Alkeran Melphalan film kapli tablet

I. Basic Drug Information

Generic Name: Melphalan

Brand Names: Alkeran, Melphalan, Aikelan

Dosage Form: Oral Tablets: 2 mg/tablet; 25 tablets/box

Manufacturer: Aspen Pharmacare Holdings

Storage: Refrigerate at 2–8°C; protect from light.

II. Indications

1. Multiple Myeloma:

First-line treatment (oral or intravenous), often used in combination with prednisone;

High-dose conditioning regimen prior to hematopoietic stem cell transplantation (intravenous injection).

2. Ovarian Cancer: Palliative treatment (oral or intravenous).

3. Breast Cancer: Palliative treatment for advanced disease (oral or intravenous).

4. Polycythemia Vera: Oral induction of remission and maintenance therapy.

5. Other:

Seminoma, chronic leukemia, malignant lymphoma;

Regional arterial perfusion therapy for malignant tumors of the limbs (e.g., melanoma, osteosarcoma). III. Dosage and Administration

Oral Regimen

| Indication                  | Dosage                                       | Duration                                 | Combination Therapy

| Multiple Myeloma        | 0.15 mg/kg/day, in divided doses         | 4 consecutive days; repeat every 6 weeks           | Prednisone 40 mg/day

| Ovarian Cancer                  | 0.2 mg/kg/day                          | 5 consecutive days; repeat every 4–8 weeks        | Monotherapy or Combination

| Advanced Breast Cancer            | 0.15 mg/kg/day or 6 mg/m²/day               | 5 consecutive days; repeat every 6 weeks   | Monotherapy

| Polycythemia Vera | 6–10 mg/day × 5–7 days → 2–4 mg/day (maintenance)    | 2–6 mg/week (maintenance)        | Requires blood count monitoring

2. Dosage Adjustments for Special Populations

Renal Impairment:

Oral: For moderate to severe impairment, the starting dose should be reduced (no fixed standard; individual adjustment required).

IV Palliative Therapy: Reduce dose by 50% when BUN ≥ 30 mg/dL.

Hepatic Impairment / Elderly: No routine adjustment required, but increased monitoring is necessary.

Pediatrics: No established guidelines; use with caution.

IV. Adverse Reactions

Common Adverse Reactions (Incidence ≥ 10%)

The table below summarizes the reactions by body system and their frequency:

| System Category   | Specific Symptoms                                          | Incidence

| Hematologic System   | Bone marrow suppression (↓ WBC, ↓ Platelets, Anemia)  | >90% (IV conditioning regimen)

| Gastrointestinal       | Nausea, Vomiting, Diarrhea, Oral Mucositis         | 48–93%

| Metabolic Disorders   | Hypokalemia, Hypophosphatemia                          | 49–74%

| Systemic      | Fatigue, Fever                                       | 48–77%

Serious Adverse Reactions

Bone Marrow Suppression: May lead to severe infections or hemorrhage; regular monitoring of blood counts is required. Allergic Reactions: Urticaria, bronchospasm, shock (incidence approximately 2%; requires permanent discontinuation of the drug).

Hepatotoxicity: Hepatitis, jaundice, hepatic veno-occlusive disease (requires monitoring of liver function).

Pulmonary Fibrosis: Rare but potentially fatal.

Secondary Malignancies: Long-term use increases the risk of leukemia.

V. Contraindications

1. Hypersensitivity to melphalan or any components of the formulation.

2. Severe bone marrow suppression or active infection.

3. Pregnant and Lactating Women:

Teratogenic risk (may cause fetal limb malformations during the first trimester);

Contraindicated during breastfeeding.

VI. Precautions

1. Management of Bone Marrow Suppression:

Monitor complete blood count (CBC) prior to each dose; suspend administration if neutrophil count falls below 2×10⁹/L.

2. Teratogenicity and Infertility Risks:

Patients of childbearing potential must use effective contraception (during treatment and for 6 months after discontinuation);

May induce permanent amenorrhea or oligospermia.

3. Monitoring of Hepatic and Renal Function:

Assess renal function prior to intravenous administration; periodically monitor blood urea nitrogen (BUN) during oral therapy.

4. Drug Interactions:

Avoid concomitant use with nephrotoxic agents (e.g., NSAIDs, aminoglycosides);

Nalidixic acid may exacerbate intestinal toxicity (fatal cases have been reported).

VII. Special Dosage Form Instructions

Oral Tablets: Administer on an empty stomach; avoid taking with food (absorption is significantly affected by food).

VIII. Pharmacology and Toxicology

Mechanism of Action: An alkylating antineoplastic agent that inhibits cancer cell division by cross-linking DNA strands.

Metabolism: Peak plasma concentrations are reached approximately 2 hours after oral administration; 50% of the dose is excreted via urine (13% as unchanged drug).

Carcinogenicity: Capable of inducing chromosomal aberrations and increasing the risk of secondary leukemia.

Note: The information provided above is a summary compilation; specific drug usage must strictly adhere to a physician's instructions. Product Specifications

Product Name: Melphalan Tablets 2mg * 25 Tablets/Box (Alkeran)

Common Name: Melphalan Tablets

Active Ingredient: Melphalan

Dosage Form: Tablets

Specification: 2mg/tablet; 25 tablets/box

Manufacturer: Aspen Pharmacare Holdings

Indications: 1. Multiple Myeloma:

First-line treatment (oral or intravenous), often used in combination with Prednisone;

High-dose conditioning prior to hematopoietic stem cell transplantation (intravenous administration).

2. Ovarian Cancer: Palliative treatment (oral or intravenous).

3. Breast Cancer: Palliative treatment for advanced disease (oral or intravenous).

4. Polycythemia Vera: Oral induction of remission and maintenance therapy.

5. Other:

Seminoma, Chronic Leukemia, Malignant Lymphoma;

Arterial perfusion therapy for malignant tumors of the limbs (e.g., melanoma, osteosarcoma).

Dosage and Administration: Multiple Myeloma: 0.15 mg/kg daily, administered in 4 divided doses for 5 consecutive days, repeated every 6 weeks; alternatively, 0.25 mg/kg daily for 4 consecutive days, repeated every 4 to 6 weeks.

Ovarian Cancer: 0.2 mg/kg daily for 5 consecutive days, repeated every 4 to 5 weeks; the duration of treatment is determined based on therapeutic response.

Polycythemia Vera: Initial dose of 6 to 10 mg daily for 5 to 7 consecutive days, followed by adjustment to a maintenance dose (2 to 4 mg daily); dosage is adjusted based on complete blood count results.