Rozel 60mg (Denosumab)

DESCRIPTION

Rozel 60mg  is a human monoclonal antibody for the treatment of osteoporosis, treatment-persuaded bone loss, metastases to bone, and giant cell tumor of bone. Rozel 60mg  is contraindicated in people with low blood calcium levels.

Rozel 60mg  is prescription drug which is used under the guidance of medical oncologist.

INDICATION

• Indicated for treatment of osteoporosis at high risk postmenopausal women with (end of menopause/ change of life), whose have serious problem of fractures raised or who failed to other medication of osteoporosis.
• Indicated for treatment of Breast cancer in women whose taking certain treatment which make severe their risk of fractures and bone loss in men with prostate cancer.
• Indicated for treatment in adults and some adolescents with giant cell tumor of bone which cannot treat with surgery / surgery is not possible is treated with Rozel 60mg injection.

MECHANISM OF ACTION

Denosumab mechanism by aiming a protein called RANKL, which is required for new osteoclasts to be made and to function. This promote to inhibit further breakdown of bone and reduces the risk of problems caused by secondary bone cancer, such as fractures. It can also promote to decreased pain caused by secondary bone cancer.

PHARMACOKINETICS

• Peak plasma concentration: 6.75mcg/mL
  • Tmax: 10days
  • Without aggregation in Rozel 60mg  pharmacokinetics with duration was noticed upon multiple dosing of 60 mg SC administered once every 6 months.
  • Pharmacokinetics of Rozel 60mg   will not affected by the binding antibodies formation.
  • Half-life is 25.4 days.

DOSAGE MANAGEMENT

For adult :
The prescribed dose for Osteoporosis is 60mg SC (subcutaneously) once every 6 months
Administer injection in upper arm, upper thigh or abdomen
The prescribed dose for Androgen Deprivation induced bone loss is 60mg SC q6months.
The prescribed dose is Glucocorticoid induced osteoporosis 60mg SC q6months.
The prescribed dose is Aromatase inhibitor induced bone loss 60mg SC q6months
For pediatric :
The prescribed dose is 13 years and older and 45kg or more for Giant Cell Tumor of bone: The recommended dose is of Rozel 60mg   tablet given SC, with additional 120mg doses on days 8 and 15 of the 1st month treatment every 4 weeks.
OVERDOSE:
No experienced with Rozel 60mg   overdose. If occurs take the patient to emergency department and call poison control

PRECAUTION

• Before starting denosumab should be corrected. Hypocalcemia may worsen, specifically in patients with renal impairment. Sufficiently supplement patients with calcium and vitamin D.
• Rozel 60mg   injection has negative effects of immuno-suppressants may improve. Especially the harm for severe infections may be raised. Discuss with your doctor of any immuno-suppressive drugs you early consume.
• Do not take any type of vaccination without your doctor's consultation while administrating denosumab.
• While treatment with Rozel 60mg  have Osteonecrosis of the jaw (ONJ) has been reported with denosumab – check for symptoms.
• Planning to become pregnant before to starting this therapy, consult with doctor before the treatment because use in pregnancy only if benefit to mother outweighs risk to fetus).

SIDE EFFECTS

Common side effects for the patient taking Rozel 60mg  :
• Nausea
• Fatigue
• Muscle weakness
• Hypophosphatemia.
Less common side effects for patients taking Rozel 60mg  :
• Diarrhae
• Shortness of breath
• Hypocalcemia
• Joint pain
• Hypocalcemia
• Cough
• Arthralgia
• Limb pain
• Eczema
• Headache
• Eczema
• Rash

DRUG INTERACTION

No formal drug-drug interaction with denosumab during trials.

When concomitant use with some anticancer drug, orthopedic drugs, vaccines will lead to risk of adverse effects can be increased

CONTRAINDICATION

Rozel 60mg   is contraindicated in

Hypocalcemia

Pregnancy

Hypersensitivity

PREGNANCY

Pregnancy category C
The Rozel 60mg   which has no enough data in pregnant women to convey any drug analog risk for adverse development outcomes the drug in pregnant women is contraindicated for use because it may cause serious risk to the fetus.

LACTATION

Rozel 60mg  is excreted into human milk is not known. Since possible for severe side effects occurs in nursing infants from Rozel 60mg  injection. Avoid breastfeeding during treatment of Denosumab.  

STORAGE

Store at 2°C to 8°C in the original container.
Avoid freeze.
Before to administration keep at room temperature.
Rozel 60mg   protect from direct light and heat.

MISSED DOSE

If dose is missed then have the dose immediately before next dose duration. Next dose time reaches then left off the missed dose and follows regular schedule.
Avoid taking double dose at same time.
Please consult the doctor for further information.