Rozel 60mg Injection contains Denosumab, a monoclonal antibody used primarily in the treatment of bone-related conditions. 

Brand Name: Rozel

Composition: Denosumab

Mechanism of Action:

Denosumab is a RANK ligand (RANKL) inhibitor that binds to and inactivates RANKL, a protein essential for the formation, function, and survival of osteoclasts (cells that break down bone). By inhibiting RANKL, Denosumab reduces bone resorption and increases bone density, thereby lowering the risk of fractures.

Uses:

·         Osteoporosis

·         Bone Loss

·         Giant Cell Tumor of Bone

·         Hypercalcemia of Malignancy

Dosage and Administration:

60 mg subcutaneously once every 6 months for osteoporosis; other conditions may have different dosing schedules. Administered as a subcutaneous injection in the upper arm, upper thigh, or abdomen.

Side Effects:

·         Back pain

·         Musculoskeletal pain

·         High cholesterol

·         Urinary tract infections

·         Rash

·         Hypocalcemia (low blood calcium levels)

·         Osteonecrosis of the jaw

·         Femur fractures

·         Hair loss

·         Nerve Pain

Safety Advise:

Kidney  

Those with serious kidney problems should take Rozel 60 Injection carefully. It could be necessary to modify the dosage of Rozel 60 Injection. Kindly speak with your Healthcare provider.

Liver  

Those with serious liver problems should take Rozel 60 Injection carefully. It could be necessary to modify the dosage of Rozel 60 Injection. Kindly speak with your Healthcare provider.

Pregnancy  

Contraindicated in pregnancy due to the risk of fetal harm. Kindly speak with your Healthcare provider.

Breast Feeding  

Given that the medication may enter the breast milk and injure the unborn child, Rozel 60 Injection is most likely dangerous to use while nursing. Kindly speak with your Healthcare provider.

Alcohol  

When using Rozel 60 Injection with alcohol, caution is recommended. Kindly speak with your Healthcare provider.

Storage:

Store in a refrigerator at 2°C to 8°C. Do not freeze. Keep in the original packaging to protect from light and out of reach of children.

How to use this Medication?

This medication is injected subcutaneously. It is delivered at a hospital or clinic by a medical professional.

You will receive a personalized MedGuide prior to every treatment. Every time, make sure to carefully read this information.

Consult your pediatrician about Prolia and the usage of this medication in young patients. There might be a need for extra caution. Consult your physician about the usage of Xgeva in young patients. Precautions do apply even though this medication may be administered for specific diseases to youngsters as young as 13 years old.

References:

1. Hanley DA, Adachi JD, Bell A, Brown V. Denosumab: mechanism of action and clinical outcomes. International journal of clinical practice. 2012 Dec;66(12):1139-46.

2. Pageau SC. Denosumab. InMAbs 2009 May 1 (Vol. 1, No. 3, pp. 210-215). Taylor & Francis.

3. Cummings SR, Martin JS, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. New England Journal of Medicine. 2009 Aug 20;361(8):756-65.

4. Narayanan P. Denosumab: A comprehensive review. South Asian journal of cancer. 2013 Oct;2(04):272-7.

Disclaimer:

The main goal of Apothecare Wellness is to make sure that the information it provides to customers is correct, reliable, and reviewed by specialists. This website's contents and information are strictly for informational purposes. They are not meant to be used in place of expert medical advice, diagnosis, or care. Please consult your physician for guidance and ask any questions you may have about any condition or medication. If you read anything on Apothecare Wellness, do not discount or delay obtaining competent medical advice. Our goal is to enhance the doctor-patient relationship, not to take its place.

Marketer details

Name: Intas Pharmaceuticals Ltd

Address: Chinubhai Centre, Off. Nehru Bridge, Ashram Road, Ahmedabad - 380009. Gujarat. India.

Country of origin: India

Frequently Asked Questions (FAQs):

1. What is Rozel 60mg Injection? 

Rozel 60mg contains Denosumab, a biological targeted therapy. It may be prescribed for the management of severe osteoporosis. Strict adherence to an endocrinologist's guidance is essential.

2. How may Rozel 60mg work?

It is believed to bind to the RANKL protein, which may potentially inhibit the cells that break down bone, thereby potentially increasing bone density over time.

3. What conditions may it be considered for?

It may be considered for postmenopausal women and men with osteoporosis who have a high fracture risk, subject to a doctor's diagnosis.

4. How is Rozel 60mg administered?

It is administered as a subcutaneous injection by a healthcare professional. You must adhere to the administration schedule ordered by your doctor.

5. How often is the injection given?

The standard dosing schedule is typically once every 6 months. Adhering to this specific timeframe is critical for potential efficacy.

6. What are the possible side effects?

Patients may potentially experience back pain, muscle pain, or urinary tract infections. Always report persistent symptoms to your physician.

7. Is a calcium supplement necessary?

Doctors generally recommend calcium and vitamin D to potentially prevent low blood calcium (hypocalcaemia). Adhere exactly to their supplementation advice.

8. What is osteonecrosis of the jaw?

It is a rare but severe jaw condition that may potentially occur. Adhering to routine dental care and informing your dentist about this medication is highly recommended.

9. Can I skip a dose?

Skipping or delaying a dose may potentially cause a rapid loss of bone density. Strict adherence to your doctor's scheduling is required.

10. Can it cause skin issues?

Some patients may potentially develop skin infections like cellulitis. Prompt medical evaluation by your doctor is necessary if skin redness or swelling occurs.

11. Can it be used in pregnancy?

It is generally contraindicated in pregnancy due to potential risks to the fetus. Adhere to your doctor's guidance regarding contraception.

12. Is Rozel 60mg a prescription medicine?

Yes, it is a prescription-only medication requiring long-term medical adherence.

Medical Disclaimer:

Rozel 60mg Injection is a prescription-only medicine and must be used strictly under the supervision and guidance of a qualified healthcare professional. Do not self-medicate, alter the dosage, or discontinue use without consulting your doctor. The information provided here is for educational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Individual results, benefits, and risks may vary. Always consult your physician before starting, changing, or stopping any medication.