Alimta 100mg Eli Lilly medicine for lung cancer, malignant pleural epithelium

Dosage form Box
Specifications Pemetrexed
Ingredient Eli Lilly & Company

Ingredient

Composition information	Content
Pemetrexed	100mg

Uses

indicated

Alimta used for treatment:

malignant pleural epithelium:

This type of cancer affects the lungs of the lungs. Alimta is used in combination with cisplatin, another anti -cancer drug (chemotherapy).

Small -cellular non -cell lung cancer:

This type of cancer is a disease in which malignant cells formed in the lung tissue. If you are initially treated for your lung cancer, Alimta can be used alone or in combination with another chemotherapy.

If this is the first time you are treated, then Alimta can be used with another anti -cancer drug, called Cisplatin. Then Alimta can be used alone.

Pharmacology

Pharmacy group: Similar substances folic acid, ATC code: l01ba04.

Alimta (Pemetrexed) is an anti -cancer anti -cancer drug targeting the target, which is effective by breaking the metabolic processes mainly dependent on folats needed for cell copying.

In vitro studies show that Pemetrexed has the effect of a folat antiviral drug aimed at the target by inhibiting thymidylate synthase (TS), dihydrofolat reductase (DHFR), and Glycinamid ribonucleotidide Formyltransferase (Garft), are key enzymes depending on Folate and purin nucleotid. Pemetrexed is transported into cells by folat reducing agents and folat -bound proteins through the membrane. Once in the cell, Pemetrexed is quickly converted and with high efficiency into polyglutamat forms by enzyme folylpolyglutamate synthetase. Polyglutamate forms are kept in cells and are also stronger TS and Garft inhibitors. Multiple glutamatization is a process of time and concentration that occurs in tumor cells, and at less, in normal tissues. The metabolites of multi-glutamate chemicals have a half-life increase in the cell, resulting in the prolongation of the effect of the drug in cancer cells.

The European Health Agency has postponed the obligation to submit Alimta's research results on all children's subgroups in the approved treatment indications (see the "Dosage and usage" section).

Clinical effect:

Please see more information about drugs in the instructions for the use of drugs attached.

Dynamic pharmacokinetics

Pemetrexed pharmacokinetic properties after using the single dose were evaluated on 426 cancer patients with dense tumors with doses from 0.2 to 838 mg/m2 transmitted in a period of 10 minutes. Pemetrexed can be distributed in equilibrium state of 9 liters/m2. In vitro studies show that Pemetrexed linked to plasma proteins is about 81%. The connection is not significantly affected by different levels of renal failure. Pemetrexed less metabolic in the liver. Pemetrexed is excreted mainly in urine, with 70% to 90% of the dose is reproduced in a constant form in the urine within the first 24 hours after transmission. In vitro studies have shown that Pemetrexed is actively excreted by OAT3 (organic transport anion). The total clearance coefficient of Pemetrexed is 91.8 ml/min and half -life eliminates from plasma is 3.5 hours in patients with normal renal function (creatinine clearance is 90 ml/min). The oscillation of clearance between patients is 19.3%. The area below the curve (AUC) of Pemetrexed and the maximum concentration in plasma increases proportional to the dose. Pemetrexed's pharmacokinetics did not change in many cycles.

Pemetrexed dynamic properties are not affected by Cisplatin simultaneously. Additional oral folic acid and intramuscular vitamin B12 does not affect the pharmacokinetics of Pemetrexed.

Before taking Alimta 100mg Eli Lilly medicine for lung cancer, malignant pleural epithelium

How to use

Caution necessary before preparing or using Alimta, see the section “Care especially in destruction and other operations.

Alimta is recommended for intravenous transmission for 10 minutes on the first day of each 21 -day cycle. See instructions on how to revert and dilute Alimta before transmitting, the section “Special prudence in destruction and other operations.

Dosage

only use Alimta under the supervision of a doctor who has experience using anti -cancer chemotherapy.

Alimta in combination with cisplatin

The recommended dose of Alimta is 500 mg/m2 of the body surface area (BSA), intravenously for 10 minutes on the first day of each 21 -day cycle. The recommended dose of cisplatin is 75 mg/m2 BSA transmitted for two hours, about 30 minutes after the infusion is complete Pemetrexed on the first day of each 21 -day cycle. Patients must receive adequate anti -vomiting therapy and appropriate water rehydration before and/or after cisplatin infusion (see more information instructions for use of cisplatin for specific dose).

Alimta used single

In patients with non -small cell lung cancer that had previously used chemotherapy, Alimta's recommended dose was 500 mg/m2 BSA, intravenously for 10 minutes on the first day of each 21 -day cycle.

Preparation before treatment

To reduce the frequency and severity of the skin reactions, it is necessary for the patient to use a corticosteroid on the previous day, the dates of infusion, and the date after the Pemetrexed infusion. Use corticosteroids with the same dose dexamethasone 4 mg orally 2 times daily (see the section "Special and cautious warning when used").

To reduce the toxicity of the drug, patients treated with Pemetrexed must use vitamin supplements (see the "Special and Caution warning"). Patients must take folic acid or a high -vitamin preparation containing folic acid (350 to 1,000 micrograms) daily. At least 5 doses of folic acid must be taken for 7 days before taking the first pemetrexed dose, and must continue to take it in the entire treatment and in 21 days after the last dose of Pemetrexed. Patients must also be intramuscularly in the first week of the first week of Pemetrexed dose and then once every 3 cycles. The next vitamin B12 injections can be on the same day as Pemetrexed.

Track

Before each Pemetrexed dose, the patient must be checked for the entire number of blood cells including leukocytes and platelets. Before each chemotherapy, it is necessary to test blood biochemistry to assess kidney and liver function. Before starting each chemotherapy cycle, patients need to meet the following requirements: The number of absolute neutrophils (ANC) must be ≥ 1,500 cells/mm3 and the number of platelets must be ≥ 100,000 cells/mm3.

Creatinine clearance must be ≥ 45 ml/min.

total bilirubin must be ≤ 1.5 times the upper limit of normal levels. Alkaline phosphatase (AP), Aspartat Aminotransaminase (AST or SGOT) and Alanin Aminotransaminase (ALT or SGPT) must be ≤ 3 times the upper limit of normal levels. Alkaline phosphatase, AST and ALT ≤ 5 times the upper limit of normal levels can be acceptable in case of metastasis to the liver.

Dose adjustment

The adjustment of the next dose at the next cycle must be based on the lowest number of blood cells or the highest toxicity on organs other than blood from the previous treatment cycle. The treatment can be postponed so that the patient has enough recovery time. When recovery, patients must be treated according to the instructions in tables 4, 5 and 6, which can be applied to Alimta used single or combined with cisplatin.

Table 4 - Alimta's dose tuning table (used or coordinated) and Cisplatin - Hematology toxicity Cisplatin) The lowest number of platelets 75% of the previous dose (both Alimta and Cisplatin) Alimta and Cisplatin)

If the patient appears to toxicity other than blood> level 3 (excluding nervous toxicity), alimta must be stopped until the remission is lower than or equal to the value before treatment of the patient. The treatment will continue to follow the instructions in Table 5.

Table 5 - Alimta's dose calibration table (used or coordinated) and cisplatin - Set of toxicity other than hematology a, b (mg/m2)

any toxicity, except for mucositis, at level 3 or 4 75% Pre -dose 75% Dosage Pre -dose Before

Inflammation of mucosa level 3 or 4 50% of the dose before 100% of the dose before

b excluded nerve toxicity.

In case of neurotoxic toxicity, adjust the dose of Alimta and Cisplatin as instructed in Table 6. The patient must stop treatment if observing nerve toxicity level 3 or 4.

Table 6. Alimta's dose calibration table (used or coordinated) and cisplatin - Neurotoxicity (mg/m2)

0-1 100% Pre-dose 100% Pre-dose 2 TD> 2 (CTC V2.0; NCI 1998).

Must stop treating with Alimta if the patient has any toxicity on the blood or in the blood level 3 or 4 after 2 dose reduction, or immediately if the nerve toxicity level 3 or 4.

Older people

In clinical research, there is no sign that patients aged 65 and over are at risk of unwanted effects than patients under 65 years old. There is no need for a mode to reduce the dose other than the recommended dose mode for all patients.

Children and teenagers

Alimta is not recommended for patients under 18 years old because they have not determined the safety and effectiveness in this group of patients. There is no data related to the use of Alimta in the group of malignant pleural epithelium children and non -small cell lung cancer.

Patients with renal impairment (Cockcroft and standard Gault or glomerular filtration speed by TE99M-DPTA serum clearance method)

Pemetrexed is excreted mainly in the form of hill by the excretion of the kidneys. In clinical studies, patients have creatinine clearance> 45ml/minute without any adjustments other than the recommended adjustment for all patients. There is no enough data on the use of Pemetrexed in patients with creatinine clearance below 45 ml/minute; Therefore, it is not recommended to use Pemetrexed (see the section "Special and cautious warning when used).

Patients with liver failure

There is no association between AST (SGOT). Alt (SGPT), or total bilirubin and pharmacokinetics of pemetrexed. However, patients with liver failure with bilirubin> 1.5 times the upper limit of normal levels and/or transaminase> 3.0 times the upper limit of normal levels (without liver metastases) or> 5.0 times the upper limit of normal level (liver base) has not been studied separately.

What to do when overdose? The foreseening complications of overdose include bone marrow inhibition with neutropenia, thrombocytopenia and anemia. In addition, there may be infections with or not accompanied by fever, diarrhea, and/or mucous inflammation.

Management: In case of an overdose, patients must monitor, check the blood formula and perform supportive therapy when needed. Consider using calcium folinat/folinic acid in the treatment of Pemetrexed overdose.

What to do when forgetting a dose?

Side Effects

Like all drugs, this drug can cause unwanted effects, although not everyone encountered.

You must contact the treating doctor immediately if you notice one of the following signs:

Fever or infection (common): If you have a fever 38oC or higher, sweat or have other signs of infection (because you may have less leukemia more than usual - this is very common). Infections (bleeding) can be severe and can lead to death. Rarely skin reactions may be severe and can lead to death.

If you get tired, feel like fainting, susceptible to shortness of breath or look pale (because your hemoglobin may be lower than usual - this is very popular). variable).

Very popular (can affect more than 1 patient out of 10 patients). (It may affect less than 1 patient out of 10,000 patients).

Unwanted effects with Alimta may include:

Very popular:

Low white leukocytes. tired.

skin rash.

Allergic reactions: Skin rash/burning. Eye).

abdominal pain.

Acute renal failure.

Tachycardia. swelling). Some patients who have had a heart attack, stroke or "mild stroke" when using Alimta regularly in combination with other cancer therapy. Alimta.

Radiosis (skin rash like heavy sunburn) may reappear on the skin that had previously been treated for radiation therapy, including days to many years after radiation therapy. red blood cells).

hepatitis.

Swelling, pain and redness in the lower limb. Must inform the treating doctor as soon as possible when you start suffering from any of these unwanted effects.

If you are worried about any adverse effects, talk to the treating doctor.

If you have any adverse effects, tell your doctor or pharmacist. Including unwanted effects that have not been listed in this user manual.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Do not use Alimta:

If you are allergic (hypersensitivity) with Pemetrexed or any other excipients of Alimta.

If you are breastfeeding; You have to stop breastfeeding during Alimta treatment.

Be cautious when using

Talk to the treating doctor or pharmacist before taking alimta.

If you are or have a kidney problem, talk to a doctor or pharmacist because you may not use Alimta.

Before each transmission, you need to take blood to assess the kidney and liver function and check if you have enough blood cells to use Alimta. The treatment doctor may decide to change the dose or postpone treatment based on your general condition and if your blood cells are too low. If you are also using cisplatin, the doctor will need to know that you have been properly rehydrated and treated appropriately before and after using cisplatin to prevent vomiting.

If you've ever or are preparing radiation, tell your doctor, because radiation can cause reactions sooner or later with Alimta.

If you have just vaccinated, tell the doctor, because this can have a bad effect when using Alimta.

If you have heart disease or have a history of heart disease, tell your doctor.

If you have fluid in the lungs, your doctor may decide to suck the fluid before using Alimta.

children and teenagers

There is no data related to the use of Alimta for children.

The effect of the drug on the ability to drive and operate machinery

Alimta can make you feel tired. Be careful when driving or operating machinery.

Using drugs for women during pregnancy and lactation

pregnancy:

If you are pregnant, or plan to get pregnant, let your doctor . Avoid using Alimta while pregnant. The treatment doctor will discuss with you the potential risks when using Alimta during pregnancy. Women need to use effective contraception during treatment with Alimta.

breastfeeding:

If you are breastfeeding, tell the doctor.

must terminate breastfeeding while treating Alimta.

Reproduction:

Men are recommended without having children in and up to 6 months after Alimta treatment and therefore need to use effective contraception during treatment with Alimta and until 6 months after treatment. If you want to have children during treatment or within 6 months after treatment, consult your doctor or pharmacist. You can use sperm storage before starting treatment.

Interactive drug

inform the treating doctor if you are taking any painkiller or anti -inflammatory (swelling), such as drugs called "non -steroid anti -inflammatory drugs" (NSAIDs), including non -prescription drugs of a doctor (such as iburoFen). There are many types of NSAIDs with different effects. Based on the time of intending to transmit Alimta and/ or based on the condition of the kidney function, the treating doctor should recommend the medication you can use and when you can use those types. If you are not sure, ask your doctor or pharmacist if any drug you are taking is NSAIDs.

Please tell your doctor or pharmacist if you are taking or just taking any medication, including non -prescribing drugs.

Storage

Do not take the drug after the expiry date indicated on the box.

Unrivaled vials: Store at a temperature not exceeding 30 ° C.

Reconcalation solution and solution for transmission: The drug should be used immediately. When prepared according to the instructions, the chemical and physical stability of the reconstitution solution and the solution for transmission has been proven for 24 hours when stored in the refrigerator (at temperatures 2 ° C - 8 ° C).

This drug is only used once; Unused solution must be handled in accordance with local regulations.

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