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Kelix - instructions for use, reviews, analogs and forms of release (injections in ampoules for injection concentrate 10 ml and 25 ml) of the drug for the treatment of breast and ovarian cancer, Kaposi's sarcoma in adults, children and pregnancy. Composition

Kelix - instructions for use, reviews, analogs and forms of release (injections in ampoules for injection concentrate 10 ml and 25 ml) of the drug for the treatment of breast and ovarian cancer, Kaposi's sarcoma in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Kelix. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Kelix in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Kelix in the presence of existing structural analogs. Use for the treatment of breast cancer, ovarian cancer and other oncological pathologies in adults, children, as well as in pregnancy and lactation.Composition of the preparation.

 

Kelix - antitumor drug. Doxorubicin (active ingredient of Kelix) is a cytotoxic anthracycline antibiotic isolated from Streptomyces peucetius var. caesius. The exact mechanism of the antitumor effect of doxorubicin is unknown. It is believed that the cytotoxic effect is due to its ability to inhibit the synthesis of deoxyribonucleic acid (DNA), ribonucleic acid (RNA) and proteins by implanting doxorubicin between adjacent base pairs of the DNA double helix, which prevents the spiral from unfolding for subsequent replication.

 

Composition

 

Doxorubicin hydrochloride pegylated liposomal + excipients.

 

Pharmacokinetics

 

With the intravenous administration of Kelix, the concentration of doxorubicin in plasma is predominantly to pegylated liposomal doxorubicin (from 90% to 95% of the measured doxorubicin, respectively), and is significantly higher than when equivalent doses of traditional (non-pegylated non-liposomal) doxorubicin are administered.

 

The pharmacokinetic profile of doxorubicin indicates that its clearance from plasma is determined by a liposome carrier.Doxorubicin becomes available only after the release of liposomes from the vascular bed and penetration into the tissues.

 

Pharmacokinetic parameters for violations of liver function and hyperbilirubinemia slightly differ from pharmacokinetic parameters of normal concentration of total bilirubin. Renal failure (KK 30-156 ml per minute) does not affect the pharmacokinetic parameters. There is no data on the pharmacokinetics of the drug in patients with creatinine clearance less than 30 ml per minute. The age of patients (21-75 years) does not significantly affect the pharmacokinetic parameters of Kelix.

 

Indications

  • metastatic breast cancer in the presence of indications for the therapy with anthracyclines in the case of an increased risk of cardiac complications and in the ineffectiveness of therapy with taxanes;
  • widespread ovarian cancer with ineffective chemotherapy with platinum drugs;
  • progressive multiple myeloma (in combination with bortezomib) in patients who received at least one chemotherapy line and who underwent bone marrow transplantation (BMT) or who are not candidates for BMT;
  • AIDS-associated Kaposi's sarcoma in patients with a low CD4 count (less than 200 CD4 lymphocytes per cubic meter) and extensive skin and mucous membrane lesions or visceral organs, other than Kaposi's sarcoma, which can be treated locally or systemically treated with interferon alfa. Kelix can be used as the first or second line of chemotherapy in patients with AIDS-associated Kaposi's sarcoma, insensitive to drugs such as vinca alkaloids, bleomycin and standard doxorubicin (or other anthracyclines).

 

Form of issue

 

Injections in ampoules for injection (concentrate) 10 ml and 25 ml.

 

Instructions for use and dosing regimen

 

The drug is administered intravenously drip. The drug can not be injected or undiluted. Treatment continues until signs of progression or development of unacceptable toxicity.

 

Kelix has unique pharmacokinetic properties and should not be replaced by other forms of doxorubicin hydrochloride. Treatment with Kelix should be performed only under the supervision of a qualified oncologist who has experience in cytostatic therapy.

 

Breast cancer or ovarian cancer

 

In breast cancer and ovarian cancer, the drug is administered intravenously at a dose of 50 mg per square meter every 4 weeks, until the disease progresses and while tolerable tolerance remains.

 

At a calculated dose of less than 90 mg concentrate is diluted in 250 ml of a solution of 5% Dextrose for infusion; at a dose of 90 mg or more - in 500 ml of a solution of 5% dextrose for infusion.

 

To reduce the risk of developing infusion reactions, the first administration is performed at a rate of not more than 1 mg per minute. In the absence of reactions, subsequent infusions can be carried out for 60 minutes.

 

Repeated administration of the drug to patients who had infusion reactions to the previous administration should be carried out as follows: 5 percent of the calculated dose is administered slowly for 15 minutes. In the absence of reactions, the administration is continued at a doubled rate for another 15 minutes. With good tolerability, the infusion is continued for the next hour (total time of administration is 90 minutes).

 

Subsequent infusions of Kelix can be performed within 60 minutes.

 

Multiple myeloma

 

In the treatment of multiple myeloma, the drug is administered at a dose of 30 mg per square meter on the 4th day of a three-week cycle in combination with bortezomib (1.3 mg per square meter at 1, 4,8 and 11 days). The drug is administered immediately after bortezomib for 1 hour. The therapy is shown until the effect of the treatment is observed with its tolerable tolerance.

 

At a calculated dose of less than 90 mg, concentrate is diluted in 250 ml of 5% (50 mg / ml) dextrose solution for infusion; at a dose of 90 mg or more in 500 ml of a 5% (50 mg / ml) solution of dextrose for infusion.

 

An intravenous catheter and a drip system between the administration of bortezomib and doxorubicin should be washed with a solution of 5% dextrose. If it is not possible to administer doxorubicin and bortezomib on day 4 of the cycle, their administration can be postponed for 48 hours. If the administration of bortezomib was made later than the time indicated by the therapy regimen, then the subsequent administration of bortezomib should be performed no earlier than 72 hours after the administration of the last dose of the drug. The first infusion of Kelix can be prescribed for 90 minutes according to the scheme:

  • 10 ml first 10 minutes;
  • 20 ml for the next 10 minutes;
  • 40 ml for the next 10 minutes;
  • then the remaining amount of solution for 60 minutes.

 

In the subsequent dose of Kelix can be administered within 1 hour. If there is an occurrence of reactions to the infusion with Kelix,the infusion is stopped and after the disappearance of the symptoms Kelix preparation is prescribed according to the following scheme:

  • 10 ml in the first 10 minutes;
  • 20 ml over the next 10 minutes;
  • 40 ml over the next 10 minutes;
  • then the remaining amount of solution in 60 minutes.

 

Infusion administration can be performed through a central or peripheral venous catheter.

 

AIDS-associated Kaposi's sarcoma

 

The drug is administered intravenously at a dose of 20 mg per square meter 1 time every 2-3 weeks, until the disease progresses and while tolerable tolerance remains. Avoid intervals between doses of less than 10 days, since in this case, the accumulation of the drug in the body and increase its toxicity. To achieve therapeutic effect, the course of treatment should be 2-3 months. Treatment should be continued to maintain therapeutic effect.

 

Concentrate is diluted in 250 ml of a 5% dextrose solution for infusion and administered as an intravenous infusion for 30 minutes.

 

All patients

 

If the patient has initial symptoms or signs of reaction to the drug, the infusion is immediately stopped, premedication with antihistamines and / or high-speed glucocorticosteroids (GCS) is performed and the infusion is resumed at a slower rate.

 

Do not administer the drug in the form of bolus injections or as an undiluted solution. When carrying out infusions, it is recommended to combine the Kelix solution through the marginal port of intravenous infusion with an aqueous solution of 5% dextrose to achieve further dissolution and reduce the risk of thrombosis and bruising. Infusion can be carried out through the peripheral vein. Kelix should not be administered intramuscularly or subcutaneously, nor should infusion systems with built-in filters be used.

 

To reduce the appearance of some side effects, such as palmar-plantar syndrome (erythrodysesthesia), stomatitis or hematologic toxicity, the dose of the drug can be reduced or canceled.

 

Rules for the preparation and administration of a solution for infusions

 

Do not use the drug with signs of precipitation or presence of suspended particles.

 

When using the drug, it is necessary to follow the rules of working with antitumor drugs. Use gloves. In case of contact with the skin or mucous membranes, immediately flush this area with soap and water.

 

Determine the dose of doxorubicin needed for administration. The required volume of the drug is typed in a sterile syringe. All manipulations should be carried out with strict adherence to the rules of aseptic (the drug does not contain preservatives and bacteriostatic additives).

 

It is recommended to inject the drug through the side port of the infusion system, through which a solution of 5% dextrose is injected to achieve greater dilution and minimize the risk of thrombosis and extravasation. Infusion can be carried out in the peripheral vein.

 

The drug can not be administered intramuscularly or subcutaneously. Do not use infusion systems with built-in filter for Kelix administration.

 

It is recommended to administer Kelix immediately after dilution with a 5% dextrose solution for infusion. In cases where this is not possible, the prepared solution can be stored at a temperature of 2-8 degrees and used within 24 hours.

 

Side effect

  • pharyngitis (inflammation of the mucous membrane of the pharynx);
  • folliculitis (inflammation of the hair follicles);
  • fungal infections;
  • upper respiratory tract infection;
  • urinary tract infections;
  • febrile rashes on the skin (not herpetic);
  • disorders of hematopoiesis - leukopenia (decrease in the number of leukocytes), anemia (low concentration of hemoglobin), neutropenia (decrease in the level of neutrophilic leukocytes), thrombocytopenia (decrease in the number of platelets), thrombocythemia (increased production of platelets in the bone marrow);
  • myelosuppression (decrease in blood levels of leukocytes and platelets);
  • paresthesia (a violation of the sensitivity of the skin, which is characterized by numbness, tingling and "crawling crawling");
  • peripheral neuropathy (peripheral nerve disease);
  • tides;
  • drowsiness;
  • insomnia;
  • headache;
  • dizziness;
  • increased blood pressure;
  • lacrimation;
  • blurred vision;
  • ventricular arrhythmia (cardiac rhythm disturbance);
  • dyspnea;
  • cough;
  • nose bleed;
  • anorexia (pathological desire to lose weight);
  • nausea, vomiting;
  • stomatitis (inflammation of the oral mucosa);
  • ulceration of the oral mucosa;
  • abdominal pain;
  • constipation, diarrhea;
  • flatulence (swelling);
  • perversion of taste;
  • gingivitis (inflammation of the gums);
  • pain in the oral cavity;
  • dyspepsia (indigestion);
  • alopecia (baldness);
  • erythema (abnormal redness of the skin);
  • dry skin;
  • Pigmentation disorder;
  • itching;
  • change in skin color;
  • rash;
  • dermatitis (inflammation of the skin);
  • defeat of nails;
  • palmar-plantar syndrome (redness in the area of ​​the feet and palms);
  • scaly skin;
  • leg cramps;
  • pain in the bones;
  • backache;
  • muscle pain;
  • pain in the mammary gland;
  • fatigue;
  • inflammation of the mucous membranes;
  • weakness;
  • fever;
  • decreased body weight;
  • swelling in the legs;
  • allergic reactions;
  • dehydration (dehydration);
  • cachexia (severe weight loss);
  • anxiety, depression;
  • dysuria (violation of urination);
  • muscle weakness;
  • Retinitis (inflammation of the retina).

 

Contraindications

  • hypersensitivity to the components of the drug;
  • children's age till 18 years;
  • pregnancy;
  • the period of breastfeeding;
  • Kaposi's sarcoma, amenable to local treatment or systemic treatment of interferon alfa.

 

Carefully:

  • circulatory insufficiency;
  • previous use of other anthracyclines;
  • simultaneous use with drugs that have a cytotoxic (especially myelotoxic) effect;
  • oppression of bone marrow hematopoiesis (including bone marrow infiltration by tumor cells, prior chemo- or radiation therapy);
  • parasitic and infectious diseases of viral, fungal or bacterial origin (currently or recently transferred, including the recent contact with the patient): herpes simplex, herpes zoster (viremicheskaya phase), chicken pox, measles, amoebiasis, strongyloidiasis (or suspected), gout (including in the anamnesis), urate nefrourolitiaz (including in the anamnesis);
  • heart disease (cardiotoxicity may occur at lower total doses), liver failure;
  • diabetes.

 

Application in pregnancy and lactation

 

The use of Kelix during pregnancy is not recommended.

 

Women of childbearing age should use contraceptive methods if the patient or her partner receives Kelix therapy and within 6 months after the end of treatment.

 

It is not known whether the drug is excreted in breast milk, so to prevent potential severe reactions of the infant to Kelix, women should stop breastfeedingperiod of therapy with Kelix.

 

Use in children

 

Contraindicated in children and adolescents under 18 years. The safety and efficacy of the drug in patients under the age of 18 years have not been fully investigated.

 

Application in elderly patients

 

It is recommended that lower doses are administered or that the intervals between cycles are increased in elderly patients.

 

special instructions

 

Infusion reactions

 

On the background of the use of Kelix, mainly during the first infusion and as a result of interaction with other drugs, anaphylactoid reactions, asthma attack, asthma, facial edema, vasodilation, increased or decreased blood pressure, hives, back pain, chest pain, chills, fever, tachycardia, dyspepsia, nausea, dizziness, difficulty breathing, pharyngitis, skin rash, skin itching, excessive sweating, seizures (very rarely), and reactions at the injection site. Temporary cessation of infusion usually leads to resolution of these symptoms without additional treatment. Nevertheless, with the introduction of the drug should be prepared drugs for the purpose of symptomatic therapy,intended for the management of infusion reactions (epinephrine, antihistamines, anticonvulsants, GCS and other medicines for emergency medical care). Virtually all patients who received Kelix, the therapy can be resumed after resolving all the symptoms without relapse.

 

When symptoms of an infusion reaction appear, stop the infusion immediately and perform symptomatic therapy (antihistamines and / or short-acting SCS). Renewal of infusion is possible after complete relief of all symptoms with a decrease in the rate of doxorubicin administration. Infusion reactions are rarely repeated after the first cycle of drug therapy.

 

Stomatitis

 

Stomatitis was noted in patients who received continuous infusions of standard doxorubicin hydrochloride and was often noted in patients receiving Kelix, this did not prevent patients from completing therapy. Dose adjustments are usually not required, except when the stomatitis leads to the impossibility of eating the patient.In this case, it is possible to extend the intervals between administration of drugs for 1-2 weeks or dose reduction.

 

Palmar-plantar syndrome

 

It is characterized by painful macular skin rashes of a reddish color. In patients who report this phenomenon, it is usually observed after two to three cycles of therapy. In most patients, the condition occurs within one to two weeks with or without GCS therapy. For the prevention and treatment of this syndrome, pyridoxine is used in a dose of 50-150 mg per day. Other methods of treatment and prevention of the palmar-plantar syndrome: should keep your hands and feet in a cool state (baths for hands and feet and baths for the body with a low water temperature, swimming in cool water); Also avoid excessive exposure to warm / hot water and try not to wear tight fitting socks, gloves, tight shoes, so as not to disturb blood circulation in the legs and hands.

 

The condition is probably related to the dose and schedule of application and can be reduced by increasing the medication interval for 1-2 weeks or reducing the dose. However, this reaction in some patients can be severe and debilitating and may require the drug to be discontinued.

 

When there are symptoms of extravasal ingestion (burning, redness), immediately stop the infusion and place the injection site for 30 minutes with ice. The drug is continued into another vein.

 

Repeated skin reactions associated with previous radiotherapy were rarely seen with Kelix.

 

Risk of development of cardiovascular complications

 

Cardiotoxicity. All patients receiving therapy with the drug are recommended to carry out ECG monitoring. Transient changes in the ECG, such as flattening of the T wave, a decrease in the ST segment and clinically insignificant rhythm disturbances, are not mandatory indications for the abolition of doxorubicin. A specific manifestation of cardiotoxic action is a decrease in the voltage of the QRS complex. If such a change occurs, the possibility of a biopsy of the myocardium as the most specific test for the diagnosis of damage to the heart muscle caused by anthracyclines should be considered.

 

Methods for measuring the left ventricular ejection fraction - echocardiography and the preferred MUGA scan (multivariate arteriography) - refer to more specific methods for monitoring cardiac functionin comparison with an electrocardiogram. These methods should be used before and during drug therapy. Measurement of the left ventricular ejection fraction is mandatory for each subsequent administration of the drug at a total dose of the drug exceeding 450 mg per square meter.

 

If there is a suspicion of cardiomyopathy, that is, when the left ventricular ejection fraction is lower than before the start of treatment and / or with a prognostically significant decrease of this index (less than 45%), a biopsy of the myocardium should be performed.

 

The listed research methods to identify the possible negative effects of anthracycline therapy on cardiac activity are recommended in the following order: ECG control, measurement of the left ventricular ejection fraction, myocardial biopsy.

 

If the results of the examination suggest damage to the myocardium associated with drug therapy, a careful assessment of the ratio of the prospective benefit of continuing the use of the drug and the risk of developing cardiotoxicity should be carried out.

 

Congestive heart failure due to cardiomyopathy can develop unexpectedly,without previous changes on the ECG, and may also appear a few weeks after discontinuation of therapy.

 

Patients with cardiac diseases requiring appropriate therapy, the use of the drug is possible only if the benefit of using the drug exceeds the risk for the patient.

 

When calculating the cumulative dose of doxorubicin, any prior or concomitant use of cardiotoxic drugs (other anthracyclines / anthraquinones or fluorouracil) should be taken into account.

 

Myelosuppression

 

During therapy with doxorubicin, a picture of peripheral blood should be monitored regularly and at least before each administration of the drug with a mandatory count of the number of cells.

 

Myelosuppression, accompanied by anemia, thrombocytopenia, leukopenia and, in rare cases, febrile neutropenia, were noted in patients receiving Kelix. Persistent expressed myelosuppression can lead to the development of superinfection or bleeding.

 

Secondary hematologic malignant neoplasms

 

In patients receiving combined chemotherapy, including doxorubicin,(as well as with the use of other DNA-binding antitumor drugs), there were cases of development of secondary acute myeloblastic leukemia and myelodysplastic syndrome, and therefore it is recommended that such patients be periodically monitored for hematological parameters.

 

Diabetes

 

When using the drug in diabetics, it should be taken into account that the preparation contains sucrose, and that the drug is administered together with a 5% solution of dextrose.

 

Secondary cancer of the oral cavity

 

Very rare cases of secondary oral cancer have been reported in patients with long-term (more than one year) treatment with Kelix or in those receiving aggregate doses of the drug exceeding 720 mg per square meter. Cases of secondary oral cancer were diagnosed both during treatment and for 6 years after the last dose. Patients should be examined regularly for ulcers in the oral cavity or any discomfort that may indicate secondary cancer of the oral cavity.

 

Pharmaceutical interaction

 

The presence of bacteriostatic additives in the infusion solution, such as benzyl alcohol, can cause precipitation of the drug.

 

Since the Kelix preparation has special pharmacokinetic properties, alternating cycles of Kelix therapy and traditional doxorubicin should not be performed.

 

Influence on the ability to drive and drive machinery

 

Although the drug does not directly affect the ability to drive a car, nevertheless, some patients may experience dizziness, drowsiness. Therefore, during the treatment period, these patients should refrain from driving the car and controlling the mechanisms.

 

Drug Interactions

 

With the combined use of doxorubicin with cyclophosphamide or taxanes in patients with solid tumors (including ovarian cancer and breast cancer) no increase in toxicity was detected. Nevertheless, it should be borne in mind that Kelix, like other preparations of doxorubicin hydrochloride, can enhance the toxic effect of other antitumor drugs.

 

There have been reports of an exacerbation of cyclophosphamide-induced hemorrhagic cystitis and an increase in hepatotoxicity of mercaptopurine in patients with AIDS-associated Kaposi's sarcoma during treatment with standard doxorubicin hydrochloride.Caution should be exercised when using any other cytotoxic agents, especially myelotoxic agents.

 

The drug should not be mixed with other solutions, except for a solution of 5% dextrose for infusion.

 

Analogues of the drug Kelix

 

Structural analogs for the active substance:

  • Adriablastin is instantly soluble;
  • Doxol;
  • Doxorubifer;
  • Doxorubicin;
  • Doxophos;
  • Rastocin;
  • Syndroxocin.

 

Analogues for the pharmacological group (antitumor antibiotics):

  • Aknomid D;
  • Blenamax;
  • Bleomycetin hydrochloride;
  • Bleomycin RONC;
  • Bleocin;
  • Dactinomycin;
  • Daunorubicin LENS;
  • Zavedos;
  • Idarubicin;
  • Ikzempra;
  • Cosmegen;
  • Mitomycin;
  • Mutamycin;
  • Pixusvri;
  • Rubid;
  • Rubomycin;
  • Pharmorubicin;
  • Epilek;
  • Epirubicin;
  • Epindandan.

 

Review of the oncologist's doctor

 

Kelix is ​​an effective chemotherapeutic drug. I prescribe it for the treatment of breast cancer, ovaries, primary and secondary Kaposi's sarcoma. Sometimes I use in complex therapy of lung cancer, thyroid gland, bladder. The advantage of the active substance of this drug is that its molecules are covered with liposomes - a kind of fat layer.Because of this active ingredients in the blood stay longer, the therapeutic effect of this is stronger, while healthy cells are damaged less than from the effects of other similar drugs.

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