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testosterone blend 250mg

Testosterone blend 250mg is a multipurpose antifolate that inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide-formiltransferazu (GARFT), which are key folate-dependent enzyme in the biosynthesis of thymidine and purine nucleotides. testosterone blend 250mg enters cells via transporter of reduced folates and folate binding protein transport systems. Proceeding in a cell, testosterone blend 250mg quickly and efficiently converted to polyglutamate forms using an enzyme-folil polyglutamate synthetase. Polyglutamate forms are retained in the cells and are more potent inhibitors of thymidylate synthase (TS) and glycinamide-ribonukleotid- formiltransferazy (GARFT). Poliglutamatsiya – this process is time-dependent and concentration, which occurs in tumor cells and to a lesser degree in normal tissues. Poliglutamirovannyh metabolites have increased half-life, thus increasing effect of the drug in the tumor cells. The combined use of testosterone blend 250mg and cisplatin in vitro studies observed antitumor effect of synergy.
Standing volume of distribution equal to 16.1 liters of testosterone blend 250mg. Approximately 81% of testosterone blend 250mg bound to plasma proteins. The binding is not affected by renal failure. testosterone blend 250mg undergoes limited hepatic metabolism. From 70 to 90% of the drug excreted by the kidneys in unchanged form in the first 24 hours after administration. Total plasma clearance of testosterone blend 250mg is 92 ml / min, and the plasma half-life of 3.5 hours in patients with normal renal function.

Indications

  • Locally advanced or metastatic non-squamous non-small cell lung cancer (adenocarcinoma, large cell carcinoma).
  • Malignant pleural mesothelioma.

Contraindications

  • Hypersensitivity to testosterone blend 250mg or excipients included in the composition of the drug;
  • Pregnancy, lactation.

Dosing and Administration:
testosterone blend 250mg is administered intravenously over 10 minutes.

Locally advanced or metastatic non-squamous non-small cell lung cancer (adenocarcinoma, large cell carcinoma).

The first line of therapy. Combined treatment with cisplatin:
The recommended dose Alimta ™ drug – 500 mg / m 2 . On the first day of each 21-day cycle
Cisplatin is administered at a dose of 75 mg / m 2 on hydration background (refer to the use of cisplatin instruction.) Approximately 30 minutes after Alimta ™ drug administration on the first day of each 21-day cycle. The second line therapy. Monotherapy: The recommended dose of Alimta ™ drug – 500 mg / m on the first day of each 21-day cycle.

Malignant pleural mesothelioma.

Combined treatment with cisplatin:
The recommended dose Alimta ™ drug – 500 mg / m 2 . On the first day of each 21-day cycle
Cisplatin is administered at a dose of 75 mg / m 2 on hydration background (refer to the use of cisplatin instruction.) Approximately 30 minutes after Alimta ™ drug administration on the first day of each 21-day cycle.

Recommendations before application recommendations before the drug Alimta ™ drug Alimta ™

Dexamethasone (or equivalent) at a dose of 4 mg 2 times a day for 1 day prior to testosterone blend 250mg treatment, on the day of administration, and the subsequent day after the administration of testosterone blend 250mg reduces the incidence and severity of skin reactions. To reduce drug toxicity, patients receiving testosterone blend 250mg must 5yt assigned folate drugs or multivitamin containing folic acid in a daily dose. Folic acid at a daily dose (350 mcg to 1000 mcg, averaging 400 mg) must be administered at least 5 days, 7 days before the first administration of testosterone blend 250mg, and a dosing should continue during the entire treatment cycle and Götschen 21 days after the last Patients also testosterone blend 250mg administration must enter vitamin B12 single dose of 1000 mcg intramuscularly during 7 days before the first administration of testosterone blend 250mg and then every three cycles after the start of treatment. Subsequent administration of vitamin B12 in the same dose may be conducted on the day of testosterone blend 250mg.

Recommendations to reduce the dose
dose adjustment to repeat courses should be based on the lowest threshold of hematological parameters or maximum hematological toxicity during the previous cycle of treatment. Treatment may be delayed for the purpose of recovery from toxicity. As restoration patients must continue the treatment using the recommendations in Tables 1-3, which relate to the use of the drug Alimta ™ monotherapy or in combination with cisplatin.

Table 1. Dosage regimen of testosterone blend 250mg (as monotherapy or combination therapy) and cisplatin
Hematological toxicity

 

The minimum content of neutrophil count <500 cells / mm and the minimum platelet count> 50,000 / microliter 75% of the previous dose
The minimum platelet count <50,000 / microliter, regardless of the minimum content of neutrophils 75% of the previous dose
The minimum platelet count <50,000 / l with bleeding a , regardless of the minimum content of neutrophils 50% of the previous dose

a These criteria meet the definition of haemorrhage> Grade 2, in accordance with Generally Accepted Toxicity Criteria, Version 2 (NCI 1998)

With the development of hematological toxicities (excluding neurotoxicity)> 3 degrees (with the exception of transaminase elevations 3 degrees), testosterone blend 250mg administration should be delayed until recovery parameters corresponding to the level before treatment. Further treatment should be continued in accordance with the recommendations set out in Table 2.

Table 2: Dosage regimen of testosterone blend 250mg (as monotherapy or combination therapy) Cisplatin and
Non-hematological toxicities a, b

 

testosterone blend 250mg dose (mg / m 2 ) Cisplatin Dose (mg / m 2 )
Any toxicity of 3 to or 4 except mucositis 75% of the previous dose 75% of the previous dose
Diarrhea requiring hospitalization (regardless of degree) or diarrhea grade 3 or 4 75% of the previous dose 75% of the previous dose
Mucositis 3 or 4 50% of the previous dose 100% of the previous dose


and NCI CTC (Common Toxicity Criterion) b Excluding neurotoxicity with the exception of grade 3 transaminase levels increase

 

In the event of neurotoxicity recommended dosage adjustment testosterone blend 250mg and cisplatin displayed in Table 3. Patients should cancel treatment if observed neurotoxicity of grade 3 or 4.

Table 3. Dosage regimen of testosterone blend 250mg (as monotherapy or combination therapy) and Cisplatin
Neurotoxicity

 

The degree of toxicity testosterone blend 250mg dose (mg / m 2 ) Cisplatin Dose (mg / m 2 )
0-1 100% of the previous dose 100% of the previous dose
2 100% of the previous dose 50% of the previous dose

testosterone blend 250mg treatment should be withdrawn if the patient has hematological and Non-hematological toxicity of grade 3 or 4 doses after two drops (with the exception of transaminase elevations 3 degrees) or canceled immediately if the neurotoxicity of grade 3 or 4.

Special patient groups

Elderly: Data about the increased risk of side effects in patients 65 years and older do not. Down mode dose corresponds to the general recommendations.

Children: testosterone blend 250mg is not recommended for use in children as safety and efficacy in children has not been established.

Patients with impaired renal function: When creatinine clearance of at least 45 mL / min dose adjustment and mode of administration is required. Patients with creatinine clearance rates of less than 45 ml / min, the use of testosterone blend 250mg is not recommended (due to lack of data on the use of the drug in this patient population).

Patients with hepatic impairment: Insufficient data on the use of the drug in patients with impaired hepatic function with increased bilirubin greater than 1.5 times the upper limit of normal (ULN) or an increase in transaminase levels greater than 3 times the ULN (in the absence of metastases in the liver) or more than 5 times the ULN (in the presence of metastases in the liver).

Recommendations for solution for infusion.

1. As the solvent used only 0.9% sodium chloride solution.

2. For the infusion solution contents of the vial (500 mg) was dissolved in 20 ml of 0.9% sodium chloride (without preservatives) tso concentration of 25 mg / ml. Each vial is gently agitated until complete dissolution of the lyophilizate. The resulting solution should be clear; acceptable solution color change from colorless to yellow or greenish-yellow color. The need for additional dilution.

3. The appropriate volume of the resulting testosterone blend 250mg solution should be further diluted to 100 mL of 0.9% sodium chloride solution.

4. Prior to administration of the drug solution should be inspected for particulates and discoloration.

5. Since the solvent is recommended and testosterone blend 250mg contain no antimicrobial preservatives and the resulting solution for injection should be used within 24 hours after reconstitution when stored at 2-8 ° C or 15-25 ° C. Unused solution to be destroyed.

Side effects
Side effects observed with a single agent testosterone blend 250mg with folic acid and vitamin B12 are set out below in accordance with the following frequency: very common (> 10%), common (> 1% and <10%), infrequent (<1% and > 0.1), rarely (<0.1%).

In parentheses indicate the frequency of toxicity as a percentage of all degrees / one grade 3-4 respectively.

From hemopoiesis system: very often – leukopenia (15.2% / 5.4%), neutropenia (14.7% / 8.2%), anemia (19.2% / 4.2%); often – thrombocytopenia.

On the part of the digestive system: very often – nausea (39.2% / 2.6%), vomiting (19.6% / 2.1%), anorexia (21.9% / 1.9%), stomatitis / pharyngitis (15.4% / 1.1%), diarrhea (15.2% /0.9%), increased levels of alanine aminotransferase (ALT) (15.6% / 7.0%) and aspartattransferazy (ACT) (13.1% / 4.4 %); often – constipation, abdominal pain.

Skin and skin appendages: very often – rash / desquamation (15.9% / 0.2%); -kozhny often itching, alopecia; rarely – erythema multiforme.

On the part of the peripheral nervous system: often – sensory or motor neuropathy.

From the mochevydelitelnoy system: often – increased creatinine.

Since the cardiovascular system: rarely – supraventricular tachycardia.

Other: often – fatigue (34.0% / 5.3%); often – fever, febrile neutropenia, allergic reaction and joining secondary infection without neutropenia.

Side effects observed with the combination of testosterone blend 250mg and cisplatin with the addition of folic acid and vitamin B12 are set out below in accordance with the following frequency: very common (> 10%), common (> 1% and <10%), infrequent (<1% and> 0.1), rarely (<0.1%).

In parentheses indicate the frequency of toxicity as a percentage of all degrees / one grade 3-4 respectively.

From hemopoiesis system: very often – leukopenia (53.0% / 14.9%), neutropenia (56.0% / 23.2%), anemia (33.0% / 5.6%); thrombocytopenia (23.2% / 5.4%).

On the part of the digestive system: very often – nausea (82.1% / 11.9%), vomiting (56.5% / 10.7%), anorexia (26.6% / 2.4%), stomatitis / pharyngitis (23.2% / 3.0%), diarrhea (16.7% /3.6%), constipation (21.0% / 0.8%); often – indigestion, increased levels of alanine aminotransferase (ALT), aspartattransferazy (ACT) and gammaglyutamiltransferazy (GGT).

Skin and skin appendages: very often – rash / desquamation (16.1% / 0.6%), alopecia (11.9% / 0%).

On the part of the peripheral nervous system: very often – sensory neuropathy (10.1% / 0%), often – taste disturbance; infrequently – motor neuropathy.

From the urinary system: very often – increased creatinine (10.7% / 0.8%) decrease in creatinine clearance (16.1% / 0.6%); often – renal failure.

Cardio-vascular system: seldom – arrhythmia.

From the respiratory system: often – pain in the chest

Other: often – fatigue (47.6% / 10.1%); often conjunctivitis, dehydration, febrile neutropenia, infection, fever, urticaria.

Post-marketing data:

From the respiratory system: rarely – interstitial pneumonitis.

On the part of the digestive system: rarely – colitis.

Overdose
Anticipated complications of overdose include bone marrow suppression, manifested by neutropenia, thrombocytopenia and anemia. Also, there may be joining secondary infections, diarrhea, mucositis, rash.Treatment: symptomatic, including the immediate application of leucovorin or thymidine.

Interaction with other drugs
combined use of nephrotoxic drugs and / or substances that are excreted by the kidneys, may reduce the clearance of testosterone blend 250mg.

Results of in vitro studies indicate that testosterone blend 250mg is minimal interaction with drugs that are metabolized by CYP3A, CYP2D6, CYP2C9, CYP1A2.

Pharmacokinetics of testosterone blend 250mg is not changed by the application of folic acid inside, vitamin B12 and intramuscularly in the combined use with cisplatin. The total clearance of platinum is not affected by the use of testosterone blend 250mg.

testosterone blend 250mg can be used in conjunction with ibuprofen (400 mg four times daily) in patients with normal renal function (creatinine clearance of> 80 ml / min). In the appointment of ibuprofen together with testosterone blend 250mg in patients with mild renal or moderate impairment (creatinine clearance 45-79 ml / min) should be careful.

Patients with mild to moderate renal insufficiency gravity does not recommend the use of nonsteroidal anti-inflammatory drugs (NSAIDs) with a short half-life for 2 days before using testosterone blend 250mg in the day and application 2 days after application.

In the absence of data on the possible interaction between testosterone blend 250mg and NSAIDs with a long half-life, all patients receiving NSAIDs should interrupt their use at least 5 days before receiving testosterone blend 250mg, the day of admission and for 2 days after administration. If you want to co-administration of NSAIDs, patients requires strict monitoring of toxicity, especially myelosuppression and gastrointestinal toxicity from.

testosterone blend 250mg is incompatible with Ringer’s lactate solution and Ringer’s solution. Co-administration of testosterone blend 250mg with other medications and solutions has not been studied and is not recommended.

Special instructions:
The drug Alimta ™ should be administered under the supervision of a physician who is experienced in the use of anticancer drugs. testosterone blend 250mg can inhibit bone marrow function, as manifested neutropenia, thrombocytopenia and anemia; myelosuppression is usually dose-limiting toxicity.

Before each dose of testosterone blend 250mg is necessary to conduct a general analysis of blood leukocyte count and platelet count. To assess liver and kidney function must be periodically blood chemistry.

Before the start of the drug absolute neutrophil count should be> 1, 500 per microliter, platelets> 100,000 in ul. Appointment of folic acid and vitamin B12 reduces the toxicity of testosterone blend 250mg and the need for dose reduction with hematological and hematological Grade 3/4 toxicities such as neutropenia, febrile neutropenia and neutropenic infection with grade 3/4.

Patients with symptomatic ascites and pleurisy effusion drainage is necessary before the application of testosterone blend 250mg, as the impact of these conditions on the effect of testosterone blend 250mg is unknown.

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