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Prolia 60mg (denosumab)

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                                              PROLIA 60mg

Description

Prolia 60mg injection is a trade name of denosumab.

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

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

Indications of Prolia 60mg

Prolia 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 Prolia 60mg injection.

Dosage and administration

For adult

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

Androgen Deprivation induced bone loss

The recommended dose is 60mg SC q6months.

Glucocorticoid induced osteoporosis

The recommended dose is 60mg SC q6months

Aromatase inhibitor induced bone loss

The recommended dose is 60mg SC q6months

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

OVERDOSE

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

Mechanism Of Action

Denosumab mechanism is based on Monoclonal antibody whichespecially targets RANKL; joints to RANKL and prohibits its binding to RANK receptor, henceinhibiting 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 Prolia pharmacokinetics with duration was noticed upon multiple dosing of 60 mg SC administered once every 6 months.

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

Half-life is 25.4 days.

Side Effects

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

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

Less common side effects for patients taking Prolia

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

Prolia 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

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

Prolia 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 Prolia 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

Prolia 60mg is excreted into human milk is not known.  Since possible for severe side effects occurs in nursing infants from Prolia 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.

Prolia 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 Prolia 60mg
  • Substance denosumab
  • Manufacturer Dr. Reddy's Laboratories
  • Packaging I injection in a prefilled syringe
  • Country of origin India
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