Gemcitabine-Teva, 1000 mg lyophilizate

.

Indications

– Non-small cell lung cancer

– Pancreatic cancer

– Bladder cancer

– Breast cancer

– Locally advanced or metastatic cervical cancer

Gemcitabine in monotherapy or in combination with other antitumor agents also shows activity in ovarian cancer, locally advanced small cell lung cancer, and locally advanced refractory testicular cancer.

Active ingredient

Composition

1 vial contains:

The active ingredient:

gemcitabine hydrochloride anhydrous 1140 mg in terms of gemcitabine – 1000 mg;

Auxiliary components: mannitol, sodium acetate trihydrate, hydrochloric acid and/or sodium hydroxide for pH.

How to take, the dosage

Intravenous drip for 30 minutes.

Non-small cell lung cancer

Monotherapy: Recommended dose is 1000 mg/m2 on days 1, 8 and 15 of each 28-day cycle.

Combination therapy with cisplatin: recommended dose is 1250 mg/m2 on days 1 and 8 of each 21-day cycle or 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle.

Cisplatin is administered at a dose of 70 mg/m2 on day 1 of the cycle against a water load after the gemcitabine infusion.

Combination therapy with carboplatin: Recommended dose is 1000 mg/m2 or 1200 mg/m2 on days 1 and 8 of each 21-day cycle. Carboplatin is administered at an AUC (area under the concentration-time curve) of 5.0 mg/mL*min on day 1 of the cycle after gemcitabine infusion.

Breast cancer

Combination therapy: As 1st-line therapy for disease progression after neoadjuvant therapy including anthracyclines, the recommended dose is 1250 mg/m2 on days 1 and 8 combined with paclitaxel, which is administered after gemcitabine at a dose of 175 mg/m2 on day 1 of each 21-day cycle by IV drip for approximately 3 hours.

Urothelial cancer

Monotherapy: the recommended dose is 1250 mg/m2 on days 1, 8, and 15 of each 28-day cycle.

Combination therapy: recommended dose is 1000 mg/m2 on days 1, 8, and 15 in combination with cisplatin, which is administered at a dose of 70 mg/m2 immediately after gemcitabine infusion on day 1 or day 2 of each 28-day cycle.

Ovarian cancer

Monotherapy: the recommended dose is 800-1250 mg/m2 on days 1, 8, and 15 of each 28-day cycle.

Combination therapy: recommended dose is 1000 mg/m2 on days 1 and 8 in combination with carboplatin at an AUC of 4.0 mg/mL*min administered immediately after gemcitabine infusion on day 1 of each 21-day cycle.

Pancreatic cancer

Monotherapy: the recommended dose is 1000 mg/m2 once weekly for 7 weeks, followed by a one-week break. Gemcitabine-Teva is then administered on days 1, 8, and 15 of each 28-day cycle.

If hematologic toxicity develops during the therapy cycle, the dose of Gemcitabine-Teva may be reduced or its administration delayed according to the following guidelines:

Dose modification of gemcitabine used in monotherapy or in combination with cisplatin in the treatment of bladder cancer, non-small cell lung cancer, and pancreatic cancer

ANR (absolute number of neutrophils) (in 1 µl)

Platelet count (in 1 µl)

%

of the standard dose

over 1000

and

over

100

Interaction

Gemcitabine Teva has a radiosensitizing effect, so if the drug is used against a background of radiation therapy, increased radiation reactions can be expected.

It reduces antibody production and increases side effects if inactivated or live viral vaccines are used at the same time (the interval between the use of the drugs should be 3 to 12 months).

Special Instructions

Treatment with Gemcitabine Teva should only be performed under the supervision of a physician experienced in the use of anti-tumor chemotherapy.

The number of platelets, leukocytes and neutrophils in the blood should be monitored before each administration of the drug. In case of signs of inhibition of bone marrow function it is necessary to stop treatment or adjust the dose. Periodic assessment of renal and hepatic function should be carried out.

Lengthening the duration of infusion and the frequency of infusions leads to increased toxicity.

The administration of Gemcitabine Teva for liver metastases, a history of hepatitis and alcoholism, and cirrhosis increases the risk of hepatic failure.

In case of the first signs of hemolytic-uremic syndrome, treatment with Gemcitabine Teva should be stopped.

In patients with lung cancer or lung metastases, there is an increased risk of respiratory side effects.

In case of the first signs of pneumonitis or lung infiltrates, treatment with Gemcitabine Teva should be stopped.

Gemcitabine Teva can be started after acute radiation reactions have resolved or not earlier than 7 days after completion of radiation therapy.

Women and men should use reliable contraception during treatment with Gemcitabine Teva and for at least 6 months after.

Contraindications

-pregnancy and lactation

Side effects

Adverse reactions are classified according to the recommendations of the World Health Organization: very frequently, at least 10%; frequently, at least 1% but less than 10%; infrequently, at least 0.1% but less than 1%; rarely, at least 0.01% but less than 0.1%; very rarely (including isolated cases), less than 0.01%.

Hematopoietic organs: very common – leukopenia, neutropenia, thrombo-cytopenia, anemia; frequent – febrile neutropenia; very rare – thrombocytosis, microangiopathic hemolytic anemia (rapid decrease of hemoglobin with accompanying thrombocytopenia, increased serum concentration of bilirubin, creatinine, urea nitrogen or increased lactate dehydrogenase (LDH) activity).

Digestive system disorders: very common – nausea, vomiting, increased activity of “hepatic” transaminases, alkaline phosphatase; common – anorexia, diarrhea, constipation, stomatitis, ulceration of the oral mucosa, increased bilirubin concentration; rare – increased activity of gamma-glutamintransferase; frequency cannot be estimated on the basis of available data – toxic liver damage, including liver failure, ischemic colitis.

Urinary system disorders: very common – mild hematuria and proteinuria; frequency cannot be estimated on the basis of available data – acute renal failure, hemolytic-uremic syndrome (microangiopathic hemolytic anemia, thrombocytopenia and acute renal failure).

Skin and skin appendages: very common – alopecia; rare – scaling, blistering and ulceration, increased sweating; very rare – severe skin desquamation, bullous skin rash.

The respiratory system: very often – shortness of breath; often – cough, rhinitis; infrequently – bronchospasm, interstitial pneumonitis, pulmonary edema; rarely – acute respiratory distress syndrome.

Cardiovascular system: rare – decreased blood pressure (BP), myocardial infarction; the frequency cannot be estimated on the basis of available data – heart failure, arrhythmia (mainly supraventricular).

Nervous system disorders: often – headache, drowsiness, insomnia, paresthesias; rarely – cerebral circulation disorders, including stroke.

Allergic reactions: very common – skin rash accompanied by itching; very rare – anaphylactic reactions; the frequency cannot be estimated on the basis of available data – Lyell syndrome, Stevens-Johnson syndrome.

Musculoskeletal system: often – back pain, myalgia.

Others: very often – feeling of malaise, flu-like syndrome, peripheral edema (usually subsides after discontinuation of treatment); often – increased body temperature, chills, asthenia; infrequently – swelling of the face; rarely – reaction at the injection site; very rarely – peripheral vasculitis, gangrene.

Overdose

Symptoms: myelosuppression, paresthesias, pronounced skin rash.

Treatment: there is no specific antidote. If overdose is suspected, the patient should be under constant medical control, including blood counts; if necessary, symptomatic treatment is administered.

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