Alkeran - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Alkeran

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 3680 rub.

Buy

Alkeran is an antineoplastic drug.

Release form and composition

• Film-coated tablets: almost white or white, round, biconvex, with the inscription "GX EH3" on one side, and "A" on the other; the core of the tablet is almost white or white (25 pieces in dark glass bottles, 1 bottle in a cardboard box);
• Lyophilized powder for solution for injection: white or almost white mass without visible particles when dissolved; solvent - a transparent colorless liquid with the smell of alcohol (50 mg in glass bottles, in a cardboard box 1 bottle complete with 1 bottle of solvent (10 ml) in a plastic case).

1 tablet of Alkeran contains:

• Active ingredient: melphalan - 2 mg;
• Auxiliary components: colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose;
• Sheath: White opadry YS-1-18097-A (titanium dioxide, hypromellose, macrogol).

1 bottle with lyophilized powder for solution for injection contains:

• Active ingredient: melphalan (in the form of hydrochloride) - 50 mg;
• Auxiliary components: hydrochloric acid, povidone K12.

Solvent composition: ethanol, propylene glycol, sodium citrate, water for injection.

Indications for use

Film-coated tablets

• Multiple myeloma;
• Widespread ovarian adenocarcinoma;
• Breast carcinoma;
• Polycythemia vera.

Lyophilized powder for solution for injection

• Advanced ovarian cancer;
• Multiple myeloma;
• Localized sarcoma of soft tissues of the extremities;
• Localized limb melanoma;
• Common neuroblastoma in children.

Contraindications

• Breastfeeding period;
• Individual intolerance to melphalan.

During pregnancy, especially the first trimester, the use of Alkeran should be avoided, except in cases that threaten the life of the mother.

Method of administration and dosage

Alkeran should be prescribed by an oncologist with experience in the treatment of malignant neoplasms with cytotoxic drugs.

Film-coated

tablets Tablets are taken orally, swallowing whole.

The dose and the period of treatment are prescribed by the doctor based on clinical indications.

Since the absorption of melphalan can vary, the dose can be gradually increased to provide a therapeutic concentration of the drug until signs of myelosuppression appear.

Recommended dosage:

• Multiple myeloma: the daily dose is prescribed at the rate of 0.15 mg per 1 kg of patient weight, it should be divided into several doses per day, the course is 4 days. The course of treatment is repeated at intervals of 6 weeks;
• Ovarian adenocarcinoma: 0.2 mg per 1 kg per day, the duration of one course is 5 days, treatment is alternated with a break of 4-8 weeks or based on clinical indications of restoration of bone marrow function;
• Breast carcinoma: 0.15 mg per 1 kg of body weight or 6 mg per 1 m ² of the patient's body surface per day, the duration of one course is 5 days, the courses are repeated every 6 weeks. If necessary, reduce the toxic effect on bone marrow hematopoiesis, reduce the dose;
• True polycythemia: induction of remission - 6-10 mg per day for 5-7 days, then the dose is reduced to 2-4 mg per day. The dosage regimen for maintenance therapy is 2-6 mg once a week.

Lyophilized powder for preparation of a solution for injection A

ready-made solution from a lyophilized powder is used for intravenous (IV) and, in exceptional cases, intra-arterial (IV) administration (using regional arterial perfusion).

Due to the limited stability, the solution is prepared before direct administration at room temperature by simultaneously adding 10 ml of solvent to the vial with lyophilized powder and vigorously shaking until completely dissolved. The content of anhydrous melphalan in 1 ml of the resulting solution is 5 mg with a pH level of about 6.5.

For additional dilution of the solution, it is recommended to use only 0.9% sodium chloride solution for injection. Alkeran must not be mixed with solutions containing dextrose!

Solution stability decreases: at temperatures above 25 ° C; subsequent dilution in an infusion solution; the passage of more than 1.5 hours from the moment of preparation of the solution to the completion of its administration. In case of turbidity or crystallization of the solution, it should be destroyed.

The introduction can be made in peripheral and central veins, for high doses of the drug, it is recommended to use the central veins, extravasation should not be allowed.

The intravenous solution must be injected slowly against the background of a rapid drip of another solution.

The use of Alkeran's solution is indicated as monotherapy and in combination with other cytotoxic agents, in some cases prednisolone is additionally prescribed.

Recommended dosage:

• Multiple myeloma: in combination with cytostatics - 8-30 mg per 1 m ² of the patient's body surface with an interval of 2-6 weeks; monotherapy - 16 mg per 1 m ² (0.4 mg per 1 kg of body weight) once every 4 weeks. Re-introduction is indicated only when the peripheral blood parameters are restored during this period. High-dose therapy - a single dose of 100-200 mg per 1 m ² (2.5-5.0 mg per 1 kg). After the introduction of doses exceeding 140 mg per 1 m ², the patient needs autologous bone marrow transplantation. With renal failure, the dose is reduced by 50%;
• Ovarian adenocarcinoma: monotherapy - 1 mg per 1 kg of body weight (approximately 40 mg per 1 m ²) once every 4 weeks; in combination with cytostatics - 0.3-0.4 mg per 1 kg (12-16 mg per 1 m ²) 1 time in 4-6 weeks;
• Progressive neuroblastoma in children: with monotherapy, combination with cytostatics and / or radiation therapy (under the protection of autologous bone marrow) - 100-240 mg per 1 m ² once or dividing it into 3 administration procedures for 3 consecutive days.

For soft tissue sarcoma and malignant melanoma, intravenous administration of Alkeran using hyperthermic regional perfusion is indicated.

It is possible to use high doses of the drug in elderly patients only with normal functioning of internal organs and a satisfactory general condition of the patient.

With moderate and severe renal failure, the initial dose should be reduced by 50%, the dose for repeated administration should be selected taking into account the degree of bone marrow suppression. In therapy with high doses of the drug, the need for dose adjustment depends on the degree of functional impairment of the kidneys, the therapeutic purpose and on whether autologous bone marrow stem cells are infused. Usually, with creatinine clearance (CC) of 30-50 ml / min, the dose is reduced by 50%, treatment is accompanied by the introduction of a sufficient amount of fluid and forced diuresis. When CC is less than 30 ml / min, high doses of Alkeran are not recommended to be prescribed.

Side effects

• Hematopoietic system and lymphatic system: very often - inhibition of bone marrow hematopoiesis, thrombocytopenia, leukopenia; rarely - hemolytic anemia;
• Immune system: rarely - allergic reactions (skin rash, itching, urticaria, edema, anaphylactic shock, more often with parenteral therapy), cardiac arrest;
• Respiratory system: rarely - pulmonary fibrosis, interstitial pneumonia (up to death);
• Digestive system: very often - nausea, vomiting, diarrhea; against the background of high-dose therapy - stomatitis; rarely - liver damage, increased activity of functional liver tests, hepatitis, jaundice, against the background of standard doses - stomatitis, veno-occlusive disease (after high-dose therapy);
• Dermatological reactions: very often - alopecia on the background of high-dose therapy, often - alopecia at standard doses; rarely - pruritus, maculopapular rash;
• Urinary system: often - an increase in the level of urea in the blood (with impaired renal function in patients with multiple myeloma);
• Other reactions: very often - a tingling sensation and / or heat upon parenteral administration.

special instructions

Immunization with a live vaccine while using melphalan is not recommended, since there is a risk of infection in patients with weakened immunity.

Alkeran's solution should be slowly injected into the central vein or through a special closure access in the infusion system against the background of rapid infusion. Extravasation can cause local damage to tissues and surrounding vessels; therefore, direct injection into a peripheral vein is not desirable.

Intravenous administration of high-dose therapy is carried out only in specialized centers, under the supervision of experienced specialists, subject to the general satisfactory condition of the patient and adequate function of his organs. Patients are shown complex supportive and prophylactic treatment, including antibacterial drugs and, if necessary, blood components.

Due to the risk of increased toxic effects on the bone marrow, caution is required when using Alkeran in patients who have recently undergone radiation or chemotherapy.

Since melphalan can cause the development of leukemia, when prescribing it, the expected effect of the drug should be compared with the risk of developing leukemia.

The myelosuppressive effect of the drug requires accompanying treatment with regular monitoring of laboratory parameters of the number of blood cells. Based on these data, during therapy, regular correction or postponement of the administration of the next dose of the drug is performed in order to reduce the likelihood of irreversible bone marrow aplasia and the development of excessive myelosuppression.

The first signs of a sharp decrease in the number of platelets or leukocytes are the basis for a temporary cessation of treatment, since the process of a decrease in the number of blood cells may continue after the drug is discontinued.

During the period of using the drug in the form of a solution or tablets by one of the partners, it is necessary to use reliable methods of contraception.

The use of Alkeran requires compliance with the rules provided for the safe handling of cytostatics. The preparation of the solution should take place under the supervision of an experienced specialist, in an isolated room, in a special laboratory cabinet with a vertical hood, under aseptic conditions. For the procedure, the medical staff must be dressed in sterile clothing and equipped with a disposable apron, gloves (made of high-quality PVC or surgical latex, but not rubber), a surgical mask and safety glasses, thoroughly washed with water after each use.

In case of accidental splashing, the solution is immediately collected with damp paper towels, which are then sent for disposal in a hazardous waste container. The surface is thoroughly washed with water.

If the solution gets on the skin, wash it off thoroughly with cold water and soap and consult a doctor.

If the solution gets on the mucous membrane of the eyes, they should be immediately washed with sodium chloride solution for the eyes or with plenty of water, and immediately consult a doctor.

The use of tablets requires the patient to follow the rules for handling cytostatics. The danger is posed by a tablet with a broken outer shell, it is strictly forbidden to break melphalan tablets.

The medical staff must comply with the requirements for the destruction of solution, tablets, ampoules and procedural instruments (syringes, needles, infusion systems).

Drug interactions

Simultaneous intravenous administration of high doses of melphalan with nalidixic acid in children is contraindicated, since this causes the development of hemorrhagic enterocolitis with a fatal outcome.

Administration of cyclosporine after hematopoietic stem cell transplantation and intravenous administration of melphalan in high doses causes renal dysfunction.

Analogs

Alkeran analogs are: Sarcolysin, Melphalan.

Terms and conditions of storage

Store in a dark place at a temperature: tablets - 2-8 ° C, lyophilized powder - up to 30 ° C. Keep out of the reach of children.

Shelf life: tablets - 2 years; lyophilized powder - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Alkeran: prices in online pharmacies

Drug name Price Pharmacy

Alkeran 2 mg film-coated tablets 25 pcs. 3680 RUB Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!