Jubbonti Side Effects
Generic name: denosumab
Note: This document provides detailed information about Jubbonti.
Applies to denosumab: subcutaneous solution Side Effects associated with denosumab. Some dosage forms listed on this page may not apply specifically to the brand name Jubbonti.
Applies to denosumab: subcutaneous solution.
Precautions
It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Prolia® contains denosumab (the active ingredient contained in Jubbonti) which can also be found in Xgeva®. Patients receiving Prolia® should not receive Xgeva®.
Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 5 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. 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.
This medicine may cause hypocalcemia (low calcium in the blood). A low blood calcium must be treated before you receive this medicine. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.
Prolia® may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are receiving this medicine. Check with your doctor right away if you have a fever or chills, red, swollen skin, severe abdominal or stomach pain, or burning or painful urination.
Skin problems may occur after receiving Prolia®. Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, rash, or swollen skin.
It is important that you tell all of your doctors that you are receiving denosumab injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.
The needle cover of the prefilled Prolia® syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this medicine.
This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thigh, groin, or hips.
Check with your doctor right away if you have severe muscle, bone, or joint pain after receiving Prolia®.
Do not suddenly stop receiving this medicine without checking first with your doctor. Doing so may increase your risk for more fractures. Talk to your doctor about other medicines that you can take.
Hypercalcemia may occur after stopping Xgeva® treatment in patients with growing bones. Tell your doctor right away if you have confusion, constipation, depression, dry mouth, headache, incoherent speech, increased urination, loss of appetite, metallic taste, muscle weakness, nausea, stomach pain, thirst, unusual tiredness, or vomiting.
Serious side effects of Jubbonti
Along with its needed effects, denosumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking denosumab:
More common side effects
- back pain
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- cracked, dry, or scaly skin
- difficult, burning, or painful urination
- frequent urge to urinate
- muscle or bone pain
- pain in the arms or legs
- rash
- skin rash, encrusted, scaly, and oozing
- swelling
Less common side effects
- arm or jaw pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- chest pain, discomfort, heaviness, or tightness
- chills
- confusion
- congestion
- cough
- difficulty with breathing
- difficulty with moving
- dryness or soreness of the throat
- ear congestion
- fast or irregular heartbeat
- fever
- headache
- hoarseness
- joint pain
- loss of voice
- muscle cramps in the hands, arms, feet, legs, or face
- muscle stiffness
- 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
- pale skin
- rapid weight gain
- runny or stuffy nose
- seizures
- sneezing
- stomach cramps
- swollen joints
- tender, swollen glands in the neck
- tremor
- trouble swallowing
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- voice changes
Rare side effects
- blood in the stool
- change in bowel habits
- clear or bloody discharge from the nipple
- constipation
- darkened urine
- difficulty with eating
- dimpling of the breast skin
- indigestion
- inverted nipple
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- loss of appetite
- lower back or side pain
- lump in the breast or under the arm
- lump or swelling in the abdomen or stomach
- nausea
- 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
- redness or swelling of the breast
- sore on the skin of the breast that does not heal
- stomach discomfort
- unexplained weight loss
- vomiting
- yellow eyes or skin
Incidence not known
- black, tarry stools
- heavy feeling in the jaw
- loose teeth
- mood or mental changes
- pain, swelling, or numbness in the mouth or jaw
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
Other side effects of Jubbonti
Some side effects of denosumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
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:
Less common side effects
- dizziness or lightheadedness
- excess air or gas in the stomach or bowels
- feeling of constant movement of self or surroundings
- feeling of fullness
- heartburn
- lack or loss of strength
- passing gas
- redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given
- sensation of spinning
- trouble sleeping
- upper abdominal or stomach pain
Incidence not known
- loss or thinning of the hair
For healthcare professionals
Applies to denosumab: subcutaneous solution.
General adverse events
The most commonly reported side effects were asthenia, fatigue, back pain, hypophosphatemia, hypocalcemia, and nausea.[Ref]
Hypersensitivity
- Postmarketing reports: Anaphylaxis, rash, urticaria, facial swelling, erythema[Ref]
Respiratory
- Very common (10% or more): Dyspnea (21%), cough (15%)
- Common (1% to 10%): Upper respiratory tract infection, pneumonia, pharyngitis, nasopharyngitis[Ref]
Cardiovascular
- Common (1% to 10%): Angina pectoris, atrial fibrillation[Ref]
Musculoskeletal
- Very common (10% or more): Back pain (35%), arthralgia (14%), pain in extremity (12%)
- Common (1% to 10%): Musculoskeletal pain, bone pain, myalgia, spinal osteoarthritis
- Rare (less than 0.1%): Atypical femoral fractures
- Frequency not reported: Osteonecrosis of the jaw, atypical subtrochanteric and diaphysealfemoral fractures
- Postmarketing reports: Musculoskeletal pain including severe cases, multiple vertebral fractures following discontinuation of this drug[Ref]
Metabolic
- Very common (10% or more): Hypophosphatemia (32%), hypocalcemia (including fatal cases) (18%)
- Common (1% to 10%): Hypercholesterolemia
- Postmarketing reports: Severe symptomatic hypocalcemia, severe symptomatic hypercalcemia following treatment discontinuation[Ref]
Dermatologic
- Very common (10% or more): Dermatitis (11%), eczema (11%), rash (11%)
- Common (1% to 10%): Pruritus, hyperhidrosis
- Uncommon (0.1% to 1%): Cellulitis
- Postmarketing reports: Cutaneous and mucosal lichenoid drug eruptions (e.g., lichen planus-like reactions), alopecia[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (31%), diarrhea (20%)
- Common (1% to 10%): Upper abdominal pain, flatulence, gastroesophageal reflux disease, constipation, abdominal discomfort, tooth extraction
- Uncommon (0.1% to 1%): Pancreatitis, diverticulitis[Ref]
Nervous system
- Very common (10% or more): Headache (13%)
- Common (1% to 10%): Vertigo, sciatica[Ref]
Genitourinary
- Common (1% to 10%): Urinary tract infections, cystitis[Ref]
Hematologic
- Common (1% to 10%): Anemia[Ref]
Endocrine
- Postmarketing reports: Marked elevation in serum PTH in patients with severe renal impairment (CrCl less than 30 mL/min) or receiving dialysis[Ref]
Immunologic
- Common (1% to 10%): Herpes zoster, serious infections (nonfatal cases)
- Uncommon (0.1% to 1%): Serious Infections (fatal cases)[Ref]
Receptor activator of nuclear factor kappa-B ligand (RANKL) is expressed on activated T and B lymphocytes and in lymph nodes; therefore, a RANKL inhibitor such as this drug may increase the risk of infection. A study of postmenopausal women with osteoporosis (n=7808), has shown a higher incidence of nonfatal serious infections in those receiving this drug compared with placebo (4% vs 3.3%). 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. Endocarditis was reported in 3 patients receiving this drug and no placebo patients. 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.[Ref]
Ocular
- Common (1% to 10%): Cataracts[Ref]
Oncologic
- Common (1% to 10%): New malignancies
- 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%). A causal relationship to drug exposure has not been established.[Ref]
Other
- Very common (10% or more): Asthenia (45%), fatigue (45%)
- Common (1% to 10%): Peripheral edema
- Uncommon (0.1% to 1%): Ear infection[Ref]
Psychiatric
- Common (1% to 10%): Insomnia[Ref]
See also:
Prolia
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Fosamax
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Evenity
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Premarin
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Reclast
Reclast (zoledronic acid) is used to treat osteoporosis in women after menopause and also to treat ...
Zometa
Zometa is used to treat high blood levels of calcium caused by cancer and multiple myeloma. Learn ...
Tymlos
Tymlos (abaloparatide) is used to treat osteoporosis in men and postmenopausal women who have a ...
Raloxifene
Raloxifene systemic is used for breast cancer, prevention, osteoporosis, prevention of osteoporosis
Calcium/vitamin d
Calcium/vitamin d systemic is used for dietary supplementation, osteoporosis
Calcium carbonate
Calcium carbonate systemic is used for duodenal ulcer, erosive esophagitis, GERD, hypocalcemia ...
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2010) "Product Information. Prolia (denosumab)." Amgen USA
4. (2018) "Product Information. Xgeva (denosumab)." Amgen USA
Frequently asked questions
- What biosimilars have been approved in the United States?
- How many years should you take Prolia?
- How long should you take Xgeva for?
- Is Xgeva a chemotherapy drug?
- Does Xgeva cause bone pain?
- Does Xgeva cause low blood pressure?
More about Jubbonti (denosumab)
- Check interactions
- Compare alternatives
- Latest FDA alerts (1)
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous bone resorption inhibitors
- Breastfeeding
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Further information
Jubbonti side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.