Pharion Speciality Medicines

1.       Brand Name: Acabrunat

2.       Generic Name: Acalabrutinib

3.       Strength: 100 mg

4.       Dosage Form: Film-coated tablet

5.       Therapeutic Class: Bruton's Tyrosine Kinase (BTK) Inhibitor

·         Chronic Lymphocytic Leukemia (CLL)

·         Small Lymphocytic Lymphoma (SLL)

·         Mantle Cell Lymphoma (MCL) – in relapsed/refractory cases

·         Acalabrutinib is a selective BTK inhibitor.

·         It binds covalently to BTK, blocking B-cell receptor signaling.

·         This prevents malignant B-cell proliferation and survival.

·         Recommended Dose: 100 mg orally twice daily.

·         Can be taken with or without food.

·         Tablets should be swallowed whole with water, not crushed/chewed.

·         Dose adjustments may be needed for drug interactions or adverse effects.

·         Bottle containing 30 tablets (100 mg each).

·         Store at 25°C (excursions permitted 15°C–30°C).

·         Keep container tightly closed and protected from moisture.

·         Keep out of reach of children.

·         Risk of bleeding (caution with anticoagulants/antiplatelets).

·         Infections: monitor for bacterial, viral, and fungal infections.

·         Cytopenias: regular CBC monitoring recommended.

·         Cardiac effects: atrial fibrillation, hypertension may occur.

·         Avoid use in severe hepatic impairment.

·         Use in pregnancy/lactation not recommended.

• Brand Name: Tegonat 20

• Manufacture: Natco Pharma Ltd.

• Generic Name: Temozolomide

• Strength: 20 mg

• Dosage Form: Capsule

• Therapeutic Class: Alkylating Agent, Antineoplastic

• Glioblastoma Multiforme (GBM): Newly diagnosed, in combination with radiotherapy followed by maintenance monotherapy.

• Anaplastic Astrocytoma: In adults with relapsed or refractory disease.

• Other High-Grade Gliomas (off-label use): Including metastatic brain tumors.

Temozolomide is an oral alkylating agent of the imidazotetrazine family.

• Under physiologic pH, it is converted to MTIC (monomethyl triazeno imidazole carboxamide).

• MTIC methylates guanine residues at the O6 and N7 DNA positions.

• This induces DNA strand breaks, inhibits replication, and triggers apoptosis in tumor cells.

• Its ability to cross the blood–brain barrier makes it highly effective for brain tumors.

• Newly Diagnosed GBM:

  • Concomitant phase: 75 mg/m² once daily with radiotherapy for 42 days.

  • Maintenance phase: 150 mg/m² daily on days 1–5 of a 28-day cycle; may increase to 200 mg/m² if tolerated.

• Recurrent Anaplastic Astrocytoma: 150 mg/m² daily on days 1–5 of a 28-day cycle; may increase to 200 mg/m² if no severe toxicity.

• Tegonat 20 is used for dose modification, step-up dosing, or patient-specific titration.

• Swallow capsules whole with water; do not open, crush, or chew.

• Take on an empty stomach or after fasting to minimize nausea.

• Antiemetics are commonly prescribed with treatment.

• Supplied in blister packs or bottles.

• Pack size: 5 or 10 capsules (20 mg each).

• Store at 20°C–25°C.

• Protect from light and moisture.

• Keep in original container, tightly closed.

• Keep out of reach of children.

• Bone Marrow Suppression: Common; monitor CBC before each cycle.

• Infections: Prolonged use increases risk of opportunistic infections, including PCP; prophylaxis may be required.

• GI Toxicities: Nausea, vomiting, constipation; antiemetics recommended.

• Liver Toxicity: Monitor liver enzymes during therapy.

• Secondary Malignancies: Rare long-term risk.

• Fertility & Reproduction: May impair fertility; teratogenic – effective contraception required for both men and women.

• Renal/Hepatic Impairment: Use cautiously; data limited.

• Drug Interactions: Avoid co-administration with strong myelosuppressive agents and enzyme inducers; monitor with valproic acid.

• Pregnancy & Lactation: Contraindicated; may cause fetal harm. Breastfeeding not advised.

SUNINAT 50 contains Sunitinib, a tyrosine kinase inhibitor indicated for renal cell carcinoma, gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors. It blocks multiple receptor pathways involved in cancer cell growth and angiogenesis, helping to slow or stop tumor progression. Available as an oral capsule, it is taken under strict medical supervision with regular monitoring to ensure safe and effective therapy.

• Brand Name: Tegonat 15

• Manufacture: Natco Pharma Ltd.

• Generic Name: Temozolomide

• Strength: 15 mg

• Dosage Form: Capsule

• Therapeutic Class: Alkylating Agent, Antineoplastic

• Glioblastoma Multiforme (GBM): Newly diagnosed, in combination with radiotherapy followed by maintenance monotherapy.

• Anaplastic Astrocytoma: For patients with refractory or relapsed disease after prior therapy.

• Other CNS Tumors (off-label in some regions): Certain high-grade gliomas and metastatic brain tumors.

Temozolomide is an oral alkylating agent of the imidazotetrazine class.

• Rapidly converted to the active metabolite MTIC (monomethyl triazeno imidazole carboxamide).

• MTIC methylates DNA at the O6 and N7 positions of guanine.

• This leads to DNA damage, impaired replication, and apoptosis of tumor cells.

• Particularly effective in CNS malignancies due to good blood-brain barrier penetration.

• Newly diagnosed GBM:

  • Concomitant phase: 75 mg/m² once daily during radiotherapy (up to 42 days).

  • Maintenance phase: 150 mg/m² once daily on days 1–5 of a 28-day cycle; may increase to 200 mg/m² from cycle 2 if tolerated.

• Recurrent Anaplastic Astrocytoma: 150 mg/m² once daily on days 1–5 of a 28-day cycle; may increase to 200 mg/m² if no severe toxicity.

• Tegonat 15 is mainly used for dose adjustment, combination regimens, or step-down dosing.

• Capsules must be swallowed whole with water; do not open or crush.

• Administer on an empty stomach or after fasting to reduce nausea.

• Antiemetic prophylaxis is often recommended.

• Supplied in blister packs or bottle packs.

• Pack size: 5 or 10 capsules (15 mg each).

• Store at 20°C–25°C.

• Protect from moisture and light.

• Keep container tightly closed.

• Keep out of reach of children.

• Myelosuppression: Monitor complete blood counts before each cycle and during therapy.

• Opportunistic Infections: Risk of Pneumocystis jirovecii pneumonia (PCP), especially during prolonged concomitant therapy with radiotherapy.

• Nausea/Vomiting: Prophylactic antiemetics often required.

• Hepatotoxicity: Monitor liver function periodically.

• Secondary Malignancies: Rare but possible after long-term use.

• Fertility & Reproduction: Teratogenic; effective contraception required for both men and women. May cause permanent infertility.

• Renal & Hepatic Impairment: Use with caution; dose adjustment may be necessary.

• Drug Interactions: Caution with myelosuppressive agents, valproic acid, and strong enzyme inducers.

• Pregnancy & Lactation: Contraindicated. Women should avoid pregnancy; breastfeeding is not recommended.

• Brand Name: Pomalid 4

• Manufacture: Natco Pharma Ltd.

• Generic Name: Pomalidomide

• Strength: 4 mg

• Dosage Form: Capsule

• Therapeutic Class: Immunomodulatory Agent, Antineoplastic

• In combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least two prior therapies including lenalidomide and bortezomib, and whose disease has progressed.

• May also be used in other hematologic malignancies under medical supervision.

Pomalidomide is a thalidomide analogue with potent immunomodulatory, antiangiogenic, and antineoplastic properties.

• Activates T-cells and NK cells to enhance immune-mediated tumor cell killing.

• Inhibits production of inflammatory cytokines (TNF-α, IL-6).

• Directly induces apoptosis of malignant plasma cells.

• Reduces angiogenesis in bone marrow tumor microenvironment, suppressing disease progression.

• Recommended dose: 4 mg orally once daily on days 1–21 of each 28-day cycle, in combination with dexamethasone.

• Continue until disease progression or unacceptable toxicity.

• Capsules must be swallowed whole with water; do not open, crush, or chew.

• May be taken with or without food.

• Dose adjustments are required for hematologic toxicity, hepatic impairment, or renal dysfunction.

• Supplied in blister packs.

• Pack size: 21 capsules (4 mg each).

• Store at 20°C–25°C (room temperature).

• Protect from light and moisture.

• Keep out of reach of children.

• Hematologic Toxicity: Risk of neutropenia, thrombocytopenia, and anemia; frequent CBC monitoring required (weekly for first 8 weeks, then monthly).

• Thromboembolic Risk: Increased risk of DVT and pulmonary embolism; prophylactic anticoagulation may be considered.

• Infections: Patients are susceptible to opportunistic infections; close monitoring recommended.

• Hepatic Toxicity: May elevate liver enzymes; monitor LFTs regularly.

• Peripheral Neuropathy: Monitor for symptoms such as numbness or tingling.

• Pregnancy & Teratogenicity: Strictly contraindicated; highly teratogenic. Mandatory pregnancy prevention program for women of childbearing potential.

• Lactation: Contraindicated; breastfeeding should be avoided.

• Drug Interactions: Metabolized by CYP1A2 and CYP3A4 pathways; avoid strong inhibitors/inducers when possible.

• Elderly Patients: May experience higher toxicity rates; dose reduction and careful monitoring required.

SUNINAT 12.5 contains Sunitinib, a multi-targeted tyrosine kinase inhibitor used in the treatment of renal cell carcinoma, gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors. By blocking pathways responsible for tumor growth and angiogenesis, it helps slow disease progression. Available as an oral capsule, it must be taken under strict medical guidance with regular monitoring for safety and effectiveness.

• Brand Name: Pomalid 1

• Manufacture: Natco Pharma Ltd.

• Generic Name: Pomalidomide

• Strength: 1 mg

• Dosage Form: Capsule

• Therapeutic Class: Immunomodulatory Agent, Antineoplastic

• Used in combination with dexamethasone for treatment of multiple myeloma in patients who have received at least two prior therapies (including lenalidomide and bortezomib) and have shown disease progression.

• May be used in certain hematologic malignancies and investigational indications as per clinician’s discretion.

Pomalidomide is a thalidomide analogue with potent immunomodulatory, antiangiogenic, and antineoplastic properties.

• Enhances T-cell and NK-cell mediated immunity.

• Inhibits pro-inflammatory cytokines (TNF-α, IL-6).

• Suppresses growth of myeloma cells and induces apoptosis.

• Reduces angiogenesis within bone marrow microenvironment.

• Recommended dose: 4 mg orally once daily on days 1–21 of repeated 28-day cycles, in combination with dexamethasone.

• Pomalid 1 (1 mg strength) is used when dose adjustments or reductions are required due to toxicity (e.g., hematologic or non-hematologic adverse events).

• Capsules should be swallowed whole, without opening or chewing.

• May be taken with or without food.

• Continue until disease progression or unacceptable toxicity.

• Supplied in blister packs.

• Pack size: 21 capsules (1 mg each).

• Store at 20°C–25°C (room temperature).

• Protect from light and moisture.

• Keep container tightly closed.

• Keep out of reach of children.

• Hematologic Toxicity: Neutropenia and anemia are common; monitor complete blood counts weekly for the first 8 weeks, then monthly.

• Thromboembolism: Increased risk of deep vein thrombosis (DVT) and pulmonary embolism; prophylactic anticoagulation may be required.

• Infections: Monitor closely; opportunistic infections may occur.

• Hepatotoxicity: Risk of elevated liver enzymes; monitor LFTs regularly.

• Peripheral Neuropathy: Though less frequent than thalidomide, cases have been reported.

• Teratogenicity: Contraindicated in pregnancy; strict pregnancy prevention program required.

• Lactation: Breastfeeding is contraindicated.

• Drug Interactions: Avoid concomitant use with strong CYP1A2 inhibitors/inducers unless necessary.

• Elderly Patients: Increased risk of myelosuppression; careful monitoring advised.

• Brand Name: Pomalid 2

• Manufacture: Natco Pharma Ltd.

• Generic Name: Pomalidomide

• Strength: 2 mg

• Dosage Form: Capsule

• Therapeutic Class: Immunomodulatory Agent, Antineoplastic

• In combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least two prior therapies including lenalidomide and bortezomib, and whose disease has progressed.

• Also used in certain hematologic malignancies under clinician’s guidance.

Pomalidomide is an immunomodulatory drug (IMiD) and a thalidomide analogue.

• Enhances activation of T-cells and natural killer (NK) cells.

• Inhibits release of pro-inflammatory cytokines (TNF-α, IL-6).

• Directly induces apoptosis in malignant plasma cells.

• Exhibits antiangiogenic activity, reducing blood supply to tumors.

• Recommended dose (standard): 4 mg orally once daily on days 1–21 of each 28-day cycle, combined with dexamethasone.

• Pomalid 2 (2 mg strength) is mainly prescribed for dose adjustments/reductions in patients unable to tolerate higher doses due to hematologic or non-hematologic toxicities.

• Capsules should be swallowed whole with water, not opened, broken, or chewed.

• May be taken with or without food.

• Continue until disease progression or unacceptable toxicity.

• Supplied in blister packs.

• Pack size: 21 capsules (2 mg each).

• Store at 20°C–25°C (room temperature).

• Protect from light and moisture.

• Keep tightly closed and out of reach of children.

• Hematologic Toxicity: Neutropenia, thrombocytopenia, and anemia are common; frequent CBC monitoring is required.

• Thromboembolism: Risk of deep vein thrombosis (DVT) and pulmonary embolism; consider prophylactic anticoagulation.

• Infections: Opportunistic infections can occur; monitor closely.

• Hepatotoxicity: Elevated liver enzymes may be seen; monitor LFTs regularly.

• Peripheral Neuropathy: Reported in some patients; monitor for symptoms.

• Pregnancy & Teratogenicity: Contraindicated in pregnancy; strict pregnancy prevention program required.

• Lactation: Contraindicated during breastfeeding.

• Drug Interactions: Avoid strong CYP1A2 inhibitors/inducers unless essential; monitor for drug interactions.

• Elderly Patients: May have higher rates of adverse events; dose modifications may be necessary.

• Brand Name: Palnat

• Generic Name: Palbociclib

• Strength: 125 mg per capsule

• Dosage Form: Oral capsule

• Therapeutic Class: CDK4/6 Inhibitor / Targeted Anticancer Therapy

• Used for the treatment of hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer

• Prescribed in combination with:

  • Aromatase inhibitors (e.g., letrozole) for first-line therapy

  • Fulvestrant in patients with progression after endocrine therapy

• Selectively inhibits Cyclin-Dependent Kinases 4 and 6 (CDK4/6)

• Prevents cancer cell progression from the G1 phase to the S phase of the cell cycle

• Leads to slowed tumor growth and increased cancer cell death

• Usual dose: 125 mg once daily for 21 consecutive days, followed by 7 days off (forming a 28-day treatment cycle)

• Take with food, at the same time every day

• Swallow capsules whole — do not chew, crush, or open

• Supplied in blister packs or bottles, depending on manufacturer specifications

• Store below 30°C

• Protect from light, moisture, and heat

• Prescription-only (Rx) — use under the supervision of an oncologist

• Requires regular monitoring of complete blood counts (CBC) due to risk of neutropenia

• Not recommended during pregnancy or breastfeeding

• Caution in patients with hepatic or renal impairment

• Brand Name: Palnat 100

• Manufacture: Natco Pharma Ltd.

• Generic Name: Palbociclib

• Strength: 100 mg

• Dosage Form: Capsule

• Therapeutic Class: Antineoplastic agent, CDK 4/6 Inhibitor

• In combination with an aromatase inhibitor for the treatment of hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer in postmenopausal women.

• In combination with fulvestrant for HR+, HER2-negative advanced or metastatic breast cancer in patients who have progressed following endocrine therapy.

Palbociclib selectively inhibits cyclin-dependent kinases 4 and 6 (CDK4/6).

• Blocks phosphorylation of retinoblastoma (Rb) protein.

• Prevents cell cycle progression from G1 to S phase.

• Leads to cell cycle arrest and inhibition of tumor cell proliferation.

• Standard dose: 125 mg orally once daily for 21 days, followed by 7 days off (28-day cycle).

• Palnat 100 is prescribed in patients requiring dose reduction from the standard 125 mg due to adverse events.

• Take orally with food, at the same time each day.

• Continue until disease progression or unacceptable toxicity.

• Dose adjustments required for hematologic or non-hematologic toxicities.

• Supplied in HDPE BOTTLE.

• Pack size: 21 capsules (100 mg each).

• Store at 20°C–25°C.

• Protect from moisture and light.

• Keep container tightly closed.

• Keep out of reach of children.

• Myelosuppression: Neutropenia, leukopenia, anemia, and thrombocytopenia are common; monitor CBC before therapy and regularly during treatment.

• Infections: Risk of serious infections; monitor and manage promptly.

• Pulmonary Toxicity: Cases of ILD/pneumonitis have been reported; discontinue if confirmed.

• Hepatic & Renal Impairment: Use with caution; dose adjustment may be necessary.

• Drug Interactions: Palbociclib is metabolized by CYP3A; avoid strong inhibitors/inducers. Avoid grapefruit products.

• Pregnancy & Lactation: Contraindicated; may cause fetal harm. Breastfeeding not recommended during treatment.

• Elderly Patients: Careful monitoring advised due to higher risk of adverse reactions.

• Brand Name: Palnat 75

• Manufacture: Natco Pharma Ltd.

• Generic Name: Palbociclib

• Strength: 75 mg

• Dosage Form: Capsule

• Therapeutic Class: Antineoplastic agent, CDK 4/6 Inhibitor

• In combination with an aromatase inhibitor for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women.

• In combination with fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer in patients who have experienced progression after endocrine therapy.

Palbociclib is a selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).

• Inhibits phosphorylation of retinoblastoma (Rb) protein.

• Prevents transition from G1 to S phase in the cell cycle.

• Results in cell cycle arrest, reducing proliferation of tumor cells.

• Recommended dose: 125 mg orally once daily for 21 consecutive days, followed by 7 days off (28-day cycle).

• Palnat 75 is prescribed for patients who require dose reduction due to adverse events or intolerance.

• Take orally with food, at the same time each day.

• Continue until disease progression or unacceptable toxicity.

• Dose adjustments required for hematologic and non-hematologic toxicities.

• Supplied in blister packs.

• Pack size: 21 capsules (75 mg each).

• Store at 20°C–25°C.

• Keep away from moisture and light.

• Keep container tightly closed.

• Keep out of reach of children.

• Hematologic Toxicity: Neutropenia, leukopenia, anemia, and thrombocytopenia are common; monitor CBC before and during treatment.

• Infections: Patients are at increased risk; monitor closely and withhold therapy in severe cases.

• Pulmonary Toxicity: Interstitial lung disease (ILD) and pneumonitis have been reported. Discontinue if confirmed.

• Hepatic/Renal Impairment: Use with caution; dose adjustments may be needed.

• Drug Interactions: Avoid strong CYP3A inhibitors/inducers (e.g., ketoconazole, rifampin). Grapefruit products should be avoided.

• Pregnancy & Lactation: Contraindicated; may cause fetal harm. Breastfeeding should be avoided.

• Elderly Patients: Adverse events may be more pronounced; careful monitoring recommended.

• Brand Name: Lenvat 4

• Manufacture: Natco Pharma Ltd.

• Generic Name: Lenvatinib

• Strength: 4 mg

• Dosage Form: Capsule

• Therapeutic Class: Antineoplastic Agent, Tyrosine Kinase Inhibitor (TKI)

• Differentiated thyroid cancer (DTC): For patients with locally recurrent or metastatic, progressive, radioactive iodine–refractory disease.

• Renal cell carcinoma (RCC): In combination with everolimus, for advanced RCC after prior anti-angiogenic therapy.

• Hepatocellular carcinoma (HCC): First-line treatment of unresectable HCC.

• Endometrial carcinoma: In combination with pembrolizumab for advanced endometrial carcinoma not amenable to curative surgery or radiation, following prior systemic therapy.

Lenvatinib is a multi-kinase inhibitor that targets VEGFR1-3, FGFR1-4, RET, KIT, and PDGFRα.

• Inhibits tumor angiogenesis.

• Blocks signaling pathways involved in tumor growth and progression.

• Suppresses tumor proliferation and induces apoptosis.

• Recommended dose (general):

  • DTC: 24 mg once daily.

  • RCC: 18 mg once daily (with everolimus 5 mg).

  • HCC: 12 mg once daily (for patients ≥60 kg) or 8 mg once daily (<60 kg).

  • Endometrial carcinoma: 20 mg once daily (with pembrolizumab).

• Lenvat 4 is used for dose adjustments/reductions in patients unable to tolerate higher doses due to adverse effects.

• Swallow capsules whole, with or without food, at the same time each day.

• Treatment continues until disease progression or unacceptable toxicity.

• Supplied in blister packs.

• Pack size: 30 capsules (4 mg each).

• Store at 20°C–25°C.

• Protect from moisture and direct light.

• Keep container tightly closed.

• Keep out of reach of children.

• Hypertension: Very common; monitor blood pressure regularly.

• Cardiac Dysfunction: Risk of heart failure, QT prolongation, arterial thromboembolic events.

• Hepatotoxicity: Elevated liver enzymes and hepatic failure may occur; monitor LFTs closely.

• Renal Impairment: Cases of renal failure reported, often due to dehydration or diarrhea; monitor renal function.

• Proteinuria: Regular urine protein monitoring required.

• Hemorrhagic Events: Including serious and fatal bleeding; caution in patients with risk factors.

• GI Perforation/Fistula: Rare but serious; monitor for abdominal symptoms.

• Pregnancy & Lactation: Contraindicated; may cause fetal harm. Breastfeeding not recommended.

• Drug Interactions: Use caution with strong CYP3A4 and P-gp modulators.

• Dose Adjustments: Required for severe adverse events (hypertension, diarrhea, fatigue, hepatotoxicity).

• Brand Name: Lenalid 5

• Manufacture: Natco Pharma Ltd.

• Generic Name: Lenalidomide

• Strength: 5 mg

• Dosage Form: Capsule

• Therapeutic Class: Immunomodulatory Agent, Antineoplastic

• Multiple Myeloma (MM): In combination with dexamethasone in adults.

• Myelodysplastic Syndromes (MDS): Treatment of transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality.

• Mantle Cell Lymphoma (MCL): For adult patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

• Follicular & Marginal Zone Lymphoma (off-label in some regions).

Lenalidomide is an immunomodulatory drug (IMiD®) with multiple actions:

• Enhances T-cell and NK-cell mediated immune response.

• Inhibits angiogenesis by blocking pro-angiogenic factors.

• Directly induces apoptosis of malignant cells.

• Modulates cytokine production in the tumor microenvironment.

• Multiple Myeloma (MM): 25 mg daily on days 1–21 of 28-day cycle with dexamethasone (adjusted for renal function).

• MDS (del 5q): 10 mg once daily continuously.

• Mantle Cell Lymphoma: 25 mg once daily on days 1–21 of a 28-day cycle.

• Lenalid 5 is used for dose adjustments, lower-dose regimens, and special populations (elderly, renal impairment, or toxicity management).

• Swallow capsules whole with water; do not open, break, or chew.

• Dose interruptions or reductions may be required for toxicity.

• Supplied in blister packs.

• Pack size: 30 capsules (5 mg each).

• Store at 20°C–25°C (room temperature).

• Protect from light and moisture.

• Keep out of reach of children.

• Hematologic Toxicity: Risk of neutropenia and thrombocytopenia; monitor CBC weekly for first 2 months, then monthly.

• Thromboembolic Events: Increased risk of DVT/PE; prophylactic anticoagulation may be required.

• Secondary Malignancies: Long-term therapy associated with risk of secondary cancers.

• Renal Impairment: Dose adjustments necessary.

• Pregnancy Prevention: Contraindicated in pregnancy; highly teratogenic (similar to thalidomide). Use strict contraception program for both men and women.

• Lactation: Contraindicated; may cause harm to infant.

• Drug Interactions: Caution with P-glycoprotein substrates/inhibitors; monitor with anticoagulants.

• Elderly: Increased susceptibility to adverse reactions; dose adjustment may be required.

• Brand Name: Lenalid 25

• Manufacture: Natco Pharma Ltd.

• Generic Name: Lenalidomide

• Strength: 25 mg

• Dosage Form: Capsule

• Therapeutic Class: Immunomodulatory Agent, Antineoplastic

• Multiple Myeloma (MM): In combination with dexamethasone for adult patients.

• Myelodysplastic Syndromes (MDS): Treatment of transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with deletion 5q cytogenetic abnormality.

• Mantle Cell Lymphoma (MCL): For adults with relapsed or progressive disease after at least two prior therapies, including bortezomib.

• Other Lymphomas (off-label in some regions): Follicular lymphoma, marginal zone lymphoma.

Lenalidomide is an IMiD® (immunomodulatory drug) with multiple antineoplastic effects:

• Activates T-cells and NK-cells to boost immune-mediated tumor destruction.

• Inhibits angiogenesis by downregulating pro-angiogenic factors.

• Directly induces apoptosis of malignant hematopoietic and tumor cells.

• Modulates cytokine release within the tumor microenvironment.

• Multiple Myeloma: 25 mg once daily on days 1–21 of each 28-day cycle, combined with dexamethasone.

• MDS (del 5q): 10 mg once daily continuously (dose reduction often required).

• Mantle Cell Lymphoma: 25 mg once daily on days 1–21 of each 28-day cycle.

• Lenalid 25 represents the maximum strength, typically used as the starting dose in most indications.

• Capsules should be swallowed whole with water; do not open, break, or chew.

• Treatment continues until disease progression or unacceptable toxicity.

• Dose adjustments required for renal impairment, elderly patients, or adverse effects.

• Supplied in blister packs.

• Pack size: 30 capsules (25 mg each).

• Store at 20°C–25°C.

• Protect from moisture and direct sunlight.

• Keep container tightly closed.

• Keep out of reach of children.

• Myelosuppression: Neutropenia and thrombocytopenia are common; CBC monitoring required weekly for the first 2 months, then monthly.

• Thrombosis Risk: Increased incidence of DVT and PE; prophylactic anticoagulation should be considered.

• Secondary Malignancies: Long-term use may increase risk of other cancers; monitor patients periodically.

• Renal Impairment: Dose adjustment based on creatinine clearance.

• Pregnancy: Contraindicated; highly teratogenic. A strict pregnancy prevention program is mandatory.

• Lactation: Contraindicated; serious adverse effects possible in infants.

• Drug Interactions: Use caution with P-gp inhibitors/substrates and anticoagulants.

• Elderly: Dose adjustments often needed due to increased sensitivity.

KNILONAT 150 contains Nilotinib, a tyrosine kinase inhibitor used in the treatment of Philadelphia chromosome–positive chronic myeloid leukemia (CML). It works by blocking BCR-ABL kinase activity, thereby slowing or stopping the growth of leukemia cells. Taken orally, it is prescribed under strict medical supervision with regular monitoring.

SUNISAM SUNITINIB 25 MG CAP is an oral multi-kinase inhibitor used for advanced renal cell carcinoma and gastrointestinal stromal tumors. It inhibits tumor growth and angiogenesis, helping control disease progression, reduce tumor size, and support improved patient outcomes.

SUNISAM SUNITINIB 50 MG CAP is an oral multi-kinase inhibitor used to treat advanced renal cell carcinoma and gastrointestinal stromal tumors. It blocks tumor cell proliferation and angiogenesis, helping slow disease progression, reduce tumor size, and improve patient outcomes.

SUNISAM 12.5 MG CAP is an oral multi-kinase inhibitor used to treat advanced renal cell carcinoma and gastrointestinal stromal tumors. It blocks tumor cell growth and angiogenesis, helping slow disease progression, reduce tumor size, and improve patient outcomes.

Acaone 100 mg Capsule contains Acalabrutinib, a selective Bruton's tyrosine kinase (BTK) inhibitor used to treat certain blood cancers such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). It works by blocking cancer cell growth and proliferation, helping to control disease progression and improve patient outcomes.

About the product:

• Contains 200 mg nilotinib, a selective BCR-ABL tyrosine kinase inhibitor used for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph⁺ CML)

• Indicated for newly diagnosed or imatinib-resistant/intolerant CML in adults and children aged 1 year and older

• Typically taken as 200 mg twice daily, approximately 12 hours apart, on an empty stomach — no food for at least 2 hours before and 1 hour after each dose

• Capsules should be swallowed whole; if swallowing is difficult, contents may be mixed with applesauce and taken immediately — do not chew or store the mixture

• Common side effects: nausea, vomiting, diarrhea, headache, fatigue, constipation, muscle or joint pain

• Serious warnings: may prolong QT interval — avoid in patients with low potassium or magnesium levels; requires ECG and electrolyte monitoring

• Other serious risks: low blood cell counts (myelosuppression), cardiovascular events (e.g., ischemia, thrombosis), liver dysfunction — regular CBC and liver tests are advised

• Drug interactions: avoid grapefruit and other drugs that prolong QT interval or interact with CYP3A4; space out from antacids, H2 blockers, and proton pump inhibitors

• Not recommended during pregnancy or breastfeeding — effective contraception is required during treatment

• Tips: take doses at the same time daily; do not share medication; report missed doses; avoid driving if experiencing dizziness; store in a cool, dry place

• Brand Name: Lenalid 10

• Manufacture: Natco Pharma Ltd.

• Generic Name: Lenalidomide

• Strength: 10 mg

• Dosage Form: Capsule

• Therapeutic Class: Immunomodulatory Agent, Antineoplastic

• Multiple Myeloma (MM): In combination with dexamethasone for adult patients.

• Myelodysplastic Syndromes (MDS): Transfusion-dependent anemia due to low- or intermediate-1-risk MDS with deletion 5q cytogenetic abnormality.

• Mantle Cell Lymphoma (MCL): For adult patients with relapsed or progressive disease after ≥2 prior therapies, one of which included bortezomib.

• Other Lymphomas (off-label in some regions): Follicular lymphoma, marginal zone lymphoma.

Lenalidomide is an immunomodulatory agent (IMiD®) that works through multiple pathways:

• Stimulates T-cell and NK-cell immune response.

• Inhibits angiogenesis by blocking growth factors.

• Promotes apoptosis of malignant hematopoietic and tumor cells.

• Alters cytokine secretion within the tumor microenvironment, suppressing cancer growth.

• Multiple Myeloma: 25 mg once daily on days 1–21 of a 28-day cycle with dexamethasone.

• MDS (del 5q): 10 mg once daily continuously.

• Mantle Cell Lymphoma: 25 mg once daily on days 1–21 of a 28-day cycle.

• Lenalid 10 provides intermediate dosing strength, useful for dose modifications in patients with toxicity, renal impairment, or elderly patients.

• Capsules should be swallowed whole with water; do not open, break, or chew.

• Dose interruptions or reductions may be needed for adverse effects.

• Supplied in blister packs.

• Pack size: 30 capsules (10 mg each).

• Store at 20°C–25°C (room temperature).

• Protect from light and moisture.

• Keep container tightly closed.

• Keep out of reach of children.

• Myelosuppression: Risk of neutropenia and thrombocytopenia; CBC monitoring essential (weekly for first 2 months, then monthly).

• Thromboembolism: Increased risk of DVT/PE; prophylactic anticoagulation may be considered.

• Secondary Malignancies: Long-term use may increase risk; monitor periodically.

• Renal Impairment: Dose reduction required depending on creatinine clearance.

• Pregnancy: Contraindicated; highly teratogenic. Strict pregnancy prevention program mandatory for both men and women.

• Lactation: Contraindicated; may cause harm to infant.

• Drug Interactions: Use caution with strong P-gp inhibitors/substrates; monitor with anticoagulants.

• Elderly Patients: Greater risk of adverse effects; dose adjustments often necessary.

• Brand Name: Lenalid 15

• Manufacture: Natco Pharma Ltd.

• Generic Name: Lenalidomide

• Strength: 15 mg

• Dosage Form: Capsule

• Therapeutic Class: Immunomodulatory Agent, Antineoplastic

• Multiple Myeloma (MM): In combination with dexamethasone for adults.

• Myelodysplastic Syndromes (MDS): For transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with deletion 5q abnormality.

• Mantle Cell Lymphoma (MCL): In adult patients with relapsed or progressive disease after ≥2 prior therapies, including bortezomib.

• Other Lymphomas (off-label in some regions): Follicular lymphoma, marginal zone lymphoma.

Lenalidomide is an IMiD® (immunomodulatory drug) that works via several mechanisms:

• Enhances T-cell and NK-cell activation for anti-tumor immune response.

• Inhibits angiogenesis by reducing pro-angiogenic factors.

• Promotes apoptosis of malignant hematopoietic cells.

• Alters cytokine secretion in the tumor microenvironment, reducing cancer cell survival.

• Multiple Myeloma: 25 mg once daily on days 1–21 of a 28-day cycle with dexamethasone.

• MDS (del 5q): 10 mg once daily continuously.

• Mantle Cell Lymphoma: 25 mg once daily on days 1–21 of a 28-day cycle.

• Lenalid 15 is commonly used for dose adjustments in patients with toxicity, renal impairment, or requiring step-down dosing.

• Swallow capsules whole with water; do not open, break, or chew.

• Treatment should continue until disease progression or unacceptable toxicity.

• Supplied in blister packs.

• Pack size: 30 capsules (15 mg each).

• Store at 20°C–25°C.

• Protect from moisture and direct light.

• Keep container tightly closed.

• Keep out of reach of children.

• Hematologic Toxicity: Neutropenia and thrombocytopenia are frequent; CBC monitoring weekly for the first 2 months, then monthly.

• Thromboembolic Events: Increased risk of DVT/PE; prophylaxis (aspirin or anticoagulation) may be considered.

• Secondary Malignancies: Long-term therapy may increase risk; periodic monitoring advised.

• Renal Impairment: Dose adjustment required according to creatinine clearance.

• Pregnancy Prevention: Contraindicated; highly teratogenic. Strict pregnancy prevention program mandatory for both men and women.

• Lactation: Contraindicated; risk of serious adverse reactions in infants.

• Drug Interactions: Caution with P-gp substrates/inhibitors and anticoagulants.

• Elderly Patients: Higher susceptibility to adverse effects; careful monitoring and dose adjustments may be required.

About the product:

• Contains 150 mg nilotinib, a selective BCR-ABL tyrosine kinase inhibitor used for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph⁺ CML) in adults and children aged 1 year and older

• Typically dosed twice daily, approximately 12 hours apart, on an empty stomach — no food 2 hours before and 1 hour after each dose

• Capsules must be swallowed whole; if swallowing is difficult, the contents may be mixed with applesauce and taken immediately — do not chew or store the mixture

• Common side effects: nausea, vomiting, diarrhea, headache, fatigue, constipation, joint/muscle pain, swelling, rash, high blood pressure

• Serious warnings:

  • May cause QT interval prolongation — requires baseline and regular ECG monitoring; correct low potassium or magnesium before use

  • Risk of low blood counts (myelosuppression) — monitor CBC frequently

  • Potential for cardiovascular events (e.g., ischemia, thrombosis) and liver toxicity — regular monitoring recommended

• Drug interactions: avoid grapefruit and strong CYP3A4 modulators; take separately from antacids, H2 blockers, or PPIs as advised

• Contraindicated in individuals with hypokalemia, hypomagnesemia, or known QT prolongation

• Not recommended during pregnancy or breastfeeding — effective contraception must be used

• May cause dizziness or blurred vision — avoid driving or operating machinery until you know how it affects you

• Storage instructions: keep at room temperature in a dry place, away from moisture

SUNINAT 25 contains Sunitinib, a tyrosine kinase inhibitor indicated for the treatment of renal cell carcinoma, gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors. It works by blocking multiple receptor pathways involved in tumor growth and angiogenesis. Taken orally as a capsule, it requires strict medical supervision with regular monitoring to manage efficacy and potential side effects.

X-TRANT 140 contains Estramustine Phosphate, an antineoplastic agent used in the treatment of metastatic or progressive prostate cancer. It combines estrogenic and alkylating properties to inhibit cancer cell division and tumor growth. Taken orally in capsule form, it should be used strictly under medical supervision, with regular monitoring to manage efficacy and potential side effects.

• Brand Name: Lenvat 10

• Manufacture: Natco Pharma Ltd.

• Generic Name: Lenvatinib

• Strength: 10 mg

• Dosage Form: Capsule

• Therapeutic Class: Antineoplastic Agent, Tyrosine Kinase Inhibitor (TKI)

• Differentiated Thyroid Cancer (DTC): For locally recurrent or metastatic, progressive, radioactive iodine–refractory disease.

• Renal Cell Carcinoma (RCC): In combination with everolimus, for patients with advanced RCC after prior anti-angiogenic therapy.

• Hepatocellular Carcinoma (HCC): First-line treatment of unresectable HCC.

• Endometrial Carcinoma: In combination with pembrolizumab, for advanced endometrial carcinoma not amenable to curative surgery or radiation after prior systemic therapy.

Lenvatinib is a multi-targeted TKI that inhibits VEGFR1-3, FGFR1-4, RET, KIT, and PDGFRα.

• Suppresses angiogenesis and tumor vascularization.

• Blocks signaling pathways that drive tumor cell proliferation.

• Leads to inhibition of tumor growth and progression.

• Standard starting doses:

  • DTC: 24 mg once daily.

  • RCC: 18 mg once daily (with everolimus 5 mg).

  • HCC: 12 mg once daily (≥60 kg) or 8 mg once daily (<60 kg).

  • Endometrial carcinoma: 20 mg once daily (with pembrolizumab).

• Lenvat 10 is commonly used for dose adjustment or reduction in patients experiencing toxicities.

• Capsules should be swallowed whole, with or without food, taken at the same time each day.

• Treatment continues until disease progression or unacceptable toxicity.

• Supplied in blister packs.

• Pack size: 30 capsules (10 mg each).

• Store at 20°C–25°C (room temperature).

• Protect from light and moisture.

• Keep tightly closed in original container.

• Keep out of reach of children.

• Hypertension: Most common adverse effect; requires close BP monitoring and control.

• Cardiac Events: Risk of heart failure, QT prolongation, and arterial thromboembolic events.

• Hepatic Toxicity: Elevated liver enzymes, hepatic failure may occur; monitor LFTs frequently.

• Renal Effects: Risk of renal impairment or failure, often associated with dehydration/diarrhea.

• Proteinuria: Regular urine monitoring recommended.

• Bleeding Risks: Increased incidence of hemorrhagic events, including severe cases.

• GI Complications: Risk of gastrointestinal perforation and fistula.

• Pregnancy & Lactation: Contraindicated due to fetal toxicity; avoid breastfeeding.

• Drug Interactions: Caution with strong CYP3A4 and P-gp modulators.

• Dose Adjustments: Necessary in response to grade ≥3 toxicities (hypertension, fatigue, hepatotoxicity, diarrhea).

SAMENZA 40 MG is an oral androgen receptor inhibitor used in the treatment of prostate cancer. It blocks testosterone effects on cancer cells, slowing disease progression, reducing tumor growth, and helping manage symptoms in patients with advanced or metastatic prostate cancer.