Vantas

Vantas contains the substance gistrelin - an artificial analogue of natural LHRH.

Indications of the vanthas

It is used for palliative therapy of locally advanced prostate cancer.

[1], [2]

Release form

Release in the form of an implant in a vial with a volume of 50 mg. The package contains 1 bottle of medicine, to which is attached 1 syringe applicator.

Pharmacodynamics

After the implantation, the release of gystrelin within the tissue results in a suppression of secretion by the pituitary gland LH. This process further leads to a decrease in testosterone in men within the plasma. A similar effect disappears after the end of treatment. At the initial stage of therapy, Vantas, like other agonists of the LHRH substance, is able to temporarily increase the plasma level of testosterone.

1 month after the implantation procedure, the testosterone index drops to the post-stress limit, and then remains at a low level all the time the implant is inside the body. This suppression causes regression of the prostate tumor, and also improves the overall health of most patients.

The implant is implanted subcutaneously, and then remains on this site for 12 months. The active component is released by means of a hydrogel reservoir at a dosage of about 50 μg of substance per day.

This reservoir is responsible for the rate of diffusion of the substance into the surrounding space together with the water base. At the same time, the hydrogel does not dissolve, and its composition resembles fatty tissue, so it has a good biocompatibility, reducing the mechanical irritation of the surrounding tissues with the cells. At the same time, it has a low surface tension in in vivo tests, which helps to reduce the protein capacity for absorption and cumulation on the surface of the implanted implant. This function is very important, because it prevents the appearance of thrombosis, as well as the emergence of biological rejection of the medicine by the body.

[3], [4], [5],

Dosing and administration

The recommended dosage size is equal to 1 implant for a period of 12 months. It is injected subcutaneously into the region of the inner part of the shoulder. Daily release of approximately 50 μg of gistrellin acetate into the body occurs.

After 12 months of use, the item must be removed. Together with the extraction of the implant, the procedure for installing a new implant is made - to continue the treatment course.

When performing the introduction and extraction of the drug, you should use sterile gloves, and also observe the existing rules of asepsis - to prevent the occurrence of infection.

Determination of the area of implementation of the introduction on the body.

It is required to lay the patient on his back, and his non-working hand (if the person is right handed, then his left arm) is bent to gain access to the inside of the shoulder. Next, support it with pillows, for quiet retention in the indicated position. A suitable area for insertion is approximately midway between the elbow and shoulder joints - on the fold between the 2 and 3-headed brachial muscle.

Preparation of the device used for the implantation procedure.

The implantation device must be prepared before the preparation procedure for the injection site. First it is taken from a sterile sachet. It has a special cannula that extends the entire length of the device. This can be checked by following the green back button, which must be fully pushed forward in the direction of the cannula and away from the instrument handle.

Next, remove the lid from the vial and remove the cork from it, then, using the Mosquito-type clamp, pick up the tip of the drug implant. You can not compress or clamp the middle area of the implant to prevent violation of its standard shape. Then the implant is inserted into the device. After that, it will be located inside the cannula so that on the bottom of the cut you can see only its tip.

Procedure for subcutaneous administration of a therapeutic implant.

It is required to treat the area of administration with a special solution of povidone-iodine, using a tampon, and then apply sterile wipes to the surgical site.

Before the anesthesia procedure, it is required to check whether the patient tolerates substances of adrenaline or lidocaine. Next, the required amount of anesthetic is introduced (starting from the area of the planned incision, and then further, performing infiltration of soft tissues along the entire length of the implant element (its length is 32 mm)).

After anesthesia, a shallow incision is made on the body using a scalpel - 2-3 mm in the region of the inner part of the shoulder - perpendicular to the length of the 2-headed brachial muscle.

The implantation device must be held by the handle when inserted (the tip is inserted into the inside of the incision made so that the syringe cannula syringe points upwards), injecting it subcutaneously until it reaches the mark indicated on the cannula. Subcutaneous placement of the device is determined by the fact that at the time of its introduction there is a visual uplift of the skin. It is necessary to make sure that the implantation apparatus did not get inside the muscle tissues.

While holding the machine in place, you must simultaneously press the button to release the lock, and pull it to the stop while continuing to hold the machine in place. This will allow the cannula to be removed from the cutaneous incision, leaving an implant under the skin. After this, the device is taken out of the skin incision. Palpation helps to determine the correctness of the performed installation of the drug element.

The incision is closed by applying 1-2 seams on it, the nodes of which are directed into the cut. Later on it is applied a little ointment containing an antibiotic, then it is sealed with a surgical plaster (2 pieces). Then a bandage of gauze (size 10x10 cm) is applied to the procedure site and fixed with bandage.

Removal of the implant, as well as the procedure for installing a new element.

Vantas should be removed from the body after 12 months.

The site on which the implant is located can be identified by the palpation of the area where the incision made a year ago is placed. Often it is easy to find. Further, it is required to press on its distal tip - to determine the location of the proximal part with respect to the previous incision. If there are difficulties with identifying the site of the drug placement, it is allowed to use ultrasound in the area of soft shoulder tissues. If it is not possible to detect the implant with ultrasound, an MRI or CT scan procedure is required.

After the aseptic treatment of the site, a scalpel incision is made on it - a length of approximately 2-3 mm - next to the tip of the implant implanted to a depth of about 1-2 mm. Often its tip is visible through a thin tissue pseudocapsule. If you can not see the element, you need to press on its distal tip, and then massage in the direction of the cut. Next, an incision is made in the pseudocapsule region - to expand the tip of the element. It is grasped using a clamp, and then taken out.

During the introduction of a new medicine, the same instructions as used in the first procedure are observed. You can introduce a new substance through the same incision or use another hand for this.

[11]

Contraindications

The main contraindications:

• intolerance to gystrelin or other additional elements of the drug, and in addition to the substance of GnRH, agonists GnRH or octadecanoic acid;
• there is information about anaphylactic manifestations due to the use of artificial LHRH or their agonists;
• is not used in children, as well as in women, since there is no information about the drug efficacy and safety of its use.

[6], [7], [8]

Side effects of the vanthas

The use of an implant can trigger the appearance of such side effects:

• infestations with infections: infectious processes on the skin are occasionally observed;
• manifestations in the lymph and blood flow: anemia develops occasionally;
• metabolic and endocrine system disorders: often weight increases or hyperglycemia occurs. Occasionally, weight loss, hypertestosteronemia with hypercholesterolemia and hypercalcemia, and also fluid retention and appetite enhancement are observed;
• problems with the psyche: often decreases libido, develops depression or dissonance;
• disorders of the central nervous system: mostly there are headaches or dizziness. Occasionally, lethargy or tremor occurs;
• manifestations in the field of CCC: most often there is a sensation of surging blood (with the development of hypothetoremonemia this is a frequent reaction). More rarely there is hyperemia. Occasionally, there are hematomas, and in addition to ventricular extrasystole or tachycardia;
• disturbances in the work of the respiratory system: mainly observed dyspnea - in the case of physical exertion;
• reactions of the digestive tract: often there is functional hepatic disorder or constipation. Occasionally, abdominal discomfort, nausea, and increased plasma LDH and AST;
• skin manifestations: mainly hypertrichosis develops. Sometimes there is increased sweating (mainly at night) and itching;
• disorders of ODA function: most often there are pain in the extremities or arthralgia. Occasionally, pain develops in the neck or back, there are infiltrates in the muscles and myospasms;
• disturbances in the work of the urinary system: mainly there is a delay in urination, renal dysfunction or pollakiuria. Occasionally, there is kidney stone disease, kidney failure, hematuria with dysuria, and a decrease in QC;
• manifestations from the side of the reproductive organs: mainly testicular atrophy, impotence, and in addition gynecomastia (these reactions are expected in the development of hypothetorememia). Sometimes there is a problem with sexual function, the sensitivity of the mammary glands increases, there are pains in the sternum, itching in the genital area and an increase in the acid phosphatase in the prostate;
• local and systemic manifestations: often develops a general state of weakness, asthenia and hypersensitivity. At the site of administration, there may be pain, erythema, and at the same time hyperesthesia. Occasionally there is a feeling of cold, malaise and irritability. In the area of implant insertion, bruising and peripheral puffiness appear, inflammation and occlusion of the stent are observed.

[9], [10]

Interactions with other drugs

No pharmacokinetic drug interactions with other drugs were tested.

Gistrelin provokes suppression of the hypothalamic-pituitary system. This circumstance needs to be taken into account during diagnostic procedures regarding the operation of the gonadal, gonadotropic and pituitary systems that are performed during or after treatment using Vantas.

[12], [13], [14]

Storage conditions

The implant should be stored in a dark place at a temperature level of 2-8 ° C. The device for implantation is also stored in a dark place at temperature values of 20-25 ° C. Do not freeze the medicine and device.

[15]

Shelf life

Vantas is suitable for use in the period of 2 years from the date of release of the medicine.

[16]