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Generic Tasigna Information
Introduction
Tasigna (generic name nilotinib) is an oral tyrosine‑kinase inhibitor marketed for the treatment of chronic myeloid leukaemia (CML) in adult patients. Developed and commercialised by Novartis, the drug targets the BCR‑ABL fusion protein that drives malignant cell growth in CML. In the United Kingdom, Tasigna is authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in patients with Philadelphia‑chromosome‑positive (Ph‑positive) chronic phase CML who have shown resistance or intolerance to prior therapy with imatinib. The medication belongs to the broader cancer therapeutics group and is prescribed under specialist supervision.
What is Tasigna?
Tasigna is a small‑molecule inhibitor of the BCR‑ABL tyrosine kinase. It was approved by the European Medicines Agency (EMA) in 201 and subsequently by the MHRA. The drug contains the active compound nilotinib, a second‑generation inhibitor that was designed to bind more tightly to the ATP‑binding site of the BCR‑ABL protein than the first‑generation agent imatinib. Tasigna is supplied as film‑coated tablets in 200 mg and 400 mg strengths. The formulation also includes inactive ingredients such as lactose, magnesium stearate and microcrystalline cellulose, which are standard in solid oral dosage forms.
How Tasigna Works
Nilotinib blocks the enzymatic activity of BCR‑ABL by occupying its ATP‑binding pocket, preventing phosphorylation of downstream signalling proteins that promote cell proliferation and survival. By inhibiting this pathway, malignant leukemic progenitors are driven towards apoptosis and are unable to proliferate. The drug exhibits high selectivity for the BCR‑ABL kinase while sparing many unrelated kinases, which reduces off‑target toxicity compared with earlier agents. After oral ingestion, nilotinib reaches peak plasma concentrations within 2–4 hours under fasting conditions. It is extensively metabolised by CYP3A4 and eliminated primarily via the faeces (approximately 84 %). The median terminal half‑life is about 17 hours, allowing twice‑daily dosing.
Conditions Treated with Tasigna
- Chronic Myeloid Leukaemia (CML), chronic phase – The only MHRA‑approved indication. Tasigna is indicated for adult patients with Ph‑positive CML who have failed or are intolerant to prior imatinib therapy.
- CML, accelerated or blast phase (off‑label) – Some clinicians use nilotinib in later disease phases when other options are exhausted, but this remains an off‑label application without formal approval.
In the UK, CML accounts for roughly 1–2 % of all leukaemias, with an incidence of about 1–2 new cases per 100 000 adults each year. Early‑generation tyrosine‑kinase inhibitors have dramatically improved survival, yet a subset of patients develop resistance due to BCR‑ABL mutations. Tasigna provides an effective alternative, particularly against many imatinib‑resistant mutations such as Y253H and E255K.
Who is Tasigna For?
- Adults with documented Ph‑positive chronic‑phase CML who have either:
- Demonstrated intolerance to imatinib (e.g., persistent grade ≥ 3 adverse events), or
- Developed resistance confirmed by molecular testing (e.g., BCR‑ABL kinase domain mutations).
- Patients able to swallow tablets and adhere to a twice‑daily schedule, preferably on an empty stomach to optimise absorption.
- Individuals without severe hepatic impairment (Child‑Pugh class C) because nilotinib exposure rises markedly in this population.
Tasigna is not appropriate for:
- Children or adolescents under 18 years of age (no safety data).
- Patients with uncontrolled cardiovascular disease, as nilotinib has been associated with arterial occlusive events.
- Pregnant or breastfeeding women, due to potential fetal toxicity.
- Patients taking potent CYP3A4 inducers (e.g., rifampicin, carbamazepine) because drug levels may fall below therapeutic thresholds.
Risks, Side Effects, and Interactions
Common
- Elevated serum lipase/amylase – May indicate subclinical pancreatic irritation.
- Rash or pruritus – Typically mild, manageable with moisturisers or antihistamines.
- Nausea, diarrhoea, or constipation – Common gastrointestinal complaints, often transient.
- Muscle cramps or arthralgia – May improve with adequate hydration and electrolyte balance.
Rare
- Hyperbilirubinaemia – Occurs in a minority of patients; monitor liver function tests regularly.
- Hypocalcaemia – May develop secondary to renal phosphate loss; periodic calcium assessment is advised.
- Peripheral oedema – Usually mild and resolves with dose adjustment or diuretic therapy.
Serious
- Cardiovascular events – Includes peripheral arterial disease, coronary artery disease, and cerebrovascular accidents. Baseline cardiovascular risk assessment is mandatory.
- QT‑interval prolongation – Can precipitate torsades de pointes, especially when combined with other QT‑prolonging agents or in the presence of electrolyte disturbances.
- Severe hepatic impairment – Leads to markedly increased nilotinib exposure; may require dose reduction or discontinuation.
- Pancreatitis – Sudden onset abdominal pain with elevated amylase/lipase warrants immediate medical review.
Drug‑Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) increase nilotinib plasma concentrations; dose reduction may be needed.
- CYP3A4 inducers (e.g., rifampicin, St. John’s wort) lower concentrations, potentially reducing efficacy.
- Concomitant antacids, H₂ blockers, or proton‑pump inhibitors decrease nilotinib absorption; these should be taken at least 2 hours apart from the dose.
- Warfarin and other anticoagulants – Enhanced anticoagulant effect reported; monitor INR closely.
Patients should provide a full medication list, including over‑the‑counter products and herbal supplements, to the prescribing clinician.
Practical Use: Dosing, Missed Dose, Overdose
- Standard dosing – The typical adult regimen is 400 mg taken twice daily (total 800 mg/day) on an empty stomach, at least 2 hours before or after any food, especially high‑fat meals. Dose reductions to 300 mg twice daily may be required for hepatic impairment or drug‑interaction concerns.
- Missed dose – If a dose is forgotten and the next scheduled dose is more than 8 hours away, take the missed tablet as soon as remembered. If the next dose is due within 8 hours, skip the missed dose and resume the regular schedule; do not double‑dose.
- Overdose – Ingestion of more than the prescribed amount can lead to severe QT prolongation, hepatic dysfunction, or pancreatitis. Seek emergency medical attention immediately; supportive care is the mainstay of treatment.
Practical precautions – Avoid grapefruit and grapefruit juice, as they inhibit CYP3A4 and raise nilotinib levels. Limit alcohol intake, maintain adequate hydration, and have regular ECG monitoring (baseline and periodically thereafter). Patients with pre‑existing diabetes should monitor blood glucose, as nilotinib can cause hyperglycaemia.
Buying Tasigna from Our Online Pharmacy
Tasigna can be purchased from our online pharmacy in the UK with a focus on safety, affordability and discretion.
- Affordable pricing – We source the medication close to manufacturer cost, passing savings directly to you.
- Verified quality – All tablets are supplied by licensed overseas pharmacies that comply with Good Manufacturing Practice (GMP) standards and are inspected by independent quality‑control agencies.
- Guaranteed delivery – Options include express delivery (typically 7 days) and standard airmail (approximately 3 weeks). All shipments are discreetly packaged to protect your privacy.
- Online‑only access – Our pharmacy broker service collaborates with internationally accredited suppliers, enabling patients who face limited availability through conventional UK pharmacies to obtain the medication legally and safely.
We operate as a pharmacy‑broker service, meaning we facilitate the purchase while adhering to UK import regulations for personal use. This model respects patient confidentiality and provides a reliable route to obtain Tasigna when local options are constrained.
FAQ
-
Is Tasigna available in both brand‑name and generic forms in the UK?
Yes. Tasigna is the brand name produced by Novartis, while several licensed manufacturers sell generic nilotinib tablets that contain the identical active ingredient. Generic versions are typically cheaper and are approved by the MHRA. -
What should I do if I need to travel abroad with Tasigna?
Keep the medication in its original packaging, carry a copy of the prescription or a letter from your specialist, and store the tablets at room temperature away from heat. If you cross international borders, be prepared to declare the medication to customs if required. -
Does food affect the absorption of Tasigna?
High‑fat meals can reduce nilotinib bioavailability by up to 40 %. The drug should therefore be taken on an empty stomach, at least 2 hours before or after eating. -
How can I tell if a tablet is authentic?
Authentic Tasigna tablets are film‑coated, round, and imprinted with “200 mg” or “400 mg” along with the “Novartis” logo. The tablet colour is pink for 200 mg and yellow for 400 mg. Counterfeit products often lack consistent imprinting and may differ in colour or texture. -
Can Tasigna be stored in a refrigerator?
No. The medication is stable at controlled room temperature (15‑30 °C). Refrigeration is unnecessary and may cause moisture condensation, potentially degrading the tablet. -
What are the specific cardiovascular warnings for nilotinib?
Patients with a history of peripheral arterial disease, coronary artery disease, or cerebrovascular disease should undergo a baseline cardiovascular assessment. Regular monitoring of blood pressure, lipid profile and peripheral pulses is advised during treatment. -
Is there any special consideration for patients with kidney disease?
While nilotinib is primarily eliminated in the feces, severe renal impairment (creatinine clearance <30 mL/min) may modestly increase exposure. Dose adjustment is generally not required, but renal function should be monitored periodically. -
How does nilotinib compare with earlier CML drugs such as imatinib?
Nilotinib has a higher affinity for the BCR‑ABL kinase and retains activity against many mutations that confer resistance to imatinib. Clinical trials have shown faster and deeper molecular responses with nilotinib in imatinib‑resistant patients. -
Are there any known drug‑testing implications of taking Tasigna?
Nilotinib is not typically screened for in standard occupational drug tests. However, its impact on liver enzymes can affect the metabolism of other substances that might be monitored, so disclose all medications to relevant testing authorities. -
What packaging does Tasigna arrive in when ordered online?
The medication is supplied in sealed, child‑resistant blister packs within a tamper‑evident cardboard box. Each pack contains a full month’s supply based on the prescribed dosage, together with an information leaflet. -
Can Tasigna be imported for personal use under UK law?
Yes, individuals may import a 3‑month supply of a prescription‑only medicine for personal use, provided they have a valid prescription from a UK‑registered prescriber. Our online pharmacy assists you in complying with these regulations. -
Does nilotinib have any known interactions with dietary supplements?
St. John’s wort, a common herbal supplement, induces CYP3A4 and can reduce nilotinib concentrations, potentially compromising efficacy. Patients should discuss all supplements with their healthcare provider.
Glossary
- Tyrosine‑kinase inhibitor (TKI)
- A class of drugs that block the activity of enzymes called tyrosine kinases, which are involved in signalling pathways that promote cancer cell growth.
- Ph‑positive
- Refers to the presence of the Philadelphia chromosome—a specific genetic abnormality that creates the BCR‑ABL fusion gene driving CML.
- QT interval
- A measurement on an electrocardiogram (ECG) representing the time for ventricular depolarisation and repolarisation. Prolongation can increase the risk of life‑threatening arrhythmias.
- CYP3A4
- An enzyme in the liver and intestine that metabolises many drugs. Inhibitors raise drug levels; inducers lower them.
⚠️ Disclaimer
The information provided about Tasigna is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Tasigna for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.