ADALBERN 100 mg Tablet/Film coated

What is ADALBERN 100 mg

ADALBERN 100 mg is a film-coated tablet formulation containing Imatinib, a tyrosine kinase inhibitor (TKI) used primarily in the treatment of various types of cancers, particularly chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs). It targets specific proteins involved in the growth of cancer cells and works by inhibiting their proliferation.

• Generic Name: Imatinib
• Brand Name: ADALBERN
• Strength: 100 mg per tablet
• Form: Film-coated tablet
• Packaging: 60 tablets per pack (10's blister × 6)

Imatinib is considered a targeted therapy because it acts specifically on certain abnormal proteins that drive cancer cell growth, particularly the BCR-ABL tyrosine kinase found in CML. It has transformed the prognosis of many cancer patients by offering improved survival and disease control with an oral treatment option.

How to use ADALBERN 100 mg

ADALBERN should be used under the supervision of an oncologist or specialist with experience in cancer treatment. The following points guide proper usage:

• Administration: Take orally with a large glass of water. It should be taken with food to reduce the risk of gastrointestinal irritation.
• Dosage Frequency: Once or twice daily, depending on the condition being treated and the prescribed total daily dose.
• Do Not Crush or Chew: Tablets should be swallowed whole to avoid local irritation.
• Missed Dose: If a dose is missed, it should be taken as soon as remembered. If it’s close to the next dose, skip the missed one. Do not double the dose.
• Duration of Therapy: Long-term or lifelong in chronic conditions like CML, as directed by the physician.

Patients should follow all medical instructions closely. Regular follow-ups, including blood tests and imaging studies, are essential to monitor response and adjust the dose if needed.

Mode of Action ADALBERN 100 mg

ADALBERN (Imatinib) acts as a selective inhibitor of specific tyrosine kinases that are overactive in certain cancers. Its mechanism of action involves:

• Inhibition of BCR-ABL: Imatinib blocks the BCR-ABL fusion protein found in Philadelphia chromosome-positive CML cells, halting uncontrolled cell division.
• c-Kit and PDGFR inhibition: It also inhibits other abnormal tyrosine kinases like c-Kit and PDGFR, which are implicated in GIST and certain myelodysplastic or myeloproliferative diseases.
• Cell Cycle Arrest: The drug induces apoptosis (cell death) in malignant cells by interfering with signaling pathways required for their survival.
• High Specificity: Imatinib targets cancer cells more specifically than traditional chemotherapy, resulting in fewer side effects.

This targeted inhibition reduces tumor burden, delays disease progression, and improves survival outcomes, especially in CML and GIST patients.

ADALBERN 100 mg Interactions ADALBERN 100 mg

Imatinib (ADALBERN) is metabolized mainly by the liver enzyme CYP3A4 and can interact with various other drugs, which may enhance or reduce its effectiveness or increase toxicity.

• Enzyme Inhibitors: Drugs like ketoconazole, erythromycin, and clarithromycin can increase Imatinib levels and toxicity risk.
• Enzyme Inducers: Rifampicin, phenytoin, carbamazepine, and St. John’s Wort may reduce Imatinib’s efficacy by lowering blood levels.
• Anticoagulants: Caution is required when co-administered with warfarin or DOACs due to potential bleeding risk.
• Grapefruit Juice: Should be avoided as it can increase Imatinib plasma concentrations.
• Paracetamol: High doses may compete with metabolism and increase hepatotoxicity.
• Drugs affecting pH: Proton pump inhibitors and antacids may reduce absorption; separate administration is recommended.

Always inform your doctor of all current medications, including supplements and herbal remedies, to avoid adverse interactions.

Dosage of ADALBERN 100 mg

The dosage of ADALBERN depends on the condition being treated, patient weight, age, and tolerance. Typical dosing guidelines include:

• Chronic Myeloid Leukemia (CML):
  • Chronic Phase: 400 mg once daily
  • Accelerated/Blast Crisis: 600 mg once daily
• Gastrointestinal Stromal Tumors (GIST):
  • Initial dose: 400 mg once daily
  • May be increased to 600–800 mg based on response
• Pediatric CML: Dose is weight-based (typically 260–340 mg/m²/day).
• Dose Adjustment: Required in cases of liver or kidney dysfunction, or severe adverse reactions (e.g., neutropenia, thrombocytopenia).

Tablets may be combined to reach the total daily dose. Doses should not be altered without a physician’s guidance. Regular monitoring ensures optimal therapeutic benefit and minimizes toxicity.

Possible side effects of ADALBERN 100 mg

Like all medications, ADALBERN may cause side effects. While not everyone will experience them, patients should be informed of potential reactions.

• Very Common:
  • Nausea, vomiting, diarrhea
  • Muscle cramps or pain
  • Fluid retention and edema (especially around eyes and legs)
  • Rash and skin discoloration
• Common:
  • Fatigue, headache, abdominal pain
  • Weight gain, anemia, low platelet or white blood cell count
  • Joint or bone pain
• Serious:
  • Liver dysfunction (elevated liver enzymes)
  • Heart complications (CHF, pericardial effusion)
  • Severe skin reactions (e.g., Stevens-Johnson Syndrome)

Side effects should be reported promptly to a healthcare provider. Periodic blood tests are essential to detect early signs of toxicity.

ADALBERN 100 mg Contraindications ADALBERN 100 mg

ADALBERN is not suitable for everyone. The following conditions contraindicate its use or require extreme caution:

• Known hypersensitivity to Imatinib or any tablet component
• Pregnancy: Imatinib may harm fetal development; it is contraindicated unless benefits clearly outweigh risks.
• Breastfeeding: Excretion in breast milk is documented; nursing should be avoided during treatment.
• Severe hepatic impairment: Risk of drug accumulation and toxicity
• Cardiac conditions: Caution in patients with heart failure or history of cardiac events
• Concurrent use of strong CYP3A4 inducers: May reduce efficacy significantly

All relevant medical history should be disclosed before starting ADALBERN to ensure safe and appropriate use.

Storage of ADALBERN 100 mg

Proper storage ensures the stability and effectiveness of ADALBERN tablets. Follow these guidelines:

• Temperature: Store below 30°C (86°F), away from moisture and heat sources
• Packaging: Keep in original blister pack until use to protect from light and humidity
• Keep out of reach of children: This medication is potentially harmful if ingested by non-patients
• Do not use after expiry date: Check the packaging regularly and dispose of expired medication responsibly
• Avoid bathroom storage: High humidity may degrade the tablet coating

Unused or expired tablets should be returned to a pharmacy or appropriate disposal facility, not flushed or thrown into household waste.