Nilotinib Accord
BCR-ABL Tyrosine Kinase Inhibitor for Chronic Myeloid Leukemia
Quick Facts About Nilotinib Accord
Key Takeaways About Nilotinib Accord
- CML treatment: Nilotinib Accord is a second-generation BCR-ABL tyrosine kinase inhibitor used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in both newly diagnosed and resistant/intolerant patients
- Must be taken on an empty stomach: Food dramatically increases absorption and may worsen QTc prolongation. No food for at least 2 hours before and 1 hour after each dose
- Cardiac monitoring essential: Nilotinib can prolong the QTc interval, potentially causing life-threatening arrhythmias. ECGs and electrolyte levels must be checked before and during treatment
- Avoid strong CYP3A4 interactions: Strong CYP3A4 inhibitors (ketoconazole, clarithromycin) and inducers (rifampicin, phenytoin) must be avoided as they significantly alter nilotinib blood levels
- Treatment-free remission possible: Select patients who achieve a sustained deep molecular response may be eligible to discontinue treatment under careful specialist monitoring
What Is Nilotinib Accord and What Is It Used For?
Nilotinib Accord contains nilotinib, a potent second-generation BCR-ABL tyrosine kinase inhibitor (TKI). It selectively blocks the abnormal BCR-ABL fusion protein produced by the Philadelphia chromosome, which is the defining genetic abnormality in chronic myeloid leukemia (CML). By inhibiting this oncoprotein, nilotinib halts the uncontrolled proliferation of leukemic cells and can induce deep molecular remission.
Nilotinib Accord is a prescription-only medication used to treat chronic myeloid leukemia (CML), a cancer of the white blood cells. CML accounts for approximately 15% of all adult leukemias, with an estimated global incidence of 1–2 cases per 100,000 people annually according to the World Health Organization. CML is characterized by the presence of the Philadelphia chromosome (Ph+), a genetic abnormality resulting from a reciprocal translocation between chromosomes 9 and 22, denoted as t(9;22)(q34;q11). This translocation creates the BCR-ABL1 fusion gene, which encodes a constitutively active tyrosine kinase that drives leukemic cell proliferation, resistance to apoptosis, and genetic instability.
The development of tyrosine kinase inhibitors (TKIs) has transformed CML from a rapidly fatal disease into a manageable chronic condition for most patients. Imatinib, the first-generation TKI, revolutionized CML treatment when it was introduced in 2001. However, approximately 20–30% of patients treated with imatinib experience suboptimal responses or develop resistance, often due to point mutations in the BCR-ABL kinase domain that reduce imatinib binding. This clinical need led to the development of second-generation TKIs, including nilotinib.
Nilotinib was rationally designed to overcome imatinib resistance by binding to the ABL kinase domain with approximately 20–50-fold greater potency than imatinib. Structural modifications allow nilotinib to fit more tightly into the ATP-binding pocket of the BCR-ABL protein, and it retains activity against most imatinib-resistant BCR-ABL mutations, with the notable exception of the T315I mutation. In addition to BCR-ABL, nilotinib also inhibits the kinase activity of platelet-derived growth factor receptor (PDGFR) and c-KIT, although its primary therapeutic target in CML remains BCR-ABL.
The landmark ENESTnd (Evaluating Nilotinib Efficacy and Safety in clinical Trials of Newly Diagnosed Ph+ CML) trial demonstrated that nilotinib achieved significantly higher rates of major molecular response (MMR) and complete cytogenetic response (CCyR) at 12 months compared to imatinib in newly diagnosed chronic-phase CML patients. Long-term follow-up data confirmed that nilotinib-treated patients had lower rates of disease progression to accelerated or blast phase, supporting its use as first-line therapy.
Approved Indications
Nilotinib Accord is approved for the following clinical indications in adult patients:
- Newly diagnosed chronic-phase Ph+ CML: As first-line treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. In this setting, nilotinib offers faster and deeper molecular responses compared to imatinib.
- Chronic-phase and accelerated-phase Ph+ CML with prior therapy: For adult patients with chronic-phase or accelerated-phase CML who are resistant to or intolerant of at least one prior therapy including imatinib. Resistance may be due to BCR-ABL kinase domain mutations, clonal evolution, or other mechanisms. Intolerance includes patients who cannot continue imatinib due to adverse effects.
Nilotinib binds to the inactive (DFG-out) conformation of the ABL kinase domain within the BCR-ABL fusion protein. By occupying the ATP-binding site with high affinity and selectivity, nilotinib prevents the phosphorylation of downstream signaling substrates including STAT5, CrkL, and the RAS/MAPK pathway. This blockade halts the proliferative signaling cascade driven by the constitutively active BCR-ABL kinase, leading to inhibition of cell growth and induction of apoptosis (programmed cell death) in BCR-ABL-expressing leukemic cells. Nilotinib is approximately 20–50 times more potent than imatinib in vitro and is active against 32 of the 33 most clinically relevant imatinib-resistant BCR-ABL mutations, with the exception of T315I (the “gatekeeper” mutation).
Phases of Chronic Myeloid Leukemia
Understanding the phases of CML is important for understanding how nilotinib is used. CML typically progresses through three phases, and the treatment approach differs for each:
- Chronic phase (CP): The initial and most common phase at diagnosis. White blood cell counts are elevated but the disease is relatively stable. Most patients are diagnosed in chronic phase, and this is where TKI therapy is most effective. The goal of treatment is to achieve deep molecular remission.
- Accelerated phase (AP): The disease begins to progress with increasing blast counts (10–19% blasts in blood or bone marrow), worsening blood counts, or emergence of additional genetic abnormalities. Nilotinib is approved for use in accelerated-phase CML in patients resistant to or intolerant of prior therapy.
- Blast crisis (BC): The most advanced phase, resembling acute leukemia with ≥20% blast cells. Nilotinib is not specifically indicated for blast crisis, and outcomes in this phase are significantly poorer regardless of treatment.
What Should You Know Before Taking Nilotinib Accord?
Before starting nilotinib, your doctor will perform a baseline ECG, check electrolyte levels (potassium, magnesium, calcium), assess liver function, and evaluate your cardiovascular risk factors. Nilotinib is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Women of childbearing potential must use effective contraception.
Nilotinib is a potent medication with specific cardiovascular risks that require careful pre-treatment assessment and ongoing monitoring. Understanding these risks and contraindications is essential for safe treatment. Your hematologist will conduct a thorough evaluation before prescribing this medication.
Contraindications
You must not take Nilotinib Accord if any of the following apply:
- Hypersensitivity: If you have a known allergy to nilotinib or any of the excipients in the formulation, including lactose monohydrate.
- Uncorrected hypokalemia or hypomagnesemia: Low potassium or magnesium levels increase the risk of life-threatening QTc prolongation and cardiac arrhythmias. These electrolyte imbalances must be corrected before starting nilotinib.
- Long QT syndrome: Patients with congenital long QT syndrome or a significant history of QTc prolongation must not receive nilotinib due to the additive risk of fatal cardiac arrhythmias.
Warnings and Precautions
The following conditions require careful evaluation and may necessitate dose adjustments, additional monitoring, or alternative treatment. Discuss all of these with your hematologist before starting Nilotinib Accord:
- Palpitations, irregular heartbeat, dizziness, or fainting — may indicate dangerous heart rhythm disturbances (QTc prolongation)
- Severe chest pain, sudden numbness or weakness on one side of the body, or sudden difficulty speaking — may indicate a cardiovascular event
- Yellowing of the skin or eyes, dark urine, or severe abdominal pain — signs of liver damage
- Unexplained bleeding, easy bruising, or signs of infection (fever, chills) — may indicate bone marrow suppression
- Severe abdominal pain radiating to the back — may indicate pancreatitis
- QTc prolongation and cardiac risk: Nilotinib causes dose-dependent QTc prolongation. This can lead to ventricular tachycardia, Torsade de Pointes, and sudden cardiac death. ECGs should be performed at baseline, 7 days after initiation, periodically during treatment, and after any dose adjustment. Electrolytes must be monitored and corrected as needed. Avoid concurrent use of other QTc-prolonging drugs, and avoid drugs that inhibit CYP3A4, as elevated nilotinib levels worsen this risk.
- Cardiovascular arterial events: Nilotinib has been associated with an increased risk of peripheral arterial occlusive disease (PAOD), ischemic heart disease, and ischemic cerebrovascular events. Cardiovascular risk factors including hypertension, hyperlipidemia, diabetes, smoking history, and obesity should be assessed before and regularly during treatment. Patients should be counseled on cardiovascular risk factor management.
- Hepatotoxicity: Nilotinib can cause elevated bilirubin and liver enzymes (ALT, AST, alkaline phosphatase). Liver function should be monitored monthly or as clinically indicated. Dose adjustments may be necessary for significant elevations.
- Myelosuppression: Treatment with nilotinib commonly causes neutropenia, thrombocytopenia, and anemia. Complete blood counts should be performed every 2 weeks for the first 2 months, then monthly thereafter, or as clinically indicated. Dose interruptions or reductions may be required for significant cytopenias.
- Pancreatitis: Elevated lipase and amylase levels are common with nilotinib, and cases of clinical pancreatitis have been reported. Serum lipase should be monitored periodically. If pancreatitis is suspected, treatment should be withheld.
- Fluid retention: Events including pleural effusion, pericardial effusion, and peripheral edema may occur. Monitor for signs of fluid retention and manage promptly.
- Tumor lysis syndrome: Patients with high tumor burden at baseline are at risk of tumor lysis syndrome (TLS). Ensure adequate hydration and monitor electrolytes, renal function, and uric acid levels, particularly during the first weeks of treatment.
- Lactose intolerance: Nilotinib Accord capsules contain lactose monohydrate. Patients with rare hereditary galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Monitoring Schedule
Your hematologist will order regular tests throughout treatment to ensure safety and assess treatment response:
- ECG: at baseline, 7 days after starting, then periodically (at least every 3 months in the first year)
- Electrolytes (potassium, magnesium, calcium): at baseline, periodically during treatment
- Complete blood count: every 2 weeks for the first 2 months, then monthly
- Liver function tests (ALT, AST, bilirubin): monthly or as clinically indicated
- Lipase: periodically
- Fasting glucose and lipid profile: periodically (cardiovascular risk assessment)
- BCR-ABL1 transcript levels (qPCR): every 3 months to assess molecular response
Pregnancy and Breastfeeding
Nilotinib Accord can cause fetal harm based on its mechanism of action and findings in animal reproductive studies. The following precautions are essential:
- Pregnancy: Nilotinib is contraindicated during pregnancy. Women of childbearing potential must use highly effective contraception during treatment and for at least 2 weeks after the last dose. A pregnancy test should be performed before starting treatment.
- Breastfeeding: It is not known whether nilotinib is excreted in human breast milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding must be discontinued during treatment and for at least 2 weeks after the last dose.
- Fertility: There are limited data on the effects of nilotinib on human fertility. Male and female patients who wish to preserve fertility should discuss options with their hematologist before starting treatment.
Driving and Operating Machinery
Nilotinib may cause dizziness, fatigue, or visual disturbances. If you experience any of these effects, avoid driving or operating heavy machinery until the symptoms resolve. Patients should be advised of this potential risk at the start of treatment.
How Does Nilotinib Accord Interact with Other Drugs?
Nilotinib is extensively metabolized by CYP3A4 and also inhibits CYP3A4, CYP2C8, CYP2C9, CYP2D6, and P-glycoprotein. This creates significant drug interaction potential. Strong CYP3A4 inhibitors increase nilotinib levels (increasing toxicity risk), while strong CYP3A4 inducers decrease nilotinib levels (reducing efficacy). Additionally, QTc-prolonging drugs must be avoided due to additive cardiac risk.
Drug interactions with nilotinib are clinically significant and can have serious consequences. Nilotinib is both a substrate and an inhibitor of multiple cytochrome P450 enzymes and drug transporters, creating a complex web of potential interactions. It is essential that your hematologist and pharmacist are aware of all medications you are taking, including over-the-counter drugs, dietary supplements, and herbal remedies.
The most critical interaction concern is the potential for QTc prolongation, which can be amplified by drug interactions that increase nilotinib plasma levels or that independently prolong the QTc interval. For this reason, concurrent use of strong CYP3A4 inhibitors and QTc-prolonging drugs should be avoided whenever possible.
Major Interactions
The following interactions are considered clinically significant and may require alternative medications, dose adjustments, or enhanced monitoring:
| Drug / Class | Interaction Mechanism | Clinical Action |
|---|---|---|
| Ketoconazole, Itraconazole, Voriconazole | Strong CYP3A4 inhibitors; increase nilotinib plasma levels up to 3-fold | Avoid concurrent use. If unavoidable, consider nilotinib dose reduction and intensive ECG/QTc monitoring |
| Clarithromycin, Telithromycin | Strong CYP3A4 inhibitors; significantly increase nilotinib exposure | Avoid. Use alternative antibiotics (e.g., azithromycin which has minimal CYP3A4 inhibition) |
| Rifampicin, Rifabutin | Strong CYP3A4 inducers; decrease nilotinib levels by up to 80% | Avoid concurrent use — significant loss of efficacy. No safe dose adjustment established |
| Phenytoin, Carbamazepine, Phenobarbital | Strong CYP3A4 inducers; substantially reduce nilotinib plasma levels | Avoid. Consider alternative anti-epileptic drugs (e.g., levetiracetam, valproate) |
| St. John’s Wort (Hypericum perforatum) | CYP3A4 inducer; unpredictably reduces nilotinib levels | Contraindicated. Must not be used during nilotinib treatment |
| QTc-prolonging drugs (amiodarone, sotalol, haloperidol, methadone) | Additive QTc prolongation; increased risk of Torsade de Pointes | Avoid concurrent use. If essential, intensive ECG monitoring and electrolyte correction required |
| Warfarin | Nilotinib inhibits CYP2C9; may increase warfarin exposure and bleeding risk | Monitor INR closely. Consider LMWH as alternative anticoagulation |
Minor Interactions and Precautions
The following interactions are of moderate clinical significance and require awareness and potential monitoring:
- Midazolam and other CYP3A4 substrates: Nilotinib inhibits CYP3A4, which can increase plasma levels of midazolam, simvastatin, ciclosporin, and other CYP3A4-metabolized drugs. Monitor for increased effects and consider dose adjustments.
- Proton pump inhibitors (PPIs) and H2 blockers: Nilotinib solubility is pH-dependent. Drugs that raise gastric pH (omeprazole, ranitidine) can reduce nilotinib absorption. If acid-reducing therapy is needed, H2 blockers should be taken at least 10 hours before and 2 hours after nilotinib. PPIs should be avoided if possible.
- Grapefruit and grapefruit juice: Contains CYP3A4 inhibitors; may increase nilotinib levels. Avoid consumption during treatment.
- P-glycoprotein substrates: Nilotinib is a P-gp inhibitor. Drugs that are P-gp substrates (digoxin, dabigatran) may have increased plasma levels. Monitor and adjust doses accordingly.
- Metformin: Nilotinib inhibits organic cation transporter OCT1, which may affect metformin absorption. Monitor blood glucose in diabetic patients.
Nilotinib must be taken on an empty stomach. Food significantly increases its bioavailability: a high-fat meal increases AUC by approximately 82% and Cmax by approximately 112%. This increased exposure raises the risk of adverse effects, particularly QTc prolongation. No food should be consumed for at least 2 hours before and at least 1 hour after taking each dose. The capsules should be swallowed whole with water.
What Is the Correct Dosage of Nilotinib Accord?
The recommended dosage depends on the clinical indication. For newly diagnosed chronic-phase CML, the standard dose is 300 mg twice daily. For resistant or intolerant chronic-phase or accelerated-phase CML, the dose is 400 mg twice daily. Doses must be taken approximately 12 hours apart on an empty stomach. Dose adjustments are required for hepatic impairment and certain drug interactions.
Nilotinib Accord dosing requires strict adherence to both the prescribed dose and the fasting requirements. The capsules must be swallowed whole with water; they must not be opened, crushed, or chewed. Patients who cannot swallow capsules may dissolve the contents of each capsule in one teaspoon of apple sauce and take it immediately — this is the only approved alternative method of administration.
Adults
Newly Diagnosed Chronic-Phase CML (First-Line)
300 mg twice daily (total daily dose: 600 mg), taken approximately 12 hours apart. No food for 2 hours before and 1 hour after each dose. Treatment should be continued as long as the patient derives clinical benefit or until unacceptable toxicity.
Resistant or Intolerant Chronic-Phase or Accelerated-Phase CML
400 mg twice daily (total daily dose: 800 mg), taken approximately 12 hours apart. No food for 2 hours before and 1 hour after each dose. Treatment should be continued as long as the patient derives clinical benefit or until unacceptable toxicity.
Dose Adjustments
Dose modifications may be required based on the following clinical scenarios:
| Scenario | Action | Notes |
|---|---|---|
| QTc > 480 ms | Withhold nilotinib. Correct electrolytes. Resume at prior dose when QTcF < 450 ms | If QTc returns to >480 ms, reduce dose by 200 mg/day. Discontinue if QTc >480 ms persists after reduction |
| Neutropenia (ANC <1.0 × 109/L) | Withhold until ANC ≥1.0. Resume at prior dose if recovery within 2 weeks | If recurrent, resume at reduced dose (400 mg once daily for newly diagnosed; 400 mg twice daily reduced to 400 mg once daily for resistant) |
| Thrombocytopenia (platelets <50 × 109/L) | Withhold until platelets ≥50. Resume at prior dose if recovery within 2 weeks | If recurrent, reduce dose as above |
| Hepatic impairment (mild to moderate) | No specific dose adjustment required at initiation, but close monitoring of liver function is essential | Severe hepatic impairment: limited data. Use with caution and reduce initial dose |
| Elevated bilirubin or liver enzymes (>3× ULN) | Withhold until ≤1.5× ULN, then resume at reduced dose | Monitor liver function weekly until stabilized |
| Elevated lipase/amylase (>2× ULN) | Withhold until ≤1.5× ULN. Reduce dose upon resumption | Evaluate for clinical pancreatitis |
Children
The safety and efficacy of Nilotinib Accord 50 mg capsules in children and adolescents below 18 years of age have not been established in the context of this specific formulation. Nilotinib (as Tasigna) has been studied in pediatric patients aged 2 years and older with Ph+ CML and may be used in some jurisdictions under specialist supervision. Dosing in pediatric patients is calculated based on body surface area (BSA). Any use in pediatric patients should only occur under the guidance of a pediatric hematologist-oncologist with experience in CML management.
Elderly
No specific dose adjustment is required for elderly patients solely based on age. However, elderly patients are more likely to have comorbidities including cardiovascular disease, renal impairment, and polypharmacy that may affect nilotinib metabolism, increase drug interaction risk, and amplify the risk of QTc prolongation. Close monitoring and careful attention to drug interactions are particularly important in this population.
Missed Dose
If you miss a dose of nilotinib, do not take a double dose to make up for it. Simply skip the missed dose and take the next dose at the regularly scheduled time. Taking two doses close together increases the risk of side effects, particularly QTc prolongation. If you frequently forget doses, discuss strategies with your healthcare team, as consistent dosing is important for maintaining adequate drug levels and treatment efficacy.
Overdose
In the event of suspected overdose, seek immediate medical attention. There is no specific antidote for nilotinib. Treatment is supportive and symptomatic, with particular attention to cardiac monitoring (ECG for QTc prolongation and arrhythmias), electrolyte monitoring, and liver function. Given nilotinib’s high protein binding (>98%), hemodialysis is unlikely to be effective. Cases of overdose have been reported at doses up to 3,600 mg, with events including neutropenia, vomiting, and drowsiness.
What Are the Side Effects of Nilotinib Accord?
Like all medicines, nilotinib can cause side effects, although not everybody gets them. The most common side effects include rash, itching, headache, nausea, fatigue, and abnormal laboratory values including elevated bilirubin, elevated liver enzymes, and low blood cell counts. The most clinically important risks include QTc prolongation, cardiovascular arterial events, pancreatitis, and severe myelosuppression.
Side effects of nilotinib are generally manageable with dose adjustments and supportive care. However, some side effects, particularly cardiovascular events and QTc prolongation, require careful monitoring and may necessitate treatment modification or discontinuation. It is important to report any new or worsening symptoms to your hematologist promptly.
The side effect profile of nilotinib differs in some important ways from first-generation TKI imatinib. While nilotinib generally causes less fluid retention, nausea, and muscle cramps compared to imatinib, it carries specific risks of QTc prolongation, cardiovascular arterial events, metabolic disturbances (hyperglycemia, hypercholesterolemia), and pancreatitis that require vigilant monitoring.
Very Common Side Effects
- Skin rash (various types including maculopapular, erythematous)
- Itching (pruritus)
- Headache
- Nausea
- Fatigue and asthenia
- Alopecia (hair thinning)
- Muscle pain (myalgia)
- Constipation
- Elevated bilirubin (hyperbilirubinemia)
- Low neutrophil count (neutropenia)
- Low platelet count (thrombocytopenia)
- Elevated lipase
- Upper respiratory tract infection
Common Side Effects
- Anemia (low red blood cell count)
- Diarrhea, vomiting, abdominal pain
- Dizziness
- Bone pain, joint pain (arthralgia)
- Muscle spasms
- Peripheral edema (swelling of legs/feet)
- QTc prolongation on ECG
- Elevated liver enzymes (ALT, AST)
- Elevated blood glucose (hyperglycemia)
- Elevated cholesterol (hypercholesterolemia)
- Weight gain or loss
- Insomnia
- Night sweats
- Eye disorders (periorbital edema, conjunctival hemorrhage)
- Dry skin, eczema
- Decreased appetite
Uncommon Side Effects
- Pancreatitis (inflammation of the pancreas)
- Peripheral arterial occlusive disease (PAOD)
- Ischemic heart disease (angina, myocardial infarction)
- Ischemic cerebrovascular events (stroke, TIA)
- Pleural effusion (fluid around the lungs)
- Pericardial effusion (fluid around the heart)
- Hepatotoxicity (severe liver damage)
- Tumor lysis syndrome
- Hemorrhage (gastrointestinal, central nervous system)
Rare Side Effects
- Sudden cardiac death (related to QTc prolongation)
- Torsade de Pointes (dangerous ventricular arrhythmia)
- Stevens-Johnson syndrome / toxic epidermal necrolysis (severe skin reactions)
- Hyperparathyroidism
Frequency Not Known
- Hepatitis B reactivation in carriers
- Osteonecrosis of the jaw (rare, mainly in patients with concomitant bisphosphonate use)
- Hyperammonemia
Cardiovascular Risk Management
Cardiovascular arterial events represent one of the most important long-term safety concerns with nilotinib. The ENESTnd trial and its long-term extensions revealed a higher incidence of cardiovascular events in nilotinib-treated patients compared to imatinib-treated patients. The risk increases with treatment duration and the presence of pre-existing cardiovascular risk factors. To minimize this risk:
- Cardiovascular risk factors should be assessed before starting treatment and managed aggressively throughout therapy
- Blood pressure, fasting glucose, and lipid profiles should be monitored regularly
- Patients should be advised to stop smoking, maintain a healthy weight, exercise regularly, and follow a heart-healthy diet
- Ankle-brachial index (ABI) measurement may be considered at baseline and periodically to screen for peripheral arterial disease
- Report any symptoms suggestive of vascular events (intermittent claudication, rest pain, ischemic symptoms) immediately
If you experience any side effects, including those not listed above, report them to your hematologist or healthcare provider. You can also report side effects directly to your national pharmacovigilance authority (e.g., the FDA MedWatch program in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA in the European Union). Reporting side effects contributes to the ongoing safety monitoring of this medication.
How Should You Store Nilotinib Accord?
Store Nilotinib Accord in its original packaging at room temperature below 30°C, protected from moisture. Keep out of reach and sight of children. Do not use after the expiration date.
Proper storage of Nilotinib Accord ensures the medication maintains its quality and effectiveness. The hard capsule formulation is relatively stable under normal conditions, but certain precautions should be observed:
- Temperature: Do not store above 30°C (86°F). Store at room temperature.
- Moisture protection: Store in the original package in order to protect from moisture.
- Children: Keep out of the sight and reach of children. Accidental ingestion by children or non-patients requires immediate emergency medical attention, as nilotinib is a cytotoxic drug.
- Expiration: Do not use after the expiry date which is stated on the carton and blister after “EXP.” The expiry date refers to the last day of that month.
- Disposal: Do not throw away any medicines via wastewater or household waste. As a cytotoxic medication, return unused capsules to a pharmacy for safe disposal according to local regulations. This protects the environment and prevents accidental exposure.
- Handling: Pregnant women should not handle nilotinib capsules. If a capsule is accidentally opened, contact with the contents should be avoided. In case of skin contact, wash thoroughly with soap and water. In case of eye contact, rinse with water.
What Does Nilotinib Accord Contain?
Each Nilotinib Accord hard capsule contains 50 mg of nilotinib (as nilotinib hydrochloride monohydrate). The capsules also contain inactive ingredients including lactose monohydrate.
Understanding the composition of your medication helps identify potential allergens or intolerances. The complete composition is listed below.
Active Ingredient
The active substance is nilotinib. Each hard capsule contains 50 mg of nilotinib (as nilotinib hydrochloride monohydrate). Nilotinib hydrochloride monohydrate is a white to slightly yellowish powder that is practically insoluble in water. Its solubility is pH-dependent, with greater solubility at lower pH values.
Excipients (Inactive Ingredients)
The other ingredients in Nilotinib Accord 50 mg hard capsules include:
- Capsule content: Lactose monohydrate, crospovidone (type A), poloxamer 188, colloidal anhydrous silica, magnesium stearate
- Capsule shell: Gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
- Printing ink: Shellac (E904), iron oxide black (E172), propylene glycol (E1520), ammonium hydroxide (E527)
Important Note About Excipients
Nilotinib Accord capsules contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Marketing Authorization Holder
Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a Planta, Barcelona, 08039, Spain.
Frequently Asked Questions About Nilotinib Accord
Medical References
All medical information in this article is based on peer-reviewed research, international clinical guidelines, and official drug regulatory documentation. Evidence level: 1A (systematic reviews and meta-analyses of randomized controlled trials).
- European Medicines Agency (EMA). "Nilotinib — Summary of Product Characteristics (SmPC)." EMA Official European regulatory documentation for nilotinib.
- U.S. Food and Drug Administration (FDA). "TASIGNA (nilotinib) — Prescribing Information." FDA FDA-approved labeling and safety information for nilotinib.
- Saglio G, et al. (2010). "Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia." New England Journal of Medicine. 362(24):2251–2259. doi:10.1056/NEJMoa0912614 Landmark ENESTnd trial comparing nilotinib with imatinib in newly diagnosed CML.
- Hochhaus A, et al. (2016). "Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial." Leukemia. 30(5):1044–1054. doi:10.1038/leu.2016.5 5-year follow-up of the ENESTnd trial demonstrating long-term outcomes and cardiovascular safety data.
- Hochhaus A, et al. (2020). "European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia." Leukemia. 34(4):966–984. doi:10.1038/s41375-020-0776-2 ELN recommendations for CML management including TKI selection, response milestones, and treatment-free remission criteria.
- Hochhaus A, et al. (2019). "Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study." Leukemia. 33(7):1598–1609. doi:10.1038/s41375-019-0424-y ENESTfreedom trial demonstrating feasibility of treatment-free remission after nilotinib.
- World Health Organization (WHO) (2023). "Model List of Essential Medicines — 23rd list." WHO Essential Medicines WHO essential medicines list including tyrosine kinase inhibitors for CML treatment.
- NCCN Clinical Practice Guidelines in Oncology. "Chronic Myeloid Leukemia (Version 2.2024)." NCCN National Comprehensive Cancer Network guidelines for CML management.
Evidence framework: All medical claims in this article are graded according to the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation). Primary data sources include systematic reviews, randomized controlled trials, and official regulatory documents from EMA and FDA.
About This Article
This article was written and medically reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians in hematology, oncology, and clinical pharmacology. Our editorial process follows international standards for medical content, including the GRADE evidence framework and guidelines from the European LeukemiaNet (ELN), European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and World Health Organization (WHO).
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