ROZEL 60MG INJECTION

Uses and Benefits of ROZEL 60MG INJECTION (Denosumab (60mg/ml))

Denosumab is mainly used to treat weak and brittle bones (osteoporosis), especially in postmenopausal women and men at high risk of fractures. It is also used in people with bone loss caused by certain cancer treatments or by cancer that has spread to the bones.

WHAT THIS MEDICINE IS USED FOR

• Treatment of osteoporosis in postmenopausal women and men at increased risk of fractures
• Treatment of bone loss caused by hormone-lowering treatment for prostate or breast cancer
• Prevention of bone problems (fractures, bone pain) in people with cancer that has spread to bones
• Treatment of giant cell tumour of bone in certain cases

HOW IT WORKS

• Blocks a protein (RANKL) that signals bone-removing cells to become active
• Slows down the breakdown of old bone tissue
• Helps bones become denser and stronger over time
• Reduces the risk of fractures, especially in the spine and hip

WHAT IT IS NOT USED FOR

• Not used for sudden bone injury or acute fractures
• Not a painkiller for general bone or joint pain
• Not used for children or growing bones
• Not a treatment for calcium deficiency alone

This medicine should only be used under the supervision of a qualified doctor, as it needs monitoring of calcium levels and bone health.

Side Effects of ROZEL 60MG INJECTION (Denosumab (60mg/ml))

COMMON SIDE EFFECTS

• Pain in muscles, bones, or joints
• Back pain
• Tiredness
• Mild pain, redness or swelling at the injection site

LESS COMMON SIDE EFFECTS

• Low calcium levels in blood
• Skin rash or itching
• Constipation
• High cholesterol levels noticed on blood tests

SERIOUS SIDE EFFECTS — STOP AND SEE A DOCTOR IMMEDIATELY

• Severe jaw pain, swelling, or numbness (possible sign of jaw bone problems)
• Unusual thigh pain or difficulty walking (possible unusual fracture)
• Severe muscle cramps, spasms, tingling around mouth or fingers (signs of very low calcium)
• Signs of serious infection such as high fever, chills, or skin infection
• Severe allergic reaction – swelling of face/lips/throat, difficulty breathing, severe rash

This is not a complete list. Report any unusual or persistent symptom to your doctor or pharmacist.

How to Use ROZEL 60MG INJECTION (Denosumab (60mg/ml))

HOW TO TAKE IT

• This medicine is given only as an injection under the skin (subcutaneous), usually in the upper arm, thigh, or abdomen
• It must be administered by a trained healthcare professional, not at home
• Dosing schedule (often every 6 months, or as advised for cancer-related use) will be decided by your doctor
• Your doctor may advise calcium and vitamin D supplements while you are on this treatment
• Regular blood tests to check calcium levels may be needed during treatment
• Do not stop treatment suddenly without discussing with your doctor, as this may increase fracture risk

IF YOU MISS A DOSE

• Contact your doctor or clinic as soon as possible to reschedule the injection
• Do not try to give yourself an extra dose to make up for a missed one
• Keep a record of your injection dates to avoid missing appointments

STORAGE

• This medicine is stored and handled by the healthcare facility, not typically kept at home
• If a vial is provided to carry, keep refrigerated (2–8°C), do not freeze
• Keep away from direct light and out of reach of children
• Do not shake the vial

Safety Information and Precautions for ROZEL 60MG INJECTION (Denosumab (60mg/ml))

This is a prescription-only medicine in India and must be given only under medical supervision.

DO NOT TAKE THIS MEDICINE IF YOU

• Have known low calcium levels (hypocalcaemia) that has not been corrected
• Are allergic to denosumab or any of its ingredients
• Are pregnant or planning pregnancy, unless specifically advised by your doctor

TELL YOUR DOCTOR BEFORE STARTING IF YOU

• Have kidney problems, especially severe kidney disease
• Have dental problems or need dental surgery or tooth extraction soon
• Are taking steroids or other medicines that affect bone health
• Have low vitamin D levels
• Are breastfeeding or planning to breastfeed
• Have a history of skin infections or slow-healing wounds

MEDICINES THAT CAN INTERACT

• Other medicines used for osteoporosis or bone conditions (such as bisphosphonates)
• Corticosteroids (long-term use can affect bone health monitoring)
• Calcium and vitamin D supplements (usually needed together, not a harmful interaction but should be coordinated)
• Immunosuppressant medicines (may increase infection risk)

FREQUENTLY ASKED QUESTIONS

Can I take this medicine at home?

No, it must be given by a healthcare professional in a clinic or hospital setting.

How long does treatment usually continue?

Duration depends on your condition and response; your doctor will decide based on regular bone health checks.

Will I need dental check-ups during treatment?

• Yes, a dental check-up before starting is recommended, and you should inform your dentist that you are on this medicine.
• Doctor ya pharmacist se salah lein.