Olimab 60mg Injection may be prescribed for:

• Osteoporosis in postmenopausal women: Helps increase bone strength and reduce the risk of fractures in women with osteoporosis.

• Osteoporosis in men: May be used in men with osteoporosis who are at increased risk of fractures.

• Bone loss caused by long-term systemic corticosteroid treatment: Can help increase bone mass in adults receiving prolonged glucocorticoid treatment who have an increased risk of fracture.

• Treatment-related bone loss: Denosumab 60mg may be used in selected patients receiving androgen deprivation therapy for non-metastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer when treatment-related bone loss places them at increased fracture risk.

Olimab 60mg should not be confused with 120mg denosumab products used for cancer-related skeletal complications.

Olimab contains Denosumab, which binds to a protein called RANKL (receptor activator of nuclear factor kappa-B ligand).

RANKL normally activates osteoclasts, the cells responsible for breaking down old bone. By blocking RANKL, denosumab reduces osteoclast formation and activity. This slows bone resorption, allowing bone mineral density to increase and helping reduce the risk of fractures.

The effect of denosumab is reversible after treatment is stopped. Bone turnover can rise rapidly when denosumab is discontinued, which is why another appropriate osteoporosis treatment may be needed when treatment is stopped.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• Other medicines containing denosumab: Do not use Olimab together with another denosumab-containing medicine unless specifically directed by your specialist. This can result in excessive denosumab exposure.

• Other medicines affecting calcium levels: Tell your doctor if you take medicines that can lower blood calcium or otherwise affect calcium balance.

• Other osteoporosis medicines: Your doctor should know if you take bisphosphonates or other medicines for bone health so that your treatment plan can be coordinated safely.

• Corticosteroids: Long-term corticosteroid treatment can increase fracture risk and may be one of the reasons denosumab is prescribed. Your doctor may also consider that corticosteroids can increase the risk of low calcium and other complications.

• Immunosuppressive medicines: Tell your doctor if you take medicines that suppress the immune system because denosumab treatment may increase susceptibility to certain infections.

Do not start calcium, vitamin D or another bone medicine without discussing the appropriate dose with your doctor.

• Store Olimab 60mg Injection in a refrigerator at 2°C to 8°C.

• Keep the medicine in its original carton to protect it from light.

• Do not freeze the injection.

• Do not shake the pre-filled syringe.

• If removed from the refrigerator, follow the product-specific instructions regarding room-temperature storage and do not expose it to excessive heat.

• Keep it out of the reach of children.

Olimab 60mg Injection is given as a subcutaneous injection, usually by a healthcare professional or according to specific instructions if self-administration has been authorised and taught.

For osteoporosis and other bone-loss indications using the 60mg formulation, denosumab is generally administered as 60mg once every 6 months. It is not a daily or monthly injection.

Calcium and vitamin D supplementation should be taken as prescribed. Your doctor may check calcium levels before treatment and during treatment when appropriate, particularly if you have kidney disease or other risk factors for hypocalcaemia.

Do not delay or stop scheduled doses without speaking with your doctor. If denosumab treatment needs to be discontinued, your doctor should plan appropriate follow-up treatment to reduce the risk of rapid bone loss and vertebral fractures.

Common side effects of Olimab 60mg Injection may include:

• Bone, muscle or joint pain

• Back pain

• Pain in the arms or legs

• Tiredness

• Headache

• Skin reactions such as rash

• Mild injection-site reactions

• Urinary or respiratory infections in some patients

Serious side effects

Seek prompt medical attention if you develop:

• Low calcium levels: Symptoms can include muscle cramps or spasms, tingling or numbness around the mouth or in the fingers and toes, unusual weakness or seizures.

• Serious infections: Contact your doctor if you develop persistent fever, severe weakness or other signs of infection.

• Osteonecrosis of the jaw: Persistent jaw pain, swelling, loose teeth or slow healing after dental treatment should be assessed promptly.

• Atypical femoral fracture: New or unusual pain in the thigh, hip or groin can rarely occur and should be evaluated.

• Severe allergic reaction: Swelling of the face, lips, tongue or throat or difficulty breathing requires immediate medical attention.

• Multiple vertebral fractures after stopping treatment: Do not discontinue denosumab without discussing a follow-up treatment plan with your doctor.

• Take Olimab exactly according to the six-monthly schedule prescribed by your doctor.

• Do not confuse Olimab 60mg with 120mg denosumab injections used in oncology.

• Take calcium and vitamin D exactly as prescribed.

• Have your calcium level checked when your doctor recommends it.

• Tell your doctor if you have kidney disease or a previous history of low calcium.

• Inform your dentist that you are receiving denosumab before invasive dental procedures.

• Maintain good oral hygiene and attend regular dental check-ups.

• Tell your doctor promptly about persistent jaw pain, loose teeth or delayed healing after dental treatment.

• Report new thigh, hip or groin pain because it may need assessment for an atypical femoral fracture.

• Do not stop Olimab or delay the next dose without speaking with your doctor.

• If treatment needs to be stopped, ask your doctor about a follow-up osteoporosis treatment to protect against rapid bone loss.

• Continue weight-bearing exercise and other bone-health measures recommended by your healthcare professional.