ADALBERN 400 mg Tablet/Film coated

What is ADALBERN 400 mg

ADALBERN 400 mg is a film-coated oral tablet that contains Imatinib Mesylate as its active ingredient. It is classified as a tyrosine kinase inhibitor (TKI), primarily used in the treatment of various cancers, most notably:

• Chronic Myeloid Leukemia (CML)
• Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL)
• Gastrointestinal Stromal Tumors (GIST)
• Systemic mastocytosis and other rare malignancies

Imatinib represents a cornerstone in modern targeted cancer therapy. It revolutionized cancer treatment by specifically targeting molecular abnormalities responsible for cancer growth, rather than attacking all rapidly dividing cells like conventional chemotherapy.

• Generic Name: Imatinib Mesylate
• Brand Name: ADALBERN
• Strength: 400 mg per tablet
• Form: Film-coated tablet
• Pack Size: 30 tablets (10's blister × 3)

ADALBERN is commonly prescribed for long-term use under oncologist supervision and has shown excellent outcomes in prolonging life and improving quality of life in many patients with CML and GISTs.

How to use ADALBERN 400 mg

ADALBERN 400 mg should be taken exactly as prescribed by a healthcare provider, preferably one experienced in cancer treatment. The following are general guidelines for safe and effective use:

• Administration: Take orally with a full glass of water and with food to reduce gastrointestinal irritation.
• Do not crush or split: Tablets should be swallowed whole. If patients have difficulty swallowing, the tablet can be dispersed in water or apple juice (consult physician before doing this).
• Dosage Frequency: Usually once daily, depending on the condition and response to treatment.
• Time of Day: Should be taken at the same time each day to maintain steady blood levels.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it’s near the next dose, skip the missed one. Do not double the dose.

Always follow the exact instructions on the prescription label. Do not stop taking ADALBERN unless advised by your doctor, even if you feel well. Regular blood tests are essential to monitor drug effectiveness and side effects.

Mode of Action ADALBERN 400 mg

Imatinib Mesylate, the active ingredient in ADALBERN 400 mg, is a selective tyrosine kinase inhibitor that acts by targeting abnormal proteins involved in the proliferation of cancer cells.

• Inhibits BCR-ABL: In chronic myeloid leukemia (CML), Imatinib inhibits the BCR-ABL fusion protein created by the Philadelphia chromosome. This protein is responsible for uncontrolled cell division in leukemia.
• Targets KIT and PDGFRA: In gastrointestinal stromal tumors (GISTs), it inhibits KIT (CD117) and platelet-derived growth factor receptor alpha (PDGFRA), which are mutated and overactive in many tumors.
• Prevents ATP Binding: By blocking ATP binding sites on tyrosine kinases, Imatinib halts the phosphorylation cascade required for tumor cell growth and survival.
• Triggers Apoptosis: It promotes programmed cell death (apoptosis) in cancer cells while largely sparing normal cells.

Because it selectively targets cancerous signaling pathways, Imatinib is considered a “smart drug,” offering improved efficacy with fewer side effects than traditional chemotherapies.

ADALBERN 400 mg Interactions ADALBERN 400 mg

ADALBERN (Imatinib) interacts with a number of drugs and substances due to its metabolism primarily via the cytochrome P450 3A4 (CYP3A4) enzyme system. These interactions can affect its efficacy or increase toxicity.

• Strong CYP3A4 inhibitors (↑ Imatinib levels):
  • Ketoconazole
  • Erythromycin
  • Ritonavir
• Strong CYP3A4 inducers (↓ Imatinib levels):
  • Rifampicin
  • Phenytoin
  • St. John’s Wort
• Drugs affected by Imatinib:
  • Warfarin (monitor INR closely)
  • Simvastatin (risk of myopathy)
  • Benzodiazepines like midazolam
• Food interactions: Avoid grapefruit juice as it can increase Imatinib levels.

Always inform your healthcare provider about all medications and supplements being taken. Dose adjustments may be necessary to avoid harmful interactions.

Dosage of ADALBERN 400 mg

The dosage of ADALBERN depends on the type of disease, patient’s weight, and response to treatment. The tablet contains 400 mg of Imatinib, which is commonly used as a base dose in many conditions.

• Chronic Myeloid Leukemia (CML):
  • Chronic phase: 400 mg once daily
  • Accelerated phase/blast crisis: 600–800 mg daily in divided doses
• Gastrointestinal Stromal Tumors (GIST):
  • Initial: 400 mg once daily
  • May be increased to 600–800 mg if disease progresses or response is inadequate
• Ph+ ALL or other tumors:
  • Typically 600 mg once daily
• Children and adolescents:
  • Dosage is weight-based (approx. 260–340 mg/m²/day)

Dosage may be modified in the presence of liver or kidney dysfunction, or based on patient tolerance. Treatment is generally continued as long as clinical benefit is observed.

Possible side effects of ADALBERN 400 mg

Although ADALBERN is generally well tolerated, it may cause side effects ranging from mild to serious. These should be reported and monitored during therapy.

• Very Common Side Effects (≥10%):
  • Nausea, vomiting, abdominal discomfort
  • Muscle cramps or joint pain
  • Fluid retention (swelling of face, eyes, hands, or legs)
  • Fatigue, rash, and pruritus (itching)
• Common Side Effects (1–10%):
  • Headache, dizziness
  • Weight gain or loss
  • Anemia, leukopenia, or thrombocytopenia
  • Elevated liver enzymes
• Serious Side Effects (Rare):
  • Heart failure or arrhythmias
  • Severe skin reactions (e.g., Stevens-Johnson Syndrome)
  • Severe liver injury or hepatitis

Periodic blood tests (CBC, liver function, kidney function) are necessary to monitor for complications and dose-related effects. Prompt medical attention should be sought if unusual symptoms develop.

ADALBERN 400 mg Contraindications ADALBERN 400 mg

ADALBERN (Imatinib) is contraindicated or requires extreme caution in the following conditions:

• Hypersensitivity: Known allergy to Imatinib or any of the excipients in the tablet formulation.
• Pregnancy: Category D. May cause fetal harm. Avoid use unless benefits outweigh risks. Contraception is advised during therapy.
• Breastfeeding: Imatinib is excreted in breast milk. Nursing should be discontinued during treatment.
• Severe hepatic impairment: Increases the risk of drug accumulation and liver toxicity.
• Pre-existing heart conditions: Use with caution in patients with cardiac history, due to fluid retention and possible cardiac toxicity.

Before starting treatment, a full medical history, including liver and kidney function tests, should be conducted. Patients should be monitored closely for any worsening of comorbid conditions.

Storage of ADALBERN 400 mg

To maintain its stability and effectiveness, ADALBERN 400 mg tablets should be stored under appropriate conditions:

• Storage temperature: Below 30°C (86°F)
• Humidity: Store in a dry place. Avoid bathroom storage due to moisture exposure.
• Light exposure: Keep in the original blister pack until use to protect from light.
• Child safety: Store out of reach and sight of children.
• Do not use expired tablets: Check expiry date on the blister or outer carton.
• Disposal: Return unused or expired tablets to the pharmacy. Do not dispose of in household waste or water systems.

Proper storage preserves the integrity of the medication and ensures maximum therapeutic efficacy during its shelf life.