Veenat 100 — Imatinib 100 mg Capsules, 120 Capsules

Veenat 100 is supplied in the form of hard capsules for oral administration.

Qualitative and Quantitative Composition per Capsule:

• • Active Ingredient: Imatinib mesylate equivalent to imatinib — 100 mg.
• • Excipients: Microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide; capsule shell: gelatin, titanium dioxide, approved colorants.

Packaging and Presentation: Hard gelatin capsules. 10 capsules per blister strip. 12 blister strips (total 120 capsules) are packaged in an outer carton displaying Veenat 100 (Imatinib Capsules I.P.) along with Natco Pharma corporate design graphics.

Pharmacodynamics:
Imatinib inhibits the Bcr-Abl tyrosine kinase enzyme at the cellular level in vitro and in vivo. It selectively inhibits proliferation and induces apoptosis in cell lines expressing Bcr-Abl (including immature leukemic cells in CML and Ph+ ALL). Imatinib also inhibits the receptor tyrosine kinases for c-Kit (CD117) and PDGFR, blocking growth signal transduction in GIST and dermatofibrosarcoma protuberans.

Pharmacokinetics:

• • Absorption: Mean absolute oral bioavailability of imatinib is 98%. Peak plasma concentration is achieved within 2 to 4 hours post-dose.
• • Distribution: Highly bound to human plasma proteins (approximately 95%), mainly albumin and alpha-1-acid glycoprotein.
• • Metabolism: Extensively metabolized in the liver primarily by CYP3A4, forming its main active N-demethylated piperazine derivative.
• • Elimination: Terminal elimination half-life is approximately 18 hours. Excreted mainly in feces (68%) and urine (13%) within 7 days.

Veenat 100 is indicated in adult and pediatric patients for:

• • Chronic Myeloid Leukemia (CML): Newly diagnosed Ph+ CML in chronic phase, accelerated phase, or blast crisis.
• • Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL): Integrated into combination chemotherapy or as monotherapy for relapsed/refractory cases.
• • Myelodysplastic/Myeloproliferative Diseases (MDS/MPD): Associated with PDGFR gene rearrangements.
• • Gastrointestinal Stromal Tumors (GIST): Unresectable or metastatic c-Kit (CD117)+ malignant tumors, and as adjuvant treatment following surgical resection.
• • Dermatofibrosarcoma Protuberans (DFSP): Unresectable, recurrent, or metastatic cases.

Veenat 100 is administered orally once or twice daily under hematologist/oncologist supervision.

Administration Instructions:

• • Capsules must be taken with a meal and swallowed with a large glass of water (at least 200 ml) to minimize GI irritation.
• • For patients unable to swallow capsules, the contents may be dispersed in a glass of water or apple juice and consumed immediately.

Dosing Regimen: Dosage depends on the underlying indication and disease phase (typically ranging from 400 mg to 800 mg daily for adults) and is adjusted based on clinical response and tolerability.

Administration of Veenat 100 is contraindicated in:

• • Hypersensitivity: Known hypersensitivity to imatinib or any capsule excipient.
• • Pregnancy and Lactation: Contraindicated during pregnancy and breastfeeding.
• • Pediatric Age Limit: Children under 2 years of age (safety and efficacy have not been established).

Key evaluated drug interactions for Veenat include:

• • CYP3A4 Inhibitors: Co-administration with CYP3A4 inhibitors (ketoconazole, erythromycin, grapefruit juice) increases imatinib plasma levels.
• • CYP3A4 Inducers: Potent CYP3A4 inducers (rifampicin, carbamazepine, phenobarbital, St. John's wort) significantly reduce imatinib exposure and clinical efficacy.
• • Paracetamol / Acetaminophen: Caution is advised due to risk of increased hepatotoxicity.
• • Warfarin: Imatinib inhibits warfarin metabolism; low-molecular-weight heparin should be considered if anticoagulation is required.

Pregnancy:
Veenat 100 is strictly contraindicated during pregnancy due to teratogenic and embryotoxic risks. Women of childbearing potential must use effective contraception during treatment and for at least 1–2 months post-therapy.

Lactation:
Imatinib and its active metabolite pass into human milk. Breastfeeding is strictly contraindicated during therapy.

The most frequent adverse events reported during imatinib therapy include:

• • Fluid Retention and Edema (Very Common): Periorbital edema, lower limb edema, rare pleural/pericardial effusion, ascites.
• • Gastrointestinal Tract: Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence.
• • Musculoskeletal System: Muscle cramps, spasms, myalgia, arthralgia, bone pain.
• • Hematologic Toxicity: Neutropenia, thrombocytopenia, anemia.
• • Dermatologic Reactions: Skin rash, pruritus, dry skin, alopecia.
• • General Disorders: Fatigue, headache, weight gain.

Symptoms:
Overdose manifests as exaggeration of known adverse effects: severe nausea, vomiting, diarrhea, rash, severe neutropenia, and elevated transaminases/bilirubin levels.

Treatment:
No specific antidote exists. Supportive care and medical monitoring are indicated. Hemodialysis is ineffective due to high protein binding.

Storage Requirements for Veenat 100:

• 🌡️ Temperature Range: Store at temperatures not exceeding 25–30 °C in a dry place.
• 💧 Moisture Protection: Keep in original blister packaging to protect capsules from moisture and direct light.
• 👶 Safety Precautions: Keep out of reach of children.
• ⏳ Shelf Life: Stated on the outer box and blisters. Do not use past expiration date. Prescription-only medicine.

To verify the authenticity of genuine Veenat 100 manufactured by Natco Pharma, inspect the following features:

• ✅ Corporate Logo: Distinctive blue-green Natco Pharma corporate logo printed on the carton box and blister foil.
• ✅ Packaging Markings: Clear factory embossing/printing of Batch No., Mfg. Date, Exp. Date, and product designation Veenat 100 (Imatinib Capsules I.P.).
• ✅ Blister Quantity: Box contains exactly 12 blister strips of 10 capsules each (total 120 capsules).
• ✅ Print Quality: High-grade packaging artwork without color fading or typography errors.