Universal reference book for medicines
Product name: HOLOXAN

Active substance: ifosfamide

Type: Antitumor preparation

Manufacturer: BAXTER ONCOLOGY (Germany)
Composition, form of production and packaging
Powder for the preparation of a solution for intravenous administration of
white color, crystalline.

1 f.

ifosfamide 500 mg

- "- 1 g

- "- 2 g

Vials (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Ifosfamide is an alkylating cytostat from the group of nitrogen mustard gas, an oxazaphosphorin derivative.
Antitumor activity of ifosfamide is caused by alkylation of nucleophilic centers, violation of DNA synthesis and blocking of mitotic division of tumor cells. DNA damage most often occurs in the phases G1 and G2 of the cell cycle.
PHARMACOKINETICS

After intravenous administration, the active substance, which is a prodrug (inactive transport form), is metabolized into the pharmacologically active metabolite 4 -hydroxyiphosphamide.
It is activated by enzymes (phosphoamidases) of the liver and tumor tissue. In patients with impaired liver function, activation is slowed and even reduced.
After a single intravenous injection of 5 g / m 2, the plasma concentration is reduced bioexponentially, with T 1/2 of the final phase - 15 hours and the withdrawal of 61% of the dose in unchanged form;
at lower doses (1.6-2.4 g / m 2 ) the excretion proceeds monoexponentially, with T 1/2 about 7 hours, while the proportion of unchanged drug in the urine decreases 4-5 times (12-18% of the dose).
INDICATIONS

- germinogenic tumors;

ovarian cancer;

- malignant testicular tumors;

- lung cancer;

- mammary cancer;

- pancreas cancer;

- endometrial cancer;

- cervical cancer;

- malignant lymphomas;

- soft tissue sarcomas;

osteogenic sarcomas;

- Wilms tumor;

Ewing's sarcoma.

DOSING MODE

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

The drug is injected intravenously into the drip for 30 minutes or as a 24-hour infusion.
Use a solution with a concentration of not more than 4%.
- 1.2-2.4 g / l / day for 3-5 consecutive days or a day before the total exchange rate of 10-12 g / m 2, the courses are repeated every 3 weeks;

- 3-5 g / m 2 once in 2 weeks;

- 5-8 g / m 2 as a 24-hour infusion once every 3-4 weeks or 3.2 g / m 2 / day as a 5-day continuous infusion with an interval of 3-4 weeks.

To reduce the likelihood of hemorrhagic cystitis concomitantly with ifosfamide, mesna is used in a total dose of 60% of the dose of ifosfamide.

Preparation of solution for intravenous administration

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

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

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

SIDE EFFECT

On the part of the hematopoiesis system: leukopenia, thrombocytopenia, anemia.
The lowest level of white blood cells and platelets is observed after 7-14 days, the restoration of the blood picture is usually 21 days after the end of the course.
On the part of the digestive system: nausea and vomiting;
rarely - stomatitis, a violation of liver function, usually manifested in the form of increased activity of hepatic enzymes and / or serum levels of bilirubin.
From the urinary system: hemorrhagic cystitis, dysuria, frequent urination and other symptoms of bladder inflammation (blood in the urine, painful urination), impaired renal function (increased serum creatinine and urea concentration, decreased creatinine clearance, glucosuria).
There may also be proteinuria and metabolic acidosis.
From the side of the central nervous system: disorientation, confusion, hallucinations, fatigue, agitation, encephalopathy;
less often - dizziness; rarely convulsive seizures, coma, peripheral polyneuropathy.
From the side of the reproductive system: a violation of the sexual glands (azoospermia, amenorrhea).

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

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

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

CONTRAINDICATIONS

- marked suppression of bone marrow function;

- pronounced impairment of kidney function;

- Obstruction of the urinary tract;

- Cystitis;

- Pregnancy;

- lactation;

- hypersensitivity to ifosfamidu.

With caution: hypoproteinemia, hypoalbuminemia, electrolyte imbalance, elderly 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.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in the following diseases:

- pronounced impairment of kidney function;

- Obstruction of the urinary tract.

If there is a violation of kidney function and urine outflow, it is possible to increase the frequency of the toxic effect of the drug on the central nervous system, so there may be a need to reduce the dose of ifosfamide.

To ensure the excretion of uric acid, patients should consume a sufficient amount of liquid.

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

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution: chronic hepatic insufficiency.

APPLICATION IN ELDERLY PATIENTS

Use with caution in old age.

SPECIAL INSTRUCTIONS

Before the start of treatment, it is necessary to sanitize foci of chronic infection and correct possible electrolyte imbalance.

During treatment with the drug, it is necessary to regularly monitor the peripheral blood picture (especially paying attention to the number of neutrophils and platelets), laboratory indicators of liver function, kidney function, and regularly conduct urinalysis for erythrocytes, 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.

If there is a violation of the kidney function and urine outflow, it is possible to increase the frequency of the toxic effect of the drug on the central nervous system, so there may be a need to reduce the dose of ifosfamide.

To ensure the excretion of uric acid, patients should consume a sufficient amount of liquid.

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

In the treatment with ifosfamide, the suppression of natural defense mechanisms is possible, 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 manage mechanisms

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

Symptoms: faster development and a sharp manifestation of major side effects.

Treatment : symptomatic, with obligatory use mesna.

DRUG INTERACTION

When used simultaneously with drugs that cause myelotoxic, neurotoxic and nephrotoxic effects, side effects may be increased.

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

With simultaneous use increases the hypoglycemic effect of antidiabetic drugs.

Allopurinol increases myelosuppression.

Mesna reduces nephrotoxicity.

Ifosfamide can enhance the skin's reaction to irradiation.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored at a temperature of no higher than 25 ° C in places inaccessible to children.
Shelf life - 5 years
The prepared solution must be used within 24 hours (stored at a temperature not exceeding 8 ° C).

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