ALEXAN 1000mg/20ml Injection/Solution for

What is ALEXAN 1000mg/20ml

ALEXAN is an injectable chemotherapy medication that contains the active ingredient Cytarabine, also known as cytosine arabinoside. It is commonly used in the treatment of certain types of blood cancers, particularly leukemias and lymphomas.

• Generic Name: Cytarabine
• Strength: 1000mg per 20ml
• Form: Injectable solution (Vial)
• Therapeutic Class: Antimetabolite / Antineoplastic agent

ALEXAN is most commonly used for:

• Acute Myeloid Leukemia (AML)
• Acute Lymphoblastic Leukemia (ALL)
• Chronic Myelogenous Leukemia (CML) – blast crisis
• Meningeal leukemia

It may be used alone or in combination with other chemotherapy drugs as part of induction or consolidation therapy. It is generally administered under strict medical supervision in a hospital or oncology setting due to its potent cytotoxic nature and risk of side effects.

How to use ALEXAN 1000mg/20ml

ALEXAN (Cytarabine Injection) is administered under the supervision of a qualified healthcare professional, typically an oncologist or trained chemotherapy nurse. It is given via intravenous (IV) or subcutaneous (SC) injection, depending on the treatment protocol.

• Route of Administration:
  • Intravenous infusion (IV)
  • Subcutaneous injection (less commonly)
  • In some cases, intrathecal injection (into cerebrospinal fluid)
• Location: Only in a hospital or specialized cancer treatment center
• Monitoring: Blood counts, liver function, and kidney function must be monitored regularly

Administration Tips:

• Avoid self-administration; it must be given by trained personnel.
• Premedication may be required to reduce nausea or allergic reactions.
• Hydration is often provided to support renal function during high-dose therapy.
• Dose modifications may be necessary based on toxicity, age, or organ function.

Patients should inform their doctor of any signs of infection, unusual bleeding, neurological symptoms, or visual disturbances during treatment.

Mode of Action ALEXAN 1000mg/20ml

Cytarabine, the active ingredient in ALEXAN, is a cell cycle-specific antimetabolite that interferes with DNA synthesis, primarily targeting rapidly dividing cancer cells.

• Mechanism: Cytarabine is converted within the cell to its active form, cytarabine triphosphate (ara-CTP).
• DNA synthesis inhibition: ara-CTP competes with deoxycytidine triphosphate (dCTP) and incorporates into DNA, leading to faulty DNA strands and chain termination.
• Cell cycle specificity: It is most active during the S-phase (DNA replication phase) of the cell cycle.
• Apoptosis: This DNA damage leads to apoptosis (programmed cell death) in cancerous cells.

While effective against rapidly dividing leukemic cells, Cytarabine can also affect normal rapidly dividing cells (e.g., bone marrow, GI tract), which contributes to its side effect profile.

Pharmacokinetics:

• Short plasma half-life (10 minutes)
• Rapid hepatic metabolism to inactive uracil arabinoside (ara-U)
• Eliminated via the kidneys

ALEXAN 1000mg/20ml Interactions ALEXAN 1000mg/20ml

Cytarabine can interact with various medications, potentially altering its efficacy or increasing toxicity. Drug interactions should be carefully considered before starting treatment.

• Other chemotherapeutics: Combination with other cytotoxic drugs like cyclophosphamide, doxorubicin, or methotrexate may increase bone marrow suppression.
• Live vaccines: Use is contraindicated due to immunosuppression; risk of severe infection is increased.
• Digoxin: High-dose Cytarabine may reduce digoxin absorption and serum levels.
• Gentamicin: There is evidence that Cytarabine may antagonize the antimicrobial effect of gentamicin against certain bacteria (e.g., Klebsiella).
• Fluorocytosine (5-FC): Cytarabine may interfere with the antifungal efficacy of 5-FC.

Monitoring:

• Regular complete blood counts (CBCs)
• Renal and hepatic function monitoring
• Neurological assessments during high-dose therapy

Always provide a full medication list, including OTC and herbal supplements, to your oncologist before starting ALEXAN.

Dosage of ALEXAN 1000mg/20ml

Dosage of ALEXAN (Cytarabine 1000mg/20ml) depends on the type of leukemia, the treatment phase (induction, consolidation, maintenance), patient age, renal and hepatic function, and prior chemotherapy tolerance.

• Standard-dose regimen:
  • 100–200 mg/m²/day by continuous IV infusion or twice daily IV injections for 5–7 days (induction phase)
• High-dose therapy:
  • 1–3 g/m² every 12 hours for 2–6 days (used in consolidation or relapse settings)
• Intrathecal use: Lower doses (5–30 mg) directly into the spinal fluid for meningeal leukemia

Special Considerations:

• Dosage may be reduced in renal or hepatic impairment.
• Patients receiving high doses require close neurological monitoring.
• Dose adjustment is mandatory in cases of severe toxicity (e.g., pancytopenia, neurotoxicity).

Important: All dosing regimens should be tailored and administered by oncology specialists. Never self-administer or adjust the dose independently.

Possible side effects of ALEXAN 1000mg/20ml

ALEXAN (Cytarabine) can cause both common and serious side effects, many of which are dose-dependent. Side effects must be carefully managed under medical supervision.

• Common Side Effects:
  • Bone marrow suppression (anemia, leukopenia, thrombocytopenia)
  • Nausea, vomiting, loss of appetite
  • Fever, fatigue
  • Diarrhea
  • Mouth sores (mucositis)
• Neurological Toxicity:
  • Ataxia, unsteady gait
  • Dizziness, confusion
  • Seizures (especially with high-dose therapy)
• Ocular Toxicity:
  • Conjunctivitis, excessive tearing
  • Eye pain (prophylactic steroid eye drops may be used)
• Others:
  • Skin rash
  • Liver enzyme elevation
  • Rarely, pulmonary toxicity or cardiac events

Promptly report any signs of infection, bleeding, vision changes, or neurological symptoms. Regular blood monitoring is crucial during therapy.

ALEXAN 1000mg/20ml Contraindications ALEXAN 1000mg/20ml

ALEXAN (Cytarabine) should not be used in patients with certain medical conditions or histories, due to the risk of severe adverse effects.

• Hypersensitivity: Known allergy to Cytarabine or any of its excipients.
• Active severe infections: Use is contraindicated until infection is controlled due to immune suppression.
• Pre-existing severe bone marrow suppression: If not due to cancer, cytotoxic therapy may worsen pancytopenia.
• Pregnancy: Contraindicated unless benefit outweighs risk. It is teratogenic and may cause fetal harm.
• Breastfeeding: Not recommended as Cytarabine may be excreted in breast milk.

Additional caution is warranted in patients with:

• Hepatic or renal dysfunction
• History of neurotoxicity
• Gastrointestinal ulceration or bleeding disorders

A thorough medical history and baseline tests should be done before initiating therapy.

Storage of ALEXAN 1000mg/20ml

Proper storage of ALEXAN (Cytarabine Injection) is essential to maintain its stability, potency, and safety.

• Storage Temperature: Store between 15°C and 25°C (59°F to 77°F).
• Do Not Freeze: Freezing may compromise the stability of the solution.
• Protect from light: Store the vial in its original packaging or in a light-resistant container.
• Inspect before use: Do not use if the solution is cloudy, discolored, or contains particulate matter.
• After dilution (if required): Use within the period specified by local protocol or product insert (typically 6–24 hours if refrigerated).

Keep out of reach of children. ALEXAN is a hazardous drug and must be handled with appropriate safety measures. Dispose of vials and unused product through approved cytotoxic waste procedures.