Oxaliplatin powder for solution for infusions 5 mg/ml. №1 vial

Description

Oxaliplatin composition
The main substance in the composition is oxaliplatin 50 mg, lactose is designated as an auxiliary component in the composition.

Release form
The drug is produced in the form of a lyophilisate for preparing a solution for infusion; it is a compact mass or fragments of a porous mass of almost white color.
One carton pack contains one bottle of colorless glass 100 mg.

Pharmacological properties
Oxaliplatin is an anticancer drug that also has cytostatic, immunosuppressive, and alkylating effects targeting various types of tumors.

Indications
The drug is used in the adjuvant therapy of stage III colorectal cancer in combination with fluoropyrimidine agents and for the treatment of metastatic colorectal cancer.
Oxaliplatin is also used as a second-line drug for ovarian cancer.

Contraindications
The drug is contraindicated in:

• hypersensitivity to constituent substances;
• peripheral sensory neuropathy with dysfunction before the start of the first course of treatment;
• inhibition of bone marrow functions before the start of the first course of treatment (thrombocytopenia <100 x 109 / l or neutropenia 2 x 109 / l);
• in childhood;
• severe impairment of the functional activity of the kidneys, if creatinine clearance is <30 ml / min.

Children
Not for use in pediatrics.

Application during pregnancy and lactation
The use of the drug during pregnancy is possible only if absolutely necessary and if the benefit to the mother significantly outweighs the risk to the fetus. During breastfeeding, the drug is contraindicated for use.

Method of administration and dosage
The drug Oxaliplatin is administered mainly before 5-fluorouracil (fluoropyrimidines) by long-term (within 2-6 hours) infusion into the central or peripheral veins.
In the adjuvant therapy of colorectal cancer and in the treatment of metastatic colorectal cancer, the recommended dose of the drug is 85 mg / m2 with an interval of 2 weeks, a total of 12 courses or 130 mg / m2 once every 3 weeks. The duration of treatment is six months.
The dosage can be adjusted depending on how the patient tolerates the drug.
To dissolve the lyophilized powder, it is necessary to add 10 ml of 5% glucose solution or water for injection to the bottle (50 mg), respectively, to the bottle (100 mg) – 20 ml of 5% glucose solution or water for injection, to obtain a solution (concentration of oxaliplatin 5 mg / ml). The solution should be transparent, without any mechanical impurities. The prepared solution is injected into a 5% glucose solution (250-500 ml).
During the preparation of the solution, do not use components and products that contain aluminum or alkali (parts of infusion systems, needles containing aluminum). The infusion systems should be flushed after use, as the oxaliplatin solution is not recommended to be mixed with other infusion media.

Overdose
An overdose of the drug can cause an increase in the manifestations of side effects. In this case, symptomatic treatment should be applied.

Side effects
When using the drug, side effects such as anemia, thrombocytopenia, neutropenia, leukopenia, hemolytic uremic syndrome, lymphopenia, sepsis, diarrhea, vomiting, nausea, stomatitis, constipation, abdominal pain, anorexia, dyspepsia, taste disturbance, gastroesophageal reflux are possible , bowel obstruction, hiccups, bowel obstruction, pancreatitis, colitis, and gastrointestinal bleeding.
Also, disturbances from the outside of the psyche and the nervous system are possible: depression, nervousness, insomnia, peripheral sensory neuropathy, sensory disturbances, headache, dizziness, meningism, loss of deep tendon reflexes, motor nerve neuritis, dysarthria, Lermitte’s symptom and reverse posterior leukoencephalopathy syndrome.
Administration of the drug can cause: dehydration, changes in blood glucose levels, back and bone pain, metabolic acidosis, arthralgia, epistaxis, hematuria, bleeding, deep vein thrombophlebitis, arterial hypertension and pulmonary embolism, dermatological reactions, exfoliative skin lesions, alopecia, skin and erythematous rashes, excessive sweating and nail changes.
On the part of the respiratory system, hearing and visual organs, the use of the drug can lead to shortness of breath, interstitial lung disease (even fatal), cough, pulmonary fibrosis, deafness, ototoxic effects, visual impairment, conjunctivitis, temporary loss of vision, optic neuritis.
From the urinary system and kidneys, hematuria, dysuria, painful and frequent urge to urinate are possible.
Also, the drug can cause rhinitis, infections, including acute respiratory infections, reactions at the injection site (inflammation, pain, swelling, flushing and thrombosis).

Storage conditions and periods
The drug should be stored in its original packaging at temperatures up to + 25 ° C, the storage place should not be accessible to children.
Expiration date 36 months.
The prepared solution must be used immediately.