Ifosfamide - Instructions For Use, Price, Reviews, Powder Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ifosfamide

Ifosfamide: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. In case of impaired renal function
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Ifosfamide

ATX code: L01AA06

Active ingredient: Ifosfamide (Ifosfamide)

Manufacturer: JSC "Biochemist" (Russia)

Description and photo update: 2019-11-06

Ifosfamide is an antineoplastic drug with alkylating and cytostatic effects.

Release form and composition

The drug is produced in the form of a powder for preparing a solution for infusion: a fine-crystalline dry mass of white or almost white color, the presence of a weak specific odor is allowed (0.2 g or 0.5 g each in vials made of a glass tube for medicines, 10 ml, hermetically sealed with a rubber stopper, crimped with an aluminum cap, in a cardboard box of 1, 5 or 10 vials and instructions for the use of Ifosfamide; 1 g or 2 g each in injection colorless glass vials, hermetically sealed with a rubber stopper, crimped with an aluminum cap, with a volume of 25 ml, respectively or 50 ml, in a cardboard box of 1, 5 or 10 bottles; for hospitals - in a cardboard box, 50 bottles of 0.2; 0.5; 1 or 2 g).

1 bottle contains the active substance ifosfamide - 0.2; 0.5; 1 or 2 g.

Pharmacological properties

Pharmacodynamics

Ifosfamide is an anticancer drug, the active substance of which is an alkylating cytostatic from the group of nitrogen mustard gas, a derivative of oxazaphosphorines. The clinical activity of ifosfamide is due to its ability to introduce an alkyl substituent into nucleophilic centers, disrupt DNA (deoxyribonucleic acid) synthesis and block mitotic division of tumor cells. Most often, DNA damage occurs during the G1 and G2 phases of the cell cycle.

Pharmacokinetics

Ifosfamide is a prodrug or inactive transport form. The formation of a pharmacologically active metabolite, 4-hydroxyphosphamide, occurs only as a result of its biotransformation after intravenous administration. It is activated by the action of liver enzymes (phosphoamidase) and tumor tissue. If the liver function is impaired, the activation process slows down and its value decreases.

After a single intravenous injection of the drug at a dose of 5 g per 1 m ² of the patient's body surface (g / m ²), the decrease in plasma concentration occurs biexponentially. The half-life (T _1/2) of the final phase is 15 hours. It is excreted through the kidneys, unchanged, up to 61% of the dose received.

With the introduction of the drug in the dose range from 1.6 g / m ² to 2.4 g / m ^2, its excretion proceeds monoexponentially, T _{1/2 is} reduced to 7 hours, and the proportion of unchanged ifosfamide in urine decreases by 4-5 times.

Indications for use

The use of Ifosfamide powder is indicated in the treatment of the following inoperable malignant tumors sensitive to the drug:

• germ cell tumors;
• nephroblastoma (Wilms tumor);
• lung cancer;
• mammary cancer;
• ovarian, cervical, endometrial cancer;
• pancreas cancer;
• malignant neoplasms of the testicle;
• malignant lymphomas;
• sarcoma of soft tissues;
• Ewing's sarcoma, osteosarcoma.

Contraindications

• pronounced inhibition of bone marrow function;
• severe renal dysfunction;
• cystitis;
• obstruction of the urinary tract;
• period of pregnancy;
• breast-feeding;
• individual intolerance to the drug.

Ifosfamide should be prescribed with caution in acute infectious diseases of viral, bacterial or fungal etiology (including chickenpox, shingles), immunosuppression, hypoproteinemia (hypoalbuminemia), chronic liver failure, electrolyte imbalance, diabetes mellitus, metastases in the brain, cerebral as well as elderly patients.

Ifosfamide, instructions for use: method and dosage

An infusion solution prepared from Ifosfamide powder is administered intravenously over 0.5 hours or as an infusion for 24 hours.

To dissolve the powder in vials, water for injection is used in the amount necessary to obtain a concentration of 40 mg per 1 ml. In order to prepare a solution for intravenous administration within 0.5 h, the resulting solution is mixed with 500 ml of 0.9% sodium chloride solution, 5% dextrose solution or Ringer's solution. For a 24 hour infusion, the resulting ifosfamide solution is diluted in 3000 ml of 5% dextrose solution or 0.9% sodium chloride solution.

The concentration of the drug in the infusion solution should not exceed 4%.

The doctor determines the dose and mode of administration taking into account the individual chemotherapy treatment regimen.

Possible dosage options:

• dose 1.2-2.4 g / m ² (intravenous administration for 0.5 hours): once a day for 3-5 consecutive days or every other day until the total dose for the course is reached - 10-12 g / m ²; then the course is repeated with an interval of 21 days;
• dose 3-5 g / m ²: 24-hour infusion once a day with an interval of 14 days;
• dose 5-8 g / m ² / 3.2 g / m ²: 24-hour infusion once a day with an interval of 21-28 days / 5-day continuous infusion with an interval of 21-28 days.

To reduce the risk of developing hemorrhagic cystitis, the use of the drug Mesna is indicated, the dose of which must correspond to 60% of the dose of ifosfamide. The drugs can be mixed in the same infusion solution and administered at the same time.

Side effects

• from the hematopoietic system: anemia, leukopenia, thrombocytopenia;
• from the digestive system: nausea, vomiting; rarely - an increase in the activity of hepatic enzymes, an increase in the level of bilirubin in the blood serum and other violations of liver function, stomatitis;
• from the nervous system: increased fatigue, confusion, disorientation, hallucinations, encephalopathy, agitation; less often - dizziness; rarely - peripheral polyneuropathy, coma, seizures;
• from the urinary system: inflammatory pathologies of the bladder - dysuria, frequent urination, hemorrhagic cystitis, painful urination, blood in the urine, impaired renal function (glucosuria, increased serum urea and creatinine concentration, decreased creatinine clearance, proteinuria, metabolic acidosis;
• from the reproductive system: amenorrhea, azoospermia;
• on the part of the skin and cutaneous appendages: photosensitivity, reversible alopecia;
• local reactions: pain, redness or swelling at the injection site;
• others: fever, infectious complications, allergic reactions, cardiotoxic effects, slowing the rate of wound healing, immunosuppression, cough, shortness of breath.

Overdose

Ifosfamide overdose can cause acute development of severe symptoms of the main adverse events.

In case of drug intoxication, symptomatic therapy and the mandatory appointment of Mesna are recommended.

special instructions

Before starting the use of Ifosfamide, conduct a thorough examination of the patient to identify foci of chronic infection. If necessary, they provide their sanitation, as well as the correction of electrolyte imbalance.

Treatment should be accompanied by regular monitoring of the peripheral blood picture (especially the number of neutrophils and platelets), laboratory indicators of renal and liver function. A systematic urinalysis is required for the presence of red blood cells, due to the increased risk of hemorrhagic cystitis.

It should be borne in mind that the minimum level of the number of leukocytes and platelets after administration of the drug can be observed after 7-14 days. After the end of the course, the blood picture is usually restored after 21 days.

In patients with impaired renal function or urinary outflow, it is necessary to consider reducing the dose of ifosfamide, this will reduce the likelihood of an increase in the toxic effect of the drug on the central nervous system. Patients should consume enough fluids to ensure that uric acid is removed from the body. The appearance of symptoms indicating inflammation of the bladder, or blood in the urine, is the basis for the immediate discontinuation of ifosfamide therapy.

As a result of the suppression of natural defense mechanisms in the patient's body against the background of the use of the drug, it is possible to reduce the production of antibodies in response to the administration of vaccines.

Influence on the ability to drive vehicles and complex mechanisms

During the period of therapy, patients are advised to refrain from driving vehicles and working with complex mechanisms.

Application during pregnancy and lactation

The use of Ifosfamide is contraindicated during gestation and lactation.

In the course of experimental studies, the embryotoxic and teratogenic effects of ifosfamide have been proven.

During the entire period of therapy and three months after the end of treatment, women and men need to use reliable methods of contraception.

With impaired renal function

The appointment of Ifosfamide is contraindicated for the treatment of patients with severe renal impairment, cystitis, urinary tract obstruction.

For violations of liver function

It is recommended to use Ifosfamide with caution in chronic liver failure.

Use in the elderly

Ifosfamide should be prescribed with caution in elderly patients.

Drug interactions

Simultaneous use with Ifosfamide:

• drugs with myelotoxic, neurotoxic and nephrotoxic effects: a combination with these drugs may increase the side effects of Ifosfamide;
• mesna (sodium 2-mercaptoetanesulfonate): helps to reduce the nephrotoxicity of the drug;
• inducers of liver microsomal enzymes: capable of potentiating an increase in the formation of alkylating metabolites;
• hypoglycemic agents: an increase in their clinical effect should be taken into account;
• allopurinol: enhances myelosuppression;
• warfarin: Causes a decrease in blood clotting, increasing the risk of bleeding.

Against the background of therapy with Ifosfamide, the reaction of the skin to radiation increases.

Analogs

Ifosfamide analogs are Vero-Ifosfamide, Holoxan.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ifosfamide

Chemotherapy is a combination of various cytostatic drugs that suppress cell proliferation and tumor growth. It is almost impossible to assess the effectiveness and safety of a single drug in its composition. In this connection, there are no reviews about Ifosfamide.

Price for Ifosfamide in pharmacies

The price of Ifosfamide, a powder for the preparation of a solution for infusion, per package can be:

• dose 0.5 g: 1 bottle - from 300 rubles, 5 bottles - from 1500 rubles;
• dose of 1 g: 1 bottle - from 670 rubles, 5 bottles - 3175 rubles;
• dose of 2 g: 1 bottle - from 1230 rubles, 5 bottles - from 6150 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!