Denosumab

DENOSUMAB (PROLIA®) — CLINICIAN SUMMARY

(Based ONLY on SAHPRA-approved PIL: 02 September 2024)

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🔴 RED FLAG (IMPORTANT) INFORMATION

(Most critical safety information from the leaflet)

• Hypocalcaemia can be severe and life-threatening, requiring hospitalisation → calcium levels must be checked before each dose and monitored after initiation in high-risk patients.

• Calcium and vitamin D supplementation is mandatory during treatment.

• Osteonecrosis of the jaw (ONJ) has been reported → dental problems, tooth extractions, or poor oral hygiene increase risk.

• Serious skin infections (cellulitis) may occur → patients must seek urgent care if symptoms develop.

• Unusual thigh bone fractures have been reported → new hip, groin, or thigh pain must be investigated.

• Severe allergic reactions (including facial swelling and breathing difficulty) may occur.

• Not for use in patients with low blood calcium.

• Do NOT use together with another medicine containing denosumab.

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1. BASIC INFORMATION

• Generic name: Denosumab

• Brand name: PROLIA®

• Drug class: Monoclonal antibody

• Formulation: Solution for injection (pre-filled syringe)

• Strength: 60 mg / 1 mL

• Route: Subcutaneous

• Scheduling status: S4

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2. INDICATIONS

PROLIA® is used to treat:

• Osteoporosis:

  • Postmenopausal women at increased fracture risk

  • Men at increased fracture risk

• Bone loss due to hormone reduction:

  • Men receiving treatment for prostate cancer

• Bone loss due to long-term glucocorticoid therapy:

  • Patients at increased fracture risk

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3. DOSING & ADMINISTRATION

• Dose:

  • 60 mg subcutaneously once every 6 months

• Injection sites:

  • Thigh

  • Abdomen

  • Outer upper arm (if administered by carer)

• Supplementation:

  • Calcium and vitamin D must be taken throughout treatment

• Missed dose:

  • Administer as soon as possible

  • Resume 6-monthly schedule from date of last injection

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4. DOSE MODIFICATIONS

• No dose adjustments described in the leaflet

• Do not administer if hypocalcaemia is present

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5. CO-MEDICATIONS

Required

• Calcium supplementation

• Vitamin D supplementation

Avoid

• Other medicines containing denosumab

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6. CONTRAINDICATIONS

• Hypocalcaemia

• Hypersensitivity to denosumab or any excipients

• Pregnancy

• Breastfeeding

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7. MONITORING REQUIREMENTS

Laboratory

• Serum calcium:

  • Before each dose

  • Within 2 weeks after first dose in patients predisposed to hypocalcaemia

• Additional monitoring in:

  • Severe renal impairment

  • Dialysis patients

  • Patients on glucocorticoids

Clinical

• Symptoms of hypocalcaemia:

  • Muscle spasms or cramps

  • Tingling of fingers, toes, or around mouth

  • Seizures, confusion, loss of consciousness

• Dental symptoms:

  • Jaw pain

  • Loose teeth

  • Non-healing mouth sores

• Signs of infection (especially cellulitis)

• New or unusual thigh, groin, or hip pain

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8. SIDE EFFECTS

Very common (>1 in 10)

• Bone, joint, or muscle pain (may be severe)

• Arm or leg pain

Common (≤1 in 10)

• Upper respiratory tract infections

• Urinary tract symptoms

• Constipation

• Abdominal discomfort

• Rash, eczema

• Sciatica

• Hair loss (alopecia)

Uncommon (≤1 in 100)

• Cellulitis

• Diverticulitis

• Ear infection

• Lichenoid skin or mouth eruptions

Rare / very rare

• Hypocalcaemia (severe, life-threatening)

• Osteonecrosis of the jaw

• Unusual femoral fractures

• Severe allergic reactions

• Bone damage of the ear

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9. DRUG INTERACTIONS

• Do NOT use with another denosumab-containing medicine

• Increased hypocalcaemia risk in:

  • Severe kidney disease

  • Dialysis

  • Glucocorticoid use

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10. USE IN SPECIAL POPULATIONS

• Pregnancy: Not recommended; effective contraception required during treatment and for 5 months after stopping

• Breastfeeding: Not recommended

• Renal impairment: Increased risk of hypocalcaemia

• Children/adolescents: Not recommended (<18 years)

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11. DURATION OF USE / WHEN TO STOP

• Continue treatment as prescribed by the doctor

• Do not stop treatment without medical advice

• Inform clinician immediately if serious side effects occur

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12. TOXICITY MANAGEMENT (SIMPLIFIED – FROM PIL)

Hypocalcaemia

• Recognise symptoms early

• Urgent medical review if symptomatic

Jaw problems

• Dental review before treatment if risk factors present

• Maintain good oral hygiene

• Report jaw pain or non-healing sores immediately

Infections

• Prompt medical attention for cellulitis or fever

 

 

https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2025/11/Prolia-PIL-Approved-02Sep2024.pdf