Алкеран

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Алкеран

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Алкеран

What is Алкеран?

Алкеран (Alkeran) is a specialized, prescription-only medication used as a powerful cytotoxic agent in chemotherapy. Its active component is the synthetic chemical substance Melphalan.

Property Description
Active ingredient Melphalan (INN)
Pharmacological class Alkylating Agent, Cytotoxic Agent
Origin Synthetic compound (Nitrogen Mustard derivative)
Form Oral Tablet, Powder for IV Injection/Infusion
Status Prescription-only (Rx)

Алкеран: Classification as a Nitrogen Mustard Alkylating Agent

Алкеран is a recognized brand name for the generic drug Melphalan, which is classified as an antineoplastic agent of the alkylating agent class. This group of chemotherapy drugs, including the nitrogen mustard derivatives, has been clinically recognized as a standard component of systemic cancer treatment. The drug is a synthetic compound derived from L-phenylalanine, a feature that distinguishes it from generic nitrogen mustards.

Pharmacological studies confirm that the activity of Melphalan is based on its ability to directly target and chemically modify the DNA within a cell's genome, leading to a strong cytotoxic effect. This established mechanism is crucial for its typical use in intensive regimens, such as conditioning before hematopoietic stem cell transplants.

Composition, Forms, and General Therapeutic Purpose

The active component, Melphalan, is offered as a single-ingredient product in two distinct drug forms to provide flexibility in clinical use. It is available as an oral tablet for administration by mouth and as a sterile powder for solution for injection/infusion for intravenous use.

The general therapeutic purpose of Алкеран is to deliver its potent cytotoxic effect throughout the body. By interfering with the replication of abnormal cells, the medication helps to control the proliferation of malignant disease. Melphalan is a cornerstone agent in protocols used to manage conditions like multiple myeloma, confirming its critical role in reducing the overall burden of disease.

What side effects are possible with Алкеран?

Possible side effects and safety information

The safety profile of Melphalan (Алкеран), a cytotoxic alkylating agent, is defined by regulatory documents based on the classification of observed adverse reactions. The most notable safety pattern is dose-limiting myelosuppression, which involves the suppression of blood cell production.

Frequency and System Classification

Adverse reactions are classified by frequency, with specific effects grouped by the affected System Organ Class. The most frequent reactions are classified as Very Common (ge 1/10):

Classification Representative Adverse Reactions
Blood and Lymphatic Leukopenia, Thrombocytopenia, Anemia
Gastrointestinal Nausea, Vomiting, Diarrhea
General Disorders Fatigue, Pyrexia (fever)

Less frequent, or Rare (ge 1/10,000 to < 1/1,000), reactions affecting other systems include pulmonary fibrosis, interstitial pneumonitis, and severe hypersensitivity reactions, including anaphylaxis. Hepatobiliary disorders such as jaundice and hepatic veno-occlusive disease are documented as Uncommon.

Serious Adverse Reactions and Constraints

Regulatory safety information documents severe bone marrow depression, which may lead to infection or bleeding, as a serious consequence. A critical long-term concern is the documented risk of secondary malignancies, such as acute leukemia and myelodysplastic syndrome, which is noted to increase with the chronicity of treatment and cumulative dose.

Specific safety considerations exist for certain populations. Renal impairment may require caution and potential dose adjustment, as drug clearance can be reduced. Use during pregnancy is contraindicated due to the documented risk of fetal harm. Furthermore, Melphalan is classified as leukemogenic and mutagenic in humans, and the timing of maximum bone marrow depression (nadir) is expected to occur approximately 2 to 3 weeks following administration.

Overdose and Emergency Response

Manifestations and Severe Outcomes

The most significant toxicity documented in regulatory sources following Алкеран (Melphalan) overdosage is marked bone marrow suppression, which manifests as severe hematologic abnormalities, including leukopenia, thrombocytopenia, and anemia. Excessive dose levels are also associated with severe gastrointestinal toxicity, potentially involving mucositis, colitis, severe diarrhea, and gastrointestinal hemorrhage. Overdosage carries a risk of potentially irreversible and life-threatening outcomes, specifically irreversible bone marrow aplasia or failure, which may result in severe infection or critical bleeding. Cardiac arrest has been reported rarely in association with severe hypersensitivity reactions.

Emergency Action and Supportive Management

Regulatory documents mandate that immediate medical advice or contacting a healthcare professional immediately must occur following any suspected overdosage. Urgent medical attention is required for observed signs of irreversible bone marrow failure or its severe complications. Treatment is defined as symptomatic and supportive, since no specific antidote is known. Careful and continuous monitoring of blood counts is essential, as these counts may continue to fall even after the cessation of the drug. Special consideration applies to patients with moderate renal impairment in high-dose scenarios, who may require a dose reduction due to documented increased toxicity risk.

Therapeutic Uses of Алкеран

What Алкеран Treats: Main Uses and Benefits

Алкеран (Melphalan) is commonly used to help with symptomatic relief and supportive therapeutic benefit in situations involving certain distressing symptoms. It is applied across domains where additional symptomatic support is needed. It is considered relevant in conditions involving episodic or fluctuating manifestations, and is commonly used across conditions presenting with acute episodes.

Supportive Symptom Management

This medication is generally used in clinical settings that involve acute or unstable symptom patterns, particularly during episodes where symptoms become more noticeable or sudden. It is applied when symptom clusters create noticeable interference with daily comfort, providing support that helps ease the overall symptom burden. This supports general well-being during symptomatic phases.

It assists with managing symptoms that may become intense or disruptive, and is relevant for easing the overall symptom load. It may assist with maintaining functional stability when symptoms are more noticeable. This supportive approach is applied across therapeutic domains where short-term symptomatic assistance is appropriate.


Quick Fact: Relief for Symptoms that interfere with daily functioning

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Alkeran (Melphalan)

This section outlines the population eligibility and non-eligibility requirements for Alkeran, strictly based on official government regulatory documents.


Populations That Must NOT Use Melphalan (Contraindicated)

Melphalan is contraindicated and must not be used in:

  • Individuals with a known hypersensitivity or severe allergic reaction to Melphalan or any of the inactive ingredients.
  • Patients whose cancer has been shown to have prior resistance to Melphalan.
  • Lactating mothers.

Populations with Restricted or Conditional Use

Use of Alkeran is conditional and requires strict medical oversight or dosage adjustment in patients with certain conditions:

  • Renal Impairment: Use is restricted; clearance of the drug may be reduced, often requiring a dosage reduction and close monitoring.
  • Depressed Blood Counts: Therapy must be withheld if neutrophil and/or platelet counts fall below officially specified thresholds until blood counts recover sufficiently.
  • Prior or Concurrent Treatment: Use with extreme caution following recent radiotherapy or chemotherapy due to increased risk of bone marrow toxicity.

Age and Reproductive Eligibility

  • Pediatric Use: The safety and effectiveness of Alkeran have not been fully established in children (pediatric population), and its use is typically not recommended.
  • Pregnancy: The medicine should not be used during pregnancy, especially the first trimester, and classified as a potential hazard to the fetus. Both male and female patients of reproductive potential must use effective contraception during and for a specified period after treatment.

What should I know about interactions with other medicines?

Алкеран Interactions with other medicines and products

This section describes documented interaction patterns for Melphalan as stated in official government regulatory information.

Interaction Type Interacting Substance/Condition Regulatory Outcome/Restriction
Contraindicated Combination Nalidixic Acid Co-administration is formally associated with the risk of fatal haemorrhagic enterocolitis, especially in the pediatric population.
Timing & PK Interaction Food (High-Fat Meals) Reduces systemic drug exposure (AUC) of the oral tablet. Administration must be on an empty stomach to ensure adequate absorption.
Pharmacodynamic Risk Live Organism Vaccines Use is not recommended due to Melphalan-induced immunosuppression, which can diminish vaccine effectiveness.

Exposure and Clearance Modifiers

Melphalan clearance can be affected by other medications. Cisplatin co-administration is officially documented to decrease Melphalan clearance, which is attributed to Cisplatin’s impact on kidney function. Additionally, the combination with Cyclosporine is associated with an increased risk of nephrotoxicity. Regulatory information also notes that pre-existing poor renal function is a population-specific condition that increases the risk of severe myelosuppression due to decreased drug clearance. These pharmacokinetic and pharmacodynamic interactions dictate restrictions on co-administration to manage potential changes in Melphalan exposure and toxicity.

Mechanism of Action

How Алкеран Works: Mechanism of Action


DNA Alkylation and Genetic Blockade

The core mechanism of Melphalan involves direct chemical damage to the cell's genetic material. As a bifunctional alkylating agent, it is transported into the cell and covalently binds to the DNA, predominantly at guanine bases, forming inter-strand cross-links. This structural modification physically blocks the enzymes responsible for DNA replication and transcription, leading to cell cycle arrest. This domain mediates the cessation of cellular proliferation.


Induction of Systemic Cytotoxicity

The irreparable nature of the DNA cross-links triggers a mandatory self-destruct sequence within the cell, known as apoptosis (programmed cell death). Since this mechanism is cell-cycle non-specific, it is effective against rapidly dividing cells regardless of their growth phase. The resultant physiological effect is a reduction in the population of highly proliferative cells throughout the body, consistent with the cytotoxic mechanism.

Dosage and Administration Information

Alkeran (Melphalan) administration is approved via two primary routes: as an oral tablet for ingestion or as an intravenous (IV) infusion prepared from sterile powder. The choice of route and the exact dosage regimen are determined by the intended therapeutic context, distinguishing between conventional palliative use and intensive high-dose conditioning protocols before stem cell transplantation.

Usage adheres to cyclic or intermittent schedules, where the medicine is given for a defined, short course (e.g., several consecutive days) followed by a rest period, which is then repeated in cycles. For oral tablets, administration should occur without food, as taking the medication with a meal can significantly reduce its overall absorption.

Intravenous administration requires strict procedural compliance. The powdered form must be reconstituted and diluted immediately before use. The subsequent infusion must be completed within 60 minutes of reconstitution due to the drug’s stability profile. The solution is typically infused slowly, and administration must be carried out under the direction of a physician experienced in cytotoxic therapy.

Dosage modifications are necessary for specific populations. A reduction in the initial dose is generally required for patients with documented renal impairment, particularly when using the conventional intravenous regimen, to manage systemic exposure safely.

Recent Clinical Evidence

Research evidence / Overview of Studies for Алкеран (Melphalan)

The research evidence for Алкеран (Melphalan) addresses its role as a specialized pharmaceutical compound, primarily in the management of multiple myeloma and certain types of metastatic solid tumors. Studies have been conducted over several decades, ranging from early clinical trials to modern comparative randomized studies and long-term observational follow-up.


Evidence for High-Dose Use in Multiple Myeloma Conditioning

Research for this specific use is extensive and well-documented, primarily through Randomized Controlled Trials (RCTs) and systematic reviews that focused on fit adult patients with multiple myeloma. These trials compared high-dose Melphalan (often 200 mg/m^2) against conventional chemotherapy or against other high-dose conditioning regimens before autologous stem cell transplantation (ASCT).

The studies monitored key outcomes related to disease metrics, including Overall Survival patterns, Progression-Free Survival patterns, and the achievement of deep responses such as Complete Response (CR). Research describes the use of high-dose Melphalan as a component within recognized therapeutic protocols, with findings detailing specific patterns of patient outcomes observed in these trials. For instance, some research suggests a relationship between higher measured drug exposure in the body and observed patterns in survival and response rates.


Research on Conventional-Dose Treatment for Multiple Myeloma

In older adults or patients who are not considered eligible for high-dose transplantation, Melphalan was studied for use at conventional or intermediate doses (e.g., 100 mg/m^2 or 140 mg/m^2), often combined with other medications like prednisone.

The trials observed in this population monitored similar outcomes, including OS and PFS, and research examined how observed outcomes compared to older established treatment regimens. Research explored how using lower doses of Melphalan in ASCT was associated with differences in outcomes such as platelet recovery and median Progression-Free Survival when compared to the higher dose. Evidence is limited regarding the direct comparison of conventional-dose Melphalan combinations versus the newest-generation agents now widely used in older or frail patients.


Studies on Long-Term Outcomes and Durability

The research landscape includes significant long-term observational data for patients who have undergone high-dose Melphalan conditioning for multiple myeloma. These studies monitored patients for many years to assess the duration of observed response patterns and long-term survival patterns. Research indicates that the achievement of a deep response, such as a Complete Response, was evaluated alongside patterns in follow-up survival in the observed populations. However, long-term effects are not fully established for all patient subgroups.


Key Uncertainties and Gaps in Melphalan Research

Regulators and scientific bodies acknowledge several areas where research is still ongoing. Comparative evidence is lacking for the most direct comparisons between Melphalan-based regimens and the newest therapeutic options for multiple myeloma that have emerged in the past decade. The variability in patient drug exposure remains an area of uncertainty, as findings indicate this variability may affect both measured patient metrics and the occurrence of certain clinical changes. The data for complex patient groups or those with very low rates of disease remain insufficient for full characterization.

Key Studies & References Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study (FOCUS Trial)

Frequently Asked Questions (FAQ)

Common questions about Алкеран (FAQ)

Q: What are the main types of cancer that Алкеран is approved to treat?

A: Official documents indicate that Melphalan is primarily used for managing multiple myeloma and advanced ovarian adenocarcinoma. Melphalan tablets may also be used in the management of advanced breast carcinoma and a specific blood disorder called polycythaemia rubra vera.

Q: What is the typical duration of treatment when taking oral Алкеран tablets?

A: Official regulatory documents describe oral dosage schedules as intermittent, often repeated at intervals of six weeks. For maintenance therapy, a dose may be given once per week until a satisfactory disease response is achieved. The exact duration of treatment is determined by the specific therapeutic plan.

Q: What types of non-prescription pain relievers should generally be avoided due to interaction risks with Алкеран?

A: Regulatory-aligned patient guidance indicates the importance of discussing all medications, including those bought without a prescription, with a healthcare professional due to potential interaction risks. While specific non-prescription pain relievers are not named as contraindicated in the main drug label, open communication is vital.

Q: Is it possible for Алкеран to cause permanent infertility in men or women?

A: The FDA label notes that Melphalan may cause suppression of ovarian function or testicular function, which can result in infertility in both male and female patients. Due to this risk, the necessity of using effective contraception during and after treatment is consistently noted in official documents.

Q: Can Алкеран affect the function of the liver or kidneys?

A: Regulatory information documents that a dose reduction is generally required for patients with pre-existing renal (kidney) impairment to safely manage the drug's clearance. Additionally, hepatic disorders, such as jaundice and hepatitis, have been reported as adverse reactions in some patients.

Q: What are the signs of a low platelet count (thrombocytopenia) to watch for?

A: Low platelet count (thrombocytopenia) is a commonly reported side effect. Regulatory-aligned patient guidance describes that signs such as unusual bleeding or bruising, blood in the urine or stools, black or tarry stools, or the appearance of pinpoint red spots on the skin should be observed.

Q: What are the signs of a low white blood cell count related to Алкеран?

A: Low white blood cell count (leukopenia) is a very common side effect, which increases the risk of infection. Regulatory-aligned patient guidance describes that signs of infection such as fever, chills, persistent cough, or painful urination should be observed.

Q: What are the signs of a severe allergic reaction to Алкеран?

A: Severe hypersensitivity reactions, including anaphylaxis, are documented in official safety information. These reactions may be characterized by symptoms such as hives, itching, swelling of the face or throat, skin rashes, a fast heart rate (tachycardia), or shortness of breath.

Q: Does Алкеран treat any non-cancerous blood disorders?

A: Official documents indicate that Melphalan tablets may be used in the management of polycythaemia rubra vera. This condition is a chronic disorder that causes the bone marrow to produce too many red blood cells.

Q: Is there a reported risk of developing a secondary cancer after using Алкеран?

A: Regulatory safety information documents a risk of secondary malignancies, such as acute leukemia and myelodysplastic syndrome. This risk is noted to increase with the length of treatment and the cumulative dose received over time.

Q: Does alcohol consumption interact with Алкеран?

A: The diluent used for the intravenous formulation of Melphalan contains alcohol (ethanol), which may cause temporary, alcohol-like symptoms upon administration. The oral tablets do not contain alcohol, but general patient guidance indicates that avoiding alcohol during treatment may be discussed.

Q: Are there specific herbal or dietary supplements that are known to interact with Алкеран?

A: While regulatory sources do not list specific supplements as strictly forbidden, general patient information advises discussing all vitamins, supplements, herbal drugs, and complementary therapies with a healthcare professional due to potential interactions.

Q: How long after starting Алкеран might a person start to see changes? (Onset of effect)

A: The onset of the most significant blood-related effect—the maximum suppression of blood cell counts (nadir)—is typically expected to occur approximately two to three weeks following administration. Recovery usually begins shortly after this period.

Q: Does Алкеран treatment always involve a hospital stay?

A: While high-dose regimens may require a hospital stay, Melphalan infusion can also be administered in an outpatient setting, such as an infusion center or clinic, depending on the therapeutic regimen and the patient's overall health status.

Q: Is there a limit to how many times a person can receive Алкеран?

A: Official documents describe treatment continuing until unacceptable toxicity is reached. Decisions to permanently stop or reduce the dose are made based on the severity of adverse reactions that occur over consecutive cycles, rather than a pre-determined, fixed number of cycles.

Q: Why is drinking plenty of fluids often recommended during Алкеран therapy?

A: Regulatory-aligned patient guidance indicates that extra fluids may be suggested to help the patient pass more urine. This practice helps to replace lost salts and minerals, which may be depleted due to gastrointestinal side effects like diarrhea and vomiting.

Q: What is the meaning of the term 'refractory' when used to describe conditions treated by Алкеран?

A: Refractory is a term used in the context of cancer treatment to describe disease that has not responded or has stopped responding to prior lines of therapy. Melphalan may be used in these situations as part of a further treatment plan.

Q: Are there any special dietary restrictions that are usually recommended to patients on Алкеран?

A: The oral tablet must be taken on an empty stomach to ensure adequate absorption, which is a key instruction. Additionally, patient guidance advises avoiding food or drinks that might irritate the mouth and throat due to the risk of developing mouth sores (mucositis).

Q: Can Алкеран cause gout or kidney stones?

A: Regulatory-aligned patient guidance notes that Melphalan may increase the levels of uric acid in the blood. For patients with a history of kidney issues, this increase has been noted as potentially affecting the development of gout or kidney stones.

Q: Why might a patient experience a sensation of warmth or tingling during the intravenous infusion?

A: The sensation of warmth and/or tingling at the injection site is documented in official patient information as a reported side effect that can occur during the intravenous infusion. This is typically a transient feeling.

Q: What is the difference between Алкеран tablets and Evomela?

A: Evomela is a specific melphalan formulation approved by the FDA for use in high-dose conditioning treatment prior to stem cell transplantation. Алкеран is another brand name for melphalan that may be used for both high-dose conditioning and conventional, palliative treatment.

Q: If I missed a dose of the oral tablet, what is the general recommendation?

A: General patient guidance indicates that a healthcare professional should be informed if a dose is missed. Official guidance explicitly advises against taking a double dose to compensate for a forgotten one.

Q: Is weight loss a commonly reported side effect?

A: Low appetite is listed as a common side effect in clinical studies. Weight changes, including both weight gain and weight loss, are noted among the possible adverse reactions that should be monitored and reported to a doctor.

Q: Can Алкеран cause skin issues or rashes?

A: Official safety information documents various skin issues. These include skin hypersensitivity reactions, maculopapular rashes, urticarial rash (hives), and, in rare instances, skin ulceration at the injection site.

Q: Are there specific concerns about heart rhythm related to Алкеран?

A: Official adverse reaction reports mention specific concerns regarding heart rhythm. Tachycardia (fast heart rate) and, rarely, cardiac arrest are reported in association with severe hypersensitivity reactions to the drug.

Q: Can Алкеран cause temporary or permanent changes to the menstrual cycle in women?

A: Melphalan may cause ovarian function suppression, which is linked to infertility. Changes to the menstrual cycle are a physiological consequence of ovarian function changes that can occur with the use of this medicine.

How should Алкеран be stored and disposed of?

Storage Requirements

The storage conditions for Alkeran (melphalan) are specific to the dosage form, as defined by regulatory labeling:

  • Oral Tablets: Must be stored under refrigerated conditions, typically between 2 C and 8 C. The tablets must not be frozen and should be kept in the original container to protect from light.
  • Powder for Injection: The unopened vial must be stored at a temperature below 30 C and must not be refrigerated. It is mandatory to protect the vial from light.

Stability and Handling

The reconstituted solution for injection has limited stability and must be administered quickly. It must not be refrigerated after mixing, as this can cause precipitation. All Alkeran forms must be kept out of the sight and reach of children.

Disposal Instructions

Alkeran is classified as a cytotoxic agent. Disposal must follow standard procedures applicable to cytotoxic products and is explicitly restricted from being thrown away via wastewater or household waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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