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Rozel 60mg (denosumab)

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                                              ROZEL 60mg

Description

Rozel 60mg injection is a trade name of denosumab.

Rozel 60mg belongs to a new class of osteoporosis treatment called a human monoclonal antibody which inhibits RANKL-RANK interaction and thereby prevents osteoclast formation. Rozel is the first therapy approved by Health Canada in this class.

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

Indications of Rozel 60mg

Rozel 60mg injection is indicated for

Treatment of postmenopausal women with osteoporosis at high risk (end of menopause/ change of life), whose have serious problem of fractures raised or who failed to other medication of osteoporosis.

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.

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.

Dosage and administration

For adult

Hypercalcemia

The recommended dose is of 120mg  tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

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

Osteoporosis

The recommended dose is 60mg SC (subcutaneously) once every 6 months

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

Giant Cell Tumor of bone

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

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

Osteolytic Bone Metastases of Solid Tumors

The usual dose for the patient with Osteolytic Bone Metastases of Solid Tumors

is 120mg subcutaneously every 4 weeks

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

For pediatric

The recommended dose is 13 years and older and 45kg or more for Giant Cell Tumor of bone: The recommended dose is of 120mg Rozel tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

OVERDOSE

No experienced with Rozel overdose. If occurs seek to emergency department and call poison control

Mechanism Of Action

Denosumab mechanism is based on Monoclonal antibody which especially targets RANKL; joints to RANKL and prohibits its binding to RANK receptor, hence inhibiting osteoclast formation; this results in reduced bone resorption and have high bone mass in osteoporosis; in solid tumors with bony metastases, RANKL prohibition decreases tumor-induced bone destruction and SREs.

Absorption: Peak plasma concentration: 6.75mcg/mL

Tmax: 10days

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

Pharmacokinetics of Rozel will not affected by the binding antibodies formation.

Half-life is 25.4 days.

Side Effects

Common side effects for the patient taking Rozel 60mg as follows

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

Less common side effects for patients taking Rozel

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

Rozel Drugs Interaction

No formal drug-drug interaction with denosumab during trials.

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

Contraindication

Rozel is contraindicated in

Hypocalcemia

Pregnancy

Hypersensitivity

Precaution

Should be corrected before starting denosumab. Hypocalcemia may worsen, specifically in patients with renal impairment. Sufficiently supplement patients with calcium and vitamin D.

While treatment with Rozel have Osteonecrosis of the jaw (ONJ) has been reported with denosumab – check for symptoms.

Rozel injection may improve the negative effects of immuno-suppressants.  Especially the risk for severe infections may be raised.  Inform your doctor of any immuno-suppressive drugs you early consume.  

Not to receive any type of vaccination without your doctor's consultation while administrating denosumab.

 Any plan to become pregnant prior to starting this treatment, consult with doctor before the treatment because use in pregnancy only if benefit to mother outweighs risk to fetus).

Pregnancy

The Rozel belongs to category C 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 And Handling

Store at 20C to 80C in the original container.

Avoid freeze.

Before to administration keep at room temperature.

Rozel protect from direct light and heat.

Missed Dose

Take the dose immediately before next dose duration. Next dose time reaches then left off the missed dose and follow regular schedule.

Avoid taking double dose at same time.

Please consult the doctor for further information.

  • Trade name Rozel 60mg
  • Substance denosumab
  • Manufacturer Intas Pharmaceuticals
  • Packaging I injection in a prefilled syringe
  • Country of origin India
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