Prolia 60mg (Denosumab)

Description of Rozel 60mg (Denosumab 60mg)

Prolia 60mg (Denosumab 60mg)  belongs to novel, fully human IgG2 monoclonal antibody especially to receptor activator of nuclear factor kappa-B ligand (RANKL), restrain bone resorption markers in patients with a difference of metastatic tumors and is being examined in multiple clinical trials for the inhibition and treatment of bone metastases.

Chemically, it exists of 2 heavy and 2 light chains. Each light chain contains of 215 amino acids.

Each heavy chain contains of 448 amino acids with 4 intramolecular disulfides.

Medical use /Indication of Rozel 60mg (Denosumab 60mg)

Treatment for patients having postmenopausal women with osteoporosis at high risk for fracture. Treatment for patients with increase bone mass in men at more risk for fracture getting androgen deprivation therapy for non-metastatic prostate cancer. Treatment for patients having to increase bone mass in women at more risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Mechanism of Action Rozel 60mg (Denosumab 60mg)

Denosumab linked to RANKL, a protein which is specific for the formation, function and survival of osteoclasts, the cells necessary for bone resorption. Denosumab prohibits osteoclast formation, function and survival hence, reducing bone resorption and raising bone mass and strength of the bone.

ADME of Prolia 60mg (Denosumab 60mg) 

Peak plasma concentration: 6.75mcg/mL

Tmax : 10days

Without aggregation in Prolia 60mg (Denosumab 60mg) pharmacokinetics with duration was noticed upon multiple dosing of 60 mg SC administered once every 6 months.

Pharmacokinetics of Prolia 60mg (Denosumab 60mg) will not affected by the binding antibodies formation.

Half-life is 25.4 days.

Side effects of Rozel 60mg (Denosumab 60mg)

Common side effects for the patient taking Prolia 60mg (Denosumab 60mg) 60mg as follows : 

Fatigue, Muscle weakness, Phosphorus level reduced in blood, Nausea

Less common side effects for patients taking Prolia 60mg (Denosumab 60mg):

Dyspnea, Hypocalcemia, Cough, Arthralgia, Limb pain, Eczema, Headache

Precautions of Rozel 60mg (Denosumab 60mg)

• Before to start treatment with Prolia 60mg (Denosumab 60mg), discuss with the doctor about any other regimens you are using (including over-the-counter medicines, vitamins, or herbal remedies). Do not take aspirin or products containing aspirin unless your doctor permits this.
• Prolia 60mg (Denosumab 60mg) injection may improve the negative effects of immuno-suppressants. Especially the risk for serious infections may be increased. Inform your doctor of any immuno-suppressive medicines you early consume.
• Not to receive any type of vaccination without your doctor's consultation while admonishing denosumab.
• Use in pregnancy only if benefit to mother outweighs risk to fetus. Consult with doctor before the treatment
• During Prolia 60mg (Denosumab 60mg) treatment do not breastfeed your infants.

Drug interaction of Rozel 60mg (Denosumab 60mg)

No formal drug-drug interaction with denosumab during trials.

When interacting with some anticancer medicine, orthopedic medicines, vaccines will lead to risk of adverse effects can be increased

Contraindication of Rozel 60mg (Denosumab 60mg)

Prolia 60mg (Denosumab 60mg) is contraindicated in patients having Hypocalcemia, Pregnancy, Hypersensitivity

Pregnancy of Rozel 60mg (Denosumab 60mg)

Pregnancy category C: There has no sufficient data in pregnant women to convey any medicine analog risk for adverse development outcomes. The medicine in pregnant women is contraindicated for use because it may cause serious risk to the fetus.

Lactation of Rozel 60mg (Denosumab 60mg)

Prolia 60mg (Denosumab 60mg) 60mg is excreted into human milk is not known. Since possible for severe side effects occurs in nursing infants from Prolia 60mg (Denosumab 60mg) 60mg injection, a decision should be considered that to discontinue nursing or discontinue the medicine by giving preference of the importance of the medicine to the mother.

Dosage of Rozel 60mg (Denosumab 60mg)

For adult :

Osteoporosis :

60mg SC (subcutaneously) once every 6 months

Injection of medicine should be done in upper arm, upper thigh or abdomen

Giant Cell Tumor of bone :

120mg SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

Injection of medicine should be done in upper arm, upper thigh or abdomen

Osteolytic Bone Metastases of Solid Tumors :

120mg subcutaneously every 4 weeks

Injection of medicine should be done in upper arm, upper thigh or abdomen

Hypercalcemia :

Dose of 120mg Prolia 60mg (Denosumab 60mg) tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

Injection of medicine should be done in upper arm, upper thigh or abdomen

Dosage and administration in pediatric :

13 years and older and 45kg or more

Giant Cell Tumor of bone:

Dose of 120mg Prolia 60mg (Denosumab 60mg) tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

Over dosage of Rozel 60mg (Denosumab 60mg)

Prolia 60mg (Denosumab 60mg) overdose has no overdose. If occurs seek to emergency department and call poison control

Storage of Rozel 60mg (Denosumab 60mg)

Store at 2℃ to 8℃ in the original container, avoid freeze

Before to administration keep at room temperature

Prolia 60mg (Denosumab 60mg) protect from direct light and heat.

Missed dose of Rozel 60mg (Denosumab 60mg)

Take the dose immediately before next dose duration, then left off the missed dose and continue regular schedule. Avoid taking double dose at same time.

Please consult the doctor for further information.