Subcutaneous injection technique and its features. The introduction of drugs: ways. Administration of drugs in various ways: advantages and disadvantages
Pharmacodynamics is one of the parts of pharmacology (the science of medicines ah), studying the effect of the body on drugs, i.e. how medicinal substances enter the body, adsorbed into the bloodstream, transported to organs and tissues, metabolized and excreted from it. One of important issues, which are considered by pharmacodynamics - the ways of administering drugs. All routes of administration are divided into integral (through gastrointestinal tract) and parenteral (bypassing the gastrointestinal tract). And if everything is more or less clear with the former, then the parenteral administration of drugs raises a lot of questions in patients.
Injection routes of administration
Among the injection routes, the most common are intravenous and intramuscular. In addition to them, there are also subcutaneous, intradermal, intraarterial and intraosseous. Let's take a look, parenterally - how is it?
Intravenous administration of drugs is perhaps the most common among injections. Combining relative simplicity, it provides fast delivery of the drug to organs and tissues with 100% bioavailability. Parenteral administration is both a unique opportunity to deliver minimal volumes of drugs, and to produce a round-the-clock infusion using an installed venous catheter and a special device. In addition, the intravenous route is the only way to administer drugs in critical conditions and in cases where the patient is in unconscious, and also makes it possible to administer drugs that are poorly soluble in the gastrointestinal tract.
In addition to all the advantages, the intravenous route of administration has its own disadvantages. So, you can only enter intravenously parenteral agent, representing water solution or a water-based suspension, and during the manipulation it is necessary to avoid getting air into the blood vessel, as this can lead to the development of an embolism.
Intramuscular administration, at first glance, may seem equivalent to intravenous, but this is far from being the case. In addition to lower bioavailability, intramuscular injection is not carried out in critical conditions, as this reduces central hemodynamics, blood supply muscle tissue falls and, consequently, the delivery of drugs decreases. Also, do not inject more than 10 ml of solutions intramuscularly.
Intra-arterial administration has found its application in cardiac surgery and angiology, as well as diagnostic procedures. In this case, parenteral administration is like a new breakthrough in medicine, because in this way, for example, contrast agents are administered for research vascular system and determining the scope of further medical measures. This, in turn, allows you to take a fresh look at the diagnostic process.
Parenterally - how is it?
Among the non-injection routes, it is necessary to note transdermal, intravaginal, intratracheal, as well as intranasal, etc.
The transdermal route is the penetration of drugs through the skin. This path for an adult can cause only a local effect from the administered drug (for example, in the form of creams or ointments), but in a child, medicinal substances can have a systemic effect. This is due to the fact that the child's skin has a high sorption capacity, which causes the penetration of drugs into the bloodstream.
Intratracheal administration refers to inhalation routes. In this case, the introduction of the drug occurs through the trachea into the bronchial tree. As a rule, this method is used to administer drugs that affect the respiratory system.
Intranasal administration in the form of sprays and drops, as well as the use of drugs in the form of eye drops, has become widespread.
Which way to choose?
The question of choice is always relevant. When possible, use oral route should be limited to them, and when choosing parenteral administration of drugs, it is necessary to focus on the severity of the patient's condition and the drug itself.
Conclusion
Parenteral drugs are drugs intended for administration to the human body, bypassing the gastrointestinal tract. The choice of such a route of administration should be based on the principles of rationality, as well as extreme necessity for the patient, since in any case given type introduction is associated with certain risks.
The subcutaneous fat layer is well supplied with blood vessels, so for more fast action medicinal substance is used by subcutaneous injections (s / c). Subcutaneously administered medicinal substances are absorbed faster than when administered through the mouth. S / c injections are made with a needle to a depth of 15 mm and injected up to 2 ml medicines, which are quickly absorbed into the loose subcutaneous tissue and have no harmful effect on it.
Characteristics of needles, syringes for s / c injections:
Needle length -20 mm
Cross section -0.4 mm
Syringe volume - 1; 2 ml
Sites for subcutaneous injection:
The middle third of the anterolateral surface of the shoulder;
The middle third of the anterolateral surface of the thigh;
Subscapular region;
Front abdominal wall.
In these places, the skin is easily captured in the fold and there is no danger of damage to blood vessels, nerves and periosteum. It is not recommended to make injections: in places with edematous subcutaneous fat; in seals from poorly absorbed previous injections.
Equipment:
Sterile: a tray with gauze tuffs or cotton balls, a 1.0 or 2.0 ml syringe, 2 needles, 70% alcohol, drugs, gloves.
Non-sterile: scissors, couch or chair, containers for disinfection of needles, syringes, dressings.
Execution algorithm:
1. Explain to the patient the course of the manipulation, get his consent.
2. Put on a clean gown, mask, treat your hands at a hygienic level, put on gloves.
3. Draw up the drug, release the air from the syringe, put it in the tray.
4. Sit or lay the patient down, depending on the choice of injection site and drugs.
5. Inspect and palpate the injection site.
6. Treat the injection site sequentially in one direction with 2 cotton balls moistened with a 70% alcohol solution: first a large area, then the second ball directly at the injection site, put it under the little finger of the left hand.
7. Take the syringe in your right hand (forefinger right hand hold the cannula of the needle, with the little finger - the plunger of the syringe, with fingers 1,3,4 hold the cylinder).
8. With your left hand, gather the skin into a triangular fold, base down.
9. Insert the needle at an angle of 45° with the cut up into the base of the skin fold to a depth of 1-2 cm (2/3 of the length of the needle), hold the cannula of the needle with your index finger.
10. Reschedule left hand on the plunger and inject the drug (do not transfer the syringe from one hand to the other).
11. Press the injection site with a cotton ball with 70% alcohol.
12. Remove the needle by holding it by the cannula.
13. Discard the disposable syringe and needle in a container of 3% chloramine for 60 minutes.
14. Remove gloves, place in a container with a disinfectant solution.
15. Wash your hands, dry.
Note. During the injection and after it, after 15-30 minutes, ask the patient about his well-being and about the reaction to the injected drug (detection of complications and reactions).
Fig.1.Places for s / c injections
Fig.2. Technique of subcutaneous injection.
- It is a blood sugar lowering drug that is dosed in units of insulin (IU). Produced in vials of 5 ml, 1 ml of insulin contains 40 IU, 80 IU or 100 IU - look carefully at the bottle label.Insulin is administered with a special disposable insulin syringe of 1 ml.
On one side of the scale on the cylinder - divisions for ml, on the other - divisions for EI, on it and carry out a set of the drug, after evaluating the scale of division. Insulin is administered s / c, in / in.
Target: therapeutic - to lower the level of glucose in the blood.
Contraindications:
Equipment:
Sterile: a tray with gauze tuffs or cotton balls, an insulin syringe with a needle, a 2nd needle (if the needle is changed on the syringe), alcohol 70%, insulin preparation, gloves.
Non-sterile: scissors, couch or chair, containers for disinfection of needles, syringes, dressings.
Patient and drug preparation:
1. Explain to the patient the need to comply with the diet when receiving insulin. Insulin short action administered 15-20 minutes before meals, its hypoglycemic effect begins in 20-30 minutes, reaches maximum effect after 1.5-2.5 hours, total duration action 5-6 hours.
2. The needle can be inserted into the vial with insulin and s / c only after the stopper of the vial and the injection site are dry from 70% alcohol, because. alcohol reduces the activity of insulin.
3. When drawing insulin solution into a syringe, draw 2 UI more than the dose prescribed by the doctor, because. it is necessary to compensate for losses during the removal of air and checking the second needle (provided that the needle is removable).
4. Vials with insulin are stored in the refrigerator, preventing them from freezing; direct hit is excluded sun rays; warm to room temperature before administration.
5. After opening, the bottle can be stored for 1 month, do not tear off the metal cap, but bend it.
Execution algorithm:
1. Explain to the patient the course of the manipulation, get his consent.
2. Put on a clean gown, mask, clean your hands at a hygienic level, put on gloves.
3. Read the name of the insulin, dosage (40,80,100 IU per 1 ml) - must correspond to the doctor's prescription.
4. Look at the date, expiration date - must match.
5. Check the integrity of the packaging.
6. Open the package with the selected sterile insulin syringe, put it in a sterile tray.
7. Open the aluminum cover by treating it with 70% alcohol twice.
8. Pierce the rubber cap of the vial after the alcohol has dried, dial in insulin (the dose prescribed by your doctor plus 2 units).
9. Change the needle. Release the air from the syringe (2 units will go into the needle).
10. Put the syringe on a sterile tray, prepare 3 sterile, cotton balls (2 moistened with 70% alcohol, the 3rd dry).
11. Treat the skin first with the 1st, then with the 2nd cotton ball (with alcohol), hold the 3rd (dry) in your left hand.
12. Gather the skin into a triangular fold.
13. Insert the needle into the base of the fold at an angle of 45° to a depth of 1-2 cm (2/3 of the needle), holding the syringe in your right hand.
14. Inject insulin.
15. Apply pressure to the injection site dry cotton ball.
16. Remove the needle by holding it by the cannula.
17. Discard the disposable syringe and needle in a container of 3% chloramine for 60 minutes.
18. Remove gloves, place in a container with a disinfectant solution.
19. Wash hands, dry.
Possible complications with insulin administration:
1. Lipodystrophy (disappearance of adipose tissue at the site of numerous injections, scarring).
2. Allergic reaction (redness, urticaria, angioedema).
3. Hypoglycemic state (in case of overdose). Observed: irritability, sweating, hunger. (Help for hypoglycemia: give the patient sugar, honey, sweet drink, biscuits).
Release form, composition and packLyophilizate for preparation of solution for s / c injection of almost white color, dispersible in the supplied solvent to form a clear solution, practically free of particles. 1 vial triptorelin (as acetate) 100 mcg. Excipients: mannitol 10 mg. Solvent: sodium solution chloride 0.9% - 1 ml.
Clinico-pharmacological group: An analogue of gonadotropin-releasing hormone.
pharmachologic effect
Synthetic decapeptide, analogue of natural GnRH. Diferelin, after the initial period of stimulation, with long-term use, suppresses the secretion of gonadotropin with subsequent inhibition of ovarian function. The constant use of Diphereline inhibits the secretion of gonadotropin (FSH and LH). Suppression of intermediate endogenous LH peaks improves the quality of folliculogenesis, while increasing the number of maturing follicles, and as a result, the likelihood of pregnancy per cycle increases.
Pharmacokinetics
Suction
After s / c administration of Diferelin at a dose of 100 μg, triptorelin is rapidly absorbed. Cmax in blood plasma is reached after 0.63±0.26 h and is 1.85±0.23 ng/ml.
Distribution
The distribution phase ends after 3-4 hours, Vd is 1562±158 ml/kg.
breeding
T1 / 2 is 7.6 ± 1.6 hours. The total plasma clearance is 161 ± 28 ml / min.
Indications
female infertility, ovarian stimulation together with gonadotropins (hMG, hCG, FSH) in programs in vitro fertilization and embryo transfer, as well as other assisted reproductive technologies.
Dosing regimen
Short course of treatment Diphereline is injected sc at a dose of 100 mcg/day every day, starting from the 2nd day of the cycle (simultaneously starting ovarian stimulation), and finishing treatment 1 day before the planned introduction of human chorionic gonadotropin. The course of treatment is 10-12 days. Long-term treatment Diferelin is administered s / c at a dose of 100 mcg / day every day, starting from the 2nd day of the cycle.
With desensitization of the pituitary gland (E2 less than 50 pg / ml, i.e. approximately on the 15th day after the start of treatment), ovarian stimulation with gonadotropins is started and s / c injections of Diferelin are continued at a dose of 100 mcg / day, finishing them 1 day before planned administration of human chorionic gonadotropin. The duration of treatment is determined by the doctor individually.
Solution preparation rules
The enclosed solvent is introduced into the vial with the lyophilisate and shaken until completely dissolved.
Used needles should be placed in a sharps container.
Side effect
At the start of treatment
From the side reproductive system: when combined with gonadotropins, ovarian hyperstimulation is possible (increase in the size of the ovaries, abdominal pain).
During treatment
From the reproductive system: most often - sudden hot flashes, vaginal dryness, decreased libido and dyspareunia associated with pituitary-ovarian blockade.
From the side digestive system: not often - nausea, vomiting, weight gain.
From the CNS and peripheral nervous system: infrequently - emotional lability, blurred vision; in some cases - headache.
From the side musculoskeletal system: possible demineralization of bones, increased risk of osteoporosis (with long-term use of the product); in some cases - arthralgia, myalgia.
From the side of cardio-vascular system: not often - an increase in blood pressure.
Allergic reactions: urticaria, skin rash, itching; not often - Quincke's edema.
Local reactions: infrequently - pain at the injection site of the product.
Contraindications
pregnancy;
high susceptibility to product components.
Pregnancy and lactation
Diphereline is contraindicated for use during pregnancy. However, practice has shown that after ovulation stimulated in the previous cycle, in some cases, pregnancy occurred without stimulation, and a further course of ovulation stimulation continued. In two well-performed experimental studies in animals, no teratogenic effects of Diferelin were detected.
Therefore, when using the product, no development is expected congenital anomalies in a person. Results of the clinical research in a small number of pregnant women who received a GnRH analogue showed no fetal malformations or fetotoxicity.
However, further study is needed into the effects of the product on pregnancy.
special instructions
The ovarian response to s / c administration of Diphereline in combination with gonadotropins may increase markedly in predisposed patients, in particular in the case of polycystic ovaries. The response of the ovaries to the administration of the product in combination with gonadotropins in patients may vary, in addition, the reaction may be different in the same patients with different cycles.
Stimulation of ovulation should be carried out under the supervision of a physician and regular analysis using biological and clinical methods: an increase in the content of estrogen in the plasma and ultrasound echography. If the response of the ovaries is excessive, then it is recommended to interrupt the stimulation cycle and stop the injection of gonadotropin.
Influence on the ability to drive vehicles and control mechanisms
The drug does not affect the ability to drive vehicles and control mechanisms.
Overdose
Cases of overdose of Diferelin are not known.
drug interaction
Diferelin drug interaction is not described.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 2 years.
Attention!Before using the medication "Diphereline (Diphereline) for subcutaneous injection" it is necessary to consult a doctor.
The instructions are provided solely for familiarization with " Diphereline (Diphereline) for subcutaneous injection».
Erythropoiesis stimulator
Active substance
Epoetin alfa (epoetin alfa)
Release form, composition and packaging
transparent, colorless.
Excipients: polysorbate 80, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, glycine, water for injections.
Solution for intravenous and s / c administration transparent, colorless.
Excipients: polysorbate 80, sodium chloride, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injections.
0.5 ml - glass syringes (3) - blister packs (2) - cardboard boxes.
0.5 ml - glass syringes (3) complete with a needle protection device "PROTECS" - blister packs (2) - cardboard boxes.
Solution for intravenous and s / c administration transparent, colorless.
0.4 ml - glass syringes (3) - blister packs (2) - cardboard boxes.
0.4 ml - glass syringes (3) complete with a needle protection device "PROTECS" - blister packs (2) - cardboard boxes.
Solution for intravenous and s / c administration transparent, colorless.
Excipients: polysorbate 80, sodium chloride, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, glycine, water for injections.
1 ml - glass syringes (3) - blister packs (2) - cardboard boxes.
1 ml - glass syringes (3) complete with a needle protection device "PROTECS" - blister packs (2) - cardboard boxes.
pharmachologic effect
Erythropoiesis stimulator. It is a purified glycoprotein. Affects the division and differentiation of progenitor cells. Epoetin alfa is produced by mammalian cells with an inserted gene encoding the synthesis of human erythropoietin. By biological properties epoetin alfa is not different from human erythropoietin.
The protein fraction is about 58% of the molecular weight and consists of 165 amino acids. Four hydrocarbon chains are attached to the protein by three N-glycosidic bonds and one O-glycosidic bond. The molecular weight of erythropoietin is approximately 32,000-40,000 daltons.
After the administration of the drug, the number of erythrocytes, reticulocytes, hemoglobin levels and the rate of absorption of 59 Fe increase. On cell culture bone marrow it has been shown that epoetin alfa selectively stimulates erythropoiesis without affecting leukopoiesis.
Epoetin alfa has a minimal ability to induce antibody formation.
Carcinogenicity studies have not been conducted.
Epoetin alfa does not cause mutations in bacterial genes (Ames test), chromosomal aberrations in mammalian cells, and mutations in the genes of the HGPRT locus.
One study found no difference in the incidence of bone marrow fibrosis between dialysis patients who received epoetin alfa for three years and similar patients who did not receive epoetin alfa.
Pharmacokinetics
Suction and distribution
The concentration of the drug in the blood serum with subcutaneous administration is significantly lower than with intravenous administration. After s / c injection C max is reached after 12-18 hours. V d is approximately equal to the volume. The bioavailability of the drug with s / c administration is about 25%.
breeding
T 1/2 when administered intravenously is 5-6 hours, regardless of the severity of the disease. T 1/2 with s / c administration is approximately 24 hours.
Indications
anemia associated with chronic kidney failure in adults and children (including in patients on hemo- or peritoneal dialysis);
- anemia in cancer patients with non-myeloid tumors (for prevention and treatment);
- anemia in HIV-infected patients receiving therapy, with an endogenous erythropoietin level of less than 500 IU / ml;
- as part of a pre-deposit program before major surgery in patients with a hematocrit level of 33-39%, to facilitate the collection of autologous blood and reduce the risk associated with the use of allogeneic blood transfusions, if the expected need for transfused blood exceeds the amount that can be obtained using the autologous method collection without the use of epoetin alfa;
- before major surgery with an expected blood loss of 900-1800 ml (2-4 units) in adult patients who do not have anemia or with mild and medium degree anemia (hemoglobin level 100-130 g / l) to reduce the need for allogeneic blood transfusions and facilitate the restoration of erythropoiesis.
Contraindications
- patients with partial red cell aplasia who received therapy with any erythropoietin;
- uncontrolled arterial hypertension;
- severe pathology of the coronary, carotid, cerebral and peripheral vessels, including a recent myocardial infarction or acute disorder cerebral circulation(as part of the pre-deposit blood collection program before extensive surgical operation);
— patients who for some reason are not able to receive adequate prophylactic antithrombotic therapy;
- pregnancy;
- lactation period breast-feeding);
— hypersensitivity to the components of the drug.
C caution Eprex should be used in patients with epileptic syndrome (including history), epilepsy, thrombocytosis, thrombosis (history), obliterating peripheral vascular disease and other vascular complications, gout, sickle cell anemia, iron deficiency, B 12 - deficient or folic acid deficiency states, ischemic heart disease.
In patients diagnosed with porphyria, the drug should be used with great caution, because. V rare cases in patients with liver failure there may be an exacerbation of porphyria when using the drug Eprex.
Epoetin alfa, being a growth factor, may have a stimulating effect on some types of tumors, especially on malignant neoplasms bone marrow.
Dosage
Carefully inspect the solution for visible particles or discoloration before use. The drug should not be shaken, because. this can lead to denaturation of the glycoprotein and loss of drug activity. Eprex does not contain preservatives, so the individual packaging is intended for single use.
In / in the introduction
The duration of the injection is at least 1-5 minutes. Slower administration is preferable for patients who develop an influenza-like syndrome with the administration of the drug.
Patients on hemodialysis the injection of the drug is made through a needle into the fistula at the end of the dialysis procedure. To flush the connecting tubes, as well as to ensure a satisfactory introduction of the drug into the circulation system, after the injection of Eprex, 10 ml of isotonic sodium chloride solution is injected.
It is forbidden to administer the drug in the form of an intravenous infusion or mix it with other drugs.
S / c introduction
The maximum volume of one s / c injection should not exceed 1 ml; if large volumes are required, several injection points should be used. The drug is injected under the skin of the shoulder, thigh, anterior abdominal wall.
When changing the route of administration, the drug is administered at the same dose, then the dose is adjusted if necessary (to achieve the same therapeutic effect with s / c administration, a dose of 20-30% less is required than with iv administration.
Patients with chronic renal failure
At patients with chronic renal failure Eprex can be used in / in and s / c. In / in the introduction of the drug is preferable for patients on hemodialysis. In patients with chronic renal failure who are not receiving dialysis, and in patients on peritoneal dialysis, the drug can be administered sc.
Optimal hemoglobin content for adults patients is 100-120 g / l, for children- 95-110 g / l.
If patients have concomitant clinically pronounced coronary artery disease or chronic heart failure, the maintained hemoglobin level should not exceed the upper limit of the optimal value.
The dose of the drug is 50 IU/kg of body weight. During the selection process, the dose of Eprex is increased if the hemoglobin level rises by less than 10 g / l per month.
Adult patients on hemodialysis
Treatment is divided into two phases: the anemia correction phase and the maintenance phase.
Anemia correction phase
Supportive care
The dose to maintain the optimal level of hemoglobin is 30-100 IU / kg of body weight 3 times a week. Available data suggest that patients with severe anemia (hemoglobin levels less than 60 g/l) require a larger maintenance dose.
Adult patients on peritoneal hemodialysis
Anemia correction phase
The drug is administered at the rate of 50 IU/kg of body weight 2 times a week. If necessary, the dose can be gradually increased by 25 IU / kg of body weight (not more than 1 time in 4 weeks) 2 times a week until the optimal level of hemoglobin is reached.
Supportive care
The usual dose to maintain optimal hemoglobin levels is 25-50 IU/kg body weight twice a week.
Adult patients with chronic renal failure not receiving dialysis
Anemia correction phase
Eprex is administered at the rate of 50 IU/kg of body weight 3 times a week. If necessary, the dose can be increased (no more than 1 time in 4 weeks) by 25 IU / kg of body weight 3 times a week until the optimal hemoglobin level is reached.
Supportive care
The usual dose to maintain optimal hemoglobin levels is 17-33 IU/kg body weight 3 times a week.
Children on hemodialysis, regardless of age
Anemia correction phase
Eprex is administered at the rate of 50 IU / kg of body weight 3 times a week in / in. If necessary, the dose can be increased (no more than 1 time in 4 weeks) by 25 IU / kg of body weight 3 times a week until the optimal hemoglobin level is reached.
maintenance phase
Usually children weighing less than 30 kg a higher maintenance dose is required than adults and children weighing over 30 kg. In clinical studies, the following maintenance doses of epoetin alfa were established after six months of therapy with Eprex.
Available data suggest that patients with severe anemia (hemoglobin less than 68 g/l) require a larger maintenance dose than those with less severe anemia.
Patients suffering from cancer
For the treatment of anemia in cancer patients, Eprex is administered s / c.
The optimal hemoglobin level should be 120 g/l in men and women and should not be exceeded. Eprex may be given to patients with symptomatic anemia to prevent anemia in patients receiving chemotherapy and having a baseline low level hemoglobin during the first course of chemotherapy, (for example, a decrease in hemoglobin by 10-20 g / l with baseline hemoglobin 110-130 g / l or a decrease of more than 20 g / l with an initial hemoglobin level of more than 130 g / l).
Starting dose for prevention or treatment of anemia, should be 150 IU / kg of body weight 3 times a week. Alternatively, the starting dose may be 450 IU/kg b.w. once a week s.c. If, after 4 weeks of treatment, the hemoglobin level has increased by at least 10 g / l or the reticulocyte count has increased by more than 40,000 cells / μl above baseline, then the dose of Eprex remains the same (150 IU / kg body weight) or 450 IU / kg of body weight once a week. If, after 4 weeks of treatment, the increase in hemoglobin is less than 10 g / l and the increase in the number of reticulocytes is less than 40,000 cells / μl compared with the baseline, then over the next 4 weeks the dose is increased to 300 IU / kg of body weight. If, after an additional 4 weeks of treatment at a dose of Eprex 300 IU / kg, the hemoglobin level increased by at least 10 g / l or the number of reticulocytes increased by more than 40,000 cells / μl, then the existing dose of Eprex (300 IU / kg of body weight) is retained. bodies). If, after 4 weeks of treatment at a dose of 300 IU/kg of body weight, the hemoglobin level rises by less than 10 g/l and the increase in the number of reticulocytes is less than 40,000 cells/µl compared to baseline, treatment should be discontinued. In case of an increase in hemoglobin by more than 20 g / l within a month or reaching a hemoglobin of 120 g / l, the dose of the drug must be reduced by 25%. If the hemoglobin level exceeds 120 g / l, it is necessary to suspend treatment until the hemoglobin level drops below 120 g / l and then continue the administration of Eprex at a dose 25% lower than the initial one.
Therapy with Eprex should be continued for one month after the end of the course of chemotherapy.
HIV-infected patients receiving zidovudine therapy
It is recommended to determine the initial level of endogenous erythropoietin in the blood serum before starting treatment with Eprex. Studies show that with an erythropoietin level of more than 500 IU / ml, the effect of therapy with Eprex is unlikely.
Anemia correction phase
The drug is prescribed at a dose of 100 IU/kg of body weight 3 times a week s / c or / in for 8 weeks. If, after 8 weeks of therapy, a satisfactory effect has not been achieved (for example, to reduce the need for blood transfusions or to achieve an increase in hemoglobin levels), the dose may be gradually increased (no more than 1 time in 4 weeks) by 50-100 IU / kg of body weight 3 once a week. If it was not possible to achieve a satisfactory effect from therapy with Eprex at a dose of 300 IU / kg of body weight 3 times a week, then the appearance of a response to further therapy in more high doses unlikely.
maintenance phase
After achieving a satisfactory effect in the anemia correction phase, the maintenance dose should provide a hematocrit level in the range of 30-35%, depending on the change in the dose of zidovudine, the presence of concomitant infectious or inflammatory diseases. With a hematocrit of more than 40%, the administration of Eprex should be discontinued until the hematocrit drops to 36%. When therapy is resumed, the dose of epoetin alfa should be reduced by 25% and then adjusted to maintain the desired hematocrit. The hemoglobin content in HIV-infected patients receiving zidovudine therapy should not exceed 120 g / l.
Serum ferritin level (or serum iron) must be determined in all patients before and during treatment with Eprex. If necessary, an additional intake of iron is prescribed.
Adult patients participating in the pre-surgical autologous blood collection program
Epoetin alfa should be administered at the end of the blood collection procedure. Before prescribing Eprex, all contraindications to the collection of autologous blood should be taken into account. Before surgery, Eprex should be administered 2 times a week for 3 weeks. At each visit to the doctor, a portion of blood is taken from the patient (if hematocrit ≥33% and/or hemoglobin level ≥110 g/l) and saved for autologous transfusion. The recommended dose of Eprex is 600 IU/kg body weight twice a week.
Serum ferritin levels (or serum iron levels) should be determined in all patients before and during treatment with Eprex. If necessary, an additional intake of iron is prescribed.
In the presence of anemia, its cause must be established before starting therapy with Eprex. Required in as soon as possible ensure an adequate intake of iron in the body by prescribing an oral iron preparation at a dose of 200 mg / day (based on ferrous iron) and maintain iron intake at this level throughout the course of therapy).
Patients in pre- and postoperative period not participating in the autologous blood collection program
It is recommended to use s / c administration of the drug at a dose of 600 IU / kg of body weight per week for 3 weeks prior to surgery (21st, 14th and 7th days before surgery) and on the day of surgery. If necessary, when medical indications it is necessary to shorten the preoperative period, Eprex can be administered daily at a dose of 300 IU / kg of body weight for 10 days before surgery, on the day of surgery and for 4 days after surgery. If the hemoglobin level in the preoperative period reaches 150 g/l and above, the use of epoetin alfa should be discontinued. Before starting therapy with epoetin alfa, it is necessary to ensure that patients do not have iron deficiency.
All patients should receive adequate iron (orally 200 mg/day based on ferrous iron) throughout the course of treatment. If possible, additional oral iron should be provided prior to initiation of therapy with Eprex to ensure adequate iron depot in the patient's body.
Rules for self-administration of the drug
With s / c administration of the drug Eprex, the amount of the administered drug is usually not more than 1 ml per single injection. Eprex is prescribed separately, it is not allowed to mix it with other injection solutions.
Do not shake syringes or vials of Eprex. Prolonged vigorous shaking may damage the product. If the product has been subjected to strong shaking, it should not be used.
Syringes are equipped with a PROTECS™ needle guard to prevent needle injury after use (this is also indicated on the carton).
1. Get the syringe out of the refrigerator. The solution must be brought to room temperature (within 15-30 minutes).
2. Check the syringe for the correct dosage, shelf life, no damage, as well as the transparency of the solution and the absence of freezing.
3. Choose an injection site. Suitable places for injection is upper area thighs and anterior abdominal wall, except for the umbilical region. Injection sites should be rotated daily.
4. Wash your hands. Clean the injection site with an antiseptic swab to disinfect it.
5. Remove the packaging from the syringe by holding the syringe body and pulling the packaging without twisting it. Do not press the plunger, touch the needle, or shake the syringe.
6. Shape skin fold between big and index fingers hands. Don't pull it.
7. Insert the needle to its full length.
8. Determine the probability of a puncture blood vessel. Pull back the piston slightly. If blood enters the syringe, you should remove the needle and try to inject in another place.
9. Press the plunger all the way down to inject the entire solution. You should press it without effort and evenly, continuing to pinch the skin fold. The needle guard will not activate until the full dose has been administered.
10. With the piston as far as possible, remove the needle and straighten the skin fold.
11. Take away thumb from the piston. The needle should be allowed to move until it is completely covered by the protective cap.
12. Press a swab with an antiseptic to the injection site for a few seconds after it is completed.
13. Place the used syringe in a safe container.
Only one dose from each syringe should be used. If solution remains in the syringe after injection, the syringe should still be discarded rather than reused.
Side effects
Mostly at the beginning of treatment may develop flu-like syndrome dizziness, drowsiness, fever, headache, joint and muscle pain, weakness.
From the side of the cardiovascular system: most often - a dose-dependent increase in blood pressure, worsening arterial hypertension(most often in patients with chronic renal failure); rarely - hypertensive crisis(malignant arterial hypertension) with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic seizures (even in patients with normal blood pressure before treatment with epoetin alfa).
From the blood coagulation system: rarely - thrombocytosis, shunt thrombosis (in patients on hemodialysis, especially with a tendency to arterial hypotension or having complications from an arteriovenous fistula, incl. stenosis, aneurysm); myocardial ischemia, myocardial infarction, stroke, transient disorder cerebral circulation, deep vein thrombosis, arterial thrombosis, pulmonary embolism, arterial aneurysms, retinal vascular thrombosis and blockage in the artificial kidney system.
In rare cases, patients with chronic renal failure who have been treated for several months or years may develop partial red cell aplasia (erythroblastopenia).
Allergic reactions: most often - skin rash, eczema, urticaria, itching; in some cases - anaphylactoid reactions, angioedema.
Local reactions: hyperemia, burning, mild or moderate soreness at the injection site are possible (more often occur with s / c injection).
Others: rarely - potentially serious complications associated with respiratory failure or with a decrease in blood pressure; immune reactions for drug administration.
Overdose
With an overdose of epoetin alfa, effects occur that reflect extreme degree expressiveness pharmacological action. At very high levels hemoglobin, bloodletting is possible.
drug interaction
Data on the interaction of the drug Eprex with other drugs are not available.
With the simultaneous use of the drug Eprex with cyclosporine, it is possible to influence the concentration of the latter in plasma (when using this combination, it is necessary to control the concentration of cyclosporine in plasma and, if necessary, adjust its dose).
Pharmaceutical interaction
Do not dilute and pour the drug from original packaging in any other container, you can not enter Eprex in a mixture with other drugs.
special instructions
If a patient with chronic renal failure has experienced a sharp decline in the effectiveness of erythropoietin therapy (defined as a decrease in hemoglobin by 10-20 g / l within a month with an increase in the need for transfusions, it is necessary to determine the number of reticulocytes and conduct an examination to identify one of the typical causes of resistance ( deficiency of iron, or vitamin B 12 , severe aluminum poisoning, concomitant infectious or inflammatory processes, bleeding, hemolysis) If the reticulocyte count is less than 20,000 / µl (or less than 0.5%), the platelet and leukocyte count is normal and if there are no other causes of loss efficiency, it is necessary to conduct an analysis for the presence of antibodies to erythropoietin and a bone marrow examination to diagnose partial red cell aplasia.
If a diagnosis of partial red cell aplasia is suspected, treatment with epoetin alfa should be discontinued immediately. should not be assigned similar preparations due to the possibility of cross-reaction of antibodies to erythropoietin with other erythropoietins. According to the indications, appropriate therapy (hemotransfusion) can be carried out.
In patients with chronic renal failure receiving Eprex in the form of s / c injections, it is necessary to regularly monitor the effectiveness of therapy, defined as the absence or decrease in response to the administration of erythropoietin in patients who were previously susceptible to this therapy.
To reduce the risk of hypertension, the rate of increase in hemoglobin levels should be approximately 10 g/l (maximum 20 g/l) per month.
For all patients receiving erythropoietin alfa, regular monitoring of hemoglobin levels once a week until a stable level is reached and periodic monitoring thereafter is necessary. With an initial hemoglobin level of 140 g/l in the pre- and postoperative period, hemoglobin levels are monitored more often.
Before and after the start of therapy with Eprex, it is necessary to adequately control blood pressure. If it is impossible to reduce the pressure with antihypertensive drugs, Eprex therapy should be discontinued.
Need to pay Special attention for the occurrence of unusual headaches or worsening headaches.
The safety of Eprex in patients with hepatic impairment has not been established. In this category of patients, due to a slowdown in metabolism, there may be a more pronounced increase in erythropoiesis.
When treating with Eprex, regular monitoring of platelet levels is required, especially during the first 8 weeks, because. it is possible to develop a dose-dependent relative increase in the number of platelets, which is normalized in the future without discontinuation of therapy; in rare cases, there is an absolute increase in the number of platelets. Erythropoiesis stimulants are not necessarily equivalent to each other. Patients can be transferred from one erythropoiesis stimulator (for example, from Eprex) to another only with the permission of the attending physician.
Inadequate response to Eprex therapy is noted with iron deficiency, folic acid, vitamin B 12 , severe poisoning aluminum, concomitant infectious and inflammatory processes, injuries, hidden bleeding, hemolysis, bone marrow fibrosis various etiologies. Therefore, before starting therapy with Eprex, it is necessary to assess the iron stores in the body. Serum ferritin levels should be measured regularly throughout the course of treatment. All patients with serum ferritin levels less than 100 ng/mL are recommended oral medications iron at a dose of 200-300 mg / day (for children - 100-200 mg / day). Patients with chronic renal failure (with serum ferritin levels less than 300 ng / ml) are recommended to prescribe oral iron preparations at a dose of 200-300 mg / day.
In patients with chronic renal failure, correction of anemia may cause an improvement in appetite and an increase in potassium and protein absorption, which may require adjustment of dialysis parameters to maintain normal levels of urea, creatinine, and potassium.
Due to the increase in hematocrit during therapy with Eprex, patients on hemodialysis may need to increase the dose of heparin, otherwise occlusion of the dialysis system is possible.
Regardless of treatment with Eprex, in surgical patients with concomitant cardiovascular diseases, thrombotic and vascular lesions. Therefore, in these patients, routine blood volume replacement should be done in an autologous blood collection program. It should be taken into account that a preoperative increase in hemoglobin levels in orthopedic patients, regardless of epoetin alfa therapy, can serve as a predisposing factor for the development of thrombotic complications requiring appropriate treatment. All patients scheduled for surgical intervention should receive adequate prophylactic antithrombotic therapy.
Patients with a hemoglobin level of more than 150 g / l use of epoetin alfa in the pre- and postoperative period is not recommended.
Patients with chronic renal insufficiency and clinically severe coronary artery disease or chronic heart failure, the upper limit of hemoglobin levels should not exceed 100-120 g / l for adults and 95-110 g / l for children.
Before and during treatment with Eprex, it is necessary to determine the level of serum iron and the level of serum ferritin in all patients, if necessary, additional administration of iron preparations is required.
Others must be excluded possible reasons anemia before starting treatment with Eprex.
Influence on the ability to drive vehicles and control mechanisms
Due to the high risk of developing arterial hypertension at the beginning of therapy, patients with chronic renal failure should avoid potentially dangerous species activities, such as driving and operating machinery, until the optimal maintenance dose of the drug is established.
Pregnancy and lactation
In some patients with chronic renal failure during treatment with Eprex, there was a resumption of menstruation. The possibility of pregnancy and the need for contraceptive measures should be discussed with the patient before starting therapy.
The use of the drug Eprex during pregnancy and lactation is contraindicated.
The teratogenicity of the drug in humans has not been studied.
It is not known if the drug is excreted from breast milk therefore, during treatment with Eprex, it is necessary to stop breastfeeding.
IN experimental studies in rats and rabbits, the teratogenic effect of epoetin alfa was not found.
Application in childhood
Terms and conditions of storage
The drug should be stored in a place protected from light, out of the reach of children at a temperature of 2 ° to 8 ° C, do not shake, do not freeze. Shelf life - 1.5 years. After the expiration date, do not use.
Packaging intended for use can be stored at room temperature (not higher than 25°C) for no more than 7 days in a row.
