Holoxan [Ifosfamide]

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Available since: 2019-09-19

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Clinical Pharmacology

Ifosfamide is an alkylating cytostatic from the nitrogen mustard group, derived from oxazaphosphorins. The antitumor activity of ifosfamide is due to the alkylation of nucleophilic centers, the violation of DNA synthesis and the blocking of mitotic division of tumor cells. DNA damage most often occurs in the G1 and G2 phases of the cell cycle.

Pharmacokinetics

After iv administration, the active substance, which is a prodrug (inactive transport form), is metabolized to a pharmacologically active metabolite 4-hydroxyphosphamide. It is activated by enzymes (phosphoamidase) of the liver and tumor tissue. In patients with impaired liver function activation is slowed down and even reduced.

After a single IV the introduction of 5 g / m² plasma concentration decreases bioexponentially, with T_1/2 the final phase is 15 hours and the removal of 61% of the dose in unchanged form; with smaller doses (1.6-2.4 g / m²) excretion proceeds mono-exponentially, with T_1/2 about 7 hours, while the proportion of unchanged drug in the urine is reduced by 4-5 times (12-18% of the dose).

Indications

Germ cell tumors;
ovarian cancer;
malignant testicular tumors;
lung cancer;
mammary cancer;
pancreas cancer;
endometrial cancer;
cervical cancer;
malignant lymphomas;
soft tissue sarcoma;
osteogenic sarcomas;
Wilms tumor;
Ewing's sarcoma.

Composition

1 bottle contains:

Active items: ifosfamide 1 g

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Dosage and Administration

Ifosfamide is a part of many chemotherapy regimens, and therefore the choice of the regimen and doses in each individual case should be guided by the data of special literature.

The drug is injected into / into the drip for 30 minutes or as a 24-hour infusion. Use a solution with a concentration of not higher than 4%.

1.2-2.4 g / l / day for 3-5 days in a row or every other day up to a total course dose of 10-12 g / m² Courses repeated every 3 weeks;
3-5 g / m² 1 time in 2 weeks;
5-8 g / m² in the form of a 24-hour infusion 1 every 3-4 weeks or 3.2 g / m²/ day in the form of a 5-day continuous infusion with an interval of 3-4 weeks.

To reduce the likelihood of hemorrhagic cystitis along with ifosfamide, use the drug mesna in a total dose of 60% of the dose of ifosfamide.

Preparation of solution for on / in the introduction

The powder in the vial is dissolved in water for injection to obtain a concentration of 40 mg / 1 ml.

For intravenous injection for 30 minutes, the resulting solution is diluted in 500 ml of a 0.9% sodium chloride solution, Ringer's solution or 5% dextrose solution.

For the introduction of the drug in the form of a 24-hour infusion, the resulting solution of the drug is diluted in 3 liters of a 0.9% solution of sodium chloride or 5% solution of dextrose. Ifosfamide and mesna can be mixed in the same solution for infusion.

Adverse reactions

From the hemopoietic system: leukopenia, thrombocytopenia, anemia. The lowest level of the number of leukocytes and platelets is noted in 7-14 days, the restoration of the blood picture usually occurs 21 days after the end of the course.

From the digestive system: nausea and vomiting; rarely, stomatitis, an abnormal liver function, usually manifested as an increase in liver enzyme activity and / or serum bilirubin level.

From the urinary system: hemorrhagic cystitis, dysuria, frequent urination and other symptoms of inflammation of the bladder (blood in the urine, painful urination), impaired kidney function (increased serum creatinine and urea concentrations, reduced creatinine clearance. glycosuria). Proteinuria and metabolic acidosis may also occur.

From the side of the central nervous system: disorientation, confusion, hallucinations, fatigue, agitation, encephalopathy; less often - dizziness; rarely, seizures, coma, peripheral polyneuropathy.

From the reproductive system: dysfunction of the sex glands (azoospermia, amenorrhea).

From the skin and skin appendages: reversible alopecia, photosensitivity.

Local reactions: redness, swelling, or pain at the injection site.

Other: cardiotoxic action, immunosuppression, infectious complications, slow wound healing, pulmonary symptoms (cough or shortness of breath), fever, allergic reactions.

Contraindications

Carefully: hypoproteinemia, hypoalbuminemia, electrolyte imbalance, advanced age, immunosuppression, diabetes mellitus, chronic liver failure, brain metastases, cerebral symptoms, chicken pox (including recently transferred or after contact with the sick), herpes zoster, acute infectious diseases.

Drug interactions

With simultaneous use with drugs that cause myelotoxic, neurotoxic and nephrotoxic effects, increased side effects are possible.

When combined with inducers of liver microsomal enzymes, it is possible to increase the formation of alkylating metabolites.

With simultaneous use enhances the hypoglycemic effect of antidiabetic drugs.

Allopurinol enhances myelosuppression.

Mesna reduces nephrotoxicity.

Ifosfamide may enhance skin reaction to radiation.

Simultaneous use of warfarin can lead to a decrease in blood clotting and an increased risk of bleeding.

Pregnancy and Lactation

The drug is contraindicated in pregnancy and lactation.

Special instructions

Before treatment, rehabilitation of foci of chronic infection and correction of possible electrolyte imbalance is necessary.

During drug treatment, it is necessary to regularly monitor the picture of peripheral blood (especially paying attention to the number of neutrophils and platelets), laboratory indicators of liver and kidney function, and regularly conduct urinalysis for red blood cells, the appearance of which may precede the development of hemorrhagic cystitis.

Women and men during treatment and within 3 months after the end of therapy with ifosfamide should use reliable methods of contraception.

In case of impaired renal function and urine outflow, it is possible to increase the frequency of the toxic effect of the drug on the CNS, and therefore it may be necessary to reduce the dose of ifosfamide.

To ensure the removal of uric acid patients should consume enough fluid.

When the first signs of bladder inflammation or blood appear in the urine, therapy with ifosfamide should be stopped.

When treatment with ifosfamide, it is possible to suppress the natural defense mechanisms, the production of antibodies in the patient's body in response to the introduction of vaccines may be reduced.

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

During therapy with Holoxan, nausea and vomiting may occur, as well as phenomena of encephalopathy, which may affect the ability to drive or work with other mechanisms. Therefore, you should refrain from driving and other vehicles. It should also not work with electrical tools and mechanisms.