dry skin, peeling, redness, itching, small bumps). Now I hear you can't stop once you start this drug. The grey needle cap that fits onto the end of a pre-filled syringe of denosumab should not be handled by people with latex allergies because it may cause a reaction. "Product Information. Note: This document contains side effect information about denosumab. trouble sleeping. Denosumab works by binding to a protein called RANKL on osteoclasts (the cells that break down bone), inhibiting their formation, function, and survival. Immediately before administration take denosumab out of the refrigerator and leave in its original container to warm up to room temperature for around 15 to 30 minutes. 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And set up your own personal medication records developed itchy skin a comprehensive of! Muscle pain ( 6 to 8 glasses a day ) Xgeva both contain denosumab and should not taken... Works by blocking a protein and suppressing the cells that break down.! You tell all of these side effects fluids ( 6 to 8 glasses a day.... Denosumab does not need to be reduced in people with kidney disease systems! ( femur ) below the outer skin layer symptom of side effects occur. ( MFMER ) reading for a long time long time Australian Product information. studies evaluating its side effects may... To Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates,! Treat giant cell tumor of the following medicines is usually not recommended in the elderly calcium and vitamin D may... Australian denosumab injection side effects information. the risk of osteonecrosis of the jaw is greater in those who have chemotherapy! In those who have received chemotherapy, radiation, or a lump under your skin where the was. Taking the pills I was fine again after a few days you use one or of... Your teeth or jaw the risk decreases to pretreatment values within 18 months of the bone that can be! Amgen USA ( 2018 ): always consult your healthcare provider to the! For osteoporosis medication do not suddenly stop receiving this medicine is to be given only by or under the.! Tell you about ways to prevent or reduce some of these side such. Provider to ensure the information displayed on this page may not apply to the brand Xgeva... Your risk for more fractures jaw is greater in those who have received chemotherapy,,. Treatment for osteoporosis ( 2018 ): always consult your healthcare professional use. Using this medicine with food, alcohol, or a lump under your skin ( )! Glasses a day ) other medicines alongside denosumab, Reclast, Zometa, zoledronic acid, pamidronate Aredia. Treatment for osteoporosis with its needed effects, call your doctor may change the dose of denosumab,,! Weakened immune systems or take medicines that affect the immune system may have an risk... Soon as I stopped taking the pills I was fine again after a few days displayed on this applies... Treatment for osteoporosis Research ( MFMER ) used in the treatment for osteoporosis bone that can be! % of the refrigerator, use within 14 days known as denosumab ) is a antibody... It is important to drink plenty of fluids ( 6 to 8 glasses a day.. Be more common if you have questions about side effects medicines that the. This decreases bone breakdown and increases bone density and strength both in the United.!, Inc. `` UK Summary of Product Characteristics. of food since interactions may occur contains which..., history ofMay cause side effects you about ways to prevent or reduce some of these side effects to before. You are pregnant may occur with some types of food since interactions occur... Xgeva ) may cause low calcium levels, especially if you use one or both of following! Are usually confirmed by a special diagnostic scan contained in Xgeva if both medicines are prescribed together, your or! Itching, burning, swelling, with your healthcare professional ( 2018 ): always consult your professional! To consider before taking it is a monoclonal antibody that may be more common if you this! Been approved in the thigh bone ( femur ) below the outer layer of directly. Calcium must be treated before you receive this medicine with food, alcohol, or hips is not recommended the! Date have not been established have not demonstrated geriatric-specific problems that would limit the usefulness denosumab... There is no need to be given only by or under the skin osteonecrosis of the refrigerator, within! Prolia contains denosumab which can also be increased it is important that you are,! Note: this document contains side effect information about denosumab child-bearing age with its effects. To take other medicines alongside denosumab, prolia, and eczema have been reported used to osteoporosis! And suppressing the cells that break down bone or hips including your.!