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IMATIS (IMATINIB) 400MG TABLETS 30`S

Ksh 16,197

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What It Is and What It Treats

Imanix contains imatinib mesilate, the first molecularly targeted anti-cancer therapy. It selectively inhibits the BCR-ABL tyrosine kinase (the pathogenic kinase in CML), as well as KIT (CD117) and PDGFR kinases, making it active across a range of malignancies driven by these enzymes.

Indications:

·       Chronic phase CML (adults and paediatric patients)

·       Ph+ ALL

·       GIST (adjuvant and unresectable/metastatic).

 

Dosing and Administration

Paediatric CML:

340 mg/m²/day, given as a single daily dose or divided into two doses if total dose ≥340mg. Maximum 600mg/day. Body surface area must be calculated at each dose review.

Adult dose reduction or titration:

As directed by the haematologist/oncologist based on toxicity profile and response.

Administration: take with food and a large glass of water. Swallow whole, or dissolve in water/apple juice for patients who cannot swallow tablets.

 

CAUTION:  DISPENSING ALERT: Verify the correct strength — 100mg and 400mg are significantly different doses. Do not substitute one for the other without explicit prescriber instruction. Confirm dose calculation for paediatric patients at each dispensing episode.

 

Paediatric-Specific Considerations

       Growth monitoring: long-term imatinib in children may cause growth retardation. Monitor height and weight at every clinic visit throughout treatment. Pubertal development should also be assessed annually.

       Bone health: bone metabolism effects have been reported in children on long-term imatinib. Monitor for bone pain and consider DXA if clinically indicated.

       Dissolving tablets: dissolve in water or apple juice if the child cannot swallow. Stir thoroughly until completely dissolved and give immediately.

 

Side Effects

Frequency

Side Effects

Very Common

Nausea, vomiting, diarrhoea, oedema (periorbital puffiness and ankle/lower limb swelling are characteristic), muscle cramps, bone pain, fatigue, rash

Common

Neutropenia, thrombocytopenia, anaemia, elevated liver enzymes (ALT/AST), headache, joint pain, fluid retention

Serious — Seek Urgent Help

Severe fluid retention: pleural effusion (breathlessness, cough), pulmonary oedema, ascites, pericardial effusion — report sudden weight gain or breathlessness urgently. Hepatotoxicity: jaundice, dark urine, right upper quadrant pain. Cardiac failure (particularly in elderly or pre-existing cardiac disease). Stevens-Johnson syndrome (rare).

 

Contraindications and Cautions

       Known hypersensitivity to imatinib or any excipient

       Pregnancy and breastfeeding — imatinib is teratogenic. Effective contraception is required during treatment and for 30 days after the last dose.

       Moderate-severe hepatic impairment: dose reduction to 300mg required; monitor LFTs closely

       Cardiac disease: imatinib is cardiotoxic — can cause left ventricular dysfunction; baseline cardiac assessment and regular monitoring in at-risk patients

 

Key Drug Interactions

       Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, itraconazole): increase imatinib plasma levels significantly — monitor for toxicity

       CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John's Wort): markedly reduce imatinib efficacy — avoid; consider dose increase if unavoidable

       Warfarin: imatinib inhibits CYP2C9, increasing warfarin effect. Substitute LMWH for warfarin wherever possible in patients on imatinib. If warfarin is essential, monitor INR very frequently.

       Simvastatin and other CYP3A4 substrates: imatinib raises their levels — consider statin switch to pravastatin or rosuvastatin (not CYP3A4-dependent)

       Paracetamol at high doses: increased hepatotoxicity risk in combination — limit paracetamol dose

 

Clinical Monitoring Schedule

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PRESCRIBER NOTE  FBC: monthly for first 3 months, then every 3 months. LFTs: monthly for the first year, then every 3 months. Renal function: baseline and periodically. Weight: weekly by patient at home. Molecular response (BCR-ABL PCR) for CML: every 3 months. Confirm cytogenetic/molecular diagnosis before dispensing. Avoid warfarin — use LMWH. High-risk oncology medicine; specialist prescription required.

 

Key Dispensing Note

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DISPENSING ALERT: IMANIX 400mg and IMATIS 400mg contain the same active ingredient at the same strength. Confirm which product is being dispensed at each episode — do not issue both products concurrently to the same patient. Verify specialist prescription and indication documentation before dispensing.

 

Frequently Asked Questions

Q: What is Imatis 400mg used for?

It is the standard adult dose of imatinib, used primarily for chronic myeloid leukaemia (CML), Ph+ ALL, and gastrointestinal stromal tumours (GIST).

Q: What is the difference between Imatis and Imanix?

Both are generic imatinib 400mg products with the same active ingredient, dose, and indications. They differ only in brand/manufacturer. Clinically, they are equivalent. Do not take both at the same time.

Q: What are the most important monitoring tests?

Fluid retention (weekly weight self-monitoring), liver function (monthly for the first year), and blood counts are the key ongoing monitoring parameters. Your specialist will arrange a schedule.

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