Prolaginative engineering for the protection of joint health

The preparation of Prolia is a monoclonal antibody, is available as a clear solution for subcutaneous administration.

The color of the solution can be from colorless to light yellow, with no visible inclusions. The active component of the drug is the substance denosumab.

Pharmacological action

Denosumab is a gene analogue derived from a human monoclonal antibody.

It has a selective affinity for the Kappa B receptor activator receptor ligand, which in turn stimulates the nuclear factor KB localized on the surface of bone macrophages - osteoclasts and their precursors.

As a result, the synthesis of osteoclasts is impaired and their life span is shortened.

All this leads to a decrease in the destruction of bone tissue and the improvement of the mechanical properties of the cortical and spongy layer of bones.

Mechanism of action

Once in the body, denosumab rapidly decreases serum level of the bone resorption marker of type I C-telopeptide. During the first 6 hours, its concentration is reduced by 70%, in the subsequent 3 days - by 85%, and remains stable for six months until the next injection.

When the active substance content in the blood decreases, the decrease rate of the serum C-telopeptide decreases. This indicates a reversible effect on bone remodeling.

It has been proven that densomab increases the bone mineral density, reduces the likelihood of vertebral and peripheral fractures, including hip fractures, prevents bone loss in cancer patients receiving aromatase blockers and hormone-deprivation therapy, and does not cause pathological changesin the bone tissue. At what pathologies are the drugs prescribed?

Prolias are included in the treatment regimen:

• patients suffering from postmenopausal osteoporosis;
• oncological patients taking aromatase inhibitors and receiving hormone-deprivation treatment, in such cases, the drug prevents bone loss.

Restrictions on the prescription of the medicine

Injection should not be made to patients who have:

• allergic to the active substance and auxiliary components;
• hypocalcemia.

Prescribing the drug to specific patient categories

The following features should be considered:

1. It is known that the active substance can inhibit the growth of bone tissue in children with open growth zones, and violates teething. Therefore, do not inject the monoclonal antibody to persons under the age of 18 .
2. The drug is contraindicated for the treatment of women waiting for the baby , as there is no evidence of safety of the use of denosumab in such patients. In animal experiments, anomalies were found in the development of the lymphatic system in the fetus.
3. The use of by nursing women .It is not known whether the active substance is secreted through the mammary glands, but since there is a theoretical risk of adverse effects on the baby, it is advisable to stop the natural feeding during the treatment.
4. According to the statistical data on the safety of the use of medication for therapy in elderly patients , it needs to adjust the therapy regimen.
5. In patients with with hepatic insufficiency , the safety and efficacy of the drug have not been studied.
6. No dosage adjustment is necessary for patients with renal failure .But in patients who are on hemodialysis or in individuals with QC less than 30ml / ml there is a high probability of developing a deficiency of calcium and vitamin D, so they need to be taken extra.

Possible adverse reactions

On the background of treatment with Prolia, the following undesirable effects on the part of the following systems of the body can be observed:

• of mineral metabolism : hypocalcemia;
• skin : eczema, rashes;
• Gastrointestinal : difficulty with bowel movement;
• PNS : sciatica;
• view : blurred lens of the eye, but it was observed only in men on the background of hormone-deprivation therapy;
• of the musculoskeletal system : pain in the legs, atypical hip fractures( susceptible or diaphyseal), osteonecrosis of the jaw;
• allergic reactions : erythema, facial pasteurism, urticaria;
• infectious diseases of the urinary system, subcutaneous tissue( most often), large intestine, respiratory organs, ears.

How to apply the drug?

Before the introduction of the medicine, it is necessary to make a visual inspection. The solution should not be cloudy, it is unacceptable to change its color. You should stop the injection if any part of the syringe is damaged, there is no gray cap or it is loosely closed.

The syringe should be maintained for half an hour at room temperature, and then its contents slowly enter under the skin. The remains of the medicinal product together with the syringe must be destroyed.

One injection( 60 mg) is done every six months. You can inject the drug into the upper part of the thigh, into the stomach, excluding the umbilical region( 5 cm), the outer surface of the shoulder.

It is not allowed to massage the injection site. In parallel, you need to take medicines containing calcium and vitamin D.

There is not one case of drug overdose.

Detailed instructions for use with the preparation of Prolia in photo:

Special instructions

The following features of therapy with the drug should be considered:

1. At first it is necessary to control the level of calcium in the body.
2. The patient should be informed of the symptoms of skin and subcutaneous tissue disorders .And in case of their occurrence it is necessary to consult a doctor without delay.
3. During the appointment of the densomab , the invasive dental operations of the should be avoided.
4. Since has a risk of developing apitic fractures of the femur of the , it is necessary to take care of your health and inform the doctor about cases of pain syndrome in the groin, hip and hip joint area. When these symptoms appear on the one hand, it is necessary to check both lower extremities for the presence of cracks, since atypical fractures can be symmetrical.
5. Citizens with allergic reaction to latex products should not touch the rubber cap of the needle.
6. Drug does not affect the CNS , does not cause a decrease in concentration and dizziness, so it does not affect the ability to drive a motor vehicle.

Development of osteonecrosis

In cancer patients and patients with poor oral hygiene there is a high probability of developing osteonecrosis of the jaw. Therefore, before the start of therapy, it is necessary to sanitize the oral cavity and to treat the teeth.

Patients at risk for developing osteonecrosis should be under constant supervision of a dentist or facial surgeon.

Some patients with osteonecrosis of the jaw may need to cancel Prolia treatment, but this should only be done by a specialist.

Compatibility with other medications

No information is available on the pharmacological compatibility of the preparation with other drugs. Monoclonal antibody should not be mixed in one syringe with any medication.

Who helped the drug, and to whom there is no

Reviews of doctors and patients will help to understand how safe and effective the drug is.

Specialist opinion

Despite the high effectiveness of the drug, a small number of contraindications and adverse reactions, self-medication is unacceptable to them.

Purchase and storage of

Prolya is sold in a pharmacy under the prescription of a doctor. The medicinal product can be stored in its original packaging for protection against light at temperature from 2 to 8 degrees Celsius, not allowing its freezing and shaking.

The original packaging is allowed to store the syringe at a maximum temperature of 25 degrees for not more than 1 month.

Today, in addition to the Dutch drug Prolia, one can find its analogue - Exidgiva, the US production.