Merkaptopurin 50mg Aspen 6MP Puri-nethol

Product Name: 6-Mercaptopurine (6MP)

Active Ingredient: Mercaptopurine

Specification: 50 mg * 25 tablets/box

Manufacturer: Aspen Nordic

Many patients confuse Mercaptopurine tablets with 6-Mercaptopurine (6MP), assuming they are the same medication; however, there is a distinction. "Mercaptopurine" refers to the generic drug, whereas "6-Mercaptopurine" specifically denotes the active chemical entity. The latter is generally preferred; it is well-absorbed orally and, upon entering the body, is rapidly metabolized into 6-mercaptopurine. This active metabolite inhibits the metabolism of mercaptopurine and suppresses the complex interconversion of purines—specifically, it acts to inhibit hypoxanthine.

[Indications]

6-Mercaptopurine is used for the treatment of acute leukemia in adults, adolescents, and children.

It may be used for:

Acute Lymphocytic Leukemia (ALL)

Acute Promyelocytic Leukemia (APL) / Acute Myeloid Leukemia M3 (AML M3).

[Contraindications]

Hypersensitivity to the active substance or to any of the excipients listed in the composition section.

Due to the severity of the indications, there are no other absolute contraindications.

[Dosage]

Adults: 2–2.5 mg/kg/24 hours, administered twice daily. The duration of treatment is typically 3–4 weeks.

Treatment with 6-Mercaptopurine should be conducted under the supervision of a physician or other healthcare professionals experienced in the management of patients with ALL and APL (AML M3).

6-Mercaptopurine may be taken with food or on an empty stomach; however, patients should adhere to a consistent method of administration.

This medication should not be taken with milk or dairy products (refer to the "Interactions" section). 6-Mercaptopurine should be taken at least 1 hour before, or 2 hours after, the consumption of milk or dairy products. [Special Populations]

Adults and Children

The recommended dosage for adults and children is 2.5 mg/kg of body weight per day, or 50 to 75 mg/m² of body surface area per day; however, the specific dosage and duration of treatment depend on the type and dosage of other cytotoxic agents administered in combination with 6-mercaptopurine.

The dosage should be carefully adjusted to suit the individual patient.

6-mercaptopurine has been used in combination therapy for acute leukemia according to various schedules; the literature and current treatment guidelines should be consulted for further information.

Studies conducted in children with acute lymphoblastic leukemia suggest that administering 6-mercaptopurine in the evening, rather than in the morning, may reduce the risk of relapse.

Elderly Patients

Renal and hepatic function should be monitored in these patients; a reduction in the dosage of 6-mercaptopurine should be considered in the event of any decline in function.

Renal Impairment

For patients with renal impairment, a dosage reduction should be considered (see the Pharmacokinetics section).

Hepatic Impairment

For patients with hepatic impairment, a dosage reduction should be considered (see the Pharmacokinetics section).

[Drug Interactions]

When xanthine oxidase inhibitors—such as allopurinol, oxypurinol, or thiopurinol—are co-administered with 6-mercaptopurine, it is essential to administer only 25% of the recommended dosage of 6-mercaptopurine, as these agents reduce the degradation of 6-mercaptopurine. Concomitant use of other xanthine oxidase inhibitors, such as febuxostat, should be avoided (see the Interactions section).

Patients with TPMT Deficiency

Patients with genetically low or absent Thiopurine S-methyltransferase (TPMT) activity are at increased risk of developing severe 6-mercaptopurine toxicity when receiving conventional dosages of 6-mercaptopurine, and typically require a substantial reduction in dosage. The optimal starting dosage for patients with homozygous deficiency has not yet been established. Most patients with heterozygous TPMT deficiency tolerate the recommended doses of 6-mercaptopurine; however, for some patients, a dose reduction may be necessary (see *Warnings and Precautions* and *Pharmacokinetics* sections).

Patients with NUDT15 Variants

Patients carrying inherited mutations in the *NUDT15* gene are at increased risk of developing severe 6-mercaptopurine toxicity (see *Warnings and Precautions* section). These patients typically require a dose reduction, particularly those with homozygous *NUDT15* variants (see *Warnings and Precautions* section). Genotyping for *NUDT15* variants may be considered prior to initiating 6-mercaptopurine therapy. In all cases, close monitoring of hematologic status is required.

Warnings and Precautions

6-mercaptopurine is an active cytotoxic agent and should be used only under the supervision of a physician experienced in the use of such agents.

Immunization with live vaccines may result in infection in immunosuppressed patients. Therefore, the administration of live vaccines is not recommended for patients with ALL or AML. In any case, live vaccines should not be administered to patients in remission until the patient is deemed capable of mounting a response to the vaccine. The interval between the discontinuation of chemotherapy and the recovery of the patient's ability to respond to a vaccine depends on the type of drugs used, the nature and intensity of the immunosuppression induced by the drugs, the underlying disease, and other factors.

Concomitant use of ribavirin and 6-mercaptopurine is not recommended. Ribavirin may reduce the efficacy of 6-mercaptopurine and increase its toxicity (see *Interactions* section).

Product Specifications

Product Name: 6-Mercaptopurine Tablets (Merkaptopurin 50mg) — Aspen 6MP Puri-nethol, 25 tablets/bottle

Common Name: 6-Mercaptopurine (6MP)

Active Ingredient: Mercaptopurine

Dosage Form: Tablets

Specification: 50 mg × 25 tablets/box

Manufacturer: Aspen Nordic

Indications: 6-Mercaptopurine is indicated for the treatment of acute leukemia in adults, adolescents, and children. It is indicated for:

Acute Lymphocytic Leukemia (ALL)

Acute Promyelocytic Leukemia (APL) / Acute Myeloid Leukemia M3 (AML M3).

Dosage and Administration: Adults: 2–2.5 mg/kg/24 hours, administered twice daily. The duration of treatment is 3–4 weeks.

Treatment with 6-mercaptopurine should be conducted under the supervision of a physician or other healthcare professional experienced in the management of patients with ALL and APL (AML M3).

6-mercaptopurine may be taken with food or on an empty stomach; however, patients should adhere to a consistent method of administration.

This medication should not be taken with milk or dairy products (see the Interactions section). 6-mercaptopurine should be taken at least 1 hour before, or 2 hours after, the consumption of milk or dairy products.