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Prolia® product specifics

Product specifics

Prolia® injections for osteoporosis are given once every six months as a 60 mg subcutaneous injection into the thigh, abdomen or upper arm. The product is a sterile, preservative-free solution containing the active ingredient denosumab. Prolia® (denosumab) should be stored in the outer carton in a refrigerator. Injection should be performed by someone trained in subcutaneous injection techniques. Prolia® (denosumab) is presented in a prefilled syringe at a strength of 60mg/ml. 

Excipients of Prolia® injections

The solution is preservative-free, clear, and colorless to slightly yellow. Prefilled syringes contain denosumab, sorbitol, acetate, sodium hydroxide and water for injection. The prefilled syringe also contains polysorbate 20. 

List of excipients

  • Acetic acid, glacial*
  • Sodium hydroxide (for pH adjustment)
  • Sorbitol (E420)
  • Water for injections
  • Polysorbate 20 (prefilled syringe only)
* Acetate buffer is formed by mixing acetic acid with sodium hydroxide 

Indications

Prolia® (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. It is also indicated for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

Prolia® should not be used by:

  • Patients suffering from Hypocalcemia. 
  • Patients with hypersensitivity to denosumab or to any of the ingredients, incl. dry natural rubber (found on the needle cover of the pre-filled syringe). 
  • Patients with rare hereditary problems of fructose intolerance should not use Prolia®.  
  • Prolia is not recommended in pediatric patients (age < 18) as the safety and efficacy of Prolia® in these patients have not been established. 
  • Patients being treated with Prolia® should not be treated concomitantly with other denosumab-containing medicinal products

Calcium and vitamin D supplementation

Adequate intake of calcium and vitamin D is important in all patients on Prolia® (denosumab) therapy. 

PATIENT EDUCATION

People on Prolia® (denosumab) treatment should be informed of possible side effects and know what symptoms to report to the doctor.

Uncommonly, patients receiving Prolia® may develop skin infections (predominantly cellulitis). Symptoms include: swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.

Rarely, patients receiving Prolia® may develop pain in the mouth and/or jaw, swelling or non-healing of sores in the mouth or jaw, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis).

Rarely, patients receiving Prolia® may have low calcium levels in the blood (hypocalcaemia). Symptoms include spasms, twitches, or cramps in muscles, and/or numbness or tingling in fingers, toes or around the mouth and/or seizures, confusion, or loss of consciousness. Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation which is seen by electrocardiogram (ECG). 

Patients should also be told about any other side effects that they may experience while on Prolia® (denosumab) therapy. For a full list of side effects, see the SmPC.