Jubbonti Side Effects

Generic name: denosumab

Note: This document provides detailed information about Jubbonti 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.

Serious side effects of Jubbonti

Along with its needed effects, denosumab (the active ingredient contained in Jubbonti) 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:

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:

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:

Frequently asked questions

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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.

Medical Disclaimer