ALEXAN 100mg/5ml Injection/Solution for

What is ALEXAN 100mg/5ml

ALEXAN 100mg/5ml is a chemotherapy medication used in the treatment of hematological malignancies, particularly various forms of leukemia. It contains the active ingredient Cytarabine, a cytotoxic antimetabolite that interferes with DNA synthesis in rapidly dividing cells.

• Generic Name: Cytarabine
• Strength: 100mg per 5ml
• Form: Solution for Injection
• Packaging: 5ml vial × 10 (multiple-dose therapy regimen)
• Drug Class: Antimetabolite, Antineoplastic agent

ALEXAN is commonly indicated for the treatment of:

• Acute Myeloid Leukemia (AML)
• Acute Lymphoblastic Leukemia (ALL)
• Chronic Myeloid Leukemia (CML) during blast crisis
• Meningeal leukemia (via intrathecal administration)

Its usage can be as part of induction, consolidation, or maintenance therapy. Cytarabine can be administered alone or in combination with other cytotoxic drugs as part of a chemotherapy protocol. Due to its potent cytotoxic nature, it is administered only under strict supervision in hospital settings.

How to use ALEXAN 100mg/5ml

ALEXAN 100mg/5ml is an injectable formulation of Cytarabine and must be administered by trained healthcare professionals. It can be administered through various routes depending on the type of leukemia and treatment protocol.

• Routes of Administration:
  • Intravenous (IV) bolus or infusion
  • Subcutaneous (SC) injection
  • Intrathecal injection (into the cerebrospinal fluid in cases of meningeal leukemia)
• Administration Frequency: Based on the treatment phase (induction, consolidation, maintenance)
• Preparation: The solution may be diluted as per institutional protocols for IV use

Important Instructions for Use:

• Never self-administer; must be handled by healthcare professionals trained in chemotherapy.
• Pre-treatment lab evaluations are necessary: CBC, liver enzymes, renal function tests.
• Supportive therapies such as antiemetics or corticosteroids may be prescribed.
• Protective eyewear may be used with high-dose regimens to prevent conjunctivitis.

During therapy:

• Vital signs and complete blood counts must be monitored regularly.
• Watch for signs of toxicity: infection, bleeding, or neurological changes.

Post-administration: Patients are monitored for adverse reactions and toxicity, and dosage may be adjusted based on tolerability and lab results.

Mode of Action ALEXAN 100mg/5ml

Cytarabine, the active compound in ALEXAN, is a pyrimidine analog that works by interfering with DNA synthesis in rapidly dividing cells. It is classified as a cell-cycle specific antimetabolite, primarily active during the S-phase of the cell cycle.

• Activation: Cytarabine is converted intracellularly into its active metabolite, cytarabine triphosphate (ara-CTP).
• Mechanism: ara-CTP competes with deoxycytidine triphosphate and becomes incorporated into DNA, causing premature chain termination.
• Inhibition: It also inhibits DNA polymerase, which is essential for DNA replication and repair.
• Result: The interference with DNA synthesis triggers apoptosis in malignant cells, especially those with high mitotic activity like leukemic blasts.

Pharmacological Characteristics:

• Short plasma half-life (~10 minutes)
• Rapid hepatic metabolism to inactive form (ara-U)
• Renal excretion

Because of its mechanism, Cytarabine is most effective against cancers of rapidly proliferating cells, such as leukemias. However, this same mechanism also affects healthy cells that divide quickly, leading to adverse effects like bone marrow suppression and gastrointestinal disturbances.

ALEXAN 100mg/5ml Interactions ALEXAN 100mg/5ml

ALEXAN (Cytarabine) can interact with other medications, altering their effects or increasing toxicity. Careful evaluation of all concurrent therapies is essential to avoid serious interactions.

• Live Vaccines: Avoid during Cytarabine therapy due to immunosuppression and increased infection risk.
• Other Chemotherapeutics: Combining with agents like methotrexate, daunorubicin, or cyclophosphamide can enhance efficacy but also increase toxicity, especially myelosuppression.
• Digoxin: High-dose Cytarabine may impair intestinal absorption of digoxin, reducing its serum levels.
• Gentamicin: Antagonistic interaction reported; efficacy against gram-negative organisms like Klebsiella may be reduced.
• Flucytosine: Antifungal activity of flucytosine may be reduced when used concomitantly with Cytarabine.

Monitoring Recommendations:

• Check renal and hepatic function before co-administering nephrotoxic or hepatotoxic drugs.
• Monitor CBC and signs of bone marrow suppression during combination chemotherapy.
• Watch for signs of additive neurotoxicity or gastrointestinal toxicity when used with other cytotoxics.

It is essential to disclose all prescription, over-the-counter, and herbal medications before initiating ALEXAN therapy to ensure safe and effective treatment planning.

Dosage of ALEXAN 100mg/5ml

ALEXAN 100mg/5ml dosing is individualized based on the type and phase of leukemia, patient age, organ function, and clinical protocol. It is critical to follow your oncologist’s exact instructions.

• Induction Therapy (Standard Dose):
  • 100–200 mg/m²/day as continuous IV infusion or divided IV doses for 5–7 days
• High-Dose Therapy:
  • 1–3 g/m² every 12 hours for 2–6 days (commonly in consolidation phase)
• Maintenance Therapy:
  • Lower doses given intermittently for months to years based on protocol
• Intrathecal Use (Meningeal Leukemia):
  • 5–30 mg per dose directly into cerebrospinal fluid at intervals as per protocol

Adjustments may be necessary in the following conditions:

• Renal or hepatic impairment
• Severe hematologic toxicity
• Pre-existing neurological disorders

Dosing schedules vary between patients. Always adhere to the treatment plan established by your oncology team. Never change the dose without medical guidance.

Possible side effects of ALEXAN 100mg/5ml

ALEXAN (Cytarabine) is associated with a wide range of side effects, some of which are dose-dependent. Patients receiving high doses are more likely to experience neurotoxicity and gastrointestinal effects.

• Common Side Effects:
  • Myelosuppression (anemia, neutropenia, thrombocytopenia)
  • Nausea, vomiting, loss of appetite
  • Fever and malaise
  • Oral ulcers and mucositis
• Neurological Side Effects:
  • Ataxia
  • Drowsiness or confusion
  • Peripheral neuropathy
  • Seizures (especially with high-dose therapy)
• Ocular Toxicity:
  • Conjunctivitis
  • Eye pain or blurred vision
• Other Potential Effects:
  • Elevated liver enzymes
  • Skin rash
  • Respiratory distress (rare)

Important: Any sign of infection, unusual bleeding, neurological changes, or allergic reaction (rash, difficulty breathing) should be reported immediately to a healthcare provider.

ALEXAN 100mg/5ml Contraindications ALEXAN 100mg/5ml

ALEXAN is contraindicated in certain medical conditions and patient populations due to its high toxicity profile.

• Known hypersensitivity: Allergy to Cytarabine or any component of the formulation.
• Severe bone marrow suppression: In the absence of leukemic disease, it may further impair hematopoiesis.
• Active uncontrolled infections: Risk of fatal outcomes due to immunosuppression.
• Pregnancy: Teratogenic; should be avoided unless benefits outweigh risks.
• Lactation: Breastfeeding should be discontinued due to possible drug excretion in breast milk.

Relative contraindications and precautions:

• Renal or hepatic impairment
• History of neurological disorders
• Concurrent use with other bone marrow suppressants

Careful evaluation of benefit vs. risk must be made before therapy initiation, with close monitoring for any emerging complications.

Storage of ALEXAN 100mg/5ml

Proper storage of ALEXAN 100mg/5ml is critical to maintain its efficacy and prevent contamination or degradation.

• Storage Temperature: Store at 15–25°C (59–77°F).
• Light Protection: Keep in original packaging to protect from light.
• Do Not Freeze: Freezing can compromise the solution’s stability and render it ineffective.
• Inspect Vials: Do not use if the solution appears cloudy, discolored, or contains particulate matter.
• After Opening or Dilution: Follow institutional guidelines for use and discard timelines, typically within 6–24 hours if refrigerated.

Disposal: ALEXAN is a hazardous cytotoxic drug. All unused product, equipment, and waste materials should be handled using proper protective equipment and disposed of in accordance with local regulations for cytotoxic agents.