Osemab 120mg/1.7ml

Osemab 120mg/1.7ml Injection contains Denosumab, a monoclonal antibody that prevents bone complications in cancer patients. It treats bone metastases, giant cell tumour of bone, and cancer related high blood calcium.

Osemab 120mg/1.7ml Ingredients and Usage

Osemab 120mg/1.7ml contains Denosumab, a fully human IgG2 monoclonal antibody, as its active ingredient. Denosumab belongs to the RANKL inhibitor class of bone antiresorptive medicines used in oncology care. The product received DRAP approval in September 2025 as Pakistan's first denosumab biosimilar.

Doctors prescribe Osemab 120mg/1.7ml to prevent skeletal complications in patients with multiple myeloma and bone metastases from solid tumours. These complications include pathological fractures, spinal cord compression, and bone pain requiring radiation or surgery.

Osemab 120mg/1.7ml also treats giant cell tumour of bone in adults and skeletally mature adolescents when surgery is not possible. It is indicated for hypercalcaemia of malignancy that has failed to respond to bisphosphonate therapy.

How Does Osemab 120mg/1.7ml Work?

Osemab 120mg/1.7ml targets RANKL (Receptor Activator of Nuclear factor Kappa-B Ligand), a protein essential for bone breakdown. Denosumab binds to RANKL with high affinity and stops it from activating its receptor RANK on osteoclasts. Osteoclasts are the cells that degrade bone tissue and drive cancer related bone destruction.

By blocking the RANKL and RANK interaction, Osemab inhibits the formation, function, and survival of osteoclasts. This action sharply reduces bone resorption driven by tumour cells in the bone marrow microenvironment.

Clinical trials show denosumab delays the time to first skeletal related event compared with zoledronic acid in patients with bone metastases. In giant cell tumour of bone, the medicine controls tumour growth by removing the osteoclast like cells that drive the disease.

Osemab 120mg/1.7ml Side Effects

Osemab 120mg/1.7ml can cause side effects, especially in patients with advanced cancer. Some reactions are mild, while others require urgent medical attention.

• Fatigue and weakness

• Nausea, vomiting, and diarrhoea

• Loss of appetite

• Low blood calcium (hypocalcaemia), which can be severe

• Low blood phosphate (hypophosphataemia)

• Anaemia and reduced red blood cell count

• Back pain or pain in the arms and legs

• Headache and dizziness

• Shortness of breath (dyspnoea)

• Skin rash, eczema, or dermatitis

• Mild injection site reactions such as redness or swelling

• Serious: osteonecrosis of the jaw, atypical femoral fractures, and hypersensitivity reactions

Warnings

• Osemab 120mg/1.7ml must be given by a healthcare professional through subcutaneous injection in the upper arm, thigh, or abdomen.

• Never administer Osemab intravenously, intramuscularly, or intradermally, as it is approved only for subcutaneous use.

• Correct any pre existing low blood calcium before starting Osemab, as severe and fatal hypocalcaemia has been reported with the 120mg dose.

• Take calcium, magnesium, and vitamin D supplements daily during treatment as advised by your oncologist.

• Complete a dental examination and any major dental work before starting Osemab to reduce the risk of osteonecrosis of the jaw.

• The risk of osteonecrosis of the jaw is significantly higher with the 120mg oncology dose than with the 60mg osteoporosis dose.

• Report new thigh, hip, or groin pain immediately, as it may signal an atypical femoral fracture.

• Patients with giant cell tumour of bone may develop high blood calcium for up to one year after stopping Osemab.

• Discontinuing Osemab may trigger multiple vertebral fractures in patients with existing osteoporosis risk factors.

• Do not receive other denosumab products such as the 60mg formulation while on Osemab 120mg/1.7ml therapy.

• Osemab is contraindicated during pregnancy due to the risk of fetal harm shown in animal studies.

• Use caution in patients with advanced chronic kidney disease, as they face a higher risk of severe hypocalcaemia.

• Concomitant use with calcimimetics such as cinacalcet may worsen low blood calcium.

• Stop Osemab and seek emergency care for signs of anaphylaxis such as facial swelling, throat tightness, or breathing difficulty.

Osemab 120mg/1.7ml Storage Conditions

Store Osemab 120mg/1.7ml in a refrigerator between 2°C and 8°C in its original carton to protect the vial from light. Do not freeze the product and do not shake the vial before use, as this can damage the protein structure. Keep Osemab 120mg/1.7ml out of the reach and sight of children, and bring the vial to room temperature for up to 45 minutes before administration as directed by your healthcare provider.