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About Purixan™

Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer that affects blood producing cells in the bone marrow. The word ‘acute’ means developing quickly, while ‘lymphoblastic’ refers to the type of white blood cell affected by the condition. ALL accounts for a third of all cancers inflicting children and is also the most common form of leukemia in children. Incidence of the disease peaks in childhood, but it can affect teenagers and young adults too; it then becomes increasingly more common in people over the age of 50.

ALL is a fast growing disease and so it is very important to receive effective therapy soon after diagnosis. Fortunately, most children respond very well to treatment and survival rates are very high. Over the last several decades, advances in the treatment and supportive care of children with ALL have dramatically increased its 5 year survival rates to more than 90%.

ALL is treated according to a treatment plan (also known as a ‘protocol’) and involves a number of phases of treatment; induction, consolidation and maintenance. A combination of chemotherapy drugs that have been carefully selected are given in each phase. The drugs may be given in several different ways: by mouth (tablets or liquid), into a blood vessel (intravenously), into a muscle (intramuscularly), or into the fluid around the spine and brain (intrathecally).The total length of treatment is around 2.5 years for girls and 3.5 years for boys.

PURIXAN (mercaptopurine) oral suspension is an essential drug in combination chemotherapy and is administered in all phase of treatment but is particularly important in the maintenance phase to prevent the disease returning (relapse).

More information on Acute Lymphoblastic Leukemia can be found on several oncology websites provided here.

INDICATION

PURIXAN® (mercaptopurine) is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as a component of a combination maintenance therapy regimen.

Warnings and Precautions

Myelosuppression
Monitor complete blood count (CBC) and adjust the dose of PURIXAN for excessive myelosuppression. Consider testing in patients with severe myelosuppression or repeated episodes of myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. Patients with homozygous-TPMT or homozygous-NUDT15 deficiency may require a dose reduction.

Hepatotoxicity
Monitor transaminases, alkaline phosphatase and bilirubin. Withhold PURIXAN at onset of hepatotoxicity.

Immunosuppression
Response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised pediatrics.

Treatment Related Malignancies
Aggressive and fatal cases of hepatosplenic T-cell lymphoma have occurred.

Macrophage Activation Syndrome
Monitor for and treat promptly; discontinue PURIXAN.

Embryo-Fetal Toxicity
Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

 

Adverse Reactions

Adverse Reactions – Clinical Studies Experience
The most common adverse reaction occurring in > 20% of patients was myelosuppression, including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20 % of patients included anorexia, nausea, vomiting, diarrhea, malaise, and rash. Adverse reactions occurring in < 5 % of patients included urticaria, hyperuricemia, oral lesions, elevated transaminases, hyperbilirubinemia, hyperpigmentation, infections, and pancreatitis. Oral lesions resemble thrush rather than antifolic ulcerations. Delayed or late toxicities include hepatic fibrosis, hyperbilirubinemia, alopecia, pulmonary fibrosis, oligospermia and secondary malignancies.

Adverse Reactions – Postmarketing Experience
The following adverse reactions have been identified during postapproval use of PURIXAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: photosensitivity, hypoglycemia, and portal hypertension.

See Full Prescribing Information

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